Prospective Grant of an Exclusive Patent License: Development and Commercialization of CRISPR-Engineered T Cell Therapies for the Treatment of Cancer, 59169-59174 [2021-23289]

Download as PDF Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices no later than 11:59 p.m. EDT on November 19, 2021. ADDRESSES: All comments should be emailed to CAPT Samuel Wu at Samuel.Wu@hhs.gov. Please use the subject line ‘‘OMH RFI: CIIHE NHPI’’. Submitted comments received after the deadline will not be reviewed. Please respond concisely and in plain language. You may use any structure or layout that presents your information well. You may respond to some or all of our four questions below, and you can suggest other factors or relevant questions. You may also include links to online materials or interactive presentations. Proprietary information should be marked clearly and placed it in a separate section or file. Your response will become government property, and we may publish some of its non-proprietary content. FOR FURTHER INFORMATION CONTACT: CAPT Samuel Wu atSamuel.Wu@ hhs.gov. SUPPLEMENTARY INFORMATION: Authorized under Section 1707 of the Public Health Service Act, 42 U.S.C. 300u–6, as amended, the mission of OMH is to improve the health of racial and ethnic minority populations through the development of health policies and programs that help eliminate health disparities. OMH awards and other activities are intended to support the identification of effective policies, programs, and practices for improving health outcomes and to promote the sustainability and dissemination of these approaches. Under the authority of Public Law 116–260 (2021 Consolidated Appropriations Act), Congress directed OMH to create a Center to support education, service and policy development, and research advancing indigenous solutions that ultimately address health disparities among NHPI and AI/AN populations. I. Background Information NHPI communities experience persistent health disparities, including higher rates of diabetes, high blood pressure, and obesity, compared to nonHispanic white populations. Identification and awareness of health outcomes and health determinants are essential steps toward reducing health disparities in minority communities at greatest risk. Research has shown that culturally adapted and culturally grounded health and public health approaches and interventions that are aligned with indigenous communities’ cultural values and perspectives are effective in improving clinical outcomes within NHPI and AI/AN communities. VerDate Sep<11>2014 22:39 Oct 25, 2021 Jkt 256001 Program Information In September 2021, OMH announced awards to establish a Center for Indigenous Innovation and Health Equity, for which OMH will provide the organizational structure and operational framework. The Center will support efforts including education, service and policy development, and research related to advancing sustainable solutions to address health disparities and advance health equity in the AI/AN and NHPI populations. Two award recipients will function as a single initiative, coordinated by OMH. Each award recipient will focus on one of the two focus populations: AI/AN or NHPI populations. OMH expects the award recipients to implement the Center by: (1) Managing the Center advisory board; (2) partnering with academic institutions, indigenous leaders, and NHPI and AI/AN communities on Center activities; (3) identifying and disseminating culturally appropriate evidence-based and/or evidence-informed interventions, and lessons learned; and (4) designing and providing education and training to support community capacity-building. The Center’s activities are expected to result in: (1) Increased community capacity and knowledge of culturally appropriate, evidence-based and/or evidenceinformed interventions, and policies that address health disparities among NHPI and AI/AN populations; (2) increased utilization of effective strategies to reduce NHPI and AI/AN health disparities; and (3) improved NHPI and AI/AN health and reduction of health disparities. III. Questions • Are there priority health disparity issue(s) affecting NHPI communities that the Center should address? • How can the Center engage community partners to increase knowledge and adoption of culturally appropriate, evidence-based, and/or evidence-informed interventions, and policies that reduce health disparities among NHPI populations? • What should the Center consider when disseminating public health messages or promising practices Fmt 4703 Sfmt 4703 Dated: October 18, 2021. Samuel Wu, CAPT, Public Health Advisor. [FR Doc. 2021–23200 Filed 10–25–21; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Neurological Disorders and Stroke Special Emphasis Panel, November 1, 2021, 09:00 a.m. to November 2, 2021, 06:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on October 13, 2021, FR Doc 2021– 22196, 86 FR 56965. This notice is being amended to change the dates of this meeting from November 1–2, 2021 to November 15– 16, 2021. The meeting time remains the same. The meeting is closed to the public. Dated: October 21, 2021. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P Through this RFI and notice of a listening session, OMH is seeking information from NHPI communities, NHPI-serving organizations, and interested parties on the questions below. Frm 00058 designed to reduce health disparities to diverse NHPI communities? • What should the Center consider when addressing barriers to implementing culturally appropriate interventions and policies to advance indigenous health innovation and health equity? [FR Doc. 2021–23318 Filed 10–25–21; 8:45 am] II. Request for Information PO 00000 59169 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Development and Commercialization of CRISPREngineered T Cell Therapies for the Treatment of Cancer AGENCY: National Institutes of Health, HHS. ACTION: Notice. The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to SUMMARY: E:\FR\FM\26OCN1.SGM 26OCN1 59170 Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Neogene Therapeutics, Inc. (‘‘Neogene’’), headquartered in Santa Monica, CA. DATES: Only written comments and/or applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before November 10, 2021 will be considered. ADDRESSES: Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, Telephone: (240)–276–5484; Email: andy.burke@nih.gov. SUPPLEMENTARY INFORMATION: Intellectual Property Group A 1. United States Provisional Patent Application No. 62/084,654, filed November 26, 2014 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–0–US–01]; 2. PCT Application No. PCT/US2015/ 062269, filed November 24, 2015 entitled ‘‘Anti-Mutated KRAS T Cell Receptors’’ [HHS Reference No. E–028– 2015–1–PCT–01]; 3. Australian Patent No. 2015353720, issued June 11, 2020 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–AU–02]; 4. Canadian Patent Application No. 2,968,399, effective filing date of November 24, 2015 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–CA–03]; 5. Chinese Patent Application No. 201580070673.7, effective filing date of November 24, 2015 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–CN–04]; 6. European Patent No. 3223850, issued January 8, 2020, entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–EP–05]; a. Validated in the following jurisdictions: AT, BE, CH, CZ, DE, ES, FR, GB, GR, IE, IT, NL, NO, PL, PT, SE, SI, SK, TR. 7. Israeli Patent Application No. 252258, effective filing date of November 24, 2015 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–IL–06]; 8. Japanese Patent No. 6863893, issued April 5, 2021 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–JP–07]; 9. Korean Patent Application No. 2017–7017289, effective filing date of VerDate Sep<11>2014 22:39 Oct 25, 2021 Jkt 256001 November 24, 2015 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–KR–08]; 10. Mexican Patent No. 384919, issued July 29, 2021 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–MX–09]; 11. New Zealand Patent Application No. 732045, effective filing date of November 24, 2015 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–NZ–10]; 12. Saudi Arabian Patent No. 7697, issued March 11, 2021 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–SA–11]; 13. Singapore Patent Application No. 11201704155U, effective filing date of November 24, 2015 entitled ‘‘AntiMutated KRAS T Cell Receptors’’ [HHS Reference No. E–028–2015–1–SG–12]; 14. 