Doctor of Philosophy

ACELYRIN, INC. Reports Full Year 2023 Financial Results and Recent Highlights

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Thursday, March 28, 2024
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LOS ANGELES, March 28, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the full year ended December 31, 2023 and highlighted recent corporate updates and upcoming milestones.

Key Points: 
  • R&D Expenses: Research and development expenses were $355.9 million for the full year ended December 31, 2023, as compared to $55.6 million for 2022.
  • G&A Expenses: General and administrative expenses were $66.2 million for the full year ended December 31, 2023, as compared to $13.5 million for 2022.
  • Net Loss: Net loss for the full year ended December 31, 2023 was $381.6 million, compared to $64.8 million for 2022.
  • In December 2023, the Company announced the appointment of Lynn Tetrault to its Board of Directors.

Candel Therapeutics Announces Oral Presentation During the 5th Glioblastoma Drug Development Summit with Update on Phase 1b Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma

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Thursday, March 28, 2024
SOC, Survival, Fast track (FDA), Safety, Patient, Food and Drug Administration, Standard of care, Doctor of Philosophy, MD, Clinical trial, Therapy, Injection, FDA, Drug development, CADL, Food, Serology, Pharmaceutical industry

“Dosing patients with multiple injections represents the next step forward in the development of CAN-3110 for rHGG,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “The observed data suggest that repeated injections of CAN-3110 are well tolerated, supporting the design of a future phase 2 clinical trial in this indication. We’re excited by our recent progress -- as illustrated by the publication in Nature, CAN-3110’s recent FDA Fast Track designation, and the collaboration with Batavia Biosciences -- to accelerate the development and production of CAN-3110, along with our update presented today. Together, we hope this will help to accelerate the development of a better treatment for patients with high unmet need.”

Key Points: 
  • The first cohort of patients were treated with multiple injections of CAN-3110 in the ongoing phase 1b clinical trial.
  • A second cohort is being planned for enrollment in the ongoing phase 1b clinical trial of CAN-3110.
  • The data were presented today during the 5th Glioblastoma Drug Development Summit in Boston, Massachusetts.
  • Results from the ongoing phase 1b clinical trial were published in Nature in Q4 2023.

Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

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Thursday, March 28, 2024
Galactitol, MAA, New Drug Application, Patient, Ageing, NDA, PRV, EMA, Doctor of Philosophy, Marketing, Priority review, Therapy, ARI, Food, FDA, CHMP, PDUFA, Pharmaceutical industry

The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.

Key Points: 
  • The FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024.
  • In February 2024, the Company announced that the FDA accepted and granted Priority Review to the NDA.
  • “While the PDUFA action date extension represents a delay, we remain confident in the potential for govorestat approval for Galactosemia and we will continue to work closely with the FDA throughout the review process,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.
  • If approved, govorestat would be the first medication indicated for the treatment of Galactosemia and would be Applied Therapeutics’ first commercial product.

Assembly Biosciences Reports Fourth Quarter and Year End 2023 Financial Results and Recent Highlights

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Thursday, March 28, 2024
Research, HSV, Assembly, Biotechnology, Partnership, Viral, Doctor of Philosophy, Safety, BeiGene, Simplex, Therapy, CMO

Revenues from collaborative research were $7.2 million for the year ended December 31, 2023.

Key Points: 
  • Revenues from collaborative research were $7.2 million for the year ended December 31, 2023.
  • Research and development expenses were $48.9 million for the year ended December 31, 2023, compared to $70.0 million in 2022.
  • General and administrative expenses were $22.9 million for the year ended December 31, 2023, compared to $24.1 million in 2022.
  • The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.

Gilead and Xilio Announce Exclusive License Agreement for Tumor-Activated IL-12 Program

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Thursday, March 28, 2024
Molecule, Therapeutic index, EPS, Gilead Sciences, Patient, Pharming, Tumor microenvironment, Doctor of Philosophy, MD, Senior, IPR, Investment, Therapy, Antibody, Cytokine, IL-12, Pharmaceutical industry

FOSTER CITY, Calif. and WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.

Key Points: 
  • -- Gilead Granted Exclusive License to Xilio’s Tumor-Activated IL-12 Program, Including XTX301, a Clinical-Stage IL-12 Molecule with Potential to Treat a Broad Range of Cancers --
    FOSTER CITY, Calif. and WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (Nasdaq: GILD) and Xilio Therapeutics, Inc. (Nasdaq: XLO) today announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301.
  • XTX301 is currently being evaluated in a Phase 1 dose escalation trial in patients with advanced solid tumors.
  • Xilio will receive $43.5 million in upfront payments, including a cash payment of $30.0 million and an initial equity investment by Gilead of $13.5 million in Xilio common stock at a premium.
  • Xilio will be responsible for conducting clinical development of XTX301 in the ongoing Phase 1 clinical trial through dose expansion.

