82_FR_36958 82 FR 36808 - Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers

82 FR 36808 - Prospective Grant of Exclusive Patent License: The Development of a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the Treatment of Human Liver Cancers

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 150 (August 7, 2017)

Page Range36808-36809
FR Document2017-16525

The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Salubris Biotherapeutics, Inc. (Salubris), located in Gaithersburg, Maryland, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

Federal Register, Volume 82 Issue 150 (Monday, August 7, 2017) 
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36808-36809]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: The Development of 
a Bispecific, Biparatopic Antibody-Drug Conjugate to GPC3 for the 
Treatment of Human Liver Cancers

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, National Institutes of Health, 
Department of Health and Human Services, is contemplating the grant of 
an Exclusive Patent License to Salubris Biotherapeutics, Inc. 
(Salubris), located in Gaithersburg, Maryland, 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 NCI Technology Transfer Center on or before August 
22, 2017 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: David A. Lambertson, Ph.D., Senior Licensing and 
Patenting Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702; Telephone: (240) 276-6467; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: The following represents the intellectual 
property to be licensed under the prospective agreement: (A) U.S. 
Provisional Patent Application 61/654,232 entitled ``High-affinity 
Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-
2012/0-US-01], PCT Patent Application PCT/US2013/043633 entitled 
``High-affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' 
[HHS Ref. E-136-2012/0-PCT-02], Chinese Patent Application 
201380039993.7 entitled ``High-affinity Monoclonal Antibodies To 
Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-CN-03], Japanese 
Patent Application 2015-515243 entitled ``High-affinity Monoclonal 
Antibodies To Glypican-3 And Use Thereof'' [HHS Ref. E-136-2012/0-JP-
04], South Korean Patent Application 10-2014-7037046 entitled ``High-
affinity Monoclonal Antibodies To Glypican-3 And Use Thereof'' [HHS 
Ref. E-136-2012/0-KR-05], Singapore Patent Application 11201407972R 
entitled ``High-affinity Monoclonal Antibodies To Glypican-3 And Use 
Thereof'' [HHS Ref. E-136-2012/0-SG-06], and United States Patent 
9,409,994 entitled ``High-affinity Monoclonal Antibodies To Glypican-3 
And Use Thereof'' [HHS Ref. E-136-2012/0-US-07], and all continuing 
U.S. and foreign patents/patent applications for the technology family; 
and (B) U.S. Provisional Patent Application 61/477,020 entitled ``Human 
Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. 
E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011/0-PCT-02], Chinese Patent 201280029201.3 entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011/0-EP-04], and validated in France [HHS Ref. E-130-2011/
0-FR-09], Germany [HHS Ref. E-130-2011/0-DE-08] and the United Kingdom 
[HHS Ref. E-130-2011/0-GB-10] and lodged in Hong Kong [HHS Ref. E-130-
2011/0-HK-11], United States Patent 9,206,257 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011/0-US-05], United States Patent 9,394,364, entitled 
``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' 
[HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 
entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use 
Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent 
Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific 
for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-12], Chinese 
Patent Application 201610290837.3 entitled ``Human Monoclonal 
Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-
2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human 
Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS 
Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/
patent applications for the technology family, to Salubris. The patent 
rights in these inventions have been assigned to and/or exclusively 
licensed to the Government of the United States of America.
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America.
    The prospective Exclusive Patent License territory may be worldwide 
for the following field of use:

    The development and commercialization of a bispecific, 
biparatopic antibody-drug conjugate (ADC) having:
    (1) The CDR sequences of both the hYP7 and HN3 anti-GPC3 
monoclonal antibodies; and
    (2) a microtubule inhibitor payload including, but not limited 
to, auristatin and mertansine;

for the treatment of human liver cancer. The licensed field of use 
excludes any (a) non-specified immunoconjugates, including, but not 
limited to, chimeric antigen receptors (CARs) and variants thereof, 
immunotoxins, ADCs with payloads that are not microtubule 
inhibitors, and monospecific versions of the aforementioned 
immunoconjugates, and (b) unconjugated antibodies.

    The present inventions to be licensed concern monoclonal antibodies 
that are specific for the cell surface domain of GPC3: HN3 and hYP7. 
These antibodies can potentially be used for the treatment of GPC3-
expressing cancers such as HCC. In the subject situation, the 
antibodies can be used in conjunction to target a toxic payload 
specifically to GPC3-expressing cells, leading to the selective 
destruction of the cancerous cells.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404.

