American Society for Pharmacology and Experimental Therapeutics

Astria Therapeutics Announces Publication of STAR-0215 Preclinical Data in the Journal of Pharmacology and Experimental Therapeutics

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Thursday, August 31, 2023
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“We were very pleased by our publication in the Journal of Pharmacology and Experimental Therapeutics, further validating the exciting science behind STAR-0215,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics.

Key Points: 
  • “We were very pleased by our publication in the Journal of Pharmacology and Experimental Therapeutics, further validating the exciting science behind STAR-0215,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics.
  • STAR-0215 demonstrated potent in vitro inhibition of plasma kallikrein-mediated bradykinin release from high molecular weight kininogen (HWMK) in a physiologically relevant assay.
  • The publication can be found at the following link: https://doi.org/10.1124/jpet.123.001740
    STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein in development for the treatment of HAE.
  • The Phase 1b/2 ALPHA-STAR trial evaluating STAR-0215 in people living with HAE is ongoing, with initial proof-of-concept results from single and multiple dose cohorts expected in mid-2024.

MEKanistic Therapeutics First-in-Class Cancer Clinical Candidate Approved to Receive Continued Development Support through the National Cancer Institute's Experimental Therapeutics (NExT) Program

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Tuesday, August 1, 2023
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MINNEAPOLIS, Aug. 1, 2023 /PRNewswire/ -- MEKanistic Therapeutics, a pioneering biotechnology company revolutionizing kinase inhibitors for cancer treatment, announced today that its investigational cancer clinical candidate MTX-531 has been approved for receiving continued development support from the National Cancer Institute's (NCI) Experimental Therapeutics (NExT) Program.

Key Points: 
  • MINNEAPOLIS, Aug. 1, 2023 /PRNewswire/ -- MEKanistic Therapeutics, a pioneering biotechnology company revolutionizing kinase inhibitors for cancer treatment, announced today that its investigational cancer clinical candidate MTX-531 has been approved for receiving continued development support from the National Cancer Institute's (NCI) Experimental Therapeutics (NExT) Program.
  • MEKanistic is driving its novel, highly selective dual inhibitor to the clinic with the support from NCI's NExT program.
  • The NExT Program is a translational research initiative aimed at accelerating the development of encouraging, innovative cancer therapies.
  • "We are thrilled that the NExT Program recognized the potential of MTX-531 to address unmet medical needs in cancer therapy," said Danny Cunagin, CEO of MEKanistic Therapeutics.

Reviva Pharmaceuticals Announces Presentation of Clinical Pharmacology Studies Data on Brilaroxazine at the ASPET 2023 Annual Meeting

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Monday, May 22, 2023
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CUPERTINO, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), respiratory and metabolic diseases, has presented two posters on promising clinical pharmacology and safety studies data on the novel serotonin-dopamine stabilizer brilaroxazine at the American Society for Pharmacology and Experimental Therapeutics (ASPET) 2023 annual meeting took place in St. Louis, Missouri, USA, May 18-21, 2023. The ASPET posters are available at revivapharma.com/publications. Brilaroxazine is currently in phase 3 clinical trials for schizophrenia and topline data from the pivotal phase 3 is anticipated in mid this year.

Key Points: 
  • Brilaroxazine is currently in phase 3 clinical trials for schizophrenia and topline data from the pivotal phase 3 is anticipated in mid this year.
  • “These data support the concomitant use of brilaroxazine with other medications metabolized by CYP3A4 as most schizophrenia patients take multiple concomitant medications.
  • As part of the required clinical studies for New Drug Application (NDA), the drug-drug interactions between brilaroxazine with a strong CYP3A4 inhibitor (itraconazole) and inducer (phenytoin) were evaluated.
  • Brilaroxazine single dose co-administered with phenytoin at steady-state resulted in decrease of ~33%, 57% and 54% in brilaroxazine Cmax, AUC0-t, and AUC0∞, respectively.

Terns Pharmaceuticals Reports First Quarter 2023 Financial Results and Corporate Updates

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Monday, May 15, 2023
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FOSTER CITY, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, today reported financial results for the first quarter ended March 31, 2023 and corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $17.1 million for the quarter ended March 31, 2023, as compared with $8.1 million for the quarter ended March 31, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $7.1 million for the quarter ended March 31, 2023, as compared with $5.7 million for the quarter ended March 31, 2022.
  • Net Loss: Net loss was $21.5 million for the quarter ended March 31, 2023, as compared with $13.8 million for the quarter ended March 31, 2022.

Moleculin Announces Presentation of Positive Pharmacokinetics and Tissue-Organ Distribution Data Demonstrating High Antitumor Activity of Annamycin in Preclinical Cancer Models

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Tuesday, April 18, 2023
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HOUSTON, April 18, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced that positive preclinical data regarding the Company's next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL. This research was sponsored by the Company.

Key Points: 
  • "Annamycin has continued to demonstrate in preclinical models promising results in hard-to-treat tumors.
  • The high antitumor activity seen preclinically with Annamycin is very encouraging and provides validation for expanded studies to assess activity in different tumor liver metastasis models as well as HCC models," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin .
  • The antitumor efficacy of L-ANN was studied using HEPA 1-6 hepatocellular carcinoma models (subcutaneous, orthotopic, and experimental liver metastatic models) as well as CT26 colon cancer and MIA PaCa-2 pancreatic cancer liver metastasis models.
  • Unless specifically noted otherwise, references to "Annamycin" refer to the liposome formulated form of the drug.

