On February 4, 2019 INmune Bio, Inc. ("INmune" or the "Company"), an immunotherapy company focused on developing therapies that harness the patient’s innate immune system to fight disease, reported that the Company’s common stock is expected to commence trading on The Nasdaq Capital Market, on Monday, February 4, 2019 under the ticker symbol "INMB" (Press release, INmune Bio, FEB 4, 2019, View Source [SID1234533090]).

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On February 1, 2019, INmune closed its initial public offering ("IPO") of 1,020,560 shares of its common stock at of $8.00 per share for a total of $8,166,560 in gross proceeds before placement agent fees and offering expenses.

Univest Securities, LLC served as the lead placement agent for the IPO. WallachBeth Capital, LLC and WestPark Capital, Inc. were co-placement agents.

A registration statement relating to this U.S. offering was filed with the Securities and Exchange Commission ("SEC") and was declared effective by the SEC as of December 19, 2018. The offering of the securities was made only by means of a prospectus, forming a part of the registration statement. Copies of the final prospectus relating to the U.S. offering may be obtained from Univest Securities, LLC. 375 Park Avenue Unit 1502, New York, NY 10152, by telephone at +1 212 343 8888 or email at [email protected]. In addition, a copy of the prospectus relating to the offering may be obtained via the SEC’s website at www.sec.gov.

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

On February 4, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that it has completed patient enrollment in the ongoing Phase 2 ENTRATA trial. ENTRATA is a randomized clinical study of the glutaminase inhibitor CB-839 combined with everolimus versus placebo with everolimus for the treatment of advanced renal cell carcinoma (RCC) (Press release, Calithera Biosciences, FEB 4, 2019, View Source [SID1234535231]). CB-839 now has the International Nonproprietary Name (INN) telaglenastat, as recommended by the World Health Organization.

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"The ENTRATA trial is the first randomized trial evaluating the glutaminase inhibitor telaglenastat. There is ample evidence demonstrating the potential of glutaminase inhibition to block growth and survival of cancer cells," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that patient enrollment is now complete and look forward to learning more from ENTRATA about how this promising mechanism could help heavily pre-treated patients with advanced renal cancer."

The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report efficacy and safety data from the trial in the second half of 2019.

Telaglenastat is an investigational, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. RCC tumors commonly exhibit metabolic alterations that increase their dependence on glutamine. In preclinical studies, telaglenastat produced synergistic antitumor effects when used in combination with standard-of-care RCC therapies.

Telaglenastat is also being investigated in the CANTATA trial, which will enroll approximately 400 patients and is designed with registrational intent. It is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced clear cell RCC who have been treated with one or two prior lines of systemic therapy. The primary endpoint is PFS by blinded independent review, and a key secondary endpoint is overall survival.

On February 4, 2019 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing a new class of potent and selective miniature drug conjugates (Pentarins) for the treatment of patients with a wide range of solid tumors, reported that Drew Fromkin, President and Chief Executive Officer, will present at the 2019 BIO CEO & Investor Conference, occurring February 11-12, 2019 at the New York Marriot Marquis (Press release, Tarveda Therapeutics, FEB 4, 2019, View Source [SID1234533038]).

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The presentation will take place at 2:15pm Eastern Time on Monday, February 11 in the Gramercy room.

In the presentation, Mr. Fromkin will provide an overview of the Company’s two clinical programs including PEN-221, which is currently in clinical evaluation for the treatment of patients with somatostatin receptor 2 (SSTR2) positive neuroendocrine tumors and PEN-866, the first miniature drug conjugate from Tarveda’s HSP90 binding conjugate platform, which is being developed for the treatment of patients with solid tumors including but not limited to small cell lung cancer, pancreatic cancer and sarcomas.

On February 4th, 2019 ENB Therapeutics, Inc., a clinical-stage, biopharmaceutical company developing innovative, endothelin-based oncologics, reported that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of ENB-003, a first-in class endothelin B receptor ("ETBR") inhibitor and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1/2 trial in patients with advanced solid tumors (Press release, ENB Therapeutics, FEB 4, 2019, View Source [SID1234626430]). The open-label, dose-escalation and expansion Phase 1/2 study will enroll patients with anti-PD-1 resistant malignant melanoma, platinum-resistant ovarian or pancreatic cancer with previous treatment failure. The dose escalation phase of the trial will evaluate the safety and tolerability of various doses of ENB-003 as a monotherapy and in combination with KEYTRUDA. The dose expansion will evaluate preliminary efficacy, safety and tolerability of the selected dose of ENB-003 combined with KEYTRUDA as well as changes in immunohistochemistry and pharmacodynamic biomarkers after administration of ENB-003.

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"We are thrilled to collaborate with Merck, an established leader in the field of cancer immunotherapy," said Sumayah Jamal, M.D., Ph.D., President and CSO of ENB Therapeutics. "ENB-003 has both antitumor and immune-modulatory effects and augments the efficacy of anti-PD-1 inhibition in animal models. We are optimistic about exploring the combination of ENB-003 and KEYTRUDA ."

Under the terms of the agreement, ENB Therapeutics will sponsor the ENB-003 and KEYTRUDA clinical study.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On February 4, 2019 EdiGene Inc., which develops genome editing technologies into novel therapeutics for a broad range of diseases and into creative solutions to advance drug discovery, reported the successful completion of approximately $10 Million in a Series pre-B Plus financing, and strengthening of its management team by naming Yun Li, MD, as Vice President of Clinical Development (Press release, EdiGene, FEB 4, 2019, View Source [SID1234533039]).

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The new round of financing is led by new investor Green Pine Capital Partners (Green Pine). Series A lead investor IDG Capital, Series B lead investor Lilly Asia Ventures (LAV) and other insiders also participated in this round.

"We are excited to participate in this round," said Fei Luo, founding partner of Green Pine. "We are happy to support EdiGene’s top scientists and experienced management team to accelerate the development of breakthrough therapies to treat unmet medical needs."

"We are pleased to complete this new round of financing led by Green Pine with participation of existing investors," said Dr. Wensheng Wei, founder of EdiGene. "As we are advancing our sciences, we look forward to working with Green Pine and our current investors to grow EdiGene into the next exciting phase."

Separately, Yun Li, MD, has joined EdiGene as Vice President of Clinical Development. Dr. Li has more than 20 years experiences in clinical trials of novel therapeutics, mainly focusing on oncology & hematology and immunological phase I-III clinical trials. Before EdiGene, Dr. Li had been with Parexel for over 10 years as Medical director in Global Medical Service. Prior to that, she had taken various roles with increasing responsibilities in clinical development in Novartis China, Roche China, RHONE-POUULENC RORER (now Sanofi) and Xian Janssen ( J&J company). Before that, she had 10 years practice in clinical and teaching institutions. Dr. Li has a medical degree of M.Sc in Clinical Hematology and B.Sc. in General Medicine from Second Military Medical University (Shanghai, China).

"Our portfolio is entering into an exciting stage, and this new round of financing further validates and continues to support our strategy of translating proprietary platforms into potential therapeutics to patients in need," said Dong Wei, Ph.D.,MBA，CEO of EdiGene, "We are thrilled that Dr. Li joins us at this significant point of our company’s development. Her extensive experiences in clinical development in hematology and oncology will help us advance our therapeutic candidates into clinics in the near future."