Plus Therapeutics Expands ReSPECT™ Clinical Trial to MD Anderson Cancer Center

On December 1, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, reported that the University of Texas MD Anderson Cancer Center is now an active clinical trial site in its ongoing ReSPECT Phase 1 clinical trial, currently supported by the National Cancer Institute (NCI) (Press release, PLUS THERAPEUTICS, DEC 1, 2020, View Source [SID1234572312]). ReSPECT is a multi-center, dose-finding study evaluating the Company’s lead investigational asset, Rhenium NanoLiposome (RNL), in patients with recurrent glioblastoma (GBM).

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The study will be conducted by MD Anderson’s Department of Neurosurgery with Jeffrey Weinberg, M.D., Professor of Neurosurgery and the Deputy Chair and Vice-Chair of Clinical Operations in The Department of Neurosurgery, as primary investigator.

"We are very excited to now have the MD Anderson Cancer Center enrolling patients in the ReSPECT clinical trial," said Andrew J. Brenner, M.D., Ph.D., Associate Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principle investigator of the ReSPECT trial. "Jeffrey and his team are a valuable addition to our efforts to advance RNL as a potential new treatment option for recurrent GBM."

"We are pleased to add Dr Weinberg and the MD Anderson Cancer Center team to our growing list of ReSPECT trial sites," said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "The company will significantly benefit from the exceptional team of institutions as well as clinical and scientific advisors with whom we are working that all share our dedication to improving the care of GBM patients."

As the Company previously disclosed, the sixth dose escalation cohort of the ReSPECT trial is underway and expected to enroll by the end of 2020. In September 2020, the U.S. Food and Drug Administration granted both Orphan Drug designation and Fast Track designation to RNL for the treatment of patients with glioblastoma. Additional details about the ReSPECT trial are available at clinicaltrials.gov (NCT01906385).

Junshi Biosciences Announces Dosing of First Patient in Phase I Study of Anti-TROP2 Antibody -TUB196 Conjugate

On December 1, 2020 Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the Phase I clinical study (NCT04601285) of a recombinant humanized anti-TROP2 monoclonal antibody – Tub196 conjugate (JS108), has completed the dosing of the first patient (Press release, Shanghai Junshi Bioscience, DEC 1, 2020, View Source [SID1234572162]).

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JS108 is a recombinant humanized anti-TROP2 monoclonal antibody – Tub196 Conjugate. TROP2 is an important receptor expressed at high level in a variety of solid tumors (including breast cancer, gastric cancer, non-small cell lung cancer, small cell lung cancer, colon cancer and pancreatic cancer) , implicated in promoting tumor cell proliferation, tissue invasion, and metastasis. Overexpression of TROP2 was correlated with poor prognosis clinically. In July 2020, JS108 clinical trial application was approved by the National Medical Products Administration (NMPA).

In recent years, antibody drug conjugates (ADCs) targeting cell surface receptors expressed on tumor cells have become treatment options for multiple cancer indications. Unlike non-specific chemotherapy, ADCs are designed to target and kill tumor cells while sparing normal healthy cells.

Junshi has entered an exclusive license agreement with Hangzhou DAC Biotech Co., Ltd. ("Hangzhou DAC"), to develop and commercialize JS108 (anti-TROP2-ADC) in Asian countries and regions excluding Japan and South Korea.

About NCT04601285 Study

NCT04601285 is an open label, first-in-human phase I clinical study to evaluate the safety, tolerability, PK profile and efficacy of JS108 in patients with advanced solid tumors. The primary endpoints for this study are safety and tolerability, while the secondary endpoints include PK profile, immunogenicity, efficacy and correlation with TROP2 protein expression level. The study consists of three stages: the dose escalation, the dose expansion, and the indication expansion. The planned enrollments in three stages are 16 to 36, 12 to 27 and 60 to 90 patients with advanced solid tumors.

Reata Pharmaceuticals, Inc. Announces Pricing of Class A Common Stock Offering

On December 1, 2020 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata" or the "Company"), a clinical-stage biopharmaceutical company, reported that it has priced a public offering of 2,000,000 shares by the Company of its Class A common stock at a price to the public of $140.85 per share, for gross proceeds of $281.7 million (Press release, Reata Pharmaceuticals, DEC 1, 2020, View Source(Nasdaq%3A%20RETA)%20(%E2%80%9C,gross%20proceeds%20of%20%24281.7%20million. [SID1234572087]). Reata has granted the underwriters a 30-day option to purchase 300,000 additional shares of its Class A common stock, on the same terms and conditions as the shares offered in the public offering. The offering is expected to close on or about December 4, 2020, subject to customary closing conditions.