IRBM Selected for Participation in National Chemical Biology Consortium

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Tuesday, April 4, 2023
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IRBM’s CEO Matteo Liguori said: “We are privileged to have been selected to participate in the CBC with the vital mission of progressing oncology programs globally, delivering transformational treatments for patients worldwide.

Key Points: 
  • IRBM’s CEO Matteo Liguori said: “We are privileged to have been selected to participate in the CBC with the vital mission of progressing oncology programs globally, delivering transformational treatments for patients worldwide.
  • Members contribute their expertise in high throughput screening, structural biology, medicinal chemistry, compound profiling, cancer cell biology, and in vivo & in vitro models for oncology.
  • IRBM is the only member based outside the USA to be part of the CBC network.
  • IRBM is an innovative research organization working across all aspects of drug discovery and early development.

Windtree Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Key Business Updates

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Monday, April 3, 2023
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WARRINGTON, Pa., April 03, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided key business updates.

Key Points: 
  • WARRINGTON, Pa., April 03, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for cardiovascular disorders, today reported financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided key business updates.
  • Research and development expenses were $1.2 million for the fourth quarter of 2022, compared to $4.5 million for the fourth quarter of 2021.
  • General and administrative expenses for the fourth quarter of 2022 were $2.2 million, compared to $3.0 million for the fourth quarter of 2021.
  • For the fourth quarter ended December 31, 2022, the Company reported an operating loss of $10.8 million, compared to an operating loss of $14.7 million in the fourth quarter of 2021.

Kineta to Host Key Opinion Leader Event on KVA12123: VISTA as an Immuno-Oncology Target

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Monday, March 6, 2023
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SEATTLE, March 06, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on developing next-generation immunotherapies to address cancer immune resistance, announced today it will host a virtual Key Opinion Leader (KOL) event on VISTA as an immuno-oncology target on Monday, March 20, 2023 at 10:00 AM ET.

Key Points: 
  • SEATTLE, March 06, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on developing next-generation immunotherapies to address cancer immune resistance, announced today it will host a virtual Key Opinion Leader (KOL) event on VISTA as an immuno-oncology target on Monday, March 20, 2023 at 10:00 AM ET.
  • Kineta’s leadership will provide an update on its lead program KVA12123, a novel anti-VISTA monoclonal antibody, as a treatment for patients with advanced solid tumors.
  • Kineta recently initiated a Phase 1/Phase 2 clinical study to investigate KVA12123 alone and in combination with pembrolizumab, Merck’s anti-PD-1 therapy.
  • Patricia LoRusso, DO, is a Professor of Medicine (Medical Oncology) and Associate Cancer Center Director of Experimental Therapeutics at the Yale Cancer Center.

SELLAS Life Sciences to Host Key Opinion Leader Webinar on Galinpepimut-S Acute Myeloid Leukemia Program

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Thursday, January 19, 2023
Oncology, UAB, EST, University, Therapy, AML, Experiment, Neoplasm, Acute myeloid leukemia, Division, MD, American Society for Pharmacology and Experimental Therapeutics, Haematopoietic system, Cancer, WT1, Chronic myelogenous leukemia, Assistant, Patient, Hematology, SLS, GPS, Pharmaceutical industry, Medicine

NEW YORK, Jan. 19, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, will host a virtual key opinion leader event to discuss the current treatment landscape for patients suffering from acute myeloid leukemia (AML) and the potential for galinpepimut-S (GPS) as a treatment solution.

Key Points: 
  • The webinar event will feature Omer Jamy, MD who is principal investigator of the Phase 3 REGAL study at the University of Alabama at Birmingham (UAB), one of the highest enrolling REGAL sites.
  • He is currently Assistant Professor of Medicine at UAB in the Division of Hematology and Oncology and Associate Scientist, Experimental Therapeutics at the O'Neal Comprehensive Cancer Center.
  • Dr. Jamy is principal investigator on several clinical trials in addition to REGAL, focusing on AML, chronic myelogenous leukemia, and allogeneic stem cell transplantation.
  • A live question and answer session will follow the formal presentation and replay will be available here following the event.

IO Biotech Provides Business Update

Retrieved on: 
Monday, January 9, 2023
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NEW YORK, Jan. 09, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® vaccine platform, today provided a business update.

Key Points: 
  • NEW YORK, Jan. 09, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® vaccine platform, today provided a business update.
  • “Throughout 2022, the team at IO Biotech made major progress on multiple fronts – advancing our lead program into a global Phase 3 pivotal trial for patients with advanced melanoma, initiating a Phase 2 solid tumor basket study for IO102-IO103 in combination with pembrolizumab, and continuing research on our pipeline assets,” said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech.
  • We now have four investigator-initiated studies underway in the United States and Europe, with an additional grant being finalized.
  • The company is now supporting four investigator-initiated trials evaluating IO102-IO103 in combination regimens across a variety of cancer types.