On December 3, 2019 FORMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that the company will present at two meetings in December (Press release, Forma Therapeutics, DEC 3, 2019, View Source [SID1234551872]):

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31st Annual Piper Jaffray Healthcare Conference, Thursday, Dec. 5, 2019 at 8:10 a.m. EST in New York, NY.
FORMA Investor Lunch at the 2019 ASH (Free ASH Whitepaper) Annual Meeting, Monday, Dec. 9, 2019 at 12:00 p.m. EST at the Hilton Orlando. Presentations will highlight FT-4202, a novel, selective pyruvate kinase-R (PKR) activator in sickle cell disease, and olutasidenib, an IDH1m inhibitor that acts as a single agent or in combination with azacitidine in acute myeloid leukemia (AML) and myelodysplastic syndrome. This event will be webcast and can be accessed through FORMA Therapeutics Investor page. A replay of the webcast will be available approximately two hours after the completion of the live event.

On December 3, 2019 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T-cell therapies to treat cancers, reported that new clinical data from its first-in-human study of ET019003, an anti-CD19 T-cell therapy for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL), will be presented in a poster session at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 8, 2019 (Press release, Eureka Therapeutics, DEC 3, 2019, View Source [SID1234551889]). ET019003 is engineered by incorporating a co-stimulatory molecule into T-cells expressing an anti-CD19 antibody T-cell receptor (AbTCR) core structure, representing the next generation of Eureka’s novel T-cell therapy generated with the ARTEMIS T-cell platform.

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"We are excited to be selected for poster presentation at the 2019 ASH (Free ASH Whitepaper) Meeting," said Dr. Cheng Liu, Founder & CEO of Eureka Therapeutics. "This is significant recognition of the progress we are making in the development of novel T cell therapies from our ARTEMIS platform, and we look forward to sharing additional updates from our additional programs at the conference."

Details of the poster presentation are as follows:

Title:

First-in-Human Study of ET019003, a Next Generation Anti-CD19 T-Cell Therapy, in Patients with Relapsed/Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

Publication:

2870

Session:

626

Date:

Sunday, December 8, 2019

Time:

6:00 – 8:00pm EST

Location:

Orange County Convention Center, Hall B

Presenter:

Pengcheng He, the First Affiliated Hospital of Xi’an Jiaotong University, China

The ASH (Free ASH Whitepaper) abstract is now available at www.hematology.org. The poster presentation will include additional data not available in the abstract.

On December 3, 2019 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, and Hanmi Pharmaceutical Co., LTD reported a license and collaboration agreement for FLX475 in Asia (Press release, RAPT Therapeutics, DEC 3, 2019, View Source [SID1234570684]). FLX475 is an oral, small molecule CCR4 antagonist in development for the treatment of multiple cancers.

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"We are actively building our immuno-oncology portfolio, and see FLX475 as a potential keystone in our effort to deliver new safe and effective cancer therapeutics to patients who need them," said Hanmi CEO Se-Chang Kwon, Ph.D. "This compound complements our current product portfolio and has the potential to address a large and growing population of patients suffering from cancers that are prevalent in Asian countries. We look forward to partnering with RAPT to advance FLX475 through the clinic efficiently."

Under the terms of the agreement, RAPT will receive $10 million in an upfront payment and near-term milestone payment. Additionally, RAPT will receive up to $48 million in success-based development milestones and up to $60 million in potential sales milestones, as well as double-digit royalties on any future sales of FLX475 in the specified territories. In return, Hanmi will receive an exclusive license to develop, in parallel with RAPT, and commercialize FLX475 for the treatment of cancer in South Korea and China, including Taiwan and Hong Kong. In addition to leveraging its clinical trial infrastructure in Korea and China to augment RAPT’s ongoing Phase 1/2 clinical study of FLX475, Hanmi will also conduct a Phase 2 clinical trial in Korea and China to evaluate FLX475 in patients with gastric cancer.