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Australian Patent No. 2016323017, issued February 25, 2021 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–AU–03]; 26. Canadian Patent Application No. 2,998,869, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–CA–04]; 27. Chinese Patent Application No. 201680058891.3, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–CN–05]; 28. European Patent No. 3350213, issued March 31, 2021 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–EP–06]; a. Validated in the following jurisdictions: BE, CH, DE, DK, ES, FR, GB, IE, IT, NL, NO and SE. 29. Israeli Patent Application No. 257840, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–IL–07]; 30. Japanese Patent Application No. 2018–513423, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–JP–08]; 31. Korean Patent Application No. 2018–7010326, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–KR–09]; 32. Mexican Patent Application No. MX/a/2018/003062, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–MX–10]; 33. New Zealand Patent Application No. 740714, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–NZ–11]; 34. Saudi Arabian Patent Application No. 518391109, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–SA–12]; E:\FR\FM\26OCN1.SGM 26OCN1 Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices 35. Singapore Patent Application No. 11201802069U, effective filing date of September 9, 2016 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–SG–13]; 36. United States Patent No. 10,556,940, issued February 11, 2020 entitled ‘‘T Cell Receptors Recognizing HLA–CW8 Restricted Mutated KRAS’’ [HHS Reference No. E–265–2015–0–US– 14]; 37. 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Taiwanese Patent Application No. 108138456, filed October 24, 2019 entitled ‘‘HLA–A3-Restricted T Cell Receptors Against Mutated RAS’’ [HHS Reference No. E–166–2018–0–TW–03]; 100. United States Patent Application No. 16/662,808, filed October 24, 2019 entitled ‘‘HLA–A3-Restricted T Cell Receptors Against Mutated RAS’’ [HHS Reference No. E–166–2018–0–US–04]; 101. Australian Patent Application No. 2019364436, effective filing date of October 24, 2019 entitled ‘‘HLA–A3Restricted T Cell Receptors Against Mutated RAS’’ [HHS Reference No. E– 166–2018–0–AU–05]; 102. Canadian Patent Application No. 3,116,749, effective filing date of October 24, 2019 entitled ‘‘HLA–A3Restricted T Cell Receptors Against Mutated RAS’’ [HHS Reference No. E– 166–2018–0–CA–06]; 103. European Patent Application No. 19805442.1, effective filing date of October 24, 2019 entitled ‘‘HLA–A3Restricted T Cell Receptors Against Mutated RAS’’ [HHS Reference No. E– 166–2018–0–EP–07]; 104. United States Provisional Patent Application No. 62/795,203, filed January 22, 2019 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–US–01]; 105. Taiwanese Patent Application No. 109102511 filed January 22, 2020 entitled ‘‘HLA Class II-Restricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029– 2019–0–TW–02]; 106. PCT Application No. PCT/ US2020/014382, filed January 21, 2020 entitled ‘‘HLA Class II-Restricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029– 2019–0–PCT–03]; 107. Australian Patent Application No. 2020211922, effective filing date of E:\FR\FM\26OCN1.SGM 26OCN1 Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–AU–04]; 108. Canadian Patent Application No. 3,127,096, effective filing date of January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–CA–05]; 109. Chinese Patent Application No. 202080010373.0, effective filing date of January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–CN–06]; 110. European Patent Application No. 20705599.7, effective filing date of January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–EP–07]; 111. Japanese Patent Application No. 2021–542206, effective filing date of January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–JP–08]; 112. Korean Patent Application No. 2021–7026169, effective filing date of January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–KR–09]; 113. United States Patent Application No. 17/424,591, effective filing date of January 21, 2020 entitled ‘‘HLA Class IIRestricted T Cell Receptors Against RAS with G12R Mutation’’ [HHS Reference No. E–029–2019–0–US–10]; 114. United States Provisional Patent Application No. 62/975,544, filed February 12, 2020 entitled ‘‘HLA Class I-Restricted T Cell Receptors Against RAS with G12D Mutation’’ [HHS Ref. No. E–031–2020–0–US–01]; 115. PCT Patent Application No. PCT/ US2021/017794, filed February 12, 2021 entitled ‘‘HLA Class I-Restricted T Cell Receptors Against RAS with G12D Mutation’’ [HHS Ref. No. E–031–2020– 0–PCT–02]; 116. Taiwanese Patent Application No. 110105194, filed February 12, 2021 entitled ‘‘HLA Class I-Restricted T Cell Receptors Against RAS with G12D Mutation’’ [HHS Ref. No. E–031–2020– 0–TW–03]; 117. United States Provisional Patent Application No. 62/976,655, filed February 14, 2020 entitled ‘‘HLA Class I-Restricted T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–074–2020–0–US–01]; 118. PCT Patent Application No. PCT/ US2021/017852, filed February 12, 2021 entitled ‘‘HLA Class I-Restricted T Cell Receptors Against RAS with G12V VerDate Sep<11>2014 22:39 Oct 25, 2021 Jkt 256001 Mutation’’ [HHS Ref. No. E–074–2020– 0–PCT–02]; 119. Taiwanese Patent Application No. 110105193, filed February 12, 2021 entitled ‘‘HLA Class I-Restricted T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–074–2020– 0–TW–03]; 120. United States Provisional Patent Application No. 62/981,856, filed February 26, 2020 entitled ‘‘HLA Class II-Restricted T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–088–2020–0–US–01]; 121. PCT Patent Application No. PCT/ US2021/019775, filed February 26, 2021 entitled ‘‘HLA Class II-Restricted T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–088–2020– 0–PCT–02]; 122. Taiwanese Patent Application No. 110106886, filed February 26, 2021 entitled ‘‘HLA Class II-Restricted T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–088–2020– 0–TW–03]; 123. United States Provisional Patent Application No. 63/050,931, filed July 13, 2020 entitled ‘‘HLA Class IIRestricted DRB T Cell Receptors Against RAS with G12D Mutation’’ [HHS Ref. No. E–165–2020–0–US–01]; 124. PCT Patent Application No. PCT/ US2021/041375, filed July 13, 2021 entitled ‘‘HLA Class II-Restricted DRB T Cell Receptors Against RAS with G12D Mutation’’ [HHS Ref. No. E–165–2020– 0–PCT–02]; 125. United