33176 Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: The Development of an 

Anti-Mesothelin Chimeric Antigen 

Receptor (CAR) for the Treatment of 

Mesothelin-Expressing Human 

Cancers 

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 

practice the inventions embodied in the 

Patents and Patent Applications listed 

in the Supplementary Information 

section of this notice to Evotec 

International GmbH (Evotec), located in 

Hamburg, Germany. 

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 June 16, 2022 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: David A. Lambertson, Ph.D., 

Technology Transfer Manager, NCI 

Technology Transfer Center, Telephone: 

(240) 276–6467; Email: 

david.lambertson@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

U.S. Provisional Patent Application 

62/508,197 entitled ‘‘Anti-Mesothelin 

Polypeptides and Proteins’’ [HHS Ref. 

E–106–2017–0–US–01], PCT Patent 

Application PCT/US2018/033236 

entitled ‘‘Anti-Mesothelin Polypeptides 

and Proteins’’ [HHS Ref. E–106–2017– 

0–PCT–02], U.S. Patent Application 16/ 

631,971 entitled ‘‘Anti-Mesothelin 

Polypeptides and Proteins’’ [HHS Ref. 

E–106–2017–0–US–03], U.S. Provisional 

Patent Application 63/290,761 entitled 

‘‘Anti-Mesothelin Polypeptides and 

Proteins’’ [HHS Ref. E–033–2021–0–US– 

01], and U.S. and foreign patent 

applications claiming priority to the 

aforementioned applications. 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the government of the 

United States of America. 

The license to be granted may be 

worldwide, and may be limited to the 

following field of use: 

‘‘The development, production and 

commercialization of a mono-, bi-, or multispecific anti-MLSN (Mesothelin) chimeric 

antigen receptor (CAR)-based allogeneic 

immunotherapy using genetically 

engineered, iPSC-derived human NK cells 

where the CAR has at least: 

(1) The complementary determining region 

(CDR) sequences of the (humanized) antiMSLN antibody known as 15B6; 

(2) A transmembrane domain; and 

(3) At least one signaling domain, 

for the treatment of MLSN-expressing solid 

tumors.’’ 

Mesothelin is a cell surface protein 

that is expressed on a number of types 

of cancer cells, including mesothelioma, 

pancreatic cancer, ovarian cancer, and 

certain lung cancers. There are currently 

few effective therapies for patients with 

these types of cancers, with many 

patients experiencing disease relapse. 

Upon relapse, there are even fewer 

second-line therapeutic options, 

underscoring an unmet patient need. 

The development of an anti-mesothelin 

CAR-based therapy can potentially be 

used for the treatment of mesothelinexpressing cancers. As a result, the 

development of a new therapeutic 

option targeting mesothelin will benefit 

public health by providing an effective 

treatment for patients that might 

otherwise have no options. 

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 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: May 25, 2022. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2022–11666 Filed 5–31–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Substance Abuse and 

Mental Health Services Administration 

has modified its structure. This new 

organizational structure was approved 

by the Deputy Secretary of Health and 

Human Services on April 27, 2022 and 

became effective on May 13, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Robert T. Atanda, Ph.D., Director, 

Division of Management Services, Office 

of Management, Technology, and 

Operations, Substance Abuse and 

Mental Health Services Administration, 

Parklawn Building, Room 12E49, 5600 

Fishers Lane, Rockville, MD, 20857 

Phone: 240–276–2826 

Part M of the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) Statement of Organization, 

Functions, and Delegations of Authority 

for the Department of Health and 

Human Services (DHHS) at 73, Number 

147, pages 44274–44275, July 30, 2008, 

is amended to reflect the new functional 

statement for the Center for Substance 

Abuse Prevention. This notice identifies 

a new Office of Prevention Innovation 

(OPI). This change allows innovative 

prevention implementation. The 

changes are as follows: 

Section M.20, Functions is amended 

as follows: 

The functional statement for the 

Center for Substance Abuse Prevention 

is amended to name a new Office of 

Prevention Innovation. The functional 

statement for each office is as follows: 

Office of Prevention Innovation 

The Office of Prevention Innovation 

(OPI) will provide support across the 

Center to promote leading edge 

programming in the substance misuse 

prevention and mental health 

promotion fields. The focus of the OPI 

team is to drive innovative prevention 

programming by analyzing program data 

to uncover common barriers to program 

implementation, as well as innovative 

approaches, and quickly turn these into 

technical assistance to the field. 

Historically, program evaluations have 

focused on long-term, big picture 

evaluation questions. OPI seeks to use a 

quick-turnaround implementation 

science and technical assistance model 


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