Clusters of differentiation

Targovax receives Fast Track designation for ONCOS-102 in melanoma

Retrieved on: 
Tuesday, June 22, 2021

The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.

Key Points: 
  • The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.
  • Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma.
  • This Fast Track approval comes in addition to ONCOS-102s existing Fast Track designation in malignant pleural mesothelioma.
  • Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said"Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need.

Targovax receives Fast Track designation for ONCOS-102 in melanoma

Retrieved on: 
Tuesday, June 22, 2021

The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.

Key Points: 
  • The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.
  • Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma.
  • This Fast Track approval comes in addition to ONCOS-102s existing Fast Track designation in malignant pleural mesothelioma.
  • Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said"Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need.

Xilio Therapeutics Announces FDA Acceptance of IND Application for XTX101 for the Treatment of Solid Tumors

Retrieved on: 
Thursday, June 17, 2021

XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations.

Key Points: 
  • XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations.
  • This first IND acceptance for Xilio represents a significant milestone for us as we transition to a clinical-stage organization, said Marty Huber, M.D., chief medical officer of Xilio Therapeutics.
  • It is well known that checkpoint inhibitors hold significant clinical potential; however, treatment with anti-CTLA-4 therapies has been limited because of challenging autoimmune toxicities.
  • XTX101 has also demonstrated enhanced tumor growth inhibition and tolerability when administered in combination with an anti-PD-1 in vivo.

Zai Lab and MacroGenics Enter Into Broad Strategic Collaboration to Develop and Commercialize Preclinical Bispecific Antibodies in Oncology

Retrieved on: 
Wednesday, June 16, 2021

Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.

Key Points: 
  • Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.
  • For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.
  • We are pleased to expand our strategic collaboration, which leverages both companies unique research capabilities and gives Zai Lab access to MacroGenics proprietary technologies to expand our innovative oncology portfolio on a global basis.
  • If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Labs territories.

MacroGenics and Zai Lab Enter Into Broad Strategic Collaboration to Develop and Commercialize Preclinical Bispecific Antibodies in Oncology

Retrieved on: 
Wednesday, June 16, 2021

Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.

Key Points: 
  • Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules.
  • For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.
  • We are pleased to expand our strategic collaboration, which leverages both companies unique research capabilities and gives Zai Lab access to MacroGenics proprietary technologies to expand our innovative oncology portfolio on a global basis.
  • If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Labs territories.

BeyondSpring to Host First Quarter Financial Results and Corporate Update Conference Call on June 16, 2021

Retrieved on: 
Friday, June 11, 2021

NEW YORK, June 11, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that management will host a conference call to report its financial results for the first quarter ended March 31, 2021 and provide an update on recent corporate events on June 16, 2021 at 8:30 AM Eastern Time.

Key Points: 
  • NEW YORK, June 11, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that management will host a conference call to report its financial results for the first quarter ended March 31, 2021 and provide an update on recent corporate events on June 16, 2021 at 8:30 AM Eastern Time.
  • The conference call may be accessed by dialing 877-451-6152(U.S.) or 201-389-0879(International) and referencing conference ID: 13720525.
  • A live webcast will be available on BeyondSprings website at www.beyondspringpharma.com under Events & Presentations in the Investors section.
  • Additionally, it is being broadly studied in combination with various immuno-oncology agents that could boost the effects of PD-1 / PD-L1 antibodies.

Equillium to Collaborate with Oxford University and Kennedy Institute of Rheumatology to Investigate Role of the CD6-ALCAM Pathway and Itolizumab in Rheumatic Diseases

Retrieved on: 
Monday, June 7, 2021

The research collaboration will study how CD6 monoclonal antibodies, such as itolizumab, modulate T cell responses and explore the role of the CD6-ALCAM pathway in rheumatic diseases.

Key Points: 
  • The research collaboration will study how CD6 monoclonal antibodies, such as itolizumab, modulate T cell responses and explore the role of the CD6-ALCAM pathway in rheumatic diseases.
  • This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.
  • Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

Article on CD40 agonistic antibodies published in Expert Opinion on Biological Therapy

Retrieved on: 
Monday, June 7, 2021

LUND, Sweden, June 7, 2021 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX)today announces that the scientific journal Expert Opinion on Biological Therapy has published an article by scientists at Alligator Bioscience, reviewing the field of CD40 agonistic antibodies.

Key Points: 
  • LUND, Sweden, June 7, 2021 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX)today announces that the scientific journal Expert Opinion on Biological Therapy has published an article by scientists at Alligator Bioscience, reviewing the field of CD40 agonistic antibodies.
  • The article provides an overview of the CD40 agonistic antibodies in clinical development and the current challenges and opportunities for this important class of immuno-oncology drugs.
  • The full article is available online and can be found at: https://www.tandfonline.com/doi/full/10.1080/14712598.2021.1934446
    "We're very pleased to have this peer-reviewed article prepared by Alligator's scientists published.
  • It highlights the promising role of CD40 agonists in immuno-oncology and explains how Alligator's CD40 agonist, mitazalimab, has best in class potential,"said Sren Bregenholt, CEO of Alligator Bioscience.

Article on CD40 agonistic antibodies published in Expert Opinion on Biological Therapy

Retrieved on: 
Monday, June 7, 2021

LUND, Sweden, June 7, 2021 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX)today announces that the scientific journal Expert Opinion on Biological Therapy has published an article by scientists at Alligator Bioscience, reviewing the field of CD40 agonistic antibodies.

Key Points: 
  • LUND, Sweden, June 7, 2021 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX)today announces that the scientific journal Expert Opinion on Biological Therapy has published an article by scientists at Alligator Bioscience, reviewing the field of CD40 agonistic antibodies.
  • The article provides an overview of the CD40 agonistic antibodies in clinical development and the current challenges and opportunities for this important class of immuno-oncology drugs.
  • The full article is available online and can be found at: https://www.tandfonline.com/doi/full/10.1080/14712598.2021.1934446
    "We're very pleased to have this peer-reviewed article prepared by Alligator's scientists published.
  • It highlights the promising role of CD40 agonists in immuno-oncology and explains how Alligator's CD40 agonist, mitazalimab, has best in class potential,"said Sren Bregenholt, CEO of Alligator Bioscience.

Agenus’ Presentations at ASCO 2021 Demonstrate Differentiated Activity of Balstilimab and Provide Clinical Update on AGEN2373

Retrieved on: 
Friday, June 4, 2021

Preclinical studies using Agenus proprietary R&D VISION platform underscored these observed clinical data.

Key Points: 
  • Preclinical studies using Agenus proprietary R&D VISION platform underscored these observed clinical data.
  • VISION demonstrates that balstilimab may be superior to currently approved anti-PD-1 antibodies such as pembrolizumab and nivolumab.
  • Balstilimab showed superior tumor killing in both PD-L1 positive and PD-L1 negative tumors compared to commercially available anti-PD-1 antibodies in these studies.
  • AGEN2373 continues to show no liver toxicity in the clinic, and we expect the anticipated combination trials to provide potential benefit to patients.