MSD

Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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Mercoledì, Maggio 1, 2024

Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.

Key Points: 
  • Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.
  • The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
  • In the U.S., KEYTRUDA is also approved for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, based on results from KEYNOTE-859.
  • Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.

Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

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Lunedì, Aprile 29, 2024

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
  • V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
  • V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.

FloQast Secures $100 Million in Series E Funding, Achieving $1.6 Billion Valuation

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Mercoledì, Aprile 10, 2024

With this latest investment, FloQast achieves a post-money valuation of $1.6 billion, underscoring its position as a leader in the accounting and finance technology sector.

Key Points: 
  • With this latest investment, FloQast achieves a post-money valuation of $1.6 billion, underscoring its position as a leader in the accounting and finance technology sector.
  • "Today’s accounting and finance teams have the opportunity to emerge as drivers of growth and strategic change within their organizations,” said Mike Whitmire, CPA*, CEO and co-founder of FloQast.
  • Logo Growth: FloQast now powers more than 2,600 accounting teams, including Twilio, Los Angeles Lakers, Zoom, and Snowflake, among other notable organizations.
  • Creative Brand Strategy: FloQast unveiled an all-new brand strategy , reflecting the company's commitment to innovation and modernization in the accounting industry.

Hanmi Enters into Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate BH3120 in Combination with KEYTRUDA® (pembrolizumab)

Retrieved on: 
Mercoledì, Aprile 24, 2024

SEOUL, South Korea, April 23, 2024 /PRNewswire/ -- Hanmi Pharmaceutical (KOSPI: 128940, CEO: Jae-Hyun Park), a leading biopharma company in Korea that focuses on research areas such as oncology, obesity/metabolism, and rare diseases, announced it has entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA).

Key Points: 
  • Upon the execution of the agreement, Hanmi Pharmaceutical will conduct a phase 1 clinical trial to evaluate the safety and efficacy of its immuno-oncology drug, 'BH3120', in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with progressive or metastatic solid tumors.
  • Hanmi Pharmaceutical will sponsor the clinical trial, and MSD will supply KEYTRUDA.
  • 'BH3120' is a next-generation immunotherapy drug that applies 'Pentambody', a bispecific antibody platform technology, currently under joint development by Hanmi Pharmaceutical and its Chinese subsidiary, BJHM (Beijing Hanmi Pharmaceutical).
  • He said, "Through the collaboration with MSD, we expect BH3120 in combination with KEYTRUDA could improve outcomes for patients with relapsed or refractory disease."

Guesty Raises $130M to Accelerate Global Expansion

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Mercoledì, Aprile 10, 2024

NEW YORK, April 10, 2024 /PRNewswire/ -- Guesty, the leading property management software platform for the short-term rental ("STR") and hospitality industry, today announced a $130M Series F funding round led by leading global investment firm KKR. Inovia Capital, together with existing investors Apax, BDT & MSD Partners and Sixth Street, also joined the round, extending their support following Guesty's significant expansion and sustained growth. This new round of funding will support continued development of Guesty's best-in-class enterprise-level platform for property managers and drive market consolidation to grow the company's global footprint. Stephen Shanley, Partner at KKR and Head of Tech Growth in Europe; Lauriane Requena, Principal at KKR Tech Growth, and Dennis Kavelman, Inovia Capital Partner, join Guesty's Board of Directors following this investment.

Key Points: 
  • Inovia Capital, together with existing investors Apax, BDT & MSD Partners and Sixth Street, also joined the round, extending their support following Guesty's significant expansion and sustained growth.
  • This new round of funding will support continued development of Guesty's best-in-class enterprise-level platform for property managers and drive market consolidation to grow the company's global footprint.
  • Operating in over 80 countries, Guesty is the most comprehensive and easy-to-use platform on the market today.
  • Guesty's new funding will be used for expansion across the US, enhancing vacation rental offerings with innovative features.

EQS-News: Caroline Jacquin appointed Managing Director of CHEPLAPHARM France SAS

Retrieved on: 
Mercoledì, Aprile 10, 2024

Caroline Jacquin will take over the management of CHEPLAPHARM France, based in Levallois-Perret, a subsidiary of the CHEPLAPHARM Group from Greifswald/Germany, in April 2024.

