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.

On September 1, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that it will present findings today at the 8th Annual CAR-TCR Summit from its Phase 1 clinical trial of the Company’s lead product candidate, CT-0508, a human epidermal growth factor receptor 2 ("HER2") targeted chimeric antigen receptor macrophage ("CAR-M") for the treatment of advanced/metastatic HER2 overexpressing cancers (Press release, Carisma Therapeutics, SEP 1, 2023, View Source [SID1234634843]).

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The presentation includes data from group 1 (n=9) and group 2 (n=5). Patients in both groups received the same total dose (up to 5×109 CT-0508) either via a fractionated, multi-day infusion regimen (group 1) or via a single-day bolus infusion (group 2). The data are drawn from the ongoing clinical trial led by Kim A. Reiss, MD, principal investigator of the Phase 1 clinical trial and an associate professor of Hematology-Oncology in the Perelman School of Medicine at the University of Pennsylvania.

In the presentation, Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma, will present data demonstrating that, in both groups, CT-0508 was successfully manufactured for patients and that the administration of CT-0508 was well-tolerated after infusion with no dose-limiting toxicities reported to date.

"As the CT-0508 trial progresses, it is promising to see consistent results supporting the safety profile, feasibility, and mechanism of action of this first-in-class CAR-M investigational therapy," commented Dr. Klichinsky. "We look forward to results from the CT-0508 combination sub-study with pembrolizumab and continued development of CAR-M and CAR-Monocyte therapies."

Previously, Carisma presented findings from group 1 showing that CT-0508 remodeled and activated the tumor microenvironment ("TME") and initiated anti-tumor T cell immunity. Translational analyses combining group 1 and group 2 show that various biomarkers including metrics of TME activation, T cell activation, and HER2 status correlate with best overall response ("BOR") of stable disease, providing further evidence of the CT-0508 mechanism of action.

The Phase 1 study translational analyses further demonstrate an increase in exhausted CD8 T cells on treatment, supporting the ongoing combination sub-study with Merck’s anti-PD1 therapy KEYTRUDA (pembrolizumab). This latest data readout follows the dosing of the first patient in the ongoing sub-study of the Phase 1 clinical trial of CT-0508 in combination with pembrolizumab for the treatment of HER2 overexpressing cancers.

The Company is filing a Current Report on Form 8-K today with the U.S. Securities and Exchange Commission disclosing the new data from its Phase 1 clinical trial of CT-0508, including an excerpt of the presentation being made at the 8th Annual CAR-TCR Summit.

Editor’s Note: Carisma has licensed certain Penn-owned intellectual property from the University of Pennsylvania, and Penn’s Perelman School of Medicine receives sponsored research and clinical trial funding from the company. Penn may be entitled to receive additional financial benefits from technologies licensed and optioned to Carisma. In addition, Penn is a co-founder of the company and holds equity in Carisma.

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers do not have approved HER2-targeted therapies or who do not respond to treatment. Carisma is selecting participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial marks the first time that engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) Penn Medicine’s Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.

On September 1, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that ORIC granted a total of 19,380 non-qualified stock options and 3,220 restricted stock units to three new non-executive employees who began their employment with ORIC in August 2023 (Press release, ORIC Pharmaceuticals, SEP 1, 2023, View Source [SID1234634842]).

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These inducement grants were granted pursuant to the ORIC Pharmaceuticals, Inc. 2022 Inducement Equity Incentive Plan, subject to recipient’s continued employment or service through each applicable vesting date. The stock options have an exercise price equal to the closing price of ORIC’s common stock on the Grant Date. Twenty-five percent (25%) of the shares subject to the stock options will vest on the one (1) year anniversary of the Grant Date, with one thirty-sixth (1/36th) of the remaining shares vesting each one-month period thereafter. One-third (1/3rd) of the restricted stock units will vest on each of the first three anniversaries of the Grant Date. The inducement grants are subject to the terms and conditions of the applicable stock option and restricted stock unit agreements and the ORIC Pharmaceuticals, Inc. 2022 Inducement Equity Incentive Plan.

The inducement grants were approved by ORIC’s Compensation Committee of the Board of Directors, as required by Nasdaq Rule 5635(c)(4), and were granted as a material inducement to employment in accordance with Nasdaq Rule 5635(c)(4).