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Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024

12/14/2023

— Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT — — ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2 2024 — — Caribou plans to initiate Phase…

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Erasca Announces First Patient Dosed in HERKULES-1 Phase 1b Trial Evaluating ERAS-007 and ERAS-601 MAPKlamp Combination in RAS/MAPK Pathway-Altered Solid Tumors

01/06/2023

Promising preliminary monotherapy data for ERK1/2 inhibitor ERAS-007 and SHP2 inhibitor ERAS-601 in advanced solid tumors, which had favorable safety, tolerability, and efficacy profiles that support combination development BRAF Class 2 and 3 alterations have no approved targeted therapies and represent up to 25% of all BRAF-driven tumors Excerpt from the Press Release: SAN DIEGO,…

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Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.

10/25/2021

Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups FDA also authorized the use of Moderna’s booster dose following primary vaccination with other authorized or approved COVID-19 vaccines Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering…

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Erasca Doses First Patient in SEACRAFT-1 Phase 1b Trial Evaluating Naporafenib Plus Trametinib in Patients with RAS Q61X Solid Tumors

09/08/2023

Anti-tumor activity in patients with NRAS Q61X melanoma and KRAS Q61X NSCLC supports tissue agnostic development in RAS Q61X solid tumors Initial Phase 1b combination data from SEACRAFT-1 expected in Q2-Q4 2024 Dosing of first patient in pivotal SEACRAFT-2 trial in NRAS-mutant melanoma expected in H1 2024 Excerpt from the Press Release: SAN DIEGO, Aug.…

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Aitia and G3 Therapeutics Publish Results Identifying New Causal Biomarkers of Atherosclerotic Coronary Artery Disease (ASCAD), the Leading Cause of Morbidity and Mortality Worldwide

01/18/2023

Excerpt from the Press Release: ATLANTA and SOMERVILLE, Mass., Jan. 12, 2023 /PRNewswire/ — G3 Therapeutics, a life sciences company that leverages large-scale multi-omic biological big data to develop life-changing therapeutics and diagnostics, and Aitia, the leader in the application of Causal AI and “Digital Twins” to discover and develop new drugs, today announced results…

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Vaxcyte Doses First Participants in Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants

04/07/2023

— Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by 2025 — — The Nine Incremental Serotypes in VAX-24 Cover an Additional 20-25 Percent of Strains Causing Invasive Pneumococcal Disease Over the Current Standard-of-Care PCV in Infants — Excerpt from the Press Release: SAN CARLOS, Calif., March 30, 2023…

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Ocugen Statement Regarding Publication of COVAXIN™ (BBV152) Phase 3 Study Results in The Lancet

11/19/2021

Excerpt from the Press Release: We are pleased that The Lancet, a trusted source of clinical, public health and global health knowledge, published Phase 3 data showing the COVID-19 vaccine candidate, COVAXIN™ (BBV152), has 93.4% efficacy against severe COVID-19 disease. COVAXIN™ (BBV152), a whole virion inactivated COVID-19 vaccine candidate, uses the same technology that is safely and effectively applied in the production of Bharat…

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Annexon Biosciences Completes Enrollment in ARCHER Phase 2 Trial of Novel C1q Inhibitor, ANX007, in Patients with Geographic Atrophy

04/13/2022

Topline efficacy and safety data expected in first half of 2023 Excerpt from the Press Release: BRISBANE, Calif., April 07, 2022 (GLOBE NEWSWIRE) — Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today announced the completion of enrollment in the…

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Biological Dynamics collaborates on clinical utility studies to examine the impact of its early pancreatic cancer detection assay

11/29/2022

The company partners with QURE and Curta to assess value of early identification in high-risk cohorts Excerpt from the Press Release: SAN DIEGO, Nov. 22, 2022 /PRNewswire/ — Biological Dynamics, an exosome-isolation technology and early disease detection diagnostic company, today announced that it has partnered with both QURE Healthcare and Curta to explore how the…

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Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement to Commence Investigator-Initiated and Funded Phase 1/2a Study of SON-1210 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer

09/03/2024

Preclinical data has demonstrated the potential of SON-1210, the first albumin-binding bifunctional IL-12/IL-15 fusion protein, for solid tumor immunotherapy An Innovative Immuno Oncology Consortium (“IIOC”) led by Oncology experts funded by the Sarcoma Oncology Center will conduct an investigator-initiated Phase 1/2a study of SON-1210 in pancreatic cancer, an indication with significant unmet medical need Company…

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