Trial of the century

BioVaxys Confirms First Clinical Site and Principal Investigators for Ovarian Cancer Vaccine Trial and Enters into Second Tumor Cell Supply Agreement

Retrieved on: 
Wednesday, May 18, 2022
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HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.

Key Points: 
  • HCL is a public hospital and France's second University Hospital Center, and a premier site for clinical studies in the EU.
  • Benot You, MD, PhD, of HCL who are planned Clinical Investigators for the Phase I study of BVX-0918.
  • BioVaxys is preparing to file a Clinical Trial Application ("CTA") with the European Medicines Agency ("EMA") later in 2022.
  • Access to surgically removed ovarian cancer tumor cells is a critical step enabling BioVaxys to validate the manufacturing process for BVX-0918.

Sorrento Announces FDA Authorization to Proceed With Phase 2 Study of Abivertinib (Fujovee™) to Treat Metastatic Castrate Resistant Prostate Cancer (MAVERICK Trial)

Retrieved on: 
Tuesday, May 17, 2022
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FDA granted IND clearance for Abivertinib (Fujovee) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castrate resistant prostate cancer (mCRPC) at multiple centers in the United States.

Key Points: 
  • FDA granted IND clearance for Abivertinib (Fujovee) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castrate resistant prostate cancer (mCRPC) at multiple centers in the United States.
  • The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-nave and abiraterone-progressing mCRPC.
  • Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19.
  • RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients.

Veru to Present at the H.C. Wainwright Global Investment Conference on May 24th 2022

Retrieved on: 
Tuesday, May 17, 2022
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MIAMI, May 17, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the Company will present at the H.C. Wainwright Global Investment Conference.

Key Points: 
  • MIAMI, May 17, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the Company will present at the H.C. Wainwright Global Investment Conference.
  • The presentation will be available through the Conference on Tuesday, May 24th at 11:30 AM 12:00 PM (Eastern Daylight Time).
  • The webcast will be archived and accessible on the web site for at least 30 days.
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.

Equillium to Present at Two Upcoming Investor Conferences

Retrieved on: 
Tuesday, May 17, 2022
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An archived replay of both conferences will be available for 90 days.

Key Points: 
  • An archived replay of both conferences will be available for 90 days.
  • Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need.
  • The companys pipeline consists of the following novel immunomodulatory assets targeting immuno-inflammatory pathways.
  • Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Aptinyx Announces Poster Presentation Highlighting Preclinical Data on NYX-783 in Models of PTSD at the 2022 American Psychiatric Association Annual Meeting

Retrieved on: 
Tuesday, May 17, 2022
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The poster highlights data from preclinical studies showing that NYX-783, an NMDA receptor positive allosteric modulator, builds long-lasting fear-inhibitory memories in PTSD-relevant models, ultimately leading to reduced spontaneous recovery (i.e., return) of fear.

Key Points: 
  • The poster highlights data from preclinical studies showing that NYX-783, an NMDA receptor positive allosteric modulator, builds long-lasting fear-inhibitory memories in PTSD-relevant models, ultimately leading to reduced spontaneous recovery (i.e., return) of fear.
  • PTSD can result from various forms of trauma, including combat exposure, car accidents, sexual or other physical assault, abuse, natural disasters, and others.
  • In preclinical studies of NYX-783, particularly strong results were observed in psychiatric models, models of fear extinction, and models of substance abuse.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

GRAIL and Intermountain Healthcare Expand Partnership to Offer Galleri® Multi-Cancer Early Detection Blood Test to Eligible Patients in Utah

Retrieved on: 
Tuesday, May 17, 2022
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Starting this month, Intermountain will offer the Galleri test to eligible health system patients at elevated risk for cancer, such as adults over 50 years old or with additional risk factors.

Key Points: 
  • Starting this month, Intermountain will offer the Galleri test to eligible health system patients at elevated risk for cancer, such as adults over 50 years old or with additional risk factors.
  • In addition, the test will be available to eligible employees and their families who are enrolled in a company-sponsored health plan.
  • The Galleri test is the first-of-its-kind multi-cancer early detection blood test available.
  • Intermountain, the largest private employer in Utah, is a not-for-profit health system with 33 hospitals and more than 3,800 physicians.

Oragenics Issues Letter to Shareholders

Retrieved on: 
Tuesday, May 17, 2022
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Immunoglobulin A, Severe acute respiratory syndrome coronavirus 2, Death, Hamster, RNA transfection, Degenerative disease, Rabbit, Annual general meeting, Toxicology, Immortalised cell line, Hospital, Epithelium, Nasal cavity, Infection, Vaccine, GLP, COVID-19, CHO, Executive, Trial of the century, Vaccination, NIH, Research, Mouse, Efficiency, Transport, Refrigeration, Immunization, CTA, Immunity, Compliance, Program, Technology, Safety, Temperature, Nose, Health Canada, National, Administration, Synthetic control method, NRC, Laboratory, National Research Council, NYSE, Pharmaceutical industry, Oragene, IND

I thank you for your continued support of Oragenics and our vision, and am delighted to report on our recent progress.

Key Points: 
  • I thank you for your continued support of Oragenics and our vision, and am delighted to report on our recent progress.
  • In previous letters I affirmed the strategic direction Oragenics is taking and discussed our commitment to the speedy yet prudent execution of our development work.
  • Through this letter I aim to provide clarity on the opportunity, rationale and pathway toward human clinical testing.
  • On behalf of the Oragenics Board of Directors, I thank you for your continued support and look forward to keeping you apprised of our ongoing progress.

Incannex Announces Positive Pre-IND Meeting with U.S. FDA for IHL-42X for Obstructive Sleep Apnoea

Retrieved on: 
Tuesday, May 17, 2022
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IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea ('OSA') in adults.

Key Points: 
  • IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea ('OSA') in adults.
  • Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022.
  • FDA provided guidance on Incannex's proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies.
  • In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals.

LAVA Therapeutics Provides Business Update and Reports First Quarter Financial Results

Retrieved on: 
Tuesday, May 17, 2022
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We will continue to enroll patients in this dose escalation trial and announce initial data later this year.

Key Points: 
  • We will continue to enroll patients in this dose escalation trial and announce initial data later this year.
  • Ed Smith, chief financial officer of LAVA Therapeutics, has resigned to pursue other interests, effective as ofMay 17, 2022.
  • Research and development expenses were $7.6 million for the quarter ended March 31, 2022, compared to $18.7 million for the quarter ended March 31, 2021.
  • General and administrative expenses were $4.3 million for the quarter ended March 31, 2022, compared to $1.7 million for the quarter ended March 31, 2021.

Kamada Announces Expansion of Pivotal Phase 3 Clinical Trial of Inhaled AAT to Additional Six Clinical Sites Across Europe; and Positive Recommendation by DSMB to Continue the Trial Without Modification

Retrieved on: 
Tuesday, May 17, 2022
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Following the recent moderation of the global COVID-19 pandemic, the Company is expanding the study to new European sites.

Key Points: 
  • Following the recent moderation of the global COVID-19 pandemic, the Company is expanding the study to new European sites.
  • In the coming weeks, three additional sites in the UK, Ireland and the Netherlands are expected to open for patients enrollment.
  • Moreover, as part of routine and planned monitoring processes, the Independent Data Safety Monitoring Board (DSMB) recently recommended that the trial continue without modification.
  • To date, no patients have discontinued treatment prematurely and no drug-related serious adverse events have been reported.