[[Page 36809]]

The prospective Exclusive Patent License will be royalty bearing and 
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.
    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 License. 
Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: July 25, 2017.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2017-16525 Filed 8-4-17; 8:45 am]
BILLING CODE 4140-01-P

36808 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices would constitute a clearly unwarranted 1E530 MSC 9702, Bethesda, MD 20892– entitled ‘‘Human Monoclonal invasion of personal privacy. 9702 (for business mail), Rockville, MD Antibodies Specific for Glypican-3 And Name of Committee: National Institute of 20850–9702; Telephone: (240) 276– Use Thereof’’ [HHS Ref. E–130–2011/0– Allergy and Infectious Diseases Special 6467; Email: david.lambertson@nih.gov. US–06], European Patent Application Emphasis Panel; Asthma and Allergic SUPPLEMENTARY INFORMATION: The 15188264.4 entitled ‘‘Human Diseases Cooperative Research Centers. following represents the intellectual Monoclonal Antibodies Specific for Date: September 7–14, 2017. property to be licensed under the Glypican-3 And Use Thereof’’ [HHS Ref. Time: 12:00 p.m. to 6:00 p.m. prospective agreement: (A) U.S. E–130–2011/0–EP–07], United States Agenda: To review and evaluate grant Patent Application 15/090,873 entitled applications. Provisional Patent Application 61/ 654,232 entitled ‘‘High-affinity ‘‘Human Monoclonal Antibodies Place: The William F. Bolger Center, 9600 Specific for Glypican-3 And Use Newbridge Drive, Potomac, MD 20854. Monoclonal Antibodies To Glypican-3 Contact Person: Paul A. Amstad, Ph.D., And Use Thereof’’ [HHS Ref. E–136– Thereof’’ [HHS Ref. E–130–2011/0–US– Scientific Review Officer, Scientific Review 2012/0–US–01], PCT Patent Application 12], Chinese Patent Application Program, NIAID/NIH/DHHS, Division of PCT/US2013/043633 entitled ‘‘High- 201610290837.3 entitled ‘‘Human Extramural Activities, Room 3G41, 5601 affinity Monoclonal Antibodies To Monoclonal Antibodies Specific for Fishers Lane, Bethesda, MD 20892–7616, Glypican-3 And Use Thereof’’ [HHS Ref. Glypican-3 And Use Thereof’’ [HHS Ref. 240–669–5067, pamstad@niaid.nih.gov. E–136–2012/0–PCT–02], Chinese Patent E–130–2011/0–CN–13], European Patent (Catalogue of Federal Domestic Assistance Application 201380039993.7 entitled Application 16166924.7 entitled Program Nos. 93.855, Allergy, Immunology, ‘‘High-affinity Monoclonal Antibodies ‘‘Human Monoclonal Antibodies and Transplantation Research; 93.856, Specific for Glypican-3 And Use Microbiology and Infectious Diseases To Glypican-3 And Use Thereof’’ [HHS Ref. E–136–2012/0–CN–03], Japanese Thereof’’ [HHS Ref. E–130–2011/0–EP– Research, National Institutes of Health, HHS) 14], and all continuing U.S. and foreign Patent Application 2015–515243 Dated: August 1, 2017. entitled ‘‘High-affinity Monoclonal patents/patent applications for the Sylvia L. Neal, Antibodies To Glypican-3 And Use technology family, to Salubris. The Program Analyst, Office of Federal Advisory Thereof’’ [HHS Ref. E–136–2012/0–JP– patent rights in these inventions have Committee Policy. been assigned to and/or exclusively 04], South Korean Patent Application [FR Doc. 2017–16522 Filed 8–4–17; 8:45 am] licensed to the Government of the 10–2014–7037046 entitled ‘‘High- United States of America. BILLING CODE 4140–01–P affinity Monoclonal Antibodies To With respect to persons who have an Glypican-3 And Use Thereof’’ [HHS Ref. obligation to assign their right, title and E–136–2012/0–KR–05], Singapore interest to the Government of the United DEPARTMENT OF HEALTH AND Patent Application 11201407972R HUMAN SERVICES States of America, the patent rights in entitled ‘‘High-affinity Monoclonal these inventions have been