Standard of care

New Study Finds Statistically Significantly Faster Healing Rates for Diabetic Wound Patients Treated with Kerecis Fish Skin

Monday, September 20, 2021 - 9:53pm

A study published in the peer-reviewed journal Wounds reports statistically significantly higher healing rates for diabetic foot ulcers (DFUs) treated with Kerecis Omega3 fish skin compared to DFUs treated with Fibrocol, a collagen-alginate dressing.

Key Points: 
  • A study published in the peer-reviewed journal Wounds reports statistically significantly higher healing rates for diabetic foot ulcers (DFUs) treated with Kerecis Omega3 fish skin compared to DFUs treated with Fibrocol, a collagen-alginate dressing.
  • Of the patients treated with the Kerecis product , 67% had healed after 12 weeks of treatment versus 32% in the control group.
  • These statistically significant results may give new hope to patients suffering from diabetic foot ulcers and other wounds, explained Kerecis founder and CEO Fertram Sigurjonsson.
  • The doctors in this study documented the healing efficacy of the Kerecis Omega3 fish-skin graft technology.

CytoDyn Announces Resolution of Federal Litigation with Rosenbaum/Patterson Activist Group

Monday, September 20, 2021 - 3:18pm

Specifically with respect to the resolution of the Federal Lawsuit, the Activist Group took the following steps, which were conveyed in its public filings made after the close of the market on Friday, September 17, 2021:

Key Points: 
  • Specifically with respect to the resolution of the Federal Lawsuit, the Activist Group took the following steps, which were conveyed in its public filings made after the close of the market on Friday, September 17, 2021:
    The Activist Group dissolved its Schedule 13D group and filed an exit Schedule 13D.
  • The Activist Group maintains its narrative that these individuals and entities decided to gift the group with at least hundreds of thousands of dollars.
  • Moreover, the Activist Group has now created a new category of financial supporters called the "Contributing Persons."
  • To reiterate, CytoDyn urges shareholders to ignore any further emails or mailings from the Activist Group.

OSE Immunotherapeutics Presented Positive Final Results of Tedopi® Phase 3 Clinical Trial in Secondary Resistant Non-Small Cell Lung Cancer Patients at the European Society for Medical Oncology (ESMO) Virtual Congress 2021

Monday, September 20, 2021 - 12:45pm

Applying the 2020 SITC(2) guidelines defining resistance categories for PD-1/PD-L1 checkpoint inhibitors to our trial, developed while this trial was ongoing, suggest there is great potential for Tedopi in patients with secondary resistance(3).

Key Points: 
  • Applying the 2020 SITC(2) guidelines defining resistance categories for PD-1/PD-L1 checkpoint inhibitors to our trial, developed while this trial was ongoing, suggest there is great potential for Tedopi in patients with secondary resistance(3).
  • Therefore, we are very pleased to share such very promising results demonstrating the substantial benefits of Tedopi for NSCLC patients with secondary resistance to anti-PD-1 treatments, a hard to treat patient population with high medical need.
  • The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.
  • A good tolerance profile of Tedopi with fewer Severe Adverse Events (Tedopi 38% vs SoC 68%, p

Oncternal Therapeutics and Celularity Enter into Research Collaboration to Evaluate Targeted Placental-Derived Cellular Therapies

Monday, September 20, 2021 - 1:00pm

As part of the collaboration, Celularity will explore the use of Oncternals ROR1-targeted monoclonal antibody, cirmtuzumab, in combination with Celularitys natural killer cells.

Key Points: 
  • As part of the collaboration, Celularity will explore the use of Oncternals ROR1-targeted monoclonal antibody, cirmtuzumab, in combination with Celularitys natural killer cells.
  • As part of the collaboration, Celularity will also evaluate ROR1-targeted CAR-NK and CAR-T cell therapies as extensions of its CYNK and CyCART programs, respectively.
  • We believe that targeted cellular therapies have the potential to extend the clinical benefit of our research and improve the standard of care for patients.
  • Forward-looking statements include statements regarding the anticipated benefits of the research collaboration and the potential for targeted therapies to address unmet needs.

Celularity and Oncternal Therapeutics Enter into Research Collaboration to Evaluate Targeted Placental-Derived Cellular Therapies

Monday, September 20, 2021 - 1:00pm

As part of the collaboration, Celularity will explore the use of Oncternals ROR1-targeted monoclonal antibody, cirmtuzumab, in combination with Celularitys natural killer cells.

