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 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."

On December 3, 2019 Luye Pharma of Yantai reported that it has acquired Shandong Boan Biological, a company developing biosimilar products, at a price unofficially reported to be $205 million (Press release, Luye Pharma, DEC 3, 2019, View Source [SID1234551907]). Luye said the acquisition includes Boan’s drug portfolio, antibody screening platform, antibody manufacturing platform and related IP. Boan currently has 8 biosimilar drugs in development, three of them in clinical trials. Previously, Luye in-licensed four biosimilars from Boan, including biosimilars to Avastin, Prolia,Xgeva and Eylea. Luye said the molecules at at the IND stage in the US and/or Europe and/or Japan.

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On December 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government (Press release, Puma Biotechnology, DEC 2, 2019, View Source [SID1234551817]). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

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STA Chief Executive Officer Carlo Montagner said, "The approval in Singapore is a key milestone for the company as NERLYNX is the first drug in our portfolio to be approved by the HSA for commercialization in Singapore. We look forward to extending the reach of this medicine, with regulatory dossiers also submitted in Malaysia, Brunei and the Philippines."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "We have been extremely pleased with the strong commercial strategy implemented by Specialised Therapeutics in Australia and we look forward to their continued success throughout South East Asia. We are committed to expanding access to NERLYNX to breast cancer patients around the world."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.