On May 21, 2020 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) reported receipt of the final results of E2112, the Phase 3 clinical trial conducted by ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), that evaluated the investigational compound entinostat, Syndax’s class I HDAC inhibitor, plus exemestane in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have progressed on a non-steroidal aromatase inhibitor (Press release, Syndax, MAY 21, 2020, View Source [SID1234558393]). The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival (OS) benefit over hormone therapy alone.

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"We’re disappointed that the combination of entinostat and exemestane did not demonstrate a survival benefit in this historically difficult-to-treat patient population," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "On behalf of the entire Syndax team, we extend our sincerest gratitude to all the patients, their families and the investigators who participated in this important trial, as well as our colleagues at ECOG-ACRIN and the NCI. Based on these results, we will not be filing a New Drug Application with the U.S. Food and Drug Administration for metastatic breast cancer."

Dr. Morrison added, "We remain focused on advancing our broader portfolio, including our targeted therapy, SNDX-5613, an inhibitor of the Menin-MLL interaction, and axatilimab, our anti-CSF-1R monoclonal antibody. Later this year, we expect to present additional clinical data from the AUGMENT-101 trial of SNDX-5613 in adults with relapsed/refractory acute leukemias. Based on preclinical data reported to date, as well as recent Phase 1 results representing the first clinical evidence that inhibition of the Menin-MLL1 interaction can induce response in patients with genetically-defined acute leukemias, we believe SNDX-5613 has the potential to offer patients with both NPM1 mutant acute myeloid leukemia and MLL-r acute leukemias a much-needed, effective therapeutic option. We also anticipate the presentation of additional results from our ongoing Phase 1/2 trial of axatilimab in patients with chronic graft versus host disease in the fourth quarter of this year."

The E2112 trial was designed and conducted independently by ECOG-ACRIN under the sponsorship of the NCI, which is part of the National Institutes of Health. The double-blind, placebo-controlled trial randomized a total of 608 patients with HR+, HER2- advanced breast cancer to receive exemestane in combination with entinostat or placebo.

On May 21, 2020 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that it has completed its previously announced distribution of all of the Company’s 13,333,334 shares of common stock of Evofem Biosciences, Inc. ("Evofem") (Nasdaq: EVFM), which represented approximately 26.7% of the outstanding shares of Evofem common stock as of the close of business on May 15, 2020 (the "record date") (Press release, PDL BioPharma, MAY 21, 2020, View Source [SID1234558392]).

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The distribution was made today in the form of a pro rata common stock dividend to PDL stockholders of record as of the close of business on the record date. Based on the shares of PDL common stock outstanding as of the close of business on the record date, PDL stockholders of record as of the record date are entitled to receive 0.11591985 shares of Evofem common stock for every share of PDL common stock held as of the close of business on the record date.

No fractional shares of Evofem common stock were distributed. Instead, PDL stockholders will receive cash in lieu of any fraction of a share of Evofem common stock that they otherwise would have received.

An information statement describing the distribution is included as an exhibit to the Current Report on Form 8-K filed by PDL with the U.S. Securities and Exchange Commission (the "SEC") on May 18, 2020. Additional information on the distribution, including a copy of the information statement, will be posted to PDL’s website at View Source

On May 21, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported it will host a conference call and audio webcast on Friday, May 29 at 4:30 p.m. ET (Press release, MacroGenics, MAY 21, 2020, http://ir.macrogenics.com/news-releases/news-release-details/macrogenics-host-conference-call-and-webcast-review-preliminary [SID1234558390]). MacroGenics management will be joined by external guest presenters to review the preliminary clinical results from the ongoing Phase 1 studies of MGD013 and MGC018 that are part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.

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To participate in the MacroGenics ASCO (Free ASCO Whitepaper) 2020 Conference Call, please dial (833) 651-1036 (domestic) or (918) 922-6233 (international) ten minutes prior to the start of the call and provide the Conference ID: 7765546. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days.

Selected Presentations at ASCO (Free ASCO Whitepaper) to be Reviewed on Conference Call

A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms (Abstract #3004)
Preliminary dose escalation results from a phase I/II, first-in-human study of MGC018 (anti-B7-H3 antibody-drug conjugate) in patients with advanced solid tumors (Abstract #3071, Poster #135)
About MGD013

MGD013 is an investigational, first-in-class bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MGD013 has been engineered to concomitantly or independently bind to PD-1 and LAG-3 and disrupt these non-redundant inhibitory pathways to further restore exhausted T-cell function. MGD013 is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types, including both solid tumors and hematological malignancies, and in combination with margetuximab, an investigational Fc-engineered monoclonal antibody targeting HER-2, in a cohort of patients with advanced HER2-positive cancers (NCT03219268). MGD013 will also be evaluated in combination with margetuximab and chemotherapy as part of the ongoing Phase 2/3 MAHOGANY study in patients with HER2-positive gastric or gastroesophageal junction cancer (NCT04082364). MacroGenics’ regional partner in Greater China, Zai Lab, plans to participate in MAHOGANY and is also evaluating MGD013 independently in Phase 1 combination studies with niraparib, a PARP inhibitor, and brivanib, a dual target tyrosine kinase inhibitor of the VEGF and FGF receptors, for the study of advanced gastric cancer and hepatocellular carcinoma, respectively.

About MGC018

MGC018 is an investigational antibody-drug conjugate (ADC) that is designed to target solid tumors expressing B7-H3, a protein in the B7 family of immune regulator proteins. B7-H3 is widely expressed on many different solid tumor types, with limited expression on normal tissues. Over-expression of B7-H3 is associated with disease severity, risk of recurrence, and reduced survival. MGC018 uses a synthetic duocarmycin-based payload with a cleavable peptide linker that was licensed from Byondis (formerly Synthon Biopharmaceuticals). Duocarmycins are potent cell cycle independent DNA-damaging alkylating agents and are not subject to multi-drug resistance. MGC018 is being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors (NCT03729596).

On May 21, 2020 GlaxoSmithKline and Samsung Biologics reported that have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK’s innovative biopharmaceutical therapies (Press release, GlaxoSmithKline, MAY 21, 2020, View Source [SID1234558389]).

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Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK’s future needs and will supplement GSK’s existing manufacturing network.

Regis Simard, President, Pharmaceuticals Supply Chain, GSK, said, "Today’s agreement with Samsung Biologics complements and reinforces our existing world-class pharmaceutical manufacturing capability and will help ensure we can continue to deliver the transformative medicines that patients need."

"We are very proud and excited to announce this long-term agreement with GSK," said Dr. Tae Han Kim, CEO of Samsung Biologics. "Samsung Biologics entered the biopharma industry with the goal to help our clients bring valuable biological medicines to patients faster. We are thrilled to partner with GSK, a company who shares the vision."

The agreement is worth more than $231 million US over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.

On May 21, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Dynavax Technologies, MAY 21, 2020, View Source [SID1234558387]). Dynavax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the common stock being offered in the public offering. All of the shares in the offering will be sold by Dynavax. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Cowen, Evercore ISI and William Blair are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

Dynavax anticipates using the net proceeds from the offering to fund activities associated with the ongoing commercialization of HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted], to advance its CpG 1018 vaccine platform, including any scale up efforts in support of a potential COVID-19 vaccine by Dynavax and its collaborators, and for general corporate purposes, including working capital.

The securities described above are being offered by Dynavax pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (SEC) on April 30, 2020. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, New York, NY 10055, by telephone at (888) 474-0200 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.