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bridgebio pharma and affiliate qed therapeutics announce fda acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma

On December 1, 2020 BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate QED Therapeutics reported that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts (Press release, BridgeBio, DEC 1, 2020, View Source [SID1234576220]).

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The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Additionally, BridgeBio will submit for review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

Cholangiocarcinoma, a cancer of the bile ducts of the liver, is a serious and often fatal disease which affects approximately 20,000 people in the United States and European Union each year. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have this disease. Currently, treatment options are limited, and the five-year survival rate is only 9%.

"We want to thank the patients, families, scientists, physicians and all others involved who helped us move this NDA forward. At BridgeBio we believe that every minute counts for patients and their families, and we are eager to help as many people suffering from cholangiocarcinoma as possible – as quickly as possible," said BridgeBio CEO and Founder Neil Kumar, Ph.D.

This is BridgeBio’s second NDA acceptance following the acceptance of its NDA for fosdenopterin in molybdenum cofactor deficiency (MoCD) Type A in September 2020.

About Infigratinib

Infigratinib is an orally administered, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (bladder cancer) and achondroplasia, a bone growth condition in children.

Aptose to Hold Corporate Update Sunday, December 6th

On December 1, 2020 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that the company management team will provide a corporate update on Sunday, December 6th, at 2:00 PM PT, in conjunction with participation at the 2020 ASH (Free ASH Whitepaper) Annual Meeting (Press release, Aptose Biosciences, DEC 1, 2020, View Source [SID1234573620]). The event will include the current clinical status of CG-806, Aptose’s oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor currently in two Phase 1 a/b trials, one in patients with relapsed or refractory acute myeloid leukemia (AML) and another in patients with relapsed or refractory B cell malignancies, as well as a review of APTO-253, a first-in-class small molecule MYC inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

Aptose Corporate Update Details

Date & Time: Sunday, December 6, 2020, 2:00 PM PT

Participant Webcast Link: View Source

The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

As announced previously, early clinical data, along with certain preclinical data for CG-806 and APTO-253, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held virtually Saturday, December 5 – Monday, December 7, 2020. The posters will be available on the presentations page of Aptose website here.

Poster Presentation Details

Abstract #1042: A Phase 1a/b Dose Escalation Study of the MYC Repressor Apto-253 in Patients with Relapsed or Refractory AML or High-Risk MDS
Poster Session Date & Time: Saturday, December 5, 2020, 7:00 AM – 3:30 PM PT
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Abstract #1174: Pharmacologic Inhibition of B Cell-Receptor-Associated Kinases with CG-806 Induces Apoptosis and Metabolic Reprogramming in Aggressive Non-Hodgkin Lymphoma (NHL) Models
Poster Session Date & Time: Saturday, December 5, 2020, 7:00 AM – 3:30 PM PT
Session Name: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I

Abstract #2228: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic BTK/FLT3 Inhibitor CG-806 in Patients with Relapsed or Refractory CLL/SLL or Non-Hodgkin’s Lymphomas
Poster Session Date & Time: Sunday, December 6, 2020, 7:00 AM – 3:30 PM PT
Session Name: 642. CLL: Therapy, excluding Transplantation: Poster II

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).

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]).

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.

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.