Eiger BioPharma Starts Peginterferon Lambda Phase 3 Study of Newly Diagnosed COVID-19 Outpatients

 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients were dosed with Peginterferon Lambda (Lambda) in the Phase 3 TOGETHER platform study in outpatients with COVID-19. Lambda is administered as a convenient, one-time, subcutaneous dose.

TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled Phase 3 study evaluating multiple therapeutics in newly diagnosed, outpatients with COVID-19. The primary endpoint is a clinical outcome comparing emergency room visits and/or hospitalization in each active arm versus placebo. Each arm targets enrollment of up to 800 patients at high risk for developing complications from progression of COVID-19, with planned interim analyses for futility.

"Effective treatments are desperately needed for newly diagnosed COVID-19 outpatients that can be quickly and easily administered upon diagnosis, outside the hospital," said David Cory, President and CEO of Eiger. "Lambda stimulates immune responses that are critical for the development of host protection during viral infections and may be ideal for addressing variants of SARS-CoV-2, which remain an ongoing concern with approved monoclonal antibodies and vaccines. We are excited to include Lambda in the TOGETHER study and look forward to reporting results in the future."

For more information about the TOGETHER platform study, please visit www.togethertrial.com.

https://finance.yahoo.com/news/eiger-biopharmaceuticals-announces-first-patients-120000883.html

Dynavax to Supply Adjuvant for Biological E's COVID-19 Vaccine Candidate

  Dynavax Technologies Corporation (Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines and Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, today announced the execution of a commercial supply agreement of Dynavax's CpG 1018TM advanced adjuvant, for use in BE's subunit COVID-19 vaccine candidate, CORBEVAX™. The commercial supply agreement extends through 2022. The agreement includes doses for delivery in 2021, which were manufactured under the previously announced funding agreement between the Coalition for Epidemic Preparedness Innovations (CEPI) and Dynavax. Pending conditional regulatory approvals in India, BE expects to commence product launch of CORBEVAX™ later this year.

In June 2021, India's Union Ministry of Health announced that it had finalized arrangements with BE to reserve 300 million doses of CORBEVAX™. The arrangement with BE is part of the wider endeavor from the Government of India to encourage indigenous vaccine manufacturers by providing financial support.

https://finance.yahoo.com/news/dynavax-biological-e-announce-commercial-120000844.html

MediciNova: New Patent Covering MN-166 (ibudilast) for Ophthalmic Disease

 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of ophthalmic disease.

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than October 2039. The allowed claims cover methods of treating an ophthalmic disease/disorder or injury associated with a neurodegenerative disease/disorder or a neuro-ophthalmologic disorder by administering to a human patient a therapeutically effective amount of MN-166 (ibudilast). The allowed claims specifically cover the treatment of macular injury. The allowed claims cover a wide range of doses and formulations of MN-166 (ibudilast) and a range of different dosing frequencies.

https://finance.yahoo.com/news/medicinova-receives-notice-allowance-patent-103000250.html

Expanded Indication OKd for Merck’s KEYTRUDA in Locally Advanced Cutaneous Squamous Cell Carcinoma

 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the second interim analysis of the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated an objective response rate (ORR) of 50% (95% CI, 36-64) (n=54), including a complete response rate of 17% and a partial response rate of 33% in the cohort of patients with locally advanced disease. Among the 27 responding patients, 81% had a duration of response (DOR) of six months or longer, and 37% had a DOR of 12 months or longer. In June 2020, KEYTRUDA was granted its first indication in cSCC, as monotherapy for the treatment of patients with recurrent or metastatic disease that is not curable by surgery or radiation.

"This approval is great news for these patients and further demonstrates Merck’s commitment to the skin cancer community. KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation," said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. "This expanded indication reinforces the role of KEYTRUDA in this cancer type, which is the second most common form of non-melanoma skin cancer."

https://finance.yahoo.com/news/fda-approves-expanded-indication-merck-104500094.html

Opthea Gets FDA Fast Track Designation for Wet Age-Related Macular Degeneration Med

 Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s VEGF-C/-D ‘trap’ inhibitor, OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD).

The FDA’s Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly. This Fast Track designation acknowledges the significant unmet medical need in the management of neovascular AMD, and the potential role that OPT-302 may have in addressing it.

With the Fast Track designation, Opthea is eligible for more frequent regulatory meetings and communications with the FDA, as well as a Rolling Review of completed sections of its Biologic Drug Application (BLA) which will help expedite the Phase 3 development program and subsequent approval review process. Under the Fast Track designation, OPT-302 may also be eligible for Accelerated Approval and Priority Review if relevant criteria are met.

