AnPac Bio to Receive Up To USD $8 Million Dollar Grants and Award for R&D, Product Commercialization, and Milestone Achievements

On October 7, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported that in recognition of its successes in leading edge life science innovations and advancements and in support of its R&D and product commercialization efforts, AnPac Bio has obtained three grants and one rental award from various local authorities in China with a portion of the funding subject to milestone achievements (Press release, Anpac Bio, OCT 7, 2020, View Source [SID1234568196]). In total, these grants and award reached approximately US$8 million. Grant and award payments or benefits are expected to be received over a few years starting from this quarter and will help AnPac Bio fund R&D and new product commercialization.

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Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We are pleased and thankful for the grant and award recognitions. We believe that we are well positioned to successfully execute our goals this year and in 2021, during which we will accelerate our R&D, cancer detection product commercialization in China (class III medical device) and US (Laboratory Developed Tests (LDT)), and increase our revenue."

Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA

On October 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the FDA has granted Orphan Drug Designation ("ODD") and Rare Pediatric Disease Designation ("RPDD") for its leading bispecific antibody program nivatrotamab for the treatment of neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 7, 2020, View Source [SID1234568195]).

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Nivatrotamab, a humanized bispecific anti-GD2 antibody, is currently in Phase 1 clinical development in collaboration with Memorial Sloan Kettering Cancer Center ("MSK") in patients with relapsed/refractory neuroblastoma, as well as high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy.

"We are very pleased with the ODD granted for nivatrotamab, as this potentially would give us seven years of market exclusivity upon market approval. The RPDD makes us eligible for a Priority Review Voucher ("PRV") upon potential approval of the biologics license application for this rare pediatric cancer. Among our leading compounds, four now have RPDDs, and this designation further increases our chances of ultimately receiving multiple PRVs," said Thomas Gad, Founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, further notes, "We are very pleased by this recognition by the FDA, and plan to expand the ongoing study with nivatrotamab into two separate Phase 2 arms in neuroblastoma and osteosarcoma, respectively, as well as a separate Phase 2 multicenter study in small cell lung cancer. We expect to submit an IND for the lung cancer study during the fourth quarter of 2020, and we are thrilled to widen nivatrotamab’s clinical reach to include adult indications."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed nivatrotamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.

Turning Point Therapeutics Announces Early Clinical Data For Novel MET Inhibitor TPX-0022 Selected For Late-Breaker Oral Presentation at 32nd EORTC-NCI-AACR Symposium

On October 7, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that abstracts submitted for two of its drug candidates have been selected for presentation at the Molecular Targets and Cancer Therapeutics virtual symposium hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) on Oct. 24-25 (Press release, Turning Point Therapeutics, OCT 7, 2020, View Source [SID1234568193]).

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The abstracts include a late-breaker submission selected for an oral presentation by David Hong, M.D., Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, of early clinical data for Turning Point’s novel MET/SRC/CSF1R inhibitor, TPX-0022; and two poster presentations of preclinical data for lead drug candidate repotrectinib demonstrating first, an increase in the effectiveness of a KRAS-G12C inhibitor via the simultaneous inhibition of SRC, FAK and JAK2 kinases; and second to be presented in a poster discussion session, potent anti-tumor activity as a monotherapy and in combination with chemotherapy in neuroblastoma cell lines and pediatric patient derived xenograft models.