Key Points: 
  • As part of the collaboration, Celularity will explore the use of Oncternals ROR1-targeted monoclonal antibody, cirmtuzumab, in combination with Celularitys natural killer cells.
  • As part of the collaboration, Celularity will also evaluate ROR1-targeted CAR-NK and CAR-T cell therapies as extensions of its CYNK and CyCART programs, respectively.
  • We believe that targeted cellular therapies have the potential to extend the clinical benefit of our research and improve the standard of care for patients.
  • Forward-looking statements include statements regarding the anticipated benefits of the research collaboration and the potential for targeted therapies to address unmet needs.

Endeavor BioMedicines Licenses ULK1/2 Inhibitor Program from Salk Institute and Sanford Burnham Prebys to Broaden Its Precision Oncology Pipeline

Thursday, September 16, 2021 - 1:02pm

Endeavor BioMedicines , a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases including oncology and fibrosis, today announced the in-licensing of a ULK1/2 inhibitor program from the Salk Institute for Biological Studies and Sanford Burnham Prebys.

Key Points: 
  • Endeavor BioMedicines , a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases including oncology and fibrosis, today announced the in-licensing of a ULK1/2 inhibitor program from the Salk Institute for Biological Studies and Sanford Burnham Prebys.
  • Endeavor plans to complete IND-enabling studies and advance the program into the clinic initially in colorectal and lung cancers in the next 18 months.
  • These patients are generally resistant to the standard of care (chemotherapy or immuno-oncology treatment) and face a very poor prognosis.
  • Endeavor BioMedicines is a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases, including oncology and fibrosis.

Zanidatamab Phase 2 Clinical Trial Demonstrates Promising Response Rate and Durability in First-Line HER2-Positive Gastroesophageal Adenocarcinoma (GEA) at the European Society for Medical Oncology (ESMO) Annual Congress

Thursday, September 16, 2021 - 10:30am

These data were presented today by lead study investigator, Geoffrey Ku, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), at the ESMO Annual Congress.

Key Points: 
  • These data were presented today by lead study investigator, Geoffrey Ku, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK), at the ESMO Annual Congress.
  • These data support further evaluation of zanidatamab plus chemotherapy in a randomized pivotal trial in first-line HER2-positive GEA.
  • As we embark on our second pivotal trial and prepare for commercialization, these data represent a landmark moment for zanidatamab and for Zymeworks.
  • Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.

Surgalign Appoints Sheryl Conley as Chair of the Board of Directors

Wednesday, September 15, 2021 - 9:30pm

Conley served as President and CEO of OrthoWorx, Inc., a community-based initiative that works strategically and collaboratively with the orthopedic industry, from 2012-2017.

Key Points: 
  • Conley served as President and CEO of OrthoWorx, Inc., a community-based initiative that works strategically and collaboratively with the orthopedic industry, from 2012-2017.
  • Conley is a recognized leader of innovation and creation of new markets in the orthopedic medical device space.
  • We are immensely grateful to Stuart and Jeff for their many meaningful contributions to Surgalign, said Rich.
  • Surgalign markets products throughout the United States and in more than 50 countries worldwide through an expanding network of top independent distributors.

Biovista Personalized Medicine and Diginova to deliver next generation AI-driven doctor/patient support in a deal that can generate over $5 Billion.

Wednesday, September 15, 2021 - 2:20pm

Diginova will offer Biovista Personalized Medicine's market-leading AI Health ShieldTM analytics direct-to-consumer, where the consumers are doctors, patients, their family caregivers, and national/regional health systems.

Key Points: 
  • Diginova will offer Biovista Personalized Medicine's market-leading AI Health ShieldTM analytics direct-to-consumer, where the consumers are doctors, patients, their family caregivers, and national/regional health systems.
  • "We are excited to partner with Diginova on bringing our AI Health ShieldTM to a major part of the world," said Aris Persidis, Biovista Personalized Medicine's Managing Director.
  • "Biovista Personalized Medicine helps us deliver high quality-analytics to our consumers for any real-world clinical scenarios they may be facing.
  • About Biovista Personalized Medicine: The company is a wholly-owned subsidiary of Biovista, Inc., the award-winning pioneer in AI-driven drug repositioning and personalized medicine.

GammaDelta Therapeutics Initiates First-in-Human Phase 1 Trial of GDX012 for the Treatment of Acute Myeloid Leukaemia

Wednesday, September 15, 2021 - 12:17pm

GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, today announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML).

Key Points: 
  • GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, today announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML).
  • GDX012 is an allogeneic, non-engineered, variable delta 1 (V1) gamma-delta () T cell therapy manufactured from healthy donor blood.
  • AML is the most common form of acute leukaemia in adults with an estimated 20.000 new cases per year in the US.
  • GDTs Phase I trial, conducted in the U.S., is an open-label, multi-centre study of GDX012 enrolling adults diagnosed with AML and presenting with measurable residual disease (MRD) after standard of care (SOC) treatment.