On September 1, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the following statement about the closure of COBRA, a minimum residual disease (MRD) study (Press release, Guardant Health, SEP 1, 2023, View Source [SID1234634848]).

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The COBRA study was designed to evaluate the effectiveness of using MRD testing to improve clinical outcomes in patients with stage II colon cancer after curative-intent surgery with a planned final readout in 2026.

"Our MRD test has great potential to help patients and their doctors stay ahead of cancer, and we remain confident about its promise to vastly improve patient care and its continued prospects for broad access and reimbursement," said Craig Eagle, MD, Guardant Health chief medical officer.

"We agree with the decision, based on the recent planned interim analysis, to close the COBRA study to new enrollees," said Dr. Eagle. "The field has progressed rapidly since the study was designed over four years ago, and since the study was initiated we have made tremendous progress with multiple upgrades of our MRD test. Additionally, we have many ongoing studies that will demonstrate the effectiveness of our current MRD tests in colorectal cancer and other settings."

On September 1, 2023 Medivir AB (NASDAQ Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that it will host a key opinion leader webcast on the current and future HCC (primary liver cancer) treatment landscape, including how treatment challenges and needs in HCC differs from most other cancers (Press release, Medivir, SEP 1, 2023, View Source [SID1234634847]). The webcast will take place on September 8, 2023 at 13:00 CET/07:00 EST.

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The webcast will feature presentations by Dr. Jeff Evans, Beatson West of Scotland Cancer Center, Glasgow, UK, who will discuss the current treatment landscape and unmet medical need in treating patients with HCC. He will be joined by Dr. Maria Reig, Liver Cancer Unit, Hospital Clínic BCLC group, Villarroel, Barcelona, Spain, who will discuss how HCC is different from many other tumor types and its unique treatment challenges. Both Drs are investigators in the phase 1b/2a study with fostrox in combination with Lenvima and will also share their perspectives from the ongoing study. They will be joined by Dr Pia Baumann, Medivir’s CMO who will provide an update on the ongoing study and fostrox development plans.

All three will be available to answer questions following the formal presentations.

The webcast will be streamed via a link on the website: www.medivir.com/investors/presentations The presentation will be available on Medivir´s website after the webcast.

– "The promising observations we have seen so far in the ongoing phase 1b/2a study of fostrox in combination with Lenvima mean that we are further intensifying our plans for the next phase of clinical development of fostrox. When doing so, it is critical that this is done in close collaboration with external experts to ensure that the specific needs of the disease and changes in treatment landscape are central components of future plans. We are pleased that Drs Evans and Reig, members of our Scientific Advisory Council, are able to provide their expertise on these important topics in this webcast," says Dr. Pia Baumann, CMO at Medivir.

Dr. Jeff Evans is a Professor of Translational Cancer Research in the School of Cancer Sciences, University of Glasgow, and Honorary Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre, Glasgow, UK. He is the Lead of the Glasgow Experimental Cancer Medicine Centre (ECMC) and National Clinical Lead of the NHS Scotland Cancer Research Network. He is an investigator in the fostrox clinical development program.

Dr. Maria Reig is the Head of the BCLC and Liver Oncology Unit at Hospital Clinic of Barcelona in Spain. Her expertise and area of interest is the development of prognostic models for patients with liver cancer and evaluation of treatment options with special emphasis in systemic therapy as well as new research about immune modulation and cancer emergence after antiviral treatment. She is an investigator in the fostrox clinical program.

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox
Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On September 1, 2023 ABM Therapeutics, a clinical-stage biopharmaceutical company, reported that the first patient has been successfully dosed in its multicenter Phase I study of ABM-1310 in patients with relapsed and drug resistant primary malignant brain tumors in China (Press release, ABM Therapeutics, SEP 1, 2023, View Source [SID1234634846]). This is the second clinical study of ABM-1310 in China.

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ABM-1310, the company’s proprietary clinical candidate developed as a next-generation BRAF inhibitor and demonstrated superior properties in pre-clinical animal models for treating cancer brain metastases, is a selective, highly water-soluble, orally active, and brain-penetrant small molecule BRAF inhibitor. ABM has been carrying out 2 additional studies of ABM-1310 in patients with BRAF V600X mutated advanced solid tumors in several well-known cancer centers in the United States and China. The preliminary observation of the US Phase I trial was presented at ASCO (Free ASCO Whitepaper) 2023 Annual Meeting (View Source).

The newly opened study (NCT05892653) is a phase I, open-label, multicenter clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer efficacy of ABM-1310 in patients with BRAF V600X mutant relapsed and drug resistant primary malignant brain tumors, with the goal to determine the optimal/recommended dose for phase 2 studies.

"We are excited to start this new study of ABM-1310. Primary brain tumors represent over 100 different sub-types, and patients whose tumors carry a BRAF V600X mutation are one of the clusters. Although progress has been made in the treatment of patients with primary malignant brain tumors in recent years, there is still a highly unmet medical need for those with recurrent or drug resistant diseases", said Dr. Chen Chen, CEO of ABM Therapeutics, " We have 3 clinical studies of ABM-1310 ongoing in China and the United States. We will work with investigators and clinical sites to push forward the clinical development of ABM-1310, with the passion to bring the potential therapeutic benefits to patients."