States Provisional Patent Application No. 63/052,502, filed July 16, 2020 entitled ‘‘HLA Class IIRestricted DRB1*01:01 T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–172–2020–0–US–01]; 126. PCT Patent Application No. PCT/ US2021/041737, filed July 15, 2021 entitled ‘‘HLA Class II-Restricted DRB1*01:01 T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E–172–2020–0–PCT–02]; 127. United States Provisional Patent Application No. 63/086,674, filed October 2, 2020 entitled ‘‘HLA Class IIRestricted DQ T Cell Receptors Against RAS with G13D Mutation’’ [HHS Ref. No. E–189–2020–0–US–01]; 128. PCT Patent Application No. PCT/ US2021/053060, filed October 1, 2021 entitled ‘‘HLA Class II-Restricted DQ T Cell Receptors Against RAS with G13D Mutation’’ [HHS Ref. No. E–189–2020– 0–PCT–02]; 129. Taiwanese Patent Application No. ‘‘TBD’’, filed October 1, 2021 entitled ‘‘HLA Class II-Restricted DQ T Cell Receptors Against RAS with G13D Mutation’’ [HHS Ref. No. E–189–2020– 0–TW–03]; and PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 59173 130. United States Provisional Patent Application No. 63/060,340, filed August 3, 2020 entitled ‘‘HLA Class IRestricted T Cell Receptors Against RAS with G12V Mutation’’ [HHS Ref. No. E– 190–2020–0–US–01]. Group B 1. United States Provisional Patent Application No. 62/565,383, filed September 29, 2017 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–0–US– 01]; 2. PCT Application No. PCT/US2018/ 051285, filed September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E– 237–2017–2–PCT–01]; 3. Australian Patent Application No. 2018342246 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2– AU–02]; 4. Brazilian Patent Application No. BR112020006012–7 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–BR– 03]; 5. Canadian Patent Application No. 3,077,024 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2– CA–04]; 6. Chinese Patent Application No. 201880074539.8 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2– CN–05]; 7. Costa Rican Application No. 2020– 0170, effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–CR–06]; 8. Eurasian Application No. 202090757, effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–EA– 07]; 9. European Patent Application No. 18780006.5 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–EP– 08]; 10. Israeli Patent Application No. 273515 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–IL– 09]; 11. Indian Patent Application No. 202047013911 effective filing date of September 17, 2018 entitled ‘‘T Cell E:\FR\FM\26OCN1.SGM 26OCN1 59174 Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–IN– 10]; 12. Japanese Patent Application No. 2020–517556 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–JP– 11]; 13. Korean Patent Application No. 2020–7012344 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–KR– 12]; 14. Mexican Application No. MX/a/ 2020/003504, effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2– MX–13]; 15. New Zealand Patent Application No. 763023 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2– NZ–14]; 16. Singapore Patent Application No. 11202002636P effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–SG– 15]; 17. United States Patent Application No. 16/651,242 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2–US– 16]; 18. Hong Kong Patent Application No. 62020021272.3 effective filing date of September 17, 2018 entitled ‘‘T Cell Receptors Recognizing Mutated P53’’ [HHS Reference No. E–237–2017–2– HK–17]; 19. United States Provisional Patent Application No. 62/867,619, filed June 27, 2019 entitled ‘‘T Cell Receptors Recognizing R175H or Y220C Mutation in P53’’ [HHS Reference No. E–135– 2019–0–US–01]; 20. PCT Application No. PCT/ US2020/039785, filed June 26, 2020 entitled ‘‘T Cell Receptors Recognizing R175H or Y220C Mutation in P53’’ [HHS Reference No. E–135–2019–0– PCT–02]; 21. Taiwanese Application No. 109121744, filed June 26, 2020 entitled ‘‘T Cell Receptors Recognizing R175H or Y220C Mutation in P53’’ [HHS Reference No. E–135–2019–0–TW–03]; 22. United States Provisional Patent Application No. 63/074,747, filed September 4, 2020 entitled ‘‘T Cell Receptors Recognizing R273C or Y220C Mutation in P53’’ [HHS Reference No. E–173–2020–0–US–01]; VerDate Sep<11>2014 22:39 Oct 25, 2021 Jkt 256001 23. PCT Patent Application No. PCT/ US2021/048786, filed September 2, 2021 entitled ‘‘T Cell Receptors Recognizing R273C or Y220C Mutation in P53’’ [HHS Reference No. E–173– 2020–0–PCT–02]; and 24. Taiwanese Patent Application No. ‘‘TBD’’, filed September 2, 2021 entitled ‘‘T Cell Receptors Recognizing R273C or Y220C Mutation in P53’’ [HHS Reference No. E–173–2020–0–TW–03]. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide, and the fields of use may be limited to the following: ‘‘Autologous T cell therapy products engineered by use of a CRISPR-nuclease to express a therapeutic T cell receptor claimed in the Licensed Patent Rights for the treatment or prevention of cancer in humans’’ ‘‘Allogeneic T cell therapy products engineered by use of a CRISPR-nuclease to express a therapeutic T cell receptor claimed in the Licensed Patent Rights for the treatment or prevention of cancer in humans’’ Specifically excluded from these fields of use are: 1. Autologous, peripheral blood T cell therapy products engineered by transposon-mediated gene transfer for the treatment of human cancers; 2. Autologous, peripheral blood T cell therapy products engineered via retrovirus and lentivirus-mediated gene transfer for the treatment of human cancer; and 3. Natural Killer T (NKT) cell therapy products engineered via viral and nonviral means for the treatment of human cancers. Wherein the NKT cell therapy product contains at least 50% NKT cells. Intellectual Property Group A is primarily directed to isolated T cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of several human leukocyte antigens (HLAs). Mutated KRAS, which plays a well-defined driver role in oncogenesis, is expressed by a variety of human cancers, including pancreatic, lung, endometrial, ovarian and prostate. Due to its restricted expression in precancerous and cancerous cells, this antigen may be targeted on mutant KRAS-expressing tumors with minimal normal tissue toxicity. Intellectual Property Group B is primarily directed to isolated TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the context of several HLAs. P53 is the archetypal PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 tumor suppressor gene and the most frequently mutated gene in cancer. Contemporary estimates suggest that >50% of all tumors carry mutations in P53. Because of its prevalence in cancer and its restricted expression to precancerous and cancerous cells, this antigen may be targeted on mutant P53expressing tumors with minimal normal tissue toxicity. This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published Notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: October 21, 2021. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2021–23289 Filed 10–25–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID FEMA–2008–0010] Board of Visitors for the National Fire Academy; Meeting Federal Emergency Management Agency, DHS. ACTION: Committee management; notice of open Federal Advisory Committee meeting. AGENCY: The Board of Visitors for the National Fire Academy (Board) will meet virtually on Monday, December 6, 2021. The meeting will be open to the public. SUMMARY: E:\FR\FM\26OCN1.SGM 26OCN1

