Clinical trial

Novotech Joins Expert Panel at AACR for eChinaHealth Session on Collaborating with China’s Cancer Research Sector

Retrieved on: 
Thursday, April 13, 2023

The latest data shows Asia Pacific is also the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.

Key Points: 
  • The latest data shows Asia Pacific is also the fastest-growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies, with China leading in the region.
  • Oncology accounts for the majority of cell & gene therapy trials.
  • In addition, the Asia Pacific is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022.
  • Novotech has recently acquired EastHORN a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent.

4DMT to Present Interim Data from 4D-150 Phase 1/2 PRISM Clinical Trial for Wet AMD at ARVO 2023, and Promotes Robert Kim, M.D. to Chief Medical Officer

Retrieved on: 
Thursday, April 13, 2023

from SVP to Chief Medical Officer and Therapeutic Head, Ophthalmology

Key Points: 
  • from SVP to Chief Medical Officer and Therapeutic Head, Ophthalmology
    Company to host live webcast on Thursday, April 27, 2023 at 8:00 a.m.
  • The Company will host a live webcast on Thursday, April 27, 2023 at 8:00 a.m.
  • ET to discuss the interim Phase 1 cohort clinical data and provide a program update.
  • to Chief Medical Officer, further supporting 4DMT’s strategy of becoming a fully integrated large market genetic medicines company with an expanding pipeline of product candidates for large market ophthalmologic diseases.

Conduent Features Global Medical Information Services at DIA Medical Affairs and Scientific Communications Conference

Retrieved on: 
Thursday, April 13, 2023

FLORHAM PARK, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, will showcase its Global Medical Information Services at the DIA Medical Affairs and Scientific Communications Forum, April 17-19, 2023 in Anaheim, Calif.

Key Points: 
  • FLORHAM PARK, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Conduent Incorporated (Nasdaq: CNDT), a global technology-led business solutions and services company, will showcase its Global Medical Information Services at the DIA Medical Affairs and Scientific Communications Forum, April 17-19, 2023 in Anaheim, Calif.
  • The forum provides education and information about the regulatory and compliance environment affecting the work of medical affairs and scientific communication professionals.
  • Conduent will host the special session, “Strategic Transformation of Medical Information via Global Centralization,” at DIA on Tuesday, April 18 starting at 10:25 am local time.
  • To learn more, connect with Conduent’s dedicated subject matter experts at DIA booth 311 and visit Conduent Medical and Clinical Services .

Nurix Therapeutics Reports First Quarter Fiscal 2023 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, April 13, 2023

SAN FRANCISCO, April 13, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today reported financial results for the first quarter ended February 28, 2023 and provided a corporate update.

Key Points: 
  • This is the first development candidate resulting from the 2019 Nurix-Gilead collaboration to discover, develop and commercialize a pipeline of innovative targeted protein degradation therapies.
  • Nurix is conducting a Phase 1 clinical trial of NX-2127 and anticipates presenting additional clinical results in the second half of 2023.
  • Nurix also anticipates defining a regulatory strategy for NX-2127 in the second half of 2023 based on emerging clinical data and feedback from the FDA.
  • Cash, cash equivalents and marketable securities was $325.6 million as of February 28, 2023 compared to $373.0 million as of November 30, 2022.

Insilico Medicine Successfully Discovered Potent, Selective, and Orally Bioavailable Small Molecule Inhibitor of CDK8 Using Generative AI

Retrieved on: 
Wednesday, April 12, 2023

New York and Hong Kong, April 12, 2023 (GLOBE NEWSWIRE) -- Insilico Medicine (“Insilico”), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today announced that it has successfully discovered a potent, selective, and orally bioavailable small molecule inhibitor of CDK8 for the treatment of cancer using a structure-based generative chemistry approach enabled by the Chemistry42 multi-modal generative reinforcement learning platform.

Key Points: 
  • New York and Hong Kong, April 12, 2023 (GLOBE NEWSWIRE) -- Insilico Medicine (“Insilico”), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today announced that it has successfully discovered a potent, selective, and orally bioavailable small molecule inhibitor of CDK8 for the treatment of cancer using a structure-based generative chemistry approach enabled by the Chemistry42 multi-modal generative reinforcement learning platform.
  • In addition to the published molecule, Insilico scientists are progressing with another AI-generated CDK8 inhibitor with a novel structure.
  • Some of my favorite patents combine generative chemistry and generative biology,” said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine.
  • “I am excited to see  that with the support of generative AI, we have achieved several industry milestones and advanced the drug candidates discovered by generative AI to the clinical stage.

