On January 9, 2020 Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform technology called Tumor Treating Fields, reported that the first patient has been enrolled in a phase 2 pilot clinical trial evaluating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as a first-line treatment in patients with gastric adenocarcinoma (Press release, Zai Laboratory, JAN 9, 2020, View Source [SID1234552938]).

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"Zai Lab licensed Tumor Treating Fields from Novocure in September 2018, and we have since launched Optune in Hong Kong for the treatment of patients with recurrent, or newly diagnosed glioblastoma multiforme (GBM) and submitted a Marketing Authorization Application to the China National Medical Products Administration (NMPA) for approval," said Dr. Samantha Du, Founder and CEO of Zai Lab. "Optune also has been granted the Innovative Device Designation which allows our team to accelerate dialogue with the NMPA. What is especially attractive about Tumor Treating Fields is its potential applicability to treat a wide variety of solid tumors including gastric cancer, the second most common cancer in China in terms of incidence rate. The initiation of this phase 2 pilot trial in gastric cancer represents our commitment to bringing Tumor Treating Fields to as many patients who may benefit in Greater China."

"Tumor Treating Fields is already approved for glioblastoma and malignant pleural mesothelioma in the U.S.," added William Doyle, Executive Chairman of Novocure. "We are moving forward with multiple clinical trials to evaluate Tumor Treating Fields for other indications including brain metastases, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. It is very gratifying to see our partner engaged in active dialogue with the NMPA and studying Tumor Treating Fields for gastric cancer, a serious and unmet medical need in China."

The phase 2 pilot gastric cancer trial of Tumor Treating Fields is expected to enroll approximately 50 patients in Greater China. The study is a single arm, open-label, multi-center study, investigating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as the first-line treatment of unresectable gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma. In the study, patients will receive Tumor Treating Fields at 150 kHz and XELOX chemotherapy, a combination of oxaliplatin and capecitabine, until disease progression. The primary endpoint is investigator-assessed objective response rate.

About Gastric Cancer

Gastric cancer is the second most common cancer in China (679,100 newly diagnosed cases in 2015) and the second leading cause of death in China (498,000 deaths in 2015). The 5-year overall survival rate of gastric cancer is only 35.9%. Current therapies include surgery, chemotherapy, radiotherapy and targeted therapy, which prolong progression free survival and overall survival to 6 months and 8-14 months, respectively.

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and potentially causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

On January 9, 2020 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy, reported that Usman "Oz" Azam, MD, President and Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020 at 1:30 pm Pacific Time at the Westin St. Francis Hotel in San Francisco (Press release, Tmunity Therapeutics, JAN 9, 2020, View Source [SID1234552937]).

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A live webcast of the presentation will be available on the "Events and Presentations" page of the Tmunity website at View Source Tmunity will maintain an archived replay of the webcast on the website for 30 days after the conference.

On January 9, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that Sandy Macrae, CEO of Sangamo, will present a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16th at 8:30 a.m. PT in San Francisco (Press release, Sangamo Therapeutics, JAN 9, 2020, View Source [SID1234552936]).

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The presentation will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

On January 9, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that it has entered into a securities purchase agreement with institutional investors to purchase approximately $6.5 million of its common shares (or pre-funded warrants to purchase common shares in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common shares in a concurrent private placement (Press release, Sellas Life Sciences, JAN 9, 2020, View Source [SID1234552932]). The combined purchase price for one common share (or pre-funded warrants to purchase common shares in lieu thereof) and a warrant to purchase 0.5 common shares will be $3.9825.

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Under the terms of the securities purchase agreement, SELLAS has agreed to sell 1,637,800 common shares (or pre-funded warrants to purchase common shares in lieu thereof). In a private placement, which will be consummated concurrently with the Offering, SELLAS also has agreed to issue warrants to purchase up to an aggregate of 818,900 common shares. The warrants will be immediately exercisable, will expire 5.5 years from the date of issuance and will have an exercise price of $3.93 per common share.

The gross proceeds to the Company from the registered direct offering and concurrent private placement is expected to be approximately $6.5 million before deducting the placement agents’ fees and other estimated offering expenses. The registered direct offering and concurrent private placement is expected to close on or about January 13, 2020, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The common shares are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-233869) previously filed and declared effective by the Securities and Exchange Commission (SEC). The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities law.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by SELLAS with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

On January 9, 2020 Presage Biosciences, a biotechnology company pioneering a new cancer drug development approach using its CIVO intratumoral microdosing platform, reported that the U.S. Food and Drug Administration (FDA) has approved its first Exploratory Investigational New Drug (IND) application for a Phase 0 study utilizing its CIVO platform (Press release, Presage Biosciences, JAN 9, 2020, View Source [SID1234552931]). The study, which will employ the CIVO platform to evaluate patients’ unique responses to microdoses of cancer drugs, is a collaboration with Takeda Pharmaceutical Company Limited (Takeda), with initiation planned in the first half of 2020.

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"The green light from the FDA for Presage’s first exploratory IND represents a major milestone as we seek to revolutionize early drug development through a superior approach to translational oncology," said Rich Klinghoffer, PhD, Presage CEO. "This latest success reflects our measured approach to building a long-term relationship with the FDA that will support our business model of making Phase 0 trials widely available to companies looking to gain deeper understanding of investigational drug response within the tumor microenvironment."

Takeda has previously partnered with Presage on preclinical mechanism of action and combination studies, including work highlighted by both companies at AACR (Free AACR Whitepaper) last year. "Takeda’s preclinical collaborations with Presage have been foundational to the honing of our translational insights into novel immuno-oncology agents," said Chris Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "We are excited to now leverage the CIVO platform in the clinic and we are eager to see what insights this trial can provide and if intratumoral microdosing can enable biomarker studies that enrich and accelerate clinical translation."

"Takeda’s ongoing collaboration and support has enabled Presage to bring the CIVO platform into the clinic. We are very excited for this first trial to begin and demonstrate the possibilities for improving how oncology drug candidates are evaluated," added Klinghoffer.

Earlier this year, Presage announced collaborations with Celgene and BMS for Phase 0 trials with CIVO. Those trials are expected to commence in 2020 following FDA clearance. A recently completed clinical trial to evaluate the safety and feasibility of utilizing the CIVO platform demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

About CIVO and Phase 0 Trials

To address the challenges inherent in cancer drug discovery, Presage is advancing a new approach to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. Exploratory Investigational New Drug studies, also known as Phase 0 trials, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. CIVO is a patented platform that enables intratumoral microdosing and analysis of multiple cancer agents.