"FLX475 targets "charged" tumors including virally-associated cancers, gastric cancer, non-small cell lung cancer, triple negative breast cancer and head and neck cancers, which are predicted to have high levels of CCR4 ligands, regulatory T cells and CD8+ effector T cells," said Yung-Jue Bang, M.D., Ph.D., professor of Medical Oncology at Seoul National University Hospital. "I believe FLX475 has the potential to offer patients a new therapeutic option that is desperately needed, particularly in Korea, which has the highest rate of gastric cancer in the world."

"This collaboration with Hanmi can provide us an entry point into the Asian market, allowing us to potentially expand our geographic footprint in a region with high prevalence of patients with "charged" tumors who we believe are most likely to respond to FLX475," said Brian Wong, M.D., Ph.D., president and CEO of RAPT Therapeutics. "Hanmi, with its fully integrated R&D infrastructure and nimble execution efficiency, has accumulated clinical development experiences and an extensive network of key opinion leaders. We believe Hanmi is a perfect partner for the development of FLX475."

FLX475 is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Treg represent a dominant pathway for downregulating the immune response, and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. RAPT is developing FLX475 for the treatment of a broad range of "charged" tumors, which represent cancer types the company believes are most likely to respond to FLX475, where a large quantity of Treg cells are likely to be the cause of immune suppression within the tumor. FLX475 blocks the migration of Treg to the tumor, which may restore naturally occurring antitumor immunity and synergizing with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators and adoptive T cell therapy.

RAPT is currently enrolling patients in a Phase 1/2 study of FLX475 as a monotherapy, and in combination with pembrolizumab, in patients with "charged" tumors and expect results from the Phase 2 portion of the trial in the first half of 2020.

On December 3, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease (Press release, Immunomedics, DEC 3, 2019, View Source [SID1234551873]).

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"We appreciate FDA’s guidance during the resubmission period and look forward to working closely with the Agency during the BLA review," said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "We are pleased to have reached this important milestone and believe that sacituzumab govitecan, if approved, could become an important new treatment option for patients with late-stage mTNBC."

On December 3, 2019 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that it received a $5 million milestone payment from Ipsen, triggered by Ipsen’s decision to progress the ongoing multi-part clinical trial evaluating ONIVYDE in patients with small-cell lung cancer into the second randomized portion of the trial focused on efficacy assessment (Press release, Merrimack, DEC 3, 2019, View Source [SID1234551890]). As a result of this milestone payment, Merrimack’s Board of Directors has authorized and declared a special cash dividend of $6.7 million on the Company’s common stock (the "Special Dividend").

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The Special Dividend is payable on December 23, 2019 to stockholders of record as of the close of business on December 16, 2019. The ex-dividend date for the Special Dividend will be December 13, 2019, the first business day preceding the record date. Stockholders of record on the record date who sell their shares prior to the ex-dividend date will not receive the Special Dividend. Based on the current number of shares outstanding, the Special Dividend will be approximately $0.50 per common share; this amount may vary based on the number of outstanding shares as of the record date.

Merrimack currently estimates that, for U.S. federal tax purposes, 100% of the Special Dividend (or approximately $0.50 per share) will likely be first treated as a return of capital to stockholders to the extent of their basis in Merrimack common stock, and then as capital gain.

The tax treatment of the Special Dividend will be based on Merrimack’s current and accumulated earnings and profits for Merrimack’s 2019 fiscal year ending December 31, 2019 ("FY19"). The process of determining current and accumulated earnings and profits requires a final determination of Merrimack’s financial results for FY19 and a review of certain other factors. The determination will be based in part on factors that are outside of the control of Merrimack and which cannot be ascertained at this time. Merrimack does not expect the calculation of the portion that will be treated as a taxable dividend for federal tax purposes to be finalized until after the completion of FY19. Accordingly, the portion of the Special Dividend estimated to be a taxable dividend provided in this release is based upon currently available information and is subject to change.

The precise tax impact of the Special Dividend to specific stockholders depends upon the stockholder’s individual tax situation. Stockholders are advised to consult with their personal tax advisors.

"The progress that we have made in streamlining our operating costs is reflected in the authorization of a special dividend higher than the amount of the milestone that we have received from Ipsen," said Gary Crocker, Chairman of Merrimack’s Board of Directors. "Our remaining cash balance is anticipated to support operations into 2027, when we estimate the longest-term potential Ipsen milestone may be achieved."