Industry News

Ocugen Announces Completion of Dosing in OCU400 Phase 1/2 Cohort 2

10/21/2022

• No safety concerns noted in ongoing clinical trial• Study timeline remains on track Excerpt from the Press Release: MALVERN, Pa., Oct. 12, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the…

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Corcept Therapeutics Initiates DAZALS – A Phase 2 Trial in Amyotrophic Lateral Sclerosis (ALS)

10/21/2022

Excerpt from the Press Release: MENLO PARK, Calif., Oct. 11, 2022 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today announced that it has initiated DAZALS –…

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BridgeBio Pharma Presents 12-month Results from Phase 2 Study of BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i (LGMD2i)

10/20/2022

Novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total αDG from baseline towards normal levels, suggesting that the investigational oral therapy, BBP-418, has the potential to address the root cause of LGMD2i Large, sustained reduction…

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BMF-219 Enters the Clinic for KRAS Solid Tumors

10/20/2022

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic…

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Aligos Therapeutics Initiates Dosing In Healthy Volunteers With siRNA Drug Candidate ALG-125755

10/20/2022

Single ascending doses to be evaluated in healthy volunteers in Q4 2022 Single ascending doses to be evaluated in subjects with chronic hepatitis B beginning in Q1 2023 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 14, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on…

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New CPDC spinout company aims to become global leader in developing and distributing radiopharmaceuticals

10/19/2022

AtomVie Global Radiopharma is the latest company launched by the OICR-supported centre Excerpt from the Press Release: The Centre for Probe Development and Commercialization’s (CPDC) newest spinout company has now launched as AtomVie Global Radiopharma Inc. On August 24, the Hamilton-based radiopharmaceutical company announced it had closed Series A financing with healthcare investment firm Avego…

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Allogene Therapeutics Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

10/19/2022

ALPHA2 Trial, Evaluating ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients, is Designed to Leverage the Ease and Convenience of a Single Dose of ALLO-501A Protocol Supported by Clinical and Translational Data from Phase 1 Trial Indicating Deep Responses are Achievable with a Single Dose of ALLO-501A When Used with a Lymphodepletion Regimen That Includes…

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Verastem Oncology Announces RAMP VS-6766 Clinical Trials and Corporate Update

10/18/2022

FDA Meeting Planned for Q4 to Discuss Regulatory Path Forward Based on Encouraging Results to Date in Ongoing RAMP 201 Trial in LGSOC Results of Part A of RAMP 202 Trial in KRAS G12V-Mutant NSCLC Show VS-6766 ± Defactinib Did Not Meet Criteria to Continue to Expansion Phase RAMP Trials with VS-6766 Combinations in KRAS…

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Elicio Therapeutics Announces Publication of Preclinical Data in Science Translational Medicine Demonstrating the AMP Platform Promotes Uptake of Intranasal Vaccine in the Mucosa Amplifying Immune Response

10/18/2022

AMP-protein-based vaccines administered intranasally to mice and nonhuman primates (NHPs) were transported across the epithelial lining to the nasal-associated lymphoid tissue (NALT) and persisted in the nasal mucosa eliciting immune responses at both local and distal mucosal sites Intranasal immunization with AMP-conjugated HIV Env gp120 or SARS-CoV-2 receptor binding domain (RBD) proteins elicited 100- to…

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Myrtelle Completes Dosing of 8 Patients with Canavan Disease in Its Phase 1/2 Clinical Trial of the Investigational Gene Therapy rAAV-Olig001-ASPA

10/17/2022

Eight patients have been treated in the ongoing Phase 1/2 First-in-Human clinical trial with favorable safety and tolerability observed to date Assessments of the initial 3 patients reaching their six-month follow-up showed improvements on validated functional scales and increases in brain white matter and myelin content Encouraging efficacy and safety data support further development of…

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