News & Updates

Candel Therapeutics Announces Patient-Reported Tolerability Data of Intraprostatic Injections in Ongoing Phase 3 Clinical Trial of CAN-2409 in Patients with Localized Prostate Cancer

11/04/2021

Excerpt from the Press Release: NEEDHAM, Mass., Oct. 28, 2021 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, today announced that data on patient-reported tolerability assessment of intraprostatic injections will be presented in a virtual poster session at the 28th Annual Prostate Cancer Foundation Scientific Retreat.  Date: Thursday, October 28, 2021  Presenter: Laura K. Aguilar, MD, PhD, Chief Medical Officer at…

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UPDATE – Sorrento Announces Encouraging Results From Two Phase 2 Studies of Abivertinib For Treatment Of Hospitalized Severe COVID-19 Patients

11/04/2021

Abivertinib is an oral capsule (100 mg QD or two 50-mg capsules a day) that potentially reduces cytokine storm associated with acute respiratory distress syndrome (ARDS) in severe hospitalized COVID-19 patients. Preliminary results from two completed Phase 2 studies: US study (N=96) and Brazil study (N=400) have identified an At-Risk COVID-19 Patient Population – Hospitalized COVID patients receiving oxygen support by…

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Biocom California Institute and California Life Sciences Release 2021 Life Sciences Workforce Trends Report for California

11/03/2021

California’s life sciences industry continues to be a consistent engine of economic growth and high-quality job creation for the state Excerpt from the Press Release: SAN DIEGO, LOS ANGELES & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Biocom California Institute, a 501(c)(3) non-profit that supports life science innovation by strengthening the workforce and leaders of tomorrow, and California…

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Meissa Announces Positive Preliminary Clinical Data on Safety and Immunogenicity of Intranasal COVID-19 Vaccine

11/03/2021

Meissa’s intranasal recombinant live attenuated COVID-19 vaccine, MV-014-212, induced a strong nasal IgA antibody response in seropositive and seronegative adults Safety data show that MV-014-012 is highly attenuated, with no serious adverse events reported and no infectious vaccine virus detected from any participants to date MV-014-212 was built on the company’s AttenuBlock™ platform and is…

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Synthekine Advances IL-2 Partial Agonist, STK-012, into Clinical Investigation for Treatment of Solid Tumors

11/03/2021

Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Synthekine Inc., an engineered cytokine therapeutics company, today announced it is advancing its IL-2 partial agonist, STK-012, into clinical investigation following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). Synthekine will evaluate STK-012 in a Phase 1a/1b, open-label, multi-center,…

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Entera Bio Publishes Key Study Describing its Oral Delivery Technology Platform for Biologic Drugs

11/02/2021

‒Study describes a dual mechanism of action approach to oral drug delivery of large molecules, the “Holy Grail” of drug development. ‒Technology is utilized in Entera’s EB613 oral PTH drug for osteoporosis and several other molecules now in development by Entera and in collaboration with pharmaceutical companies. Excerpt from the Press Release: BOSTON and JERUSALEM,…

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Samsung Receives FDA Clearance for AI Algorithms that Detect Lung Nodules in Chest X-rays

11/02/2021

Chest radiograph without Auto Lung Nodule Detection (ALND) and chest radiograph with lung nodule marked. (Photo: Business Wire) Excerpt from the Press Release: DANVERS, Mass.–(BUSINESS WIRE)–NeuroLogica Corp. today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool. The offering provides an on-device, computer-assisted detection (CADe)…

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Data from Phase 1/2a study of RM-1929 Photoimmunotherapy in Patients with Recurrent Head and Neck Squamous Cell Carcinoma was Published in Head and Neck

11/02/2021

Excerpt from the Press Release: SAN MATEO, Calif., Oct. 27, 2021 /PRNewswire/ — Rakuten Medical, Inc. (Rakuten Medical) announced that data from a phase 1/2a, open-label, multicenter study of RM-1929 photoimmunotherapy in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (RM-1929-101 study, ClinicalTrials.gov Identifier: NCT02422979) was accepted for publication in Head and Neck and published online on October 9th, 2021.…

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HUYABIO Announces FDA Clearance to Initiate a Phase 1 Trial of SHP2 Inhibitor in Patients with KRAS and EGFR Mutated Tumors

11/01/2021

Excerpt from the Press Release: SAN DIEGO, Oct. 28, 2021 /PRNewswire/ — HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom…

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Gilead Announces Clinical Trial Collaboration With Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With First-Line Metastatic Triple-Negative Breast Cancer

11/01/2021

Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 28, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy® (sacituzumab govitecan-hziy) in…

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