Research

PeraHealth Co-Founder Michael Rothman to be Inducted as Fellow of the American Medical Informatics Association

Tuesday, October 27, 2020 - 10:00am

PeraHealth Co-founder and Chief Science Officer, Michael Rothman, has been awarded the designation of Fellow of the American Medical Informatics Association (AMIA).

Key Points: 
  • PeraHealth Co-founder and Chief Science Officer, Michael Rothman, has been awarded the designation of Fellow of the American Medical Informatics Association (AMIA).
  • Dr. Rothman is active in both research and practice in medical informatics.
  • Dr. Rothman notes, Medical informatics has the potential of impacting the lives of anyone who interacts with the healthcare system, which is everyone.
  • PeraHealth is a SaaS software company that uses the Rothman Index to transform the clinical and financial efficiency of healthcare.

Sapreme Appoints Miriam Bujny as Chief Development Officer

Tuesday, October 27, 2020 - 10:00am

Sapreme , a biotechnology company focused on improving the delivery and efficacy of macromolecule therapeutics, today announced the appointment of Miriam Bujny, Ph.D., as Chief Development Officer.

Key Points: 
  • Sapreme , a biotechnology company focused on improving the delivery and efficacy of macromolecule therapeutics, today announced the appointment of Miriam Bujny, Ph.D., as Chief Development Officer.
  • With over ten years of experience in drug discovery, translational science and early stage clinical development, Dr. Bujny will apply her expertise in RNA and antibody therapeutic development to further advance Sapremes proprietary endosomal escape platform through preclinical development.
  • Throughout my career, I have seen the limitations of developing promising therapeutic candidates due to the lack of delivery into key cells, commented Dr. Bujny, Chief Development Officer of Sapreme.
  • Before that, she worked on anti-viral antibody therapy development and contributed to early clinical development as preclinical in vitro lead.

CN Bio to Provide Drug Metabolism and Safety Toxicity Testing Services

Tuesday, October 27, 2020 - 9:43am

CN Bio, a leading 3D cell culture company, that has developed single and multi-organ microphysiological systems (MPS) to improve the accuracy and efficiency of drug discovery, today announced the commercial launch of its Drug Metabolism and Safety Toxicity Testing Services.

Key Points: 
  • CN Bio, a leading 3D cell culture company, that has developed single and multi-organ microphysiological systems (MPS) to improve the accuracy and efficiency of drug discovery, today announced the commercial launch of its Drug Metabolism and Safety Toxicity Testing Services.
  • Liver toxicity is a principal safety concern during drug discovery and development, with the potential to terminate expensive clinical trials already underway.
  • CN Bios extended portfolio of services offers solutions to many existing workflow challenges including: drug metabolism testing, to study the human metabolism of lead candidates, identify metabolites and correlation with cell health - even for low clearance compounds, and safety toxicity testing, to provide in-depth analysis of acute or chronic drug-induced liver injury using a wide range of endpoints to determine causality and mechanism of toxicity.
  • Through our enhanced drug metabolism and safety toxicity testing services, we enable scientists to take a step beyond what is currently possible with 2D cell culture and animal studies to improve their chances of clinical success.

Alzheon Announces Dosing of First Patient in ALZ-801 Phase 2 Biomarker Study in APOE4 Carriers with Early Alzheimer’s Disease

Tuesday, October 27, 2020 - 9:30am

The biomarkers selected for this study have been shown to correlate with clinical benefit in AD patients in trials with amyloid-targeted antibody therapies.

Key Points: 
  • The biomarkers selected for this study have been shown to correlate with clinical benefit in AD patients in trials with amyloid-targeted antibody therapies.
  • This Phase 2 study is the first AD biomarker trial to prospectively evaluate APOE4 carriers using leading-edge cerebrospinal fluid (CSF) and plasma biomarkers, as well as volumetric magnetic resonance imaging (MRI) evaluating brain atrophy.
  • Furthermore, APOE4 carriers have been shown to have up to three-fold higher brain levels of soluble amyloid oligomers compared to non-carriers.
  • This biomarker study is a key element of our overall Alzheimers clinical development program for ALZ801, said Susan Abushakra, MD, Alzheon Chief Medical Officer.

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

Tuesday, October 27, 2020 - 6:30am

Key findings of the trial:

Key Points: 
  • Key findings of the trial:
    The combination of TG4001 and avelumab demonstrates anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers.
  • I believe this combination regimen has the opportunity to provide real hope for patients with HPV-16 related cancers.
  • Number and title of the late-breaking poster abstract: (793) TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) Human Papilloma Virus (HPV)-16+ cancers: clinical efficacy and immunogenicity.
  • Our study suggests that immunotherapeutic combination of TG4001 and avelumab shows valuable tumor activity in pts with previously treated advanced HPV-16+ cancers.

Sensorion and Novasep Announce Signature of a Gene Therapy Product Development and Manufacturing Agreement

Tuesday, October 27, 2020 - 6:30am

The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein.

Key Points: 
  • The agreement covers the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein.
  • Sensorion is currently advancing two preclinical gene therapy programs conducted under a broad multi-program research partnership with the Genetics and Physiology of Hearing Unit at Institut Pasteur (Paris).
  • Securing state-of-the-art research and development capabilities and Good Manufacturing Practice (GMP) capacity, like those offered by Novasep, is a key step and underlines the progress of our Otoferlin gene therapy program, said Nawal Ouzren, CEO of Sensorion.
  • We are delighted and proud to contribute to the progress of Sensorions innovative gene therapy programs targeting OTOF.

Global Coalition for Adaptive Research, Amgen, and Eisai Announce First Patient Enrolled in International COVID-19 Trial

Monday, October 26, 2020 - 11:00pm

This trial is a multicenter, randomized platform study, with treatments tested within groupings or domains based on pathway or mechanism of action.

Key Points: 
  • This trial is a multicenter, randomized platform study, with treatments tested within groupings or domains based on pathway or mechanism of action.
  • Eritoran is Eisais in-house discovered and developed investigational TLR4 (Toll-Like Receptor 4) antagonist created with natural product organic synthesis technology.
  • Global Coalition for Adaptive Research (GCAR) is the US Sponsor of REMAP-COVID and is guiding efforts to facilitate the inclusion of multiple pharma partners in REMAP-COVID globally.
  • Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan.

Aptinyx Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option

Monday, October 26, 2020 - 8:01pm

The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Aptinyx, were $48.3 million.

Key Points: 
  • The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Aptinyx, were $48.3 million.
  • SVB Leerink, Piper Sandler and Cantor are acting as joint bookrunning managers for the offering.
  • Wedbush PacGrow is acting as passive bookrunning manager and H.C. Wainwright & Co. is acting as lead manager for the offering.
  • A final prospectus supplement and the accompanying prospectus relating to the public offering were filed by the Company with the SEC.