X4 Pharmaceuticals Announces Late-Breaking Abstract of WHIM Phase 3 Clinical Data Accepted for Oral Presentation at the 2023 Annual Meeting of the Clinical Immunology Society (CIS)

Retrieved on: 
Wednesday, April 12, 2023

BOSTON, April 12, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that its submitted late-breaker abstract entitled "Results of a Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome" has been accepted for oral presentation at the Annual Meeting of the Clinical Immunology Society (CIS), which is taking place May 18-21, 2023, in St. Louis, MO. New data related to clinical secondary endpoints, among other assessments, are to be presented.

Key Points: 
  • New data related to clinical secondary endpoints, among other assessments, are to be presented.
  • In addition, X4 announced that the company will host a virtual event to present and discuss new data from the 4WHIM Phase 3 clinical trial at 4:00 pm ET on Tuesday, May 16, following expected publication of conference abstracts.
  • The X4 live-event webcast will be accessible on the investor relations section of the X4 website at www.x4pharma.com .
  • Although the session will only be accessible live to conference attendees, X4 will post the slides on its website concurrent with the presentation.

Biogen Exercises Option with Denali to Develop and Commercialize Antibody Transport Vehicle Program Targeting Amyloid Beta

Retrieved on: 
Wednesday, April 12, 2023

and SOUTH SAN FRANCISCO, Calif., April 12, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV):Amyloid beta program (ATV:Aβ).

Key Points: 
  • and SOUTH SAN FRANCISCO, Calif., April 12, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV):Amyloid beta program (ATV:Aβ).
  • “Our ATV:Aβ program is designed to safely increase exposure of the therapeutic antibody in the brain and potentially lead to improved efficacy and/or safety.
  • “This program reinforces the importance of targeting Aβ and our commitment to Alzheimer’s disease.”
    The option was exercised pursuant to a collaboration between Biogen and Denali announced in 2020.
  • Following the exercise of the option, Biogen will assume responsibility for all development and commercial activities and associated expenses.

Clinical ink Announces Strategic Partnership with Mural Health for New Patient Payment and Logistics Capabilities

Retrieved on: 
Wednesday, April 12, 2023

Horsham, PA, April 12, 2023 (GLOBE NEWSWIRE) -- Clinical ink , a global life science technology company, today announces its strategic partnership with Mural Health , a next-generation participant management platform.

Key Points: 
  • Horsham, PA, April 12, 2023 (GLOBE NEWSWIRE) -- Clinical ink , a global life science technology company, today announces its strategic partnership with Mural Health , a next-generation participant management platform.
  • With this partnership the Clinical ink eSource technology platform, which includes Direct Data Capture (DDC) , electronic Clinical Outcomes Assessments (eCOA) , Patient Engagement , eConsent , and digital biomarkers , now fully supports participant reimbursement and travel assistance, powered by the Mural Link platform.
  • “We are excited to announce this partnership,” says Chris Crucitti, Chief Commercial Officer of Clinical ink.
  • “Combining the Mural Health unique patient payment model and transportation assistance with our industry-leading eSource technology further streamlines the experience for patients and sites.

Societal CDMO Signs Multiple Project Expansion Agreements With Existing Customers

Retrieved on: 
Wednesday, April 12, 2023

SAN DIEGO and GAINESVILLE, Ga., April 12, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has signed work order extensions with multiple existing customers that span a variety of the company’s CDMO service areas of expertise.

Key Points: 
  • SAN DIEGO and GAINESVILLE, Ga., April 12, 2023 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (“Societal CDMO”; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has signed work order extensions with multiple existing customers that span a variety of the company’s CDMO service areas of expertise.
  • The expansion of the scope of work of existing customers continues to be a strategic area of growth for the company, complementing its parallel efforts dedicated to the securing of new customers.
  • The recently signed work expansions agreements include:
    Manufacturing of additional engineering batch of an antibiotic capsule formulation for the treatment of Staphylococcus aureus infections.
  • Additionally, these types of work extensions make important and meaningful contributions to Societal CDMO’s continued revenue growth,” said Scott Rizzo, chief operating officer of Societal CDMO.

First Patient Enrolled in JDRF-Funded Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes, Led by Indiana University School of Medicine

Retrieved on: 
Wednesday, April 12, 2023

The multi-site clinical trial is led by researchers at Indiana University School of Medicine and funded by JDRF, the leading global type 1 diabetes research and advocacy organization.

Key Points: 
  • The multi-site clinical trial is led by researchers at Indiana University School of Medicine and funded by JDRF, the leading global type 1 diabetes research and advocacy organization.
  • The trial entitled “TArgeting Type 1 Diabetes Using POLyamines (TADPOL)” is a double-blind placebo-controlled clinical trial to evaluate CPP-1X-T vs placebo in patients with recent onset type 1 diabetes at approximately 6 academic medical centers in the United States.
  • “We’re really excited to have the first patient enrolled in the Phase II trial for CPP-1X-T led by Indiana University School of Medicine and funded by JDRF, the leading global organization advancing life-changing breakthroughs for type 1 diabetes (T1D),” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela.
  • The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.