IND

Regulators Approve Sensorion’s Amendment to Phase 2 AUDIBLE-S Trial of SENS-401 in Sudden Sensorineural Hearing Loss

Friday, September 24, 2021 - 6:30am

The original statistical analysis plan (which was based on a combined phase 2 & phase 3 study) had required a much larger number of patients based on assumptions derived from scientific literature.

Key Points: 
  • The original statistical analysis plan (which was based on a combined phase 2 & phase 3 study) had required a much larger number of patients based on assumptions derived from scientific literature.
  • The Phase 2 AUDIBLE-S study ( NCT03603314 ) is a randomized, double-blind, placebo-controlled Phase 2 study conducted across 50 sites in Europe, Canada, Israel, and Turkey.
  • Patients with severe or profound sudden sensorineural hearing loss are being recruited within 96 hours after onset of a sudden and severe hearing loss and randomized to either two treatment arms (29mg and 43.5mg twice a day oral dosing) or placebo.
  • Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

Thursday, September 23, 2021 - 9:30pm

HIGH POINT, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced results of a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, in healthy adults. The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days. Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events. vTv therefore believes that the current safety profile allows it to move forward in development with a drug that may achieve anti-inflammatory and anti-psoriatic responses without the significant safety issues of other PDE4 inhibitors. Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.

Key Points: 
  • Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.
  • With these results, vTv held a successful pre-IND meeting with the U.S. Food and Drug Administration Division of Dermatology and Dentistry.
  • An oral, once-daily PDE4 inhibitor with robust efficacy, absent adverse events of gastrointestinal distress, would be a significant benefit for patients with psoriasis.
  • vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and psoriasis.

Fusion Pharmaceuticals To Present At The 2021 Cantor Fitzgerald Virtual Global Healthcare Conference

Thursday, September 23, 2021 - 9:10pm

HAMILTON, ONandBOSTON, Sept. 23, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference onWednesday, September 29, 2021at2:40pm ET.

Key Points: 
  • HAMILTON, ONandBOSTON, Sept. 23, 2021 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the Company will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference onWednesday, September 29, 2021at2:40pm ET.
  • A replay of the webcast will be archived on the Company's website for 90 days following the presentation.
  • Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines.
  • Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R.

Plus Therapeutics to Present Rhenium-186 NanoLiposome Data at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting

Thursday, September 23, 2021 - 12:30pm

AUSTIN, Texas, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the Company), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it will present data regarding its Rhenium-186 NanoLiposome (186RNL) investigational radiotherapeutic for recurrent glioblastoma (GBM) at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting being held in person October 24-27, 2021 in Chicago, Illinois.

Key Points: 
  • AUSTIN, Texas, Sept. 23, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (the Company), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced it will present data regarding its Rhenium-186 NanoLiposome (186RNL) investigational radiotherapeutic for recurrent glioblastoma (GBM) at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting being held in person October 24-27, 2021 in Chicago, Illinois.
  • Where: Plus Therapeutics (Nasdaq: PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets.
  • Central to the Companys drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases.
  • This press release contains statements that may be deemed forward-looking statements within the meaning of U.S. securities laws.

TransCode Therapeutics Announces Publication in Cancer Nanotechnology of Preclinical Data Supporting Therapeutic Potential of TTX-MC138 in Metastatic Breast Cancer

Thursday, September 23, 2021 - 12:30pm

The key results of the study demonstrated that TTX-MC138, when injected intravenously, accumulated in metastatic lesions.

Key Points: 
  • The key results of the study demonstrated that TTX-MC138, when injected intravenously, accumulated in metastatic lesions.
  • These results suggest that TransCodes TTX platform delivers its therapeutic candidate as intended and the company believes supports clinical evaluation of TTX-MC138.
  • Our preclinical data further suggest the therapeutic potential of TTX-MC138, and we look forward to our Phase 0 study which has the potential to establish clinical proof-of-concept for this therapy.
  • The Companys lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which causes approximately 90% of all cancer deaths representing over nine million deaths per year worldwide.

Tonix Pharmaceuticals Expands Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Thursday, September 23, 2021 - 12:00pm

CHATHAM, N.J., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has expanded its research collaboration with Columbia University. The research collaboration is focused on studying immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic, as well as studying in vitro T cell and antibody responses to SARS-CoV-2, the virus that causes COVID-19. The research is designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation for tailoring vaccines and therapeutics to appropriate individuals with precision medicine.

