Gamida Cell Presents New Data from NAM-Enabled Genetically Modified Natural Killer (NK) Pipeline at International Society for Cell & Gene Therapy 2022


Poster selected for inclusion in conference’s Elevator Pitch Session: GDA-301 produces enhanced potency and persistence with combined genetic manipulation of CISH gene editing and the engineered expression of membrane-bound IL-15 for targeting hematologic malignancies and solid tumors GDA-601 generates promising immunotherapeutic potential to target multiple myeloma cells Company plans to select a genetically modified NK…

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KVK Tech Announces Phase II Trial of COVID-19 Oral Therapy is Currently Enrolling in Nepal


Excerpt from the Press Release: NEWTOWN, Pa., May 5, 2022 /PRNewswire/ — Sen-Jam Pharmaceuticals and KVK Tech are collaborating to develop a Covid-19 oral therapy. The companies will operate in parallel while they complete the Phase II clinical trials in Nepal. KVK Tech will offer formulation and chemistry, manufacturing and controls (CMC) for the oral therapy. Furthermore, KVK…

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Spero Therapeutics Tebipenem Pivoxil Hydrobromide Phase 3 Data Published in The New England Journal of Medicine


Excerpt from the Press Release: CAMBRIDGE, Mass., April 06, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced publication in The New England Journal of Medicine (NEJM) of the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem pivoxil hydrobromide (tebipenem HBr). The paper, titled “Oral Tebipenem Pivoxil Hydrobromide in…

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Therapeutic Solutions International Completes Purchase of FDA Phase III JadiCell Stem Cell Investigational New Drug Application from University of Miami


Transfer of Trial Sponsorship Final Major Milestone before Initiation of Lung Failure Pivotal Clinical Trial Excerpt from the Press Release: CEANSIDE, Calif.–(BUSINESS WIRE)–Therapeutic Solutions International announced today the execution of a purchase agreement covering sponsorship and leadership of the FDA cleared Phase III pivotal trial assessing JadiCell adult stem cells for treatment of COVID-19 associated…

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Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)


Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…

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Karyopharm Provides U.S. Regulatory Update on Selinexor in Advanced or Recurrent Endometrial Cancer


Following Discussion with the FDA, Karyopharm Plans to Initiate a New Placebo-Controlled Randomized Study of Selinexor in the Advanced or Recurrent Endometrial Cancer p53 Wild-Type Population to Support a Future sNDA Submission as the Current Topline Data from the SIENDO Study are Unlikely to Support an sNDA Approval Karyopharm is Encouraged by the SIENDO p53…

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Pardes Biosciences Announces FDA Clearance of IND Application for PBI-0451, an Oral Antiviral Drug Candidate for the Treatment and Prevention of SARS-CoV-2 Infections


CARLSBAD, Calif., Feb. 03, 2022 (GLOBE NEWSWIRE) — Pardes Biosciences, Inc. (NASDAQ: PRDS), a clinical-stage biopharmaceutical company developing PBI-0451 as a potential novel direct-acting, oral antiviral drug candidate for the treatment and prevention of SARS-CoV-2 infections and associated diseases (i.e., COVID-19), today announced that its Investigational New Drug (IND) application for PBI-0451 has been cleared…

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Palleon Pharmaceuticals Announces IND Clearance for First-in-Class Cancer Immunotherapy Leveraging Glyco-Immunology


– Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumors – Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Palleon Pharmaceuticals, a company pioneering the field of glyco-immunology to treat cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration has cleared the company’s investigational new…

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Jubilant Therapeutics Announces FDA Clearance of IND for JBI-802, a Novel Dual LSD1 and HDAC6 Inhibitor, for treatment of Solid Tumors


Excerpt from the Press Release: BEDMINSTER, N.J., Jan. 6, 2022 /PRNewswire/ — Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual…

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Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Combination of Elzovantinib and Aumolertinib in EGFR Mutant Met-Amplified Non-Small Cell Lung Cancer


Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that the company has received clearance from the FDA for the company’s Investigational New Drug (IND) application for the combination of…

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