Details for the presentations are as follows:

Title: First-in-human safety, pharmacokinetics, and preliminary efficacy of TPX-0022, a novel inhibitor of MET/SRC/CSF1R in patients with advanced solid tumors harboring genetic alterations in MET
Session: Plenary Session 1, Late Breaking and Best Proffered Papers
Date and Time: Saturday, 24 October 2020 – 15:05 CET (9:05 a.m. ET)

Title: Repotrectinib Increases KRASG12C Inhibitor Effectiveness Via Simultaneous Inhibition of SRC, FAK, and JAK2
Session: Drug Resistance and Modifiers
Date: Saturday, 24 October 2020, Session Code 310

Title: Repotrectinib, a next-generation ALK/ROS1/NTRK 1-3 inhibitor, has potent antiproliferative and anti-tumor activity as monotherapy and in combination with chemotherapy in neuroblastoma cell lines and pediatric patient derived xenograft models
Session: Next Generation Targeted Therapies A
Date and Time: Saturday, 24 October 2020 – 22:00 – 23:20 CET (4:00 p.m. – 5:30 p.m. ET)

BIOGEN TO REPORT THIRD QUARTER 2020 FINANCIAL RESULTS OCTOBER 21, 2020

On October 7, 2020 Biogen Inc. (Nasdaq: BIIB) reported it will report third quarter 2020 financial results Wednesday, October 21, 2020, before the financial markets open (Press release, Biogen, OCT 7, 2020, View Source [SID1234568192]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

TIO-Bioventures-Launches-TCRyption-TCR-T-cell-based

On October 7, 2020 TIO Bioventures reported the launch of TCRyption Inc., a novel TCR-T cell therapy company, with the goal of expanding the availability of T-cell receptor based cellular therapeutic (TCR-T) options as effective and safe therapies across multiple cancers with a high unmet need (Press release, Tio Bioventures, OCT 7, 2020, View Source [SID1234568191]). The company’s highly diverse and growing TCR bank utilizes the proprietary TCRypt platform, originally created by Dr. Naoto Hirano at University Health Network’s (UHN) Princess Margaret Cancer Centre. With unparalleled sensitivity in its ability to mine physiologically relevant TCR’s, this platform enables the rapid discovery of an expansive bank of TCRs that can be used to better address patient needs. TCRyption was established with an initial $10 million in seed financing from TIO Bioventures.

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"Unlike chimeric antigen receptor (CAR) T cell therapies, TCR-T’s are engineered to express tumor-specific TCRs with patient-informed specificity based on patient HLA haplotype," said Dr. Naoto Hirano, Scientific Co-Founder of TCRyption and Senior Scientist and Associate Director of Research for the Tumor Immunotherapy Program at Princess Margaret Cancer Centre. "Early clinical success was demonstrated with TCR-T recognizing HLA-A2 restricted epitopes for NY-ESO-1 in patients with synovial sarcoma and myeloma. Unfortunately, the inclusion criteria of HLA-A2 is highly restrictive for patient enrollment. Using our proprietary TCRypt platform, we aim beyond HLA-A2. We hope to implement TCRs from our bank, recognizing more diverse class I and II alleles, to extend this treatment modality to serve new HLA patient populations, targeting new epitopes, and addressing new cancer types."

TCRyption was co-founded by the pioneers of T cell biology, Dr. Mark Davis and Dr. Tak Mak, who originally discovered the TCR, considered the "Holy Grail of Immunology." Drs. Mak and Davis bring together a team of visionaries, including Dr. Hirano and Dr. Pam Ohashi, also at UHN’s Princess Margaret Cancer Centre, who harbor profound expertise in TCR biology and cutting-edge technologies that will push the development of next generation immunotherapies with broad applicability to a large array of solid and liquid tumors and diverse patient populations.

Advisory board members include Dr. Tak Mak, who in addition to his work in TCR is a veteran of the biotech industry with proven commercial success. Dr. Mak is a co-founder of three biotech companies including Agios Pharmaceuticals, which has two approved cancer drugs.

"A great company has been created here in Toronto to translate UHN’s and Princess Margaret’s ground-breaking immunotherapy research into new therapies for cancer patients across the globe," said Dr. Bradly Wouters, UHN’s Executive VP of Science and Research. "UHN and our local community are creating some of the world’s best technologies in life sciences and subsequently commercializing them through the creation of well-financed companies with great teams and R&D happening right here in Toronto."