On February 22, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the ability of its CNSide cerebrospinal fluid (CSF) assay to aid in therapeutic research programs for metastatic brain cancer in a presentation at the Molecular & Precision Med Tri-Con meeting (Press release, Biocept, FEB 22, 2022, View Source [SID1234608831]). The company is also exhibiting (booth #508) at the conference, which is the leading international meeting for the precision medicine community, Feb. 21-23, 2022, in San Diego.

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During the presentation, Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director, discussed the growing interest in improving the diagnosis and treatment of leptomeningeal disease (LMD), a devastating complication in which metastatic cancer spreads to the membrane surrounding the brain and spinal cord. Newer targeted therapies can often reduce or resolve debilitating symptoms of LMD and extend life expectancy. However, the current standards of care, CSF cytology and radiological imaging, have limited sensitivity for detecting central nervous system metastasis, and do not identify molecular treatment targets or quantify tumor cell counts.

"A key to precision medicine is identifying molecular targets for therapy," Dr. Dugan said. "Relying on the primary tumor is not sufficient because biomarker status often differs between the primary and metastatic tumors. With CNSide, we have the first commercially available method to measure biomarker status in real-time during therapy and quantify changes in tumor cell counts to really understand how patients are responding to therapy—as opposed to waiting months for radiologic changes or another surgical biopsy."

"Companies developing novel therapies for metastatic brain cancers face significant challenges in determining treatment response with traditional methods," said Samuel D