On March 1, 2023 Biological Dynamics, Inc., a company developing and commercializing its exosome-isolation ExoVerita platform for early disease diagnostics and other applications, reported its collaboration with the Brenden-Colson Center for Pancreatic Care at Oregon Health & Science University (OHSU) to study its ExoVita Pancreas assay (Press release, Biological Dynamics, MAR 1, 2023, View Source [SID1234628027]). The Brenden-Colson Center has a robust, integrated clinical-translational interface to drive innovative patient care and nourish scientific collaborations.

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The ExoVita Pancreas assay significantly improves the care of patients at high risk for pancreatic cancer through earlier detection. In this study, blinded samples from up to 520 subjects will be tested. Case samples will be sourced from patients with early-stage pancreatic ductal adenocarcinoma (PDAC), while control samples will come from subjects with benign conditions (such as pancreatic cysts) and "healthy" individuals.

For patients diagnosed with advanced disease, pancreatic cancer is highly lethal. "Our core goal is to move the needle for high-risk patients through early PDAC diagnosis. Detection is limited using the standard imaging and endoscopy methods currently available," said Rosalie C. Sears, PhD, Co-Director of the Brenden-Colson Center and Professor, Department of Molecular and Medical Genetics at OHSU. According to Brett C. Sheppard MD, FACS, Professor of Surgery and Co-Director of the Brenden-Colson Center: "Finding tumors at an earlier stage will provide the opportunity for prompt neoadjuvant therapy followed by targeted interception with potentially curative minimally invasive surgical techniques to optimize survival and quality of life."

Drs. Sears and Sheppard believe ExoVita Pancreas is a promising test to isolate exosomal PDAC biomarkers from blood. ExoVita Pancreas detects Stage 1 and Stage 2 PDAC with high sensitivity, which can improve patient outcomes and quality of life.

"We have a long-standing relationship with Oregon Health & Science University and look forward to collaborating to evaluate the clinical validity of our ExoVita Pancreas test," said Paul Billings, MD, PhD, CEO of Biological Dynamics. "The Brenden-Colson Center for Pancreatic Care are pioneers in integrating cutting-edge technologies into their research, and were early adopters of exosome-isolation on the ExoVerita platform. This partnership is another step towards providing diagnostics for early cancer detection that are reliable and affordable for the surveillance of high-risk patients."

Biological Dynamics’ ExoLuminate registry study (NCT05625529), which enrolled its first patient in December 2022, will determine how the ExoVita Pancreas test performs in prospective at-risk populations.

On March 1, 2023 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM) reported that it has been informed by its partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex), that an interim analysis for ACE-Breast-02, a randomized Phase 3 breast cancer clinical trial investigating Ambrx’s ARX788, an anti-HER2 antibody drug conjugate (ADC), has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control (Press release, Ambrx, MAR 1, 2023, View Source [SID1234628026]).

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ACE-Breast-02 is a randomized, controlled pivotal Phase 3 clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in the treatment of HER2 positive patients with locally advanced or metastatic breast cancers in China.

The trial enrolled 441 HER2 positive breast cancer patients who have been previously treated with taxane and trastuzumab. Eligible subjects were randomly assigned in a 1:1 ratio to receive ARX788 or the control drugs, lapatinib combined with capecitabine. The primary endpoint was PFS based on Blinded Independent Review Committee (BIRC) assessment. An interim analysis was conducted by an Independent Data Monitoring Committee (IDMC) when two thirds (2/3) of the PFS events occurred.

After reviewing the interim results, the IDMC informed NovoCodex that the ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater PFS benefit compared to the control.

Based on the results from the interim analysis, NovoCodex plans to submit a communication application to seek marketing approval in China pending discussion with National Medical Products Administration (NMPA).

Daniel O’Connor, Chief Executive Officer of Ambrx commented: "We congratulate our partner, NovoCodex, on this positive Phase 3 study. The positive results from this large Phase 3 study provide further support for our rationale to develop ARX788 globally in HER2 positive breast cancer patients."

ARX788 is an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials with our partner NovoCodex. The United States Food and Drug Administration (FDA) has granted Fast Track Designation for ARX788 in HER2 positive metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer. The NMPA has granted Breakthrough Therapy Designations for ARX788 in breast cancer.

In June 2013, Ambrx entered into a collaboration with Zhejiang Medicine Co., Ltd., which was transferred to it subsidiary NovoCodex, to develop and commercialize ARX788, Ambrx’s most advanced internally developed site-specific ADC targeting HER2-positive breast cancer. Under the agreement, NovoCodex licensed commercial rights for ARX788 in China while Ambrx retained commercial rights outside of China and is entitled to receive royalties on sales of ARX788 in China.

