Prospective Grant of Exclusive Patent Commercialization License: CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use, 58681-58682 [2021-23092]

Download as PDF Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices 58681 TABLE 1—APPROVED ANDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED—Continued Application No. Drug ANDA 086511 ......... ANDA 086516 ......... ANDA 086550 ......... Ona-Mast (phentermine HCl) Capsules, 30 mg .................... Ona-Mast (phentermine HCl) Capsules, 30 mg .................... X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ........... ANDA ANDA ANDA ANDA ANDA ANDA 086551 086552 086553 086554 086735 086748 ......... ......... ......... ......... ......... ......... X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ........... X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ........... X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ........... X-Trozine (phendimetrazine tartrate) Tablets, 35 mg ........... Phentermine HCl Capsules, 15 mg ....................................... Theophylline Elixir, 80 mg/15 mL .......................................... ANDA ANDA ANDA ANDA 086766 087081 087226 087371 ......... ......... ......... ......... Nitrofurazone Ointment, 0.2% ............................................... Nitrofurazone Topical Solution, 0.2% .................................... Phentermine HCl Capsules, 30 mg ....................................... X-Trozine L.A. (phendimetrazine tartrate) Extended-Release Capsules, 105 mg. Aminophylline Injection, 25 mg/mL ....................................... ANDA 087392 ......... ANDA 087394 ......... ANDA 087442 ......... ANDA 087636 ......... X-Trozine (phendimetrazine tartrate) Capsules, 35 mg ........ Neosar (cyclophosphamide) for Injection, 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial. Melfiat-105 (phendimetrazine tartrate) Extended-Release Capsules, 105 mg. Tropicamide Ophthalmic Solution, 0.5% ............................... ANDA ANDA ANDA ANDA ANDA ......... ......... ......... ......... ......... Tropicamide Ophthalmic Solution, 1% .................................. Paracaine (proparacaine HCl) Ophthalmic Solution, 0.5% ... Oby-Trim (phentermine HCl) Capsules, 30 mg .................... Triamcinolone Acetonide Cream, 0.025% ............................. Sodium Polystyrene Sulfonate USP Powder, 453.6 g/bottle ANDA 088897 ......... ANDA 089514 ......... Promethazine VC Plain (phenylephrine HCl and promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL. Aerolate (theophylline) Oral Solution, 150 mg/15 mL ........... Methocarbamol Tablets USP, 500 mg .................................. Methocarbamol Tablets USP, 750 mg .................................. Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg. Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg. Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg. Trihexyphenidyl HCl Elixir, 2 mg/5 mL .................................. ANDA 089726 ......... Prednisone Oral Solution, 5 mg/5 mL ................................... ANDA 087487 ......... ANDA ANDA ANDA ANDA 087637 087681 087764 087932 088786 089141 089417 089418 089478 ......... ......... ......... ......... ANDA 089479 ......... ANDA 089480 ......... FDA finds that the holders of the ANDAs listed in table 1 have repeatedly failed to submit reports required by §§ 314.81 and 314.98. In addition, under § 314.200, FDA finds that the holders of the ANDAs have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the ANDAs listed in table 1 and all amendments and supplements thereto, is hereby withdrawn, effective October 22, 2021. lotter on DSK11XQN23PROD with NOTICES1 Applicant Dated: October 19, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23075 Filed 10–21–21; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:47 Oct 21, 2021 Jkt 256001 MM Mast and Co. Do. Shire Richwood, Inc., 7900 Tanners Gate Dr., Suite 200, Florence, KY 41042. Do. Do. Do. Do. Camall Co., Inc. Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. Wendt Laboratories, Inc. Do. Camall Co., Inc. Shire Richwood, Inc. Pharma Serve, Inc., Subsidiary of Torigian Laboratories, 218–20 98th Ave., Queens Village, NY 11429. Shire Richwood, Inc. Bedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146. Numark Laboratories, Inc., 75 Mayfield Ave., Edison, NJ 08837. Miza Pharmaceuticals USA, Inc., c/o Optopics Laboratories. Do. Optopics Laboratories Corp. Shire Richwood, Inc. Ambix Laboratories, Division of Organics Corp. of America. Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. Do. Fleming and Co. Pharmaceuticals, Inc. American Therapeutics, Inc. Do. Do. Do. Do. Pharmaceutical Ventures, Ltd., P.O. Box D3700, Pomona, NY 10970. Wockhardt EU Operations (Swiss) AG, c/o Morton Grove Pharmaceuticals, Inc. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent Commercialization License: CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use National Institutes of Health, Health and Human Services (HHS). AGENCY: ACTION: Notice. The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Ankarys Therapeutics Inc., located at SUMMARY: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 110 Cumberland Street, Suite 520, M5R 3V5, Toronto, Ontario, Canada, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice. DATES: Only written comments and/or applications for a license which are received by the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases on or before November 8, 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: Dawn Taylor-Mulneix, Technology Transfer and Patent Specialist, Technology Transfer and E:\FR\FM\22OCN1.SGM 22OCN1 lotter on DSK11XQN23PROD with NOTICES1 58682 Federal Register / Vol. 86, No. 202 / Friday, October 22, 2021 / Notices Intellectual Property Office, National Institute of Allergy and Infectious Diseases, National Institutes of Health; phone number 301–767–5189, or dawn.taylor-mulneix@nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: PCT Patent Application Number PCT/US2020/ 024985, filed March 26, 2020, entitled ‘‘CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use’’ (HHS Reference No. E–097–2020–00– PCT), and U.S. and foreign patent applications claiming priority to the aforementioned application. All rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive patent commercialization license territory may be worldwide, and the field of use may be limited to: ‘‘Use of natural killer cell immunotherapies for the treatment of multiple myeloma, non-Hodgkin lymphoma, and pancreatic cancer’’. Engineered chimeric antigen receptors (CARs) that are expressed in cytotoxic T cells and natural killer (NK) cells have been used to specifically target tumor cells. However, CAR–T and CAR–NK cells are still subject to down regulation by their inhibitory receptors after injection into patients. Scientists at NIAID have developed CAR constructs that overcome inhibition of NK cells by receptors for human major histocompatibility complex molecules HLA–E and HLA–C, based on in vitro studies. The CAR contains an antigen binding domain of receptor CD28 homolog (CD28H), a CD28H transmembrane domain (TM), a CD28H signaling domain, and other intracellular signaling domains, such as 2B4 (CD244) and CD3 zeta chain (CD3zeta). A variant of this CAR, in which the antigen binding domain of CD28H is replaced by a single-chain antibody variable region (scFv) that binds to CD19, rendered NK cells resistant to inhibition by HLA–E and HLA–C on CD19+ tumor cells. An abstract for this invention was published in the Federal Register on April 22, 2020. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing, and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases receives written evidence and argument that establishes that the grant of the license would not VerDate Sep<11>2014 17:47 Oct 21, 2021 Jkt 256001 be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. 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 in 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 19, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–23092 Filed 10–21–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Cellular and Molecular Biology of Neurodegeneration Study Section, October 28, 2021, 10:00 a.m. to October 29, 2021, 06:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on September 24, 2021, FR Doc 2021–20784 86 FR 53084. This meeting is being amended to change the Contact Person from Christine Jean DiDonato to Laurent Taupenot, Ph.D., Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (301) 435–1203. The meeting is closed to the public. Dated: October 19, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–23082 Filed 10–21–21; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Physiology and Pathobiology of Cardiovascular and Respiratory Systems. Date: November 16–17, 2021. Time: 9:00 a.m. to 9:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kimm Hamann, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118A, MSC 7814, Bethesda, MD 20892, 301–435– 5575, hamannkj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Population Sciences and Epidemiology. Date: November 17–18, 2021. Time: 9:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ananya Paria, DHSC, MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1007H, Bethesda, MD 20892, (301) 827–6513, pariaa@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Infectious Disease and Reproductive Health. Date: November 17–18, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Lisa Steele, Ph.D., Scientific Review Officer, PSE IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, E:\FR\FM\22OCN1.SGM 22OCN1