assigned to Antibodies To Glypican-3 And Use the Government of the United States of National Institutes of Health Thereof’’ [HHS Ref. E–136–2012/0–SG– America. Prospective Grant of Exclusive Patent 06], and United States Patent 9,409,994 The prospective Exclusive Patent License: The Development of a entitled ‘‘High-affinity Monoclonal License territory may be worldwide for Bispecific, Biparatopic Antibody-Drug Antibodies To Glypican-3 And Use the following field of use: Conjugate to GPC3 for the Treatment Thereof’’ [HHS Ref. E–136–2012/0–US– 07], and all continuing U.S. and foreign The development and commercialization of Human Liver Cancers of a bispecific, biparatopic antibody-drug patents/patent applications for the conjugate (ADC) having: AGENCY: National Institutes of Health, technology family; and (B) U.S. (1) The CDR sequences of both the hYP7 HHS. Provisional Patent Application 61/ and HN3 anti-GPC3 monoclonal antibodies; ACTION: Notice. 477,020 entitled ‘‘Human Monoclonal and Antibody Specific for Glypican-3 And (2) a microtubule inhibitor payload SUMMARY: The National Cancer Institute, Use Thereof’’ [HHS Ref. E–130–2011/0– including, but not limited to, auristatin and National Institutes of Health, US–01], PCT Patent Application PCT/ mertansine; Department of Health and Human US2012/034186 entitled ‘‘Human for the treatment of human liver cancer. The Services, is contemplating the grant of Monoclonal Antibodies Specific for licensed field of use excludes any (a) non- an Exclusive Patent License to Salubris specified immunoconjugates, including, but Glypican-3 And Use Thereof’’ [HHS Ref. not limited to, chimeric antigen receptors Biotherapeutics, Inc. (Salubris), located E–130–2011/0–PCT–02], Chinese Patent (CARs) and variants thereof, immunotoxins, in Gaithersburg, Maryland, to practice 201280029201.3 entitled ‘‘Human ADCs with payloads that are not microtubule the inventions embodied in the patent Monoclonal Antibodies Specific for inhibitors, and monospecific versions of the applications listed in the Glypican-3 And Use Thereof’’ [HHS Ref. aforementioned immunoconjugates, and (b) SUPPLEMENTARY INFORMATION section of E–130–2011/0–CN–03], European Patent unconjugated antibodies. this notice. 2699603 entitled ‘‘Human Monoclonal The present inventions to be licensed DATES: Only written comments and/or Antibodies Specific for Glypican-3 And concern monoclonal antibodies that are applications for a license which are Use Thereof’’ [HHS Ref. E–130–2011/0– specific for the cell surface domain of received by the NCI Technology EP–04], and validated in France [HHS GPC3: HN3 and hYP7. These antibodies Transfer Center on or before August 22, Ref. E–130–2011/0–FR–09], Germany can potentially be used for the treatment 2017 will be considered. [HHS Ref. E–130–2011/0–DE–08] and of GPC3-expressing cancers such as ADDRESSES: Requests for copies of the the United Kingdom [HHS Ref. E–130– HCC. In the subject situation, the mstockstill on DSK30JT082PROD with NOTICES patent applications, inquiries, and 2011/0–GB–10] and lodged in Hong antibodies can be used in conjunction to comments relating to the contemplated Kong [HHS Ref. E–130–2011/0–HK–11], target a toxic payload specifically to Exclusive Patent License should be United States Patent 9,206,257 entitled GPC3-expressing cells, leading to the directed to: David A. Lambertson, Ph.D., ‘‘Human Monoclonal Antibodies selective destruction of the cancerous Senior Licensing and Patenting Specific for Glypican-3 And Use cells. Manager, NCI Technology Transfer Thereof’’ [HHS Ref. E–130–2011/0–US– This notice is made in accordance Center, 9609 Medical Center Drive, RM 05], United States Patent 9,394,364, with 35 U.S.C. 209 and 37 CFR part 404. VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1

Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36809 The prospective Exclusive Patent MD 20892, 240–747–7825, anita.undale@ With respect to persons who have an License will be royalty bearing and may nih.gov. obligation to assign their right, title and be granted unless within fifteen (15) (Catalogue of Federal Domestic Assistance interest to the Government of the United days from the date of this published Program Nos. 93.866, Aging Research, States of America, the patent rights in notice, the National Cancer Institute National Institutes of Health, HHS) these inventions have been assigned to receives written evidence and argument Dated: August 1, 2017. the Government of the United States of that establishes that the grant of the David Clary, America. license would not be consistent with the Program Analyst, Office of Federal Advisory The prospective Exclusive Patent requirements of 35 U.S.C. 209 and 37 Committee Policy. License territory may be worldwide for CFR part 404. [FR Doc. 2017–16521 Filed 8–4–17; 8:45 am] the following field of use: MicroRNA Complete applications for a license in BILLING CODE 4140–01–P therapeutics for squamous cell the prospective field of use that are carcinomas. The invention relates to the use of timely filed in response to this notice DEPARTMENT OF HEALTH AND microRNAs (miRs), miR mimics, miR will be treated as objections to the grant HUMAN SERVICES mimetics, and a combination thereof as of the contemplated Exclusive Patent anti-proliferative cancer therapeutics. In License. Comments and objections National Institutes of Health this case, miRs will be administered in submitted to this notice will not be a form complexed with nanoparticles in made available for public inspection Prospective Grant of Exclusive Patent the form of liposomes decorated with and, to the extent permitted by law, will License: MicroRNA Therapeutics for anti-transferrin receptor (TfR) scFv not be released under the Freedom of Treating Squamous Cell Carcinomas fragments. Generally, miRs are a highly Information Act, 5 U.S.C. 552. conserved class of small RNA molecules AGENCY: National Institutes of Health, Dated: July 25, 2017. (about 18–24bp) that primarily bind the HHS. Richard U. Rodriguez, 3’-UTR region of mRNA molecules and ACTION: Notice. Associate Director, Technology Transfer either block translation or promote Center, National Cancer Institute. SUMMARY: The National Heart, Lung and nuclease mediated degradation. The [FR Doc. 2017–16525 Filed 8–4–17; 8:45 am] Blood Institute (NHLBI), National inventors found that mimics or BILLING CODE 4140–01–P Institutes of Health, Department of mimetics derived from several members Health and Human Services, is of the miR–30–5p family; and miR–30a– contemplating the grant of an Exclusive 5p and miR–30e–5p, have potential as DEPARTMENT OF HEALTH AND Patent License to MiRecule, Inc., located anti-proliferative therapeutics in cancers HUMAN SERVICES in Rockville, Maryland, to practice the including but not limited to squamous inventions embodied in the patent cell carcinomas and currently have a National Institutes of Health applications listed in the CRADA with NIDCD exploring their SUPPLEMENTARY INFORMATION section of uses in treating head and neck National Institute on Aging; Notice of this notice. squamous cell carcinoma (HNSSC). In Closed Meeting an in vivo proof-of-concept using a DATES: Only written comments and/or applications for a license which are murine xenograft tumor model for Pursuant to section 10(d) of the HNSSC, the inventors demonstrated that Federal Advisory Committee Act, as received by the NHLBI Office of Technology Transfer and Development intraperitoneal administration of a amended, notice is hereby given of the nanoliposome formulated with an anti- following meeting. August 22, 2017 will be considered. ADDRESSES: Requests for copies of the transferrin receptor antibody fragment The meeting will be closed to the and a synthetic miR–30a–5p mimic public in accordance with the patent applications, inquiries, and strongly delayed tumor growth. Other provisions set forth in sections comments relating to the contemplated anti-cancer miR therapeutic mimics can 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Exclusive Patent License should be be combines with miR–30 including as amended. The grant applications and directed to: Michael Shmilovich, Esq., miR–145–5p, miR–26a–5p, miR–26b– the discussions could disclose Senior Licensing and Patent Manager, 5p, miR–375–5p, miR–30b–5p, miR– confidential trade secrets or commercial 31 Center Drive, Room 4A29, MSC2479, 30d–5p, or miR–338–3p. Modes of property such as patentable material, Bethesda, MD 20892–2479, phone administration can be by intravenous and personal information concerning number 301–435–5019, or shmilovm@ injection, intraperitoneal injection, individuals associated with the grant mail.nih.gov. subcutaneous injection, or intratumoral applications, the disclosure of which SUPPLEMENTARY INFORMATION: The injection. Therapeutic design employing would constitute a clearly unwarranted following represents the intellectual miR mimicry focuses on nucleic acid invasion of personal privacy. property to be licensed under the modifications that exhibit better Name of Committee: National Institute on prospective agreement: HHS Ref. No. E– cytotoxicity than unmodified miRs or Aging Special Emphasis Panel; Drugs 043–2016/0, including provisional commercially available mimics. For Targeting Pathways of Aging. patent application 62/304,844 filed example, it is accepted that Date: September 13, 2017. March 7, 2016 and International Patent modification of the 2’ position of Time: 3:00 p.m. to 6:00 p.m. Application PCT/US2017/021178 filed individual nucleic acids in an Agenda: To review and evaluate grant March 7, 2017 both entitled oligonucleotide can improve affinity to applications. ‘‘MicroRNAs And Methods Of Their complementary strands and confer mstockstill on DSK30JT082PROD with NOTICES Place: National Institute on Aging, Use,’’ and all continuing U.S. and resistance to nucleases and reduce Gateway Building, 2W200, 7201 Wisconsin foreign patents/patent applications for adverse immunogenic reactions. By way Avenue, Bethesda, MD 20892 (Telephone Conference Call). the technology family, to MiRecule. The of another example, bases 1, 6, and 20 Contact Person: Anita H. Undale, Ph.D., patent rights in these inventions have of a passenger strand miR can be MD, Scientific Review Branch, National been assigned to and/or exclusively mutated to increase the stability of the Institute on Aging, Gateway Building, Suite licensed to the Government of the resulting duplex; however, these 2W200, 7201 Wisconsin Avenue, Bethesda, United States of America. mutation sites may differ from one VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1


Document Created: 2017-08-05 03:00:05
Document Modified: 2017-08-05 03:00:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesOnly written comments and/or applications for a license which are received by the NCI Technology Transfer Center on or before August 22, 2017 will be considered.
FR Citation82 FR 36808 
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