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Barclays Capital Inc. and Goldman Sachs & Co. LLC are acting as joint book-running managers.

The securities described above are being offered pursuant to an effective shelf registration statement on Form S-3. The offering may be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by request at Barclays Capital Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-888-603-5847, or by emailing [email protected]; or Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected].

This news release is for informational purposes only and 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 of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Lixte Biotechnology Holdings, Inc. Announces Closing of Public Offering and Uplisting to Nasdaq

On December 1, 2020 Lixte Biotechnology Holdings, Inc. ("Lixte" or the "Company") (Nasdaq: Common stock – LIXT; Warrants – LIXTW), a drug discovery company that uses biomarker technology to identify enzyme targets associated with cancer and other serious common diseases and then designs novel compounds to attack those targets, reported that it closed a public offering of 1,200,000 units of securities at an offering price of $4.75 per unit for total gross proceeds of $5.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses and before any exercise of the underwriters’ overallotment option (Press release, Lixte Biotechnology, DEC 1, 2020, View Source [SID1234572074]). Each unit consists of one share of common stock and one warrant to purchase one share of common stock at an exercise price of $5.70 per share. In addition, Lixte has granted the underwriters a 45-day option to purchase up to 180,000 additional shares of the Company’s common stock and/or up to 180,000 additional warrants to purchase shares of the Company’s common stock, or any combination thereof, to cover overallotments, if any.

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The shares and warrants were immediately separable, were issued separately, and began trading on The Nasdaq Capital Market on Wednesday, November 25, 2020, under the symbols "LIXT" and "LIXTW", respectively.

WestPark Capital, Inc. and WallachBeth Capital, LLC acted as the joint book-running managers for the offering. TroyGould PC acted as the Company’s legal counsel and Sheppard, Mullin, Richter & Hampton, LLP acted as legal counsel for the joint book-running managers.

Zai Lab Appoints Alan Sandler, M.D., as President, Head of Global Development, Oncology

On December 1, 2020 Zai Lab Limited ("Zai Lab") (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported the appointment of Alan Sandler, M.D., to the newly created position of President, Head of Global Development, Oncology, where he will lead global oncology development and related enabling functions to support the Company’s development activities (Press release, Zai Laboratory, DEC 1, 2020, View Source [SID1234572071]). Dr. Sandler was most recently the Senior Vice President and Global Head of Product Development Oncology at Genentech, a member of the Roche Group. He will report to Dr. Samantha Du, Chief Executive Officer, and serve on the executive team.

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"We are delighted to welcome Alan to Zai Lab as we continue to expand globally and strengthen our R&D leadership," said Dr. Samantha Du, Founder, Chairwoman and CEO of Zai Lab. "Throughout his distinguished career, Alan has made significant contributions as a respected leader in the oncology community, both in industry and through his clinical practice and academic research. Alan has played a key role in the development of many innovative oncology therapies. We look forward to his leadership of our oncology franchise as we advance towards our goal of becoming a leading global biopharma company."

"I’m very excited to be joining Zai Lab, given its robust pipeline of innovative clinical compounds," said Dr. Sandler. "I look forward to accelerating the development of Zai’s extensive and differentiated pipeline of oncology compounds, guide them through regulatory review, and bring them as quickly as possible to patients in need in China and around the world. I am also excited about working to identify additional product candidates to further expand Zai’s oncology portfolio."

Dr. Sandler brings nearly 30 years of oncology and drug development experience across industry and academia. During his tenure at Genentech/Roche, he led the teams responsible for the global development and regulatory approval of several innovative medicines, most recently Tecentriq. Prior to joining Genentech/Roche, Dr. Sandler served as Professor and Chief of Hematology/Oncology at Oregon Health and Science University. Previously, he served on the faculties of the medical schools of Indiana University and Vanderbilt University. He holds a Doctor of Medicine degree from Rush Medical College. Dr. Sandler completed his training in internal medicine and a fellowship in medical oncology at Yale-New Haven Medical Center. He has published over 300 peer-reviewed publications, articles, abstracts and book chapters.