Larkspur Biosciences to Present New Preclinical Research on Lead Development Program Candidate, a First-in-Class PIP4K2C Protein Degrader, at AACR 2024

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Thursday, March 28, 2024
Colorectal cancer, Patient, Neoplasm, Mouse, Systems biology, Cancer, Doctor of Philosophy, IND, PIP4K2C, AACR, CRC, Immune system, Stanford University, Probability, Family, Escape Room, Pharmaceutical industry

The data will be featured in a poster presentation at the 115th Annual Meeting of the American Association for Cancer Research (AACR 2024) in San Diego, CA.

Key Points: 
  • The data will be featured in a poster presentation at the 115th Annual Meeting of the American Association for Cancer Research (AACR 2024) in San Diego, CA.
  • “Larkspur Biosciences pursues novel targets inside the cancer, like PIP4K2C, that prevent the immune system from seeing and attacking it.
  • “Using LarkXCRC, our proprietary bioinformatics platform, Larkspur developed a patient biomarker strategy to select the patients most likely to respond to LRK-A.
  • Larkspur aims to shift the treatment paradigm – which hasn’t meaningfully changed in decades – by effectively activating the immune system against tumors by targeting PIP4K2C.

GRI Bio to Present at the MedInvest Biotech & Pharma Investor Conference

Retrieved on: 
Thursday, March 28, 2024
GRI, Natural killer T cell, NKT, Conference, Doctor of Philosophy

LA JOLLA, CA, March 28, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that Marc Hertz, PhD, Chief Executive Officer of GRI Bio, will present at the MedInvest Biotech & Pharma Investor Conference being held in New York City, NY on Wednesday, April 3, 2024 at 10:10 AM ET.

Key Points: 
  • LA JOLLA, CA, March 28, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that Marc Hertz, PhD, Chief Executive Officer of GRI Bio, will present at the MedInvest Biotech & Pharma Investor Conference being held in New York City, NY on Wednesday, April 3, 2024 at 10:10 AM ET.
  • In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.
  • For more information about the conference, please visit the conference website .

GeoVax to Present Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine, at the World Vaccine Congress

Retrieved on: 
Thursday, March 28, 2024
Immune system, Vaccine, Infection, Biotechnology, Cancer, COVID-19, Doctor of Philosophy

ATLANTA, GA, March 28, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, will present data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the upcoming 24th Annual World Vaccine Congress taking place in Washington, DC on April 1-4, 2024.

Key Points: 
  • ATLANTA, GA, March 28, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, will present data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the upcoming 24th Annual World Vaccine Congress taking place in Washington, DC on April 1-4, 2024.
  • Dr. Newman’s presentation will focus on results delineating the unique immune system driven mechanisms that contribute to the broad efficacy of GeoVax’s next-generation Covid-19 vaccine, GEO-CM04S1.

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Q&A, Exercise, Patient, Pulmonary hypertension, Cardiovascular Research, Clinical trial, IP, Therapy, LINK, Research, Science, LEVEL, Public expenditure, Heart failure, Development, Tenax, Disease, KOL, TNX-102, First, Research and development, MPH, Cardiology, Conference, Patent, Doctor of Philosophy, Faculty, MBA, Levosimendan, THT, Feinberg School of Medicine, Pharmaceutical industry

We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
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    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.

Unity Consortium Marks Adolescent Immunization Action Week (AIAW) with activities to help Parents and Adolescents get up to date on Recommended Vaccines

Retrieved on: 
Thursday, March 28, 2024
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AIAW is a national movement aimed at parents, adolescents and healthcare providers to ensure adolescents are up to date on well visits and recommended vaccines.

Key Points: 
  • AIAW is a national movement aimed at parents, adolescents and healthcare providers to ensure adolescents are up to date on well visits and recommended vaccines.
  • Across the nation, organizations interested in the health of adolescents are participating in AIAW to help protect adolescents from vaccine-preventable illnesses.
  • To address these challenges, Unity wants parents to help adolescents and young adults stay healthy by Staying on TASK with vaccines.
  • As AIAW kicks off, Unity offers activities and resources to support Adolescent Immunization Action Week efforts, including:
    A graphic and video animation of Staying on TASK.