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TG Therapeutics Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma

On January 16, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, reported that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL) (Press release, TG Therapeutics, JAN 16, 2020, View Source [SID1234553287]). The Company has received guidance from the FDA that submission of a single NDA for both the MZL and FL indications is acceptable. Umbralisib has previously been granted both orphan drug designation and breakthrough therapy designation by the FDA for MZL. The Company expects to complete the NDA rolling submission in the first half of 2020.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased to have initiated our first NDA submission for umbralisib and to have received guidance from the FDA to include both MZL and FL in a single NDA. This is an extremely important milestone for us, as it brings us one step closer to potentially offering a novel treatment option to patients with previously treated MZL and FL." Mr. Weiss continued, "I want to thank the patients, their families and the research teams who participated in these important trials and helped advance umbralisib, and the TG team for working tirelessly to initiate this NDA submission. This is the beginning of an impactful 2020 as we look forward to topline Phase 3 data from both the UNITY-CLL trial and the ULTIMATE I & II trials in multiple sclerosis, as well as potential regulatory submissions based off these data."

ABOUT THE UNITY-NHL PHASE 2b STUDY—MARGINAL ZONE LYMPHOMA AND FOLLICULAR LYMPHOMA COHORTS

The UNITY- NHL trial is a multicenter, open-label Phase 2b trial.

The Marginal Zone Lymphoma (MZL) cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.

The Follicular Lymphoma (FL) cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. The primary endpoint is overall response rate (ORR) as determined by Independent Review Committee (IRC) assessment.

Merck Completes Acquisition of ArQule

On January 16, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the cash tender offer, through a subsidiary, for all of the outstanding shares of common stock of ArQule, Inc. (NASDAQ: ARQL) at a purchase price of $20.00 per share (Press release, Merck & Co, JAN 16, 2020, View Source [SID1234553285]). As of the tender offer expiration, 103,394,298 shares of common stock of ArQule were validly tendered and not withdrawn from the tender offer, representing approximately 75.3 percent of the outstanding common stock of ArQule on a fully diluted basis. All such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for such shares.

Following the completion of the tender offer, Merck completed the acquisition of ArQule today through a merger of Merck’s wholly-owned subsidiary with and into ArQule in which all shares not tendered into the offer were cancelled and converted into the right to receive cash equal to the $20.00 offer price per share, without interest, less any applicable tax withholding. At the completion of the merger, ArQule became a wholly-owned subsidiary of Merck. The common stock of ArQule will no longer be listed or traded on the NASDAQ Global Select Market.

Entry into a Material Definitive Agreement

On January 10, 2020, our wholly-owned subsidiary, Lex-Gen Woodlands, L.P. ("Lex-Gen Woodlands"), reported that it has entered into a Real Estate Purchase and Sale Agreement (the "Agreement") with FFC Equity Holdings, L.P. ("Purchaser") (Filing, 8-K, Lexicon Pharmaceuticals, JAN 10, 2020, View Source [SID1234553284]).

Under the Agreement, we agreed to sell our facilities in The Woodlands, Texas (the "Property") to Purchaser for a purchase price of $15.0 million. Such sale is subject to normal and customary closing conditions, including a study period, which extends until April 9, 2020, during which Purchaser may conduct inspections, analyses and other studies of the Property and may terminate the Agreement in its discretion. Such sale is also subject to the negotiation and execution by the parties of a leaseback agreement for a period of six months with respect to a portion of the Property concurrently with closing.

Heat Biologics, Inc. Prices $7,000,000 Public Offering

On January 16, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients’ immune systems against cancer, reported the pricing of an underwritten public offering consisting of 20,000,000 shares of Common Stock together with Warrants to purchase 10,000,000 shares of Common Stock at a combined price to the public of $0.35 (Press release, Heat Biologics, JAN 16, 2020, View Source [SID1234553283]). The gross proceeds to the Company from this offering are expected to be approximately $7,000,000, before deducting underwriting discounts, commissions and other offering expenses. The Warrants will have an exercise price of $0.385, will be exercisable upon issuance and will expire 14 months from the date of issuance. Heat Biologics, Inc. has granted the underwriters a 45-day option to purchase up to 3,000,000 additional shares of Common Stock and/or additional Warrants to purchase up to 1,500,000 shares of Common Stock to cover over-allotments, if any. The offering is expected to close on Tuesday, January 21, 2020, subject to customary closing conditions.

