Himalaya Files Four INDs in China for Conditionally Active Biologics

On October 5, 2021 Himalaya Therapeutics of Shanghai has submitted four INDs in China for two Conditionally Active Biologics, each one aimed at two solid tumor cancer indications(Press release, Himalaya Therapeutics, OCT 5, 2021, View Source [SID1234590817]). The company describes itself as a global clinical-stage biotech developing drugs that have more selective targeting for greater safety and efficacy. It also works to be more cost-efficient with highly predictable manufacturing compared to traditional antibodies. Himalaya, a majority owned subsidiary of San Diego’s BioAtla, develops BioAtla’s products in China.

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NovoCodex Reports Positive Data from ADC for Gastric Cancer

On October 5, 2021 NovoCodex Pharma reported positive interim data from a China trial of its lead drug in patients with HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer(Press release, NovoCodex Biopharmaceuticals, OCT 5, 2021, View Source [SID1234590815]). ARX788 is an antibody-drug conjugate composed of an EGFR antibody targeting EGFR2 and HER2, joined to a apoptosis molecule. The candidate showed a tolerable safety profile and promising efficacy data. NovoCodex acquired China rights to ARX788 from Ambrx, a San Diego biotech. NovoCodex is a majority owned subsidiary of Zhejiang Medicine.

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CRISPR Therapeutics to Host Virtual Event Highlighting CTX110™ Clinical Data

On October 5, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that management will host a virtual event on October 12, 2021 at 4:30 p.m. ET to highlight clinical data from its ongoing Phase 1 CARBON trial assessing the safety and efficacy of CTX110, its wholly-owned allogeneic chimeric antigen receptor T cell (CAR-T) investigational therapy targeting CD19, for the treatment of relapsed or refractory B-cell malignancies(Press release, CRISPR Therapeutics, OCT 5, 2021, View Source [SID1234590813]).

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Conference Call and Webcast
To access the conference call, please dial +1 (866) 952-8559 (domestic) or +1 (785) 424-1743 (international) and reference the conference ID "CRISPR."

A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A webcast replay will be available on the CRISPR Therapeutics website after the event and will be archived for 14 days.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting Cluster of Differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

Adaptimmune to Present Data Updates at Upcoming CTOS and SITC Meetings

On October 5, 2021 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, will present clinical and translational data from the Phase 2 SPEARHEAD-1 trial at the Connective Tissue Oncology Society (CTOS) meeting(Press release, Adaptimmune, OCT 5, 2021, View Source [SID1234590810]). The Company will also present translational data based on the patients for whom safety and efficacy were recently reported at ESMO (Free ESMO Whitepaper) from the Phase 1 SURPASS trial, as well as a data update from the four patients treated in the Radiation sub-study of the Phase 1 trial with afami-cel, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting. Abstracts are available online on the meetings’ web sites.

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"At CTOS, we will present clinical and translational data updates from our SPEARHEAD-1 trial. Data from this trial will form the basis of our first BLA submission next year for afami-cel in synovial sarcoma and MRCLS," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "During SITC (Free SITC Whitepaper), we will present translational data from the SURPASS trial with our next-gen therapy ADP-A2M4CD8, as well as clinical data from a sub-study combining low-dose radiation with afami-cel. These two trials represent investigational approaches to improving the potency of our SPEAR T-cells. Understanding how we can continually enhance our T-cell therapies, so as to ultimately improve clinical outcomes for patients, is a key focus of our translational and early phase clinical research."

CTOS Meeting

Abstract Title: SPEARHEAD-1: A Phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (Abstract #1080870)
Oral presentation: November 12, 2021, in the Immunotherapy & Immune Microenvironment Session starting at 10:00 a.m. EST. Presenter: Dr. Brian Van Tine, Associate Professor of Medicine at Washington University School of Medicine in St. Louis

Abstract Title: SPEARHEAD-1 preliminary translational insights from a Phase 2 trial of afamitresgene autoleucel (formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (Abstract #1080366)

Poster Presentation: November 12, 2021, 2:30 p.m. – 3:15 p.m. EST during the Immunology & Immunotherapy Session. Presenter: Dr. Sandra D’Angelo, Medical Oncologist at Memorial Sloan Kettering Cancer Center
At CTOS, Adaptimmune will host its first virtual medical symposium on Thursday, November 11, 4:30-6:30 p.m. EST.

SITC meeting

Abstract Title: Enhancement of TCR-engineered T-cells targeting MAGE-A4 antigen by co-expression of CD8α and inhibition of AKT signaling during ex vivo T-cell expansion (Abstract #373)
Poster presentation: November 12-14, 2021, 7:00 a.m – 5:00 p.m. EST. Presenter: Alex Tipping, Adaptimmune
Abstract Title: Radiation sub-study to characterize safety and tolerability of low-dose radiation in combinations with afami-cel in patients with advanced cancers (Abstract #376)

Poster Presentation: November 12-14, 2021, 7:00 a.m. – 5:00 p.m. EST. Presenter: Dr. James W. Welsh, Professor, Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center

AbbVie to Host Third-Quarter 2021 Earnings Conference Call

On October 5, 2021 AbbVie (NYSE: ABBV) reported that it will announce its third-quarter 2021 financial results on Friday, October 29, 2021, before the market opens (Press release, AbbVie, OCT 5, 2021, View Source [SID1234590808]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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