"Due to unfavorable prognosis associated with most primary malignant brain tumors and the limited treatment options that are currently available, there is an imperative to explore new therapeutic approaches. ", said Dr. Zane Yang, CMO of ABM Therapeutics. "Since ABM-1310 exhibits higher water solubility, cellular and blood-brain barrier penetration capabilities, compared to other BRAF inhibitors in preclinical research, we expect that ABM-1310 will provide special clinical benefits for patients with central nervous system tumors harboring BRAF V600X mutation"

As a clinical-stage biotechnology company, ABM has got a broad and robust proprietary pipeline to construct a Brain-Penetrant Kinase Drug Development Platform (BPKddTM）. We look forward to working with international pharmaceutical companies and biotech companies from multiple perspectives and making our drugs to benefit more patients in the world.

On September 1, 2023 Innovac Therapeutics, an mRNA therapeutics company, reported the completion of an $18 million Series Pre-A financing (Press release, Innovac Therapeutics, SEP 1, 2023, View Source [SID1234634845]). The financing round includes Elikon Venture, Vision Plus Capital, Yunion Healthcare Ventures, TG Sino-Dragon Fund and other industry and private individuals. The proceeds will be used to further develop its technology platform and manufacturing capability to advance its lead programs to clinical stage.

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"We are thrilled with the great support from our investors. This financing is an important milestone for Innovac and accelerated development of novel mRNA vaccines ," says Michael Zhang, MD, Co-Founder and CEO of Innovac, who has more than ten years of experience in equity investment and venture formation in healthcare industry in both U.S. and China.

"Our mRNA technology platform has strong potential to address the huge unmet medical needs in both oncology and infectious disease. With this funding, we will take a significant step forward in bringing our lead programs into clinical stage"

"An exciting revolution is underway in the vaccine industry, fueled by the dramatic success of mRNA vaccines in response to the SARS-CoV2 pandemic and breakthrough status for a mRNA-based personalized cancer vaccine." notes Nicholas Valiante, PhD, Co-Founder and Chief Scientific Officer (CSO), who served as CSO at Caperna, a Moderna venture, and previously, Global Head of Immunology and Immunotherapy at Novartis Vaccines. Dr Valiante, a 25-year veteran of the vaccine industry, also comments on Innovac’s founding vision: "Innovac was founded to be a primary driver of this ongoing revolution and will exploit the power of mRNA vaccines to treat and prevent a wide variety of infectious diseases and cancer."

"From the beginning, our mission has been to harness the power of mRNA technology to develop therapies for patients with unmet needs," says Hang Yuan, PhD, Co-Founder and Chief Technical Officer (CTO). Dr. Yuan has more than 15 years of experience in the Chemistry Manufacturing and Control (CMC) development and commercialization of biotherapeutics. "With this new infusion of capital, we are well-equipped to expand our team, enhance our technology platforms, and build our manufacturing capability to bring our transformative ideas closer to reality."

Upon closing its Series Pre-A financing, Innovac also announced the appointments of David Bernstein, MD, Shan Lu, MD, PhD, and Elaine Mardis, PhD to its scientific advisory board (SAB). Three newly joined SAB members will bring exceptional scientific expertise and profound industry experience to Innovac.

"We are honored to have David Bernstein, MD, Shan Lu, MD, PhD, and Elaine Mardis, PhD, to join as SAB of Innovac Therapeutics." said Nicholas Valiante, PhD, Chief Scientific Officer of Innovac Therapeutics, "Innovac will work closely with our renowned SAB members to leverage their breadth and depth of expertise in different areas to further strengthen the scientific foundation of our technology platform and pipeline expansion."

David Bernstein, MD, Director of the Gamble Program at Cincinnati Children’s Hospital, as well as its Vaccine Testing and Evaluation Unit and Professor at the University of Cincinati Department of Pediatrics.

Shan Lu, MD, PhD, Director of the Laboratory of Nucleic Acid Vaccines at the University of Massachusetts Medical School and Professor Emeritus at the UMass Chan Medical School.

Elaine Mardis, PhD, Director of the Institute for Genomic Medicine at Nationwide Children’s Hospital, Professor of Pediatrics at The Ohio State University College of Medicine, and a key participant in the development of the Cancer Genome Atlas. She was the AACR (Free AACR Whitepaper) president for 2019-2020.

On September 1, 2023 United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported that James Edgemond, Chief Financial Officer and Treasurer, will provide an overview and update on the company’s business during a fireside chat session at the Morgan Stanley 21st Annual Global Healthcare Conference in New York City (Press release, United Therapeutics, SEP 1, 2023, View Source [SID1234634844]).

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The session will take place on Monday, September 11, 2023, from 12:55 p.m. to 1:25 p.m., Eastern Daylight Time, and can be accessed via a live webcast on the United Therapeutics website at View Source An archived, recorded version of the session will be available approximately 24 hours after the session ends and can be accessed for 180 days.