A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

Brookline Capital Markets, a division of Arcadia Securities, LLC and Maxim Group LLC are acting as co-managers for the offering.

A registration statement on Form S-1 (File No. 333-234105) relating to these securities has been filed with the U.S. Securities and Exchange Commission ("SEC") and became effective on January 16, 2020 and is available on the SEC’s website located at View Source This offering is being made only by means of a prospectus. Electronic copies of the prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus and the other documents that Heat Biologics, Inc. has filed with the SEC that are incorporated by reference in such prospectus, which provides more information about Heat Biologics, Inc. and such offering.

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

Partnership with China prompts change in care for high-risk type of leukemia

On January 16, 2020 Researchers from St. Jude Children’s Research Hospital and the Chinese Children’s Cancer Group led the first randomized, Phase III clinical trial comparing targeted therapies for acute lymphoblastic leukemia (ALL) driven by the Philadelphia chromosome (Press release, St Jude Children’s Research Hospital, JAN 16, 2020, View Source [SID1234553280]). Results showed that the drug dasatinib provides more benefit than the standard of care, which led to changes in the way this leukemia is treated. The findings were reported today in JAMA Oncology.

Fusions of the BCR-ABL1 genes, resulting in the formation of the Philadelphia chromosome, underlie 3-4% of cases of childhood ALL. This subtype is high risk and associated with poor outcomes.

"Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia."
JAMA Oncology, Published January, 16, 2020.

"This was a very fruitful collaboration," said corresponding and co-senior author Ching-Hon Pui, M.D., St. Jude Department of Oncology chair. "No single institution could enroll enough patients to do this kind of randomized clinical trial. By working with the Chinese Children’s Cancer Group, we were able to answer which targeted therapy provides the most benefit."

Researchers compared the efficacy of imatinib, the first targeted therapy for Philadelphia chromosome-positive (Ph+) ALL, and a next-generation inhibitor called dasatinib. The study showed that dasatinib resulted in an event-free survival rate of 71% compared to 49% with imatinib over four years.

The study enrolled patients with Ph+ ALL at 20 major hospitals throughout China. Of those, 92 patients received dasatinib, and 97 received imatinib. All patients underwent intensive chemotherapy without prophylactic cranial radiation, and only four patients underwent stem cell transplantation.

"This study demonstrates the importance of global medicine," said Carlos Rodriguez-Galindo, M.D., St. Jude Department of Global Pediatric Medicine chair. "Results from studies run in one country can save the lives of children around the world by informing changes in the standard of care."

Findings from this clinical trial were reported at the European Society for Paediatric Oncology and American Society of Hematology (ASH) (Free ASH Whitepaper) annual meetings in 2019. This data helped inform decisions by other national study groups in the U.S. and Europe to include dasatinib for the treatment of Philadelphia chromosome-positive ALL in clinical protocols going forward.

The study’s other St. Jude authors are Deqing Pei, Sima Jeha, Jun J. Yang and Cheng Cheng. Co-first authors Shuhong Shen and Jiaoyang Cai and co-senior author Jingyan Tang are from Shanghai Children’s Medical Center, Shanghai Jiao Tong University School of Medicine, Key Laboratory of Pediatric Hematology and Oncology of China Ministry of Health and National Children’s Medical Center (Shanghai). Co-first author Xiaojuan Chen and co-senior author Xiaofan Zhu are from the Chinese Academy of Medical Sciences and Peking Union Medical College. The study also included collaborators at 20 hospitals in China.

The research was funded by the U.S. National Cancer Institute (grant CA21765), the National Natural Science Foundation of China (grant 81670136), the fourth round of the Three-Year Public Health Action Plan 2015-2017, the CAMS Innovation Fund for Medical Sciences (2016-12M-1-002), St. Baldrick’s Foundation (581580), VIVA China Children’s Cancer Foundation and ALSAC, the fundraising and awareness organization of St. Jude.