On March 1, 2023 ADC Therapeutics SA (NYSE: ADCT) announced today that Ameet Mallik, Chief Executive Officer, reported a company overview at the Cowen 43rd Annual Health Care Conference in Boston, MA, on Tuesday, March 7th at 2:50 p.m. ET (Press release, ADC Therapeutics, MAR 1, 2023, View Source [SID1234628025]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

On March 1, 2023 a biotechnology company leveraging its next-generation chemoproteomics platform to discover medicines for challenging-to-drug targets, reported that management will participate in the following upcoming investor conferences (Press release, Jnana Therapeutics, MAR 1, 2023, View Source [SID1234628024]).

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Cowen 43rd Annual Health Care Conference, March 6-8, 2023. Boston Management will participate in one-on-one meetings.
Oppenheimer 33rd Annual Healthcare Conference, March 13-15, 2023 (Virtual). Joanne Kotz, Ph.D., Co-Founder and CEO, will present a company overview at 2:00 p.m. ET on March 15. Management will also participate in one-on-one meetings.

On March 1, 2023 Tachyon Therapeutics, Inc. ("Tachyon" or "the Company"), a private, clinical-stage biotechnology company developing transformative cancer therapies against novel targets reported the closing of a financing that brings the Company’s total equity financing raises to $11.6 million and, together with a recently reported CIRM grant of $7.1 million, brings total funding in the Company to $18.7 million since the Company started operations in 2020 (Press release, Tachyon Therapeutics, MAR 1, 2023, View Source [SID1234628023]). The round includes new investors, Veblen Ventures, Khosla Ventures, and Red Tree Venture Capital, and existing investors, demonstrating their continued commitment to supporting Tachyon’s potential. Proceeds from the financing are being used to run the Phase 1 clinical study in advanced solid tumors for TACH101, a first-in-class, small molecule, KDM4 histone demethylase inhibitor, as well as to advance the Company’s pipeline of emerging oncology drug candidates targeting previously unexplored mechanisms of tumorigenesis.

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"The Tachyon team are enabling new frontiers in targeted oncology by developing cancer therapies that address fundamental drivers of tumorigenesis," commented Heath Lukatch, Ph.D., Managing Director of Red Tree Venture Capital. "We look forward to supporting the team as they work towards transforming the treatment paradigms for advanced and metastatic solid tumors."

"This new capital, from a committed and distinguished investor syndicate that includes new and existing investors as well as the grant from CIRM, highlights the progress we’ve made to bring our lead program into the clinic," said Frank Perabo, M.D. Ph.D., Chief Executive Officer of Tachyon.

Founded on the scientific work of Drs. Stephen Quake and Michael Clarke at Stanford University, Tachyon Therapeutics is developing novel, first-in-class therapeutics that target pathways to fight cancer at its core tumorigenic mechanisms. In November 2019, Tachyon received an exclusive license to research, develop, and commercialize products for small molecule inhibitors of KDM4 including TACH101 (formerly QC8222) from Celgene Quanticel Research, Inc, now Bristol Myers Squibb, Summit, NJ. The Company recently received clearance of the Company’s Investigational New Drug (IND) application for TACH101 and enrolled its first patient in a Phase 1 clinical study in patients with advanced or metastatic solid tumors (ClinicalTrials.gov Identifier NCT05076552).

"The start of our first clinical trial for TACH101, our lead program, is a significant milestone for the company as we strive to bring promising new therapeutics to patients who are fighting advanced cancers," continued Dr. Perabo. "We are also pleased to welcome to our Board of Directors, Dr. Jeff Stafford, who has decades of experience in developing innovative small molecule therapeutics against novel cancer targets and led the initial discovery and development of our novel KDM4-inhibitor, TACH101."

Dr. Stafford is the President and CEO of 858 Therapeutics. Prior to this, he was the founding CSO of Quanticel Pharmaceuticals (acquired by Celgene), where his team discovered TACH101 from a single cell genomics platform for precision targeting of cancer stem cells. Dr. Stafford has also held senior scientific and management positions at Takeda and GlaxoSmithKline and was the founding CEO of Jecure. Dr. Stafford’s discovery teams have been responsible for the discovery of three FDA-approved drugs – Votrient (pazopanib), Nesina (alogliptin), and Byfavo (remimazolam) – and several others currently in clinical trials.