Agencies

[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59169-59174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23289]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Development and 
Commercialization of CRISPR-Engineered T Cell Therapies for the 
Treatment of Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to

[[Page 59170]]

practice the inventions embodied in the Patents and Patent Applications 
listed in the Supplementary Information section of this Notice to 
Neogene Therapeutics, Inc. (``Neogene''), headquartered in Santa 
Monica, CA.

DATES: Only written comments and/or applications for a license which 
are received by the National Cancer Institute's Technology Transfer 
Center on or before November 10, 2021 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer 
Manager, NCI Technology Transfer Center, Telephone: (240)-276-5484; 
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

Group A

    1. United States Provisional Patent Application No. 62/084,654, 
filed November 26, 2014 entitled ``Anti-Mutated KRAS T Cell Receptors'' 
[HHS Reference No. E-028-2015-0-US-01];
    2. PCT Application No. PCT/US2015/062269, filed November 24, 2015 
entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-
028-2015-1-PCT-01];
    3. Australian Patent No. 2015353720, issued June 11, 2020 entitled 
``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-028-2015-1-
AU-02];
    4. Canadian Patent Application No. 2,968,399, effective filing date 
of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell Receptors'' 
[HHS Reference No. E-028-2015-1-CA-03];
    5. Chinese Patent Application No. 201580070673.7, effective filing 
date of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell 
Receptors'' [HHS Reference No. E-028-2015-1-CN-04];
    6. European Patent No. 3223850, issued January 8, 2020, entitled 
``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-028-2015-1-
EP-05];
    a. Validated in the following jurisdictions: AT, BE, CH, CZ, DE, 
ES, FR, GB, GR, IE, IT, NL, NO, PL, PT, SE, SI, SK, TR.
    7. Israeli Patent Application No. 252258, effective filing date of 
November 24, 2015 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS 
Reference No. E-028-2015-1-IL-06];
    8. Japanese Patent No. 6863893, issued April 5, 2021 entitled 
``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-028-2015-1-
JP-07];
    9. Korean Patent Application No. 2017-7017289, effective filing 
date of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell 
Receptors'' [HHS Reference No. E-028-2015-1-KR-08];
    10. Mexican Patent No. 384919, issued July 29, 2021 entitled 
``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-028-2015-1-
MX-09];
    11. New Zealand Patent Application No. 732045, effective filing 
date of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell 
Receptors'' [HHS Reference No. E-028-2015-1-NZ-10];
    12. Saudi Arabian Patent No. 7697, issued March 11, 2021 entitled 
``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-028-2015-1-
SA-11];
    13. Singapore Patent Application No. 11201704155U, effective filing 
date of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell 
Receptors'' [HHS Reference No. E-028-2015-1-SG-12];
    14. United States Patent Application No. 15/528,813, effective 
filing date of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell 
Receptors'' [HHS Reference No. E-028-2015-1-US-13];
    15. Hong Kong Patent No. 1243642, issued January 22, 2021 entitled 
``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. E-028-2015-1-
HK-14];
    16. European Patent Application No. 20150279.6, filed January 3, 
2020 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. 
E-028-2015-1-EP-15];
    17. Singapore Patent Application No. 10201913978R filed December 
31, 2019 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference 
No. E-028-2015-1-SG-16];
    18. Australian Patent Application No. 2020203465, filed May 26, 
2020 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. 
E-028-2015-1-AU-36];
    19. Saudi Arabian Patent Application No. 520420365, filed October 
15, 2020 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference 
No. E-028-2015-1-SA-37];
    20. Hong Kong Patent Application No. 42020021375.9, effective 
filing date of November 24, 2015 entitled ``Anti-Mutated KRAS T Cell 
Receptors'' [HHS Reference No. E-028-2015-1-HK-38];
    21. Japanese Patent Application No. 2021-063092, filed April 1, 
2021 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS Reference No. 
E-028-2015-1-JP-40];
    22. United States Provisional Patent Application No. 62/171,321, 
filed June 5, 2015 entitled ``Anti-Mutated KRAS T Cell Receptors'' [HHS 
Reference No. E-180-2015-0-US-01];
    23. United States Provisional Patent Application No. 62/218,688, 
filed September 15, 2015 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-US-01];
    24. PCT Application No. PCT/US2016/050875, filed September 9, 2016 
entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted Mutated 
KRAS'' [HHS Reference No. E-265-2015-0-PCT-02];
    25. Australian Patent No. 2016323017, issued February 25, 2021 
entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted Mutated 
KRAS'' [HHS Reference No. E-265-2015-0-AU-03];
    26. Canadian Patent Application No. 2,998,869, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-CA-04];
    27. Chinese Patent Application No. 201680058891.3, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-CN-05];
    28. European Patent No. 3350213, issued March 31, 2021 entitled ``T 
Cell Receptors Recognizing HLA-CW8 Restricted Mutated KRAS'' [HHS 
Reference No. E-265-2015-0-EP-06];
    a. Validated in the following jurisdictions: BE, CH, DE, DK, ES, 
FR, GB, IE, IT, NL, NO and SE.
    29. Israeli Patent Application No. 257840, effective filing date of 
September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-CW8 
Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-IL-07];
    30. Japanese Patent Application No. 2018-513423, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-JP-08];
    31. Korean Patent Application No. 2018-7010326, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-KR-09];
    32. Mexican Patent Application No. MX/a/2018/003062, effective 
filing date of September 9, 2016 entitled ``T Cell Receptors 
Recognizing HLA-CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-
2015-0-MX-10];
    33. New Zealand Patent Application No. 740714, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-NZ-11];
    34. Saudi Arabian Patent Application No. 518391109, effective 
filing date of September 9, 2016 entitled ``T Cell Receptors 
Recognizing HLA-CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-
2015-0-SA-12];