Key Points: 
  • CHATHAM, N.J., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it has expanded its research collaboration with Columbia University.
  • The research is designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation for tailoring vaccines and therapeutics to appropriate individuals with precision medicine.
  • This research has the potential to lead to the isolation, characterization and cloning of therapeutically relevant fully human neutralizing monoclonal antibodies to SARS-CoV-2.
  • Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and accelerate the design of precision medicine-driven vaccines against COVID-19.

Solid Biosciences Reports 1.5-Year Data from Patients in the Ongoing IGNITE DMD Phase I/II Clinical Trial of SGT-001

Thursday, September 23, 2021 - 11:00am

CAMBRIDGE, Mass., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), will report positive 1.5-year functional data and patient-reported outcome measures (Pediatric Outcomes Data Collection Instrument, or PODCI) for Patients 4-6 in the ongoing IGNITE DMD Phase I/II clinical trial of SGT-001. Vamshi Rao, MD, Attending Physician, Neurology, Lurie Children’s Hospital of Chicago and Assistant Professor of Pediatrics (Neurology and Epilepsy), Northwestern University Feinberg School of Medicine, and an IGNITE DMD clinical investigator, will present the data today in an oral session at the World Muscle Society 2021 Virtual Congress.

Key Points: 
  • Data from additional patients should enhance our understanding of the role that SGT-001 may play in improving outcomes for patients with Duchenne.
  • We continue to believe that SGT-001 has the potential to provide differentiated benefit to patients with Duchenne and are on track to dose additional patients in IGNITE DMD, said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences.
  • Today, the company will report 1.5-year functional data and patient-reported outcome measures for Patients 4-6, all of whom received 2E14 vg/kg of SGT-001 manufactured using Solid Biosciences first-generation manufacturing process.
  • Solid Biosciences is a life sciences company focused on advancing transformative treatments to improve the lives of patients living with Duchenne.

Renovacor Announces the Appointment of Jordan Shin, M.D., Ph.D., as Senior Vice President of Clinical Development and Translational Science

Wednesday, September 22, 2021 - 9:05pm

Renovacor, Inc. (NYSE: RCOR), an early-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for devastating cardiovascular and central nervous system diseases resulting from BAG3 gene variants, today announced the appointment of Jordan Shin, M.D., Ph.D., as Senior Vice President of Clinical Development and Translational Science.

Key Points: 
  • Renovacor, Inc. (NYSE: RCOR), an early-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for devastating cardiovascular and central nervous system diseases resulting from BAG3 gene variants, today announced the appointment of Jordan Shin, M.D., Ph.D., as Senior Vice President of Clinical Development and Translational Science.
  • We are excited to welcome Jordan to Renovacors leadership team during this pivotal time for the company, said Magdalene Cook, M.D., Chief Executive Officer of Renovacor.
  • Dr. Shin added, Its an honor to join Renovacors team of highly motivated and experienced industry experts.
  • Prior to joining Renovacor, Dr. Shin served as Vice President of Medical Development at Lung Biotechnology, PBC, a subsidiary of United Therapeutics, Inc.

Cyclica and IMPACT Therapeutics Team Up to Advance Differentiated Anti-cancer Drug Development

Wednesday, September 22, 2021 - 2:37pm

Cyclica, the partner of choice for data-driven drug discovery, and IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics with synthetic lethality approach, announce today that they have entered to a collaboration agreement on IMPACT Therapeutics differentiated targeted anti-cancer drug development.

Key Points: 
  • Cyclica, the partner of choice for data-driven drug discovery, and IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics with synthetic lethality approach, announce today that they have entered to a collaboration agreement on IMPACT Therapeutics differentiated targeted anti-cancer drug development.
  • IMPACT Therapeutics will apply Cyclicas Ligand Express platform to selectively understand the targetivity profile of its novel anticancer therapeutics.
  • The insights gained from such a collaboration will further improve and validate IMPACT Therapeutics competitive advantage in its clinical candidate.
  • To learn more about Cyclica and how we partner, please visit www.cyclicarx.com
    IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality.

Sirnaomics, Inc. to Present at TIDES USA 2021

Wednesday, September 22, 2021 - 2:00pm

The hybrid conference is taking place in person at the Boston Convention and Exhibition Center, and digitally on-demand, September 20-30.

Key Points: 
  • The hybrid conference is taking place in person at the Boston Convention and Exhibition Center, and digitally on-demand, September 20-30.
  • Presenter: Michael Molyneaux, MD, MBA, Chief Medical Officer at Sirnaomics, Inc.
  • Time/Date: 11:45am ET, Thursday, September 23, 2021.
  • The session will be available to watch on demand for attendees starting on September 28 for a 30-day period.