“Given the need to improve therapeutic options for wet AMD patients, we welcome this Fast Track designation for OPT-302 and the regulatory support it provides in expediting the Phase 3 development program to advance this promising novel treatment to patients sooner,” commented Dr. Megan Baldwin, Chief Executive Officer and Managing Director of Opthea. “The recognition from the FDA to grant OPT-302 Fast Track designation reflects the seriousness of wet AMD as a debilitating eye disease and the importance of advancing new therapies such as OPT-302 to address the significant unmet medical need for wet AMD patients, many of whom experience an incomplete response to VEGF-A inhibitors despite regular, ongoing therapy. By targeting a novel mechanism of action, OPT-302 has the potential to be a truly differentiated treatment option that when used in combination offers patients improved vision outcomes over standard of care anti-VEGF-A monotherapy.”

https://finance.yahoo.com/news/opthea-opt-302-granted-fda-110000075.html

Arbutus, Vaccitech Collaborate on RNAi Therapeutic-Immunotherapeutic for Chronic Hepatitis B

 Arbutus Biopharma Corporation (Nasdaq: ABUS) and Vaccitech plc (Nasdaq: VACC) today announced that the companies have entered into a clinical trial collaboration agreement to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus (HBV) infection (CHB) who are already receiving standard-of-care nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy.

The multi-center, Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s proprietary GalNAc delivered RNAi therapeutic, AB-729, followed by Vaccitech’s proprietary immunotherapeutic, VTP-300, in NrtI-suppressed subjects with CHB. The Phase 2a clinical trial is expected to initiate in the second half of this year and will be managed by Arbutus, subject to oversight by a joint development committee comprised of representatives from Arbutus and Vaccitech. The parties retain full rights to their respective product candidates and will split all costs associated with the clinical trial. Pursuant to the agreement, the parties intend to undertake a larger Phase 2b clinical trial depending on the results of the initial Phase 2a clinical trial.

“Based on the positive clinical results we have seen in our ongoing Phase 1a/1b clinical trial for AB-729, including recent data demonstrating increased HBV-specific immune responses, we believe AB-729 has the potential to become a cornerstone therapeutic in multiple future HBV combination regimens,” stated Gaston Picchio, Chief Development Officer at Arbutus. “We are looking forward to initiating this proof-of-concept Phase 2a clinical trial, which will allow us to evaluate the combination of two promising clinical candidates with potential complimentary mechanisms of action. We believe combining AB-729, which is designed to reduce HBsAg resulting in increased HBV immune responses with VTP-300, an immunotherapeutic designed to elicit an HBV specific immune response, may offer patients with CHB a much needed and durable functional cure.”

https://finance.yahoo.com/news/arbutus-biopharma-vaccitech-announce-clinical-110000423.html

Athira Pharma Starts Label Extension Study for Trials of ATH-1017 for Alzheimer’s

 Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, today announced that it is enrolling patients into an open label extension (OLEX) study for its ongoing Phase 2/3 LIFT-AD and Phase 2 ACT-AD studies of ATH-1017 for the treatment of mild-to-moderate Alzheimer’s disease.

“This treatment extension allows us to meet investigator and patient interest in continuing treatment with ATH-1017. We can now collect up to 1 year of safety and efficacy data on ATH-1017, and patients who received placebo during the randomized portion of the trial will now be able to receive up to 26 weeks of therapy,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer at Athira. “It’s rewarding to have our first patients completing six months of study now continue their treatment. Our novel treatment approach is agnostic to the underlying disease pathology and is designed to focus on neuronal regeneration, which has the potential to improve clinical outcomes for patients.”

“There remains an urgent need for therapies that improve cognition for patients who are living with mild-to-moderate Alzheimer’s disease,” said Michael Mega, M.D., Ph.D., Director of the Center for Cognitive Health and a principal investigator in the ACT-AD trial. “The data we will continue to collect in this open label extension could help us to better understand the long-term safety and efficacy profile of ATH-1017 and could help Athira best design future clinical trials of ATH-1017.”

The LIFT-AD and ACT-AD trials are evaluating ATH-1017, a small molecule therapeutic designed to enhance the activity of Hepatocyte Growth Factor (HGF) and its receptor, MET, which are expressed in the central nervous system, in order to promote brain health and function. The randomized, double-blind, placebo-controlled trials are evaluating the safety and efficacy of ATH-1017 in mild-to-moderate Alzheimer’s disease. Patients are stratified 1:1:1 to receive low dose ATH-1017 (40 mg/day), high dose ATH-1017 (70 mg/day) or placebo.

https://finance.yahoo.com/news/athira-pharma-announces-initiation-open-110000891.html