[[Page 59171]]

    35. Singapore Patent Application No. 11201802069U, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-SG-13];
    36. United States Patent No. 10,556,940, issued February 11, 2020 
entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted Mutated 
KRAS'' [HHS Reference No. E-265-2015-0-US-14];
    37. Hong Kong Patent Application No. 19100263.9, effective filing 
date of September 9, 2016 entitled ``T Cell Receptors Recognizing HLA-
CW8 Restricted Mutated KRAS'' [HHS Reference No. E-265-2015-0-HK-15];
    38. United States Patent Application No. 16/739,310, filed January 
10, 2020 entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted 
Mutated KRAS'' [HHS Reference No. E-265-2015-0-US-16];
    39. Singapore Patent Application No. 10201913868X, filed December 
30, 2019 entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted 
Mutated KRAS'' [HHS Reference No. E-265-2015-0-SG-17];
    40. Australian Patent Application No. 2021200833, filed February 
10, 2021 entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted 
Mutated KRAS'' [HHS Reference No. E-265-2015-0-AU-18];
    41. European Patent Application No. 21162567.8 filed March 15, 2021 
entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted Mutated 
KRAS'' [HHS Reference No. E-265-2015-0-EP-19];
    42. Saudi Arabian Patent Application No. 521421309, filed February 
23, 2021 entitled ``T Cell Receptors Recognizing HLA-CW8 Restricted 
Mutated KRAS'' [HHS Reference No. E-265-2015-0-SA-20];
    43. United States Provisional Patent Application No. 62/369,883, 
filed August 2, 2016 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-US-01];
    44. PCT Application No. PCT/US2017/044615, filed July 31, 2017 
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-PCT-02];
    45. Australian Patent Application No. 2017306038, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-AU-03];
    46. Canadian Patent Application No. 3,032,870, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-CA-04];
    47. Chinese Patent Application No. 201780059356.4, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-CN-05];
    48. European Patent Application No. 17749580.1, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-EP-06];
    49. Japanese Patent Application No. 2019-505220, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-JP-07];
    50. United States Patent No. 10,611,816, issued April 7, 2020 
entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-175-
2016-0-US-08];
    51. Israeli Patent Application No. 264425, effective filing date of 
July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-IL-09];
    52. Korean Patent Application No. 2019-7005837, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-KR-10];
    53. Singapore Patent Application No. 11201900654Q, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-SG-11];
    54. Hong Kong Patent Application No. 19133082.8, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-HK-12];
    55. Hong Kong Patent Application No. 19132196.7, effective filing 
date of July 31, 2017 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS 
Reference No. E-175-2016-0-HK-13];
    56. Singapore Patent Application No. 10201913959W, filed December 
31, 2019 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference 
No. E-175-2016-0-SG-14];
    57. United States Patent Application No. 16/838,395, filed April 2, 
2020 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-
175-2016-0-US-15];
    58. United States Patent Application No. 17/345,390, filed June 11, 
2021 entitled ``Anti-KRAS G12D T Cell Receptors'' [HHS Reference No. E-
175-2016-0-US-16];
    59. United States Provisional Patent Application No. 62/560,930, 
filed September 20, 2017 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-US-01];
    60. PCT Application No. PCT/US2018/051641, filed September 19, 2018 
entitled ``HLA Class II-Restricted T Cell Receptors Against Mutated 
RAS'' [HHS Reference No. E-181-2017-0-PCT-02];
    61. Argentina Patent Application No. P180102695, effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-AR-03];
    62. Taiwanese Patent Application No. 107133221, filed September 20, 
2018 entitled ``HLA Class II-Restricted T Cell Receptors Against 
Mutated RAS'' [HHS Reference No. E-181-2017-0-TW-05];
    63. United States Patent Application No. 16/135,231, filed 
September 19, 2018 entitled ``HLA Class II-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-181-2017-0-US-06];
    64. Australian Patent Application No. 2018335274 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-AU-07];
    65. Brazilian Patent Application No. BR112020005469-0 effective 
filing date of September 19, 2018 entitled ``HLA Class II-Restricted T 
Cell Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-
BR-08];
    66. Canadian Patent Application No. 3,076,339 effective filing date 
of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-CA-09];
    67. Chinese Patent Application No. 201880060535.4 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-CN-10];
    68. Costa Rica Patent Application No. 2020-0150 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-CR-11];
    69. Eurasian Patent Application No. 202090652 effective filing date 
of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-EA-12];
    70. European Patent Application No. 18792591.2 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-EP-13];
    71. Israeli Patent Application No. 273254 effective filing date of 
September 19, 2018 entitled ``HLA Class II-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-181-2017-0-IL-14];

