On March 13, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported that the FDA has accepted the company’s IND filing for AGEN1423 – a milestone in its partnership with Gilead Sciences, Inc (Press release, Agenus, MAR 13, 2019, View Source [SID1234534290]). This milestone triggered a cash payment of $7.5M. Agenus is eligible to receive additional milestone payments in 2019 and beyond.

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"This marks the first milestones in our collaboration with Gilead," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1423 is a first-in-class molecule which we designed to block mechanisms that tumors use to escape and grow; we believe that this molecule has great potential for patients with cancer."

The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received $150 million in upfront cash payment and equity investment and is also eligible for approximately $1.7 billion in potential future fees and milestones. Gilead received worldwide exclusive rights to AGEN1423, and exclusive option to license two additional programs: AGEN1223 and AGEN2373. Agenus is responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead also received right of first negotiation for two additional, undisclosed preclinical programs.

AGEN1423, AGEN1223 and AGEN2373 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.

On March 13, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that management will present in the 31st Annual ROTH Conference taking place March 17-19, 2019 in Dana Point, CA (Press release, OncoSec Medical, MAR 13, 2019, View Source [SID1234534292]).

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The Company’s presentation is via webinar and available at View Source

On March 13, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that the European Patent Office (EPO) has issued a composition of matter patent for CK-101 (also known as RX518) (Press release, Checkpoint Therapeutics, MAR 13, 2019, View Source [SID1234534318]). CK-101 is Checkpoint’s third-generation epidermal growth factor receptor (EGFR) inhibitor that is under development for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC).

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European Patent No. 3035936 specifically covers the compound CK-101 and a broad range of related compounds, salts and pharmaceutical compositions, including various dosage forms of such pharmaceutical compositions. It also covers certain uses of such compounds or salts in treating cancer or a disorder mediated by EGFR or NSCLC, either alone or in combination with an additional anti-cancer and/or cytotoxic agent.

The U.S. Patent and Trademark Office previously issued a U.S. counterpart composition of matter patent for CK-101 (U.S. Patent No. 9,550,770). Together, the patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extension in the U.S. under the Hatch-Waxman Act.

Additionally, in January 2019 the U.S. Patent and Trademark Office issued U.S. Patent No. 10,172,868, which claims a method of treating a patient diagnosed with NSCLC, metastatic NSCLC or NSCLC with EGFR mutations that is comprised of administering a therapeutically effective amount of CK-101. This U.S. patent is scheduled to expire in August 2034, not including any potential patent term extension.

"We are very pleased by the issuance of a European composition of matter patent for CK-101, in addition to a second U.S. patent, as they represent important milestones in our intellectual property strategy," said James F. Oliviero, President and CEO of Checkpoint. "We plan to continue to expand and fortify our intellectual property estate for CK-101 in the U.S. and abroad as we advance CK-101 toward Phase 3 trial initiation, which we expect later this year."

Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK‐101, which it acquired from NeuPharma, Inc. in 2015.

On March 13, 2019 Ambry Genetics, a Konica Minolta Company (Ambry), and leading provider of clinical and research genetic testing, reported a new laboratory services agreement with Clovis Oncology Inc., a biopharmaceutical company which shares Ambry’s commitment to advancing precision medicine for cancer (Press release, Ambry Genetics, MAR 13, 2019, View Source [SID1234553909]). Through this laboratory services agreement, Ambry Genetics and Clovis Oncology seek to identify clinical trial patients who may benefit from Rubraca, a therapy currently approved in the U.S. and Europe in multiple advanced ovarian cancer settings.

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Approximately 10 to 15% of ovarian cancer diagnoses are based on hereditary mutations of BRCA, meaning they are directly linked to mutations in the BRCA1 or BRCA2 genes passed on from a parent. Ambry’s genetic tests can identify mutations in these two genes, as well as related genes involved in the DNA repair pathway, thus enabling identification of potential risk, earlier diagnosis and more precise treatment.

"We are very excited to be working with the Clovis team, which is aligned with our precision medicine initiatives," said Brigette Tippin Davis, Ph.D., FACMG, Senior Vice President of Research & Development of Ambry Genetics, Inc. "Our mission is to help identify patients eligible for optimal therapies to improve outcomes and enhance quality of life."

Clovis chose to perform retrospective BRCA testing with Ambry Genetics, a high-quality genetics lab positioned to become a key player in the precision medicine space.

On March 13, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Peter Lawrence, President and Chief Operating Officer, and Brian Schwartz, MD, Chief Medical Officer and Head of Research and Development, of ArQule will present at Oppenheimer’s 29th Annual Healthcare Conference on March 20, 2019 at 10:20 a.m. ET at the Westin New York Grand Central in New York City (Press release, ArQule, MAR 13, 2019, View Source [SID1234534276]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.