Key Points: 
  • Caroline Jacquin will take over the management of CHEPLAPHARM France, based in Levallois-Perret, a subsidiary of the CHEPLAPHARM Group from Greifswald/Germany, in April 2024.
  • The previous Managing Director of CHEPLAPHARM France, Isabelle Dalle, is retiring.
  • Caroline Jacquin, an experienced pharmaceutical manager, is taking over the position of Managing Director of the French subsidiary.
  • "I am delighted that we have been able to fill the position of the Managing Director of CHEPLAPHARM France with such a high-profile candidate as Caroline Jacquin.

Gain Therapeutics Bolsters Management Team with the Appointment of Gene Mack as Chief Financial Officer

Retrieved on: 
Lunedì, Aprile 8, 2024

BETHESDA, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announces the appointment of Gene Mack, MBA as its chief financial officer, effective as of April 8, 2024.

Key Points: 
  • BETHESDA, Md., April 08, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announces the appointment of Gene Mack, MBA as its chief financial officer, effective as of April 8, 2024.
  • “We are thrilled to welcome Gene as our new CFO,” commented Gain CEO Matthias Alder.
  • Prior to joining Gain, Gene was CFO at privately held Imcyse SA between 2021 and 2023.
  • “I am excited to join Gain Therapeutics during this important stage of corporate growth and scientific progression.

Adlai Nortye Announces Appointment of Dr. Archie Tse as the Head of Research & Development

Retrieved on: 
Venerdì, Marzo 29, 2024

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced the appointment of Dr. Archie Tse as Head of Research & Development, reporting to Mr. Carsten Lu, CEO and Chairman of Adlai Nortye, effective March 29th, 2024.

Key Points: 
  • SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced the appointment of Dr. Archie Tse as Head of Research & Development, reporting to Mr. Carsten Lu, CEO and Chairman of Adlai Nortye, effective March 29th, 2024.
  • Prior to joining Adlai Nortye, Dr. Tse served as the Chief Scientific Officer, Senior Vice President, Head of Research and Early Clinical Development, and Head of CMC at CStone Pharmaceuticals, at which he provided strategic leadership and oversight to the research, early clinical development, and CMC aspects of the entire CStone’s pipeline.
  • “We are very pleased to have Dr. Tse join our senior leadership team,” said Carsten Lu, CEO and Chairman of Adlai Nortye.
  • “I'm keen to leveraging my experiences with the outstanding team at Adlai Nortye and unlock the full potential of our pipeline.”

Transgene anticipates significant progress from immunotherapy pipeline in 2024 and extends financial visibility until Q4 2025

Retrieved on: 
Mercoledì, Marzo 27, 2024

Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.

Key Points: 
  • Extended financial visibility secured until Q4 2025 through a revised credit facility provided by the major shareholder Institut Mérieux.
  • “During 2023 Transgene continued to make significant progress, delivering compelling data that confirm the value of our approach to treating cancer using our novel immunotherapies” commented Dr. Alessandro Riva, MD, Chairman and CEO of Transgene.
  • As announced on May 5, 2023, AstraZeneca terminated its oncolytic virus research and development collaboration with Transgene following a strategic review of its pipeline.
  • In 2024, Transgene expects to communicate progress and significant results and readout on all of its clinical stage assets.

Evaxion Announces Business Update and Full Year 2023 Financial Results

Retrieved on: 
Mercoledì, Marzo 27, 2024

Closing of $5.3 million private placement on December 21, 2023, with participation of MSD Global Health Innovation Fund (MSD GHI), a corporate venture arm of Merck & Co., Inc., USA.

Key Points: 
  • Closing of $5.3 million private placement on December 21, 2023, with participation of MSD Global Health Innovation Fund (MSD GHI), a corporate venture arm of Merck & Co., Inc., USA.
  • MSD GHI is now the single largest shareholder in Evaxion, with ownership of around 15%.
  • COPENHAGEN, Denmark, March 27, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today provides a business update and announces full year 2023 financial results.
  • Evaxion hosted an R&D Day on March 19, 2024, providing deeper insights into the validated and differentiated AI-Immunology™ platform.