[[Page 59172]]

    72. Indian Patent Application No. 202047011647 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-IN-15];
    73. Japanese Patent Application No. 2020-516422 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-JP-16];
    74. Korean Patent Application No. 2020-7011112 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-KR-17];
    75. Mexican Patent Application No. MX/a/2020/003117 effective 
filing date of September 19, 2018 entitled ``HLA Class II-Restricted T 
Cell Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-
MX-18];
    76. New Zealand Patent Application No. 762831 effective filing date 
of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-NZ-19];
    77. Singapore Patent Application No. 11202002425P effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-SG-20];
    78. Hong Kong Patent Application No. 62020019700.7 effective filing 
date of September 19, 2018 entitled ``HLA Class II-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-181-2017-0-HK-21];
    79. United States Provisional Patent Application No. 62/594,244, 
filed December 4, 2017 entitled ``HLA Class I-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-239-2017-0-US-01];
    80. PCT Application No. PCT/US2018/063581, filed December 3, 2018 
entitled ``HLA Class I-Restricted T Cell Receptors Against Mutated 
RAS'' [HHS Reference No. E-239-2017-0-PCT-02];
    81. Australian Patent Application No. 2018378200 effective filing 
date of December 3, 2018 entitled ``HLA Class I-Restricted T Cell 
Receptors Against Mutated RAS'' [HHS Reference No. E-239-2017-0-AU-03];
    82. Brazilian Patent Application No. BR112020011111-2 effective 
filing date of December 3, 2018 entitled ``HLA Class I-Restricted T 
Cell Receptors Against Mutated RAS'' [HHS Reference No. E-239-2017-0-
BR-04];
    83. Canadian Application No. 3,084,246, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-CA-05];
    84. Chinese Application No. 201880087270.7, effective filing date 
of December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-CN-06];
    85. Costa Rican Application No. 2020-0287, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-CR-07];
    86. Eurasian Application No. 202091335, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-EA-08];
    87. European Application No. 18830062.8, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-EP-09];
    88. Israeli Application No. 275031, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-IL-10];
    89. Indian Application No. 202047026991, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-IN-11];
    90. Japanese Application No. 2020-530325, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-JP-12];
    91. Korean Application No. 2020-7019185, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-KR-13];
    92. Mexican Application No. MX/a/2020/005765, effective filing date 
of December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-MX-14];
    93. New Zealand Application No. 765440, effective filing date of 
December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-NZ-15];
    94. Singapore Application No. 11202005236Q, effective filing date 
of December 3, 2018 entitled ``HLA Class I-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-239-2017-0-SG-16];
    95. United States Patent Application No. 16/769,144, effective 
filing date of December 3, 2018 entitled ``HLA Class I-Restricted T 
Cell Receptors Against Mutated RAS'' [HHS Reference No. E-239-2017-0-
US-17];
    96. Hong Kong Patent Application No. 62021026617.2, effective 
filing date of December 3, 2018 entitled ``HLA Class I-Restricted T 
Cell Receptors Against Mutated RAS'' [HHS Reference No. E-239-2017-0-
HK-18];
    97. United States Provisional Patent Application No. 62/749,750, 
filed October 24, 2018 entitled ``HLA-A3-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-166-2018-0-US-01];
    98. PCT Application No. PCT/US2019/057833, filed October 24, 2019 
entitled ``HLA-A3-Restricted T Cell Receptors Against Mutated RAS'' 
[HHS Reference No. E-166-2018-0-PCT-02];
    99. Taiwanese Patent Application No. 108138456, filed October 24, 
2019 entitled ``HLA-A3-Restricted T Cell Receptors Against Mutated 
RAS'' [HHS Reference No. E-166-2018-0-TW-03];
    100. United States Patent Application No. 16/662,808, filed October 
24, 2019 entitled ``HLA-A3-Restricted T Cell Receptors Against Mutated 
RAS'' [HHS Reference No. E-166-2018-0-US-04];
    101. Australian Patent Application No. 2019364436, effective filing 
date of October 24, 2019 entitled ``HLA-A3-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-166-2018-0-AU-05];
    102. Canadian Patent Application No. 3,116,749, effective filing 
date of October 24, 2019 entitled ``HLA-A3-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-166-2018-0-CA-06];
    103. European Patent Application No. 19805442.1, effective filing 
date of October 24, 2019 entitled ``HLA-A3-Restricted T Cell Receptors 
Against Mutated RAS'' [HHS Reference No. E-166-2018-0-EP-07];
    104. United States Provisional Patent Application No. 62/795,203, 
filed January 22, 2019 entitled ``HLA Class II-Restricted T Cell 
Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-029-
2019-0-US-01];
    105. Taiwanese Patent Application No. 109102511 filed January 22, 
2020 entitled ``HLA Class II-Restricted T Cell Receptors Against RAS 
with G12R Mutation'' [HHS Reference No. E-029-2019-0-TW-02];
    106. PCT Application No. PCT/US2020/014382, filed January 21, 2020 
entitled ``HLA Class II-Restricted T Cell Receptors Against RAS with 
G12R Mutation'' [HHS Reference No. E-029-2019-0-PCT-03];
    107. Australian Patent Application No. 2020211922, effective filing 
date of

[[Page 59173]]

January 21, 2020 entitled ``HLA Class II-Restricted T Cell Receptors 
Against RAS with G12R Mutation'' [HHS Reference No. E-029-2019-0-AU-
04];
    108. Canadian Patent Application No. 3,127,096, effective filing 
date of January 21, 2020 entitled ``HLA Class II-Restricted T Cell 
Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-029-
2019-0-CA-05];
    109. Chinese Patent Application No. 202080010373.0, effective 
filing date of January 21, 2020 entitled ``HLA Class II-Restricted T 
Cell Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-
029-2019-0-CN-06];
    110. European Patent Application No. 20705599.7, effective filing 
date of January 21, 2020 entitled ``HLA Class II-Restricted T Cell 
Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-029-
2019-0-EP-07];
    111. Japanese Patent Application No. 2021-542206, effective filing 
date of January 21, 2020 entitled ``HLA Class II-Restricted T Cell 
Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-029-
2019-0-JP-08];
    112. Korean Patent Application No. 2021-7026169, effective filing 
date of January 21, 2020 entitled ``HLA Class II-Restricted T Cell 
Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-029-
2019-0-KR-09];
    113. United States Patent Application No. 17/424,591, effective 
filing date of January 21, 2020 entitled ``HLA Class II-Restricted T 
Cell Receptors Against RAS with G12R Mutation'' [HHS Reference No. E-
029-2019-0-US-10];
    114. United States Provisional Patent Application No. 62/975,544, 
filed February 12, 2020 entitled ``HLA Class I-Restricted T Cell 
Receptors Against RAS with G12D Mutation'' [HHS Ref. No. E-031-2020-0-
US-01];
    115. PCT Patent Application No. PCT/US2021/017794, filed February 
12, 2021 entitled ``HLA Class I-Restricted T Cell Receptors Against RAS 
with G12D Mutation'' [HHS Ref. No. E-031-2020-0-PCT-02];
    116. Taiwanese Patent Application No. 110105194, filed February 12, 
2021 entitled ``HLA Class I-Restricted T Cell Receptors Against RAS 
with G12D Mutation'' [HHS Ref. No. E-031-2020-0-TW-03];
    117. United States Provisional Patent Application No. 62/976,655, 
filed February 14, 2020 entitled ``HLA Class I-Restricted T Cell 
Receptors Against RAS with G12V Mutation'' [HHS Ref. No. E-074-2020-0-
US-01];
    118. PCT Patent Application No. PCT/US2021/017852, filed February 
12, 2021 entitled ``HLA Class I-Restricted T Cell Receptors Against RAS 
with G12V Mutation'' [HHS Ref. No. E-074-2020-0-PCT-02];
    119. Taiwanese Patent Application No. 110105193, filed February 12, 
2021 entitled ``HLA Class I-Restricted T Cell Receptors Against RAS 
with G12V Mutation'' [HHS Ref. No. E-074-2020-0-TW-03];
    120. United States Provisional Patent Application No. 62/981,856, 
filed February 26, 2020 entitled ``HLA Class II-Restricted T Cell 
Receptors Against RAS with G12V Mutation'' [HHS Ref. No. E-088-2020-0-
US-01];
    121. PCT Patent Application No. PCT/US2021/019775, filed February 
26, 2021 entitled ``HLA Class II-Restricted T Cell Receptors Against 
RAS with G12V Mutation'' [HHS Ref. No. E-088-2020-0-PCT-02];
    122. Taiwanese Patent Application No. 110106886, filed February 26, 
2021 entitled ``HLA Class II-Restricted T Cell Receptors Against RAS 
with G12V Mutation'' [HHS Ref. No. E-088-2020-0-TW-03];
    123. United States Provisional Patent Application No. 63/050,931, 
filed July 13, 2020 entitled ``HLA Class II-Restricted DRB T Cell 
Receptors Against RAS with G12D Mutation'' [HHS Ref. No. E-165-2020-0-
US-01];
    124. PCT Patent Application No. PCT/US2021/041375, filed July 13, 
2021 entitled ``HLA Class II-Restricted DRB T Cell Receptors Against 
RAS with G12D Mutation'' [HHS Ref. No. E-165-2020-0-PCT-02];
    125. United States Provisional Patent Application No. 63/052,502, 
filed July 16, 2020 entitled ``HLA Class II-Restricted DRB1*01:01 T 
Cell Receptors Against RAS with G12V Mutation'' [HHS Ref. No. E-172-
2020-0-US-01];
    126. PCT Patent Application No. PCT/US2021/041737, filed July 15, 
2021 entitled ``HLA Class II-Restricted DRB1*01:01 T Cell Receptors 
Against RAS with G12V Mutation'' [HHS Ref. No. E-172-2020-0-PCT-02];
    127. United States Provisional Patent Application No. 63/086,674, 
filed October 2, 2020 entitled ``HLA Class II-Restricted DQ T Cell 
Receptors Against RAS with G13D Mutation'' [HHS Ref. No. E-189-2020-0-
US-01];
    128. PCT Patent Application No. PCT/US2021/053060, filed October 1, 
2021 entitled ``HLA Class II-Restricted DQ T Cell Receptors Against RAS 
with G13D Mutation'' [HHS Ref. No. E-189-2020-0-PCT-02];
    129. Taiwanese Patent Application No. ``TBD'', filed October 1, 
2021 entitled ``HLA Class II-Restricted DQ T Cell Receptors Against RAS 
with G13D Mutation'' [HHS Ref. No. E-189-2020-0-TW-03]; and
    130. United States Provisional Patent Application No. 63/060,340, 
filed August 3, 2020 entitled ``HLA Class I-Restricted T Cell Receptors 
Against RAS with G12V Mutation'' [HHS Ref. No. E-190-2020-0-US-01].

Group B

    1. United States Provisional Patent Application No. 62/565,383, 
filed September 29, 2017 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-0-US-01];
    2. PCT Application No. PCT/US2018/051285, filed September 17, 2018 
entitled ``T Cell Receptors Recognizing Mutated P53'' [HHS Reference 
No. E-237-2017-2-PCT-01];
    3. Australian Patent Application No. 2018342246 effective filing 
date of September 17, 2018 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-2-AU-02];
    4. Brazilian Patent Application No. BR112020006012-7 effective 
filing date of September 17, 2018 entitled ``T Cell Receptors 
Recognizing Mutated P53'' [HHS Reference No. E-237-2017-2-BR-03];
    5. Canadian Patent Application No. 3,077,024 effective filing date 
of September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-CA-04];
    6. Chinese Patent Application No. 201880074539.8 effective filing 
date of September 17, 2018 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-2-CN-05];
    7. Costa Rican Application No. 2020-0170, effective filing date of 
September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-CR-06];
    8. Eurasian Application No. 202090757, effective filing date of 
September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-EA-07];
    9. European Patent Application No. 18780006.5 effective filing date 
of September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-EP-08];
    10. Israeli Patent Application No. 273515 effective filing date of 
September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-IL-09];
    11. Indian Patent Application No. 202047013911 effective filing 
date of September 17, 2018 entitled ``T Cell

[[Page 59174]]

Receptors Recognizing Mutated P53'' [HHS Reference No. E-237-2017-2-IN-
10];
    12. Japanese Patent Application No. 2020-517556 effective filing 
date of September 17, 2018 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-2-JP-11];
    13. Korean Patent Application No. 2020-7012344 effective filing 
date of September 17, 2018 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-2-KR-12];
    14. Mexican Application No. MX/a/2020/003504, effective filing date 
of September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-MX-13];
    15. New Zealand Patent Application No. 763023 effective filing date 
of September 17, 2018 entitled ``T Cell Receptors Recognizing Mutated 
P53'' [HHS Reference No. E-237-2017-2-NZ-14];
    16. Singapore Patent Application No. 11202002636P effective filing 
date of September 17, 2018 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-2-SG-15];
    17. United States Patent Application No. 16/651,242 effective 
filing date of September 17, 2018 entitled ``T Cell Receptors 
Recognizing Mutated P53'' [HHS Reference No. E-237-2017-2-US-16];
    18. Hong Kong Patent Application No. 62020021272.3 effective filing 
date of September 17, 2018 entitled ``T Cell Receptors Recognizing 
Mutated P53'' [HHS Reference No. E-237-2017-2-HK-17];
    19. United States Provisional Patent Application No. 62/867,619, 
filed June 27, 2019 entitled ``T Cell Receptors Recognizing R175H or 
Y220C Mutation in P53'' [HHS Reference No. E-135-2019-0-US-01];
    20. PCT Application No. PCT/US2020/039785, filed June 26, 2020 
entitled ``T Cell Receptors Recognizing R175H or Y220C Mutation in 
P53'' [HHS Reference No. E-135-2019-0-PCT-02];
    21. Taiwanese Application No. 109121744, filed June 26, 2020 
entitled ``T Cell Receptors Recognizing R175H or Y220C Mutation in 
P53'' [HHS Reference No. E-135-2019-0-TW-03];
    22. United States Provisional Patent Application No. 63/074,747, 
filed September 4, 2020 entitled ``T Cell Receptors Recognizing R273C 
or Y220C Mutation in P53'' [HHS Reference No. E-173-2020-0-US-01];
    23. PCT Patent Application No. PCT/US2021/048786, filed September 
2, 2021 entitled ``T Cell Receptors Recognizing R273C or Y220C Mutation 
in P53'' [HHS Reference No. E-173-2020-0-PCT-02]; and
    24. Taiwanese Patent Application No. ``TBD'', filed September 2, 
2021 entitled ``T Cell Receptors Recognizing R273C or Y220C Mutation in 
P53'' [HHS Reference No. E-173-2020-0-TW-03].
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide, and 
the fields of use may be limited to the following:
    ``Autologous T cell therapy products engineered by use of a CRISPR-
nuclease to express a therapeutic T cell receptor claimed in the 
Licensed Patent Rights for the treatment or prevention of cancer in 
humans''
    ``Allogeneic T cell therapy products engineered by use of a CRISPR-
nuclease to express a therapeutic T cell receptor claimed in the 
Licensed Patent Rights for the treatment or prevention of cancer in 
humans''
    Specifically excluded from these fields of use are:
    1. Autologous, peripheral blood T cell therapy products engineered 
by transposon-mediated gene transfer for the treatment of human 
cancers;
    2. Autologous, peripheral blood T cell therapy products engineered 
via retrovirus and lentivirus-mediated gene transfer for the treatment 
of human cancer; and
    3. Natural Killer T (NKT) cell therapy products engineered via 
viral and non-viral means for the treatment of human cancers. Wherein 
the NKT cell therapy product contains at least 50% NKT cells.
    Intellectual Property Group A is primarily directed to isolated T 
cell receptors (TCRs) reactive to mutated Kirsten rat sarcoma viral 
oncogene homolog (KRAS), within the context of several human leukocyte 
antigens (HLAs). Mutated KRAS, which plays a well-defined driver role 
in oncogenesis, is expressed by a variety of human cancers, including 
pancreatic, lung, endometrial, ovarian and prostate. Due to its 
restricted expression in precancerous and cancerous cells, this antigen 
may be targeted on mutant KRAS-expressing tumors with minimal normal 
tissue toxicity.
    Intellectual Property Group B is primarily directed to isolated 
TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the 
context of several HLAs. P53 is the archetypal tumor suppressor gene 
and the most frequently mutated gene in cancer. Contemporary estimates 
suggest that >50% of all tumors carry mutations in P53. Because of its 
prevalence in cancer and its restricted expression to precancerous and 
cancerous cells, this antigen may be targeted on mutant P53-expressing 
tumors with minimal normal tissue toxicity.
    This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published Notice, the National 
Cancer Institute receives written evidence and argument that 
establishes that the grant of the license would not be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
license application, will not be treated confidentially and may be made 
publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information from these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: October 21, 2021.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2021-23289 Filed 10-25-21; 8:45 am]
BILLING CODE 4140-01-P

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