Agencies

[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58681-58682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent Commercialization License: 
CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use

AGENCY: National Institutes of Health, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The National Institute of Allergy and Infectious Diseases, an 
institute of the National Institutes of Health, Department of Health 
and Human Services, is contemplating the grant of an exclusive patent 
license to Ankarys Therapeutics Inc., located at 110 Cumberland Street, 
Suite 520, M5R 3V5, Toronto, Ontario, Canada, to practice the 
inventions embodied in the patent applications listed in the 
Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the Technology Transfer and Intellectual Property 
Office, National Institute of Allergy and Infectious Diseases on or 
before November 8, 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: Dawn Taylor-Mulneix, Technology Transfer and 
Patent Specialist, Technology Transfer and

[[Page 58682]]

Intellectual Property Office, National Institute of Allergy and 
Infectious Diseases, National Institutes of Health; phone number 301-
767-5189, or [email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: PCT Patent 
Application Number PCT/US2020/024985, filed March 26, 2020, entitled 
``CD28H Domain-Containing Chimeric Antigen Receptors and Methods of 
Use'' (HHS Reference No. E-097-2020-00-PCT), and U.S. and foreign 
patent applications claiming priority to the aforementioned 
application.
    All rights in these inventions have been assigned to the Government 
of the United States of America.
    The prospective exclusive patent commercialization license 
territory may be worldwide, and the field of use may be limited to: 
``Use of natural killer cell immunotherapies for the treatment of 
multiple myeloma, non-Hodgkin lymphoma, and pancreatic cancer''.
    Engineered chimeric antigen receptors (CARs) that are expressed in 
cytotoxic T cells and natural killer (NK) cells have been used to 
specifically target tumor cells. However, CAR-T and CAR-NK cells are 
still subject to down regulation by their inhibitory receptors after 
injection into patients.
    Scientists at NIAID have developed CAR constructs that overcome 
inhibition of NK cells by receptors for human major histocompatibility 
complex molecules HLA-E and HLA-C, based on in vitro studies. The CAR 
contains an antigen binding domain of receptor CD28 homolog (CD28H), a 
CD28H transmembrane domain (TM), a CD28H signaling domain, and other 
intracellular signaling domains, such as 2B4 (CD244) and CD3 zeta chain 
(CD3zeta). A variant of this CAR, in which the antigen binding domain 
of CD28H is replaced by a single-chain antibody variable region (scFv) 
that binds to CD19, rendered NK cells resistant to inhibition by HLA-E 
and HLA-C on CD19+ tumor cells. An abstract for this invention was 
published in the Federal Register on April 22, 2020.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent commercialization license 
will be royalty bearing, and may be granted unless within fifteen (15) 
days from the date of this published notice, the National Institute of 
Allergy and Infectious Diseases 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.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent 
commercialization license. 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 in 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 19, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-23092 Filed 10-21-21; 8:45 am]
BILLING CODE 4140-01-P