Industry News

Larimar Therapeutics Announces FDA Clearance to Initiate the 25 mg Cohort of a Phase 2 Dose Exploration Trial of CTI-1601 in Friedreich’s Ataxia Patients

09/20/2022

Initiation of the Phase 2 trial is expected in Q4 2022, with top-line data expected in 2H 2023 Company management hosting webcast and conference call today at 8:30 a.m. ET Excerpt from the Press Release: BALA CYNWYD, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused…

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Exelixis Announces Dose-Escalation Results from the Phase 1 STELLAR-001 Trial Evaluating XL092 Alone and in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors at ESMO 2022

09/20/2022

–Both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population – – XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile – – Based on the…

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Dynavax Announces First Participant Dosed in a Phase 2 Clinical Trial Evaluating an Adjuvanted Plague Vaccine

09/20/2022

Excerpt from the Press Release: EMERYVILLE, Calif., Sept. 12, 2022 /PRNewswire/ — Dynavax Technologies Corporation ( Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, in collaboration with the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and supported by the DOD’s Chemical and Biological Defense…

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Apexigen Presents New Data from a Phase 2 Trial Evaluating its CD40 Antibody, Sotigalimab, in Combination with Neoadjuvant Chemoradiation in Patients with Resectable Esophageal and Gastroesophageal Junction Cancers at ESMO Congress 2022

09/19/2022

-Sotigalimab in combination with neoadjuvant chemoradiation induced higher pathologic complete response rates, an important predictor of survival, in patients with both adenocarcinoma and squamous cell carcinoma- Excerpt from the Press Release: SAN CARLOS, Calif., Sept. 10, 2022 (GLOBE NEWSWIRE) — Apexigen, Inc. (NASDAQ: APGN) a clinical-stage company focused on developing innovative antibody-based therapeutics for the…

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Onconova Therapeutics Announces Updated Data from Investigator-sponsored Phase 1/2a Trial Evaluating Rigosertib in Combination with Nivolumab in Advanced KRAS-mutated Non-Small Cell Lung Cancer at the ESMO Congress 2022

09/19/2022

Data show an early signal of efficacy in an extensively pre-treated population with 1 complete response and 2 partial responses achieved in 14 evaluable patients Responses achieved in patients with 3 distinct and different KRAS mutations, confirming the MOA of rigosertib being KRAS+ agnostic 4 of 14 (29%) evaluable patients demonstrated disease control The combination…

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IMFINZI® (durvalumab) plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up

09/19/2022

HIMALAYA Phase III trial exploratory results support the benefit of tremelimumab added to IMFINZI in unresectable liver cancer regardless of etiology Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab), in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit…

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Amylyx Pharmaceuticals Announces Publication of Preclinical Data Showing Potential Synergistic Effect of AMX0035 Compared to Individual Compounds

09/16/2022

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the publication of preclinical data showing the effect of sodium phenylbutyrate (PB) and taurursodiol (TURSO, also known as ursodoxicoltaurine) on the transcriptomic and metabolomic profiles of primary skin fibroblasts from adults with sporadic amyotrophic lateral sclerosis (ALS)…

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Amolyt Pharma Announces Positive Efficacy and Safety Data from First Cohort of Phase 2a Study of AZP-3601 in Patients with Hypoparathyroidism at the American Society for Bone and Mineral Research 2022 Annual Meeting

09/16/2022

– Company to host Key Opinion Leader webinar today, September 12, at 1:30 pm CT/2:30 pm ET – Excerpt from the Press Release: LYON, France and CAMBRIDGE, Mass., Sept. 12, 2022 (GLOBE NEWSWIRE) — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced positive efficacy and…

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TumorGen and PhenoVista Capture the Seeds that Drive Cancer Metastasis

09/15/2022

TumorGen’s microfluidic platform traps metastatic cancer cell clusters from lung cancer patients, creating new opportunities for anti-metastatic drug development. Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–TumorGen Inc., and PhenoVista Biosciences LLC have successfully isolated and characterized metastatic cancer cell clusters (MCCCs) from the blood of lung cancer patients’, validating TumorGen’s novel MCCC capture technology.…

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Xevinapant Five-Year Data Show Survival Rate Nearly Doubled in Patients with Unresected LA SCCHN, When Added to Standard of Care

09/15/2022

Not intended for UK-based media First randomized trial in decades to show significant improvement in overall survival in patients with LA SCCHN, reinforcing the transformative potential of xevinapant over standard of care in the curative setting Patients treated with xevinapant plus CRT almost twice as likely to be alive at five years (53% vs 28%)…

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