On January 31, 2020, Sierra Oncology, Inc. (the "Company") reported that it has entered into a security purchase agreement (the "SPA") with Gilead Sciences, Inc. ("Gilead"), pursuant to which the Company agreed to (i) issue to Gilead 725,283 shares (the "Shares") of the Company’s common stock (the "Common Stock") and (ii) issue a warrant (the "Warrant") to purchase up to 725,283 shares of Common Stock (the "Warrant Shares"), with an exercise price equal to $13.20 per share, in consideration of the Company’s and Gilead’s agreement to amend that certain Asset Purchase Agreement dated August 20, 2018, as set forth in the Amendment to the Asset Purchase Agreement dated October 28, 2019 (Filing, 8-K, Sierra Oncology, JAN 31, 2020, View Source [SID1234553919]).

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The Warrant contains customary provisions allowing for adjustment to the exercise price and number of Warrant Shares issuable including in the event of any stock split, reverse stock split, stock dividend, other dividend or distribution of assets, recapitalization or similar transaction as described in the Warrant. In addition, subject to limited exceptions, Gilead will not have the right to exercise its Warrant to the extent that, after giving effect to such exercise, it, together with any affiliates, would beneficially own in excess of 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise, which percentage may be increased or decreased, from time to time, at Gilead’s election upon 61 days’ notice to the Company. The Warrant is exercisable from any time after the date of issuance, which was January 31, 2020, until its expiration on January 31, 2025.

The Shares, the Warrant, and Warrant Shares have not been registered under the Securities Act of 1933, as amended (the "1933 Act") and were issued in a private placement pursuant to Section 4(a)(2) of the 1933 Act.

Pursuant to the SPA, upon the request of Gilead, the Company will register the resale of the Shares and Warrant Shares.

As previously stated in a Current Report on Form 8-K filed with the Securities and Exchange Commission on November 13, 2019, a copy of the Amendment to the Asset Purchase Agreement will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

The foregoing summaries of the SPA and the Warrant do not purport to be complete and are subject to and qualified in their entirety by the terms of the SPA and the Warrant, copies of which are attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively, and are incorporated by reference herein.

On January 31, 2020 A scientific team is developing a new CAR T-cell gene therapy treatment for advanced metastatic prostate cancer at the Abramson Cancer Center of the University of Pennsylvania (Philadelphia, Pennsylvania) with a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT) (Press release, University of Pennsylvania, JAN 31, 2020, View Source [SID1234554029]).

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The ACGT grant was awarded to Joseph Fraietta, PhD, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, MD, director of the Prostate and Kidney Cancer Program, associate professor of medicine, and nationally renowned expert in the field of prostate and kidney cancer. The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy, a therapy that has been successful in treating blood cancers. Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.

"The grant from ACGT will help us advance our clinical work in a very novel way," said Dr. Fraietta. "If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer."

"The ACGT Scientific Advisory Council is impressed with the potential of this research team and their successful innovations in the use of T-cell therapy," noted Kevin Honeycutt, CEO and president of ACGT. "Because Drs. Fraietta and Haas are building on direct results already achieved with patients, there may be less transition time required to get a promising new treatment into the clinic for prostate cancer patients. Plus, we believe this research could provide a tumor-attack roadmap to help fight other cancers, including lung, pancreatic, ovarian and brain."

In the ACGT-funded study, Drs. Fraietta and Haas are going from the bedside back to the benchtop to employ new insight into how to better enable T-cells to battle cancer cells in solid tumors. Drs. Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality. This research builds on durable results being achieved by Dr. Haas in related prostate cancer clinical trials. In these trials, different doses of CAR T-cell gene therapies are being used to treat metastatic patients for whom traditional hormonal therapies, chemotherapies, radiation and surgery have failed.

"For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy," said Honeycutt. "Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise."

ACGT has been instrumental in funding some of the decade’s most transformative research, including breakthroughs in the use of CAR T-cell gene therapy for leukemia by the University of Pennsylvania’s Carl H. June, MD. "Dr. June received his first ACGT grant in 2004 and a second in 2008, back when gene therapy was considered a risky proposition," says Honeycutt. "Fast forward to today and the field has changed dramatically with major pharmaceutical companies and research institutions vying for the next big discovery using gene therapy or immunotherapy."

To learn more about Alliance for Cancer Gene Therapy (ACGT), visit acgtfoundation.org, call 203-358-5055, or join the ACGT community on Facebook, Twitter, Instagram and YouTube. To learn more about University of Pennsylvania’s Abramson Cancer Center, visit pennmedicine.org/cancer.

On January 31, 2020 The University of Pennsylvania, which has helped pioneer cell therapy approaches to blood cancers, reported that it has nabbed an ACGT grant to help battle solid tumors (Press release, University of Pennsylvania, JAN 31, 2020, View Source;utm_medium=rss [SID1234553740]).

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The research team has been handed a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT), and follows on from the 2004 grant it gave Penn’s Carl June, M.D., one of the predominate scientists involved in CAR-T research.

His work helped pave the work for this type of cell therapy to halt a number of blood cancers, but the latest grant is geared toward its next-gen work: Solid tumors. This has proven a much harder nut to crack for CAR-T, but the Penn U. scientists are hoping this grant will help them on their way.

The ACGT grant was awarded to Joseph Fraietta, Ph. D, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, M.D., director of the Prostate and Kidney Cancer Program, associate professor of medicine.

"The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy," the University said in a statement.

RELATED: A personalized CAR-T to attack every solid tumor? Pact Pharma has a plan

Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.

"The grant from ACGT will help us advance our clinical work in a very novel way," said Dr. Fraietta. "If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer."

Both Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality.

"For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy," said Honeycutt. "Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise."

On January 31, 2020 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported that company management will present at the BIO CEO and Investor Conference on Monday, February 10, 2020 at 9:30 a.m. ET in New York, NY (Press release, IMV, JAN 31, 2020, View Source [SID1234553741]).

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A live webcast of this presentation will be available under "Events, Webcasts and Presentations" in the investors section of the IMV website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.

On January 30, 2020 FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the achievement of clinical development milestones for two of its exclusively-licensed, clinical-stage products to Boehringer Ingelheim (BI) and Bristol-Myers Squibb Company (BMS) (NYSE:BMY) (Press release, Forma Therapeutics, JAN 30, 2020, View Source [SID1234553692]).

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BI initiated a Phase 1 clinical trial for BI 1701963, a SOS1:KRAS inhibitor discovered in a partnership with FORMA that targets protein-protein interactions for the treatment of cancer. KRAS mutations occur in one in seven of all human metastatic cancers, making it the most frequently mutated cancer-causing oncogene. The selective inhibition of SOS1 is a therapeutic concept that could allow KRAS blockade irrespective of KRAS mutation type. In 2011, BI 1701963 was exclusively licensed to Boehringer Ingelheim, who is leading the program’s development. Financial terms are undisclosed. Preclinical data regarding the discovery and development of BI 1701963 was presented by BI at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October 2019.

BMS initiated an open-label, Phase 1B dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-95775 (formerly FT-1101) in patients with advanced or unresectable solid tumors. CC-95775 is a pan-BET bromodomain inhibitor that was discovered under a partnership between FORMA and Celgene and exclusively licensed to Celgene in 2018. BMS is responsible for further development, and FORMA is eligible to receive potential milestone payments plus royalties for this and another asset based upon development, regulatory and sales objectives. FORMA recently presented data from a Phase 1 study of CC-95775 as a single agent in patients with relapsed or refractory hematologic malignancies at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper).

Frank Lee, CEO of FORMA said, "FORMA has a deep history of collaboration, and I’m excited about the achievement of these clinical milestones announced today. Our partnership with BI was among the early drug discovery initiatives focused on difficult-to-drug protein-protein interactions in cancer. We are gratified to see this pan-KRAS inhibitor, which BI licensed following early discovery work by FORMA, advance into the clinic and potentially offer a much-needed new therapy for patients with limited treatment options."

"In addition, our broad, multi-year collaboration with Celgene, since acquired by BMS, has yielded several novel candidates and valuable intellectual property, which is reflected in BMS’ and FORMA’s development pipelines. We are pleased to see the pan-BET inhibitor CC-95775 continue to advance in clinical studies with the potential to benefit patients with unresectable solid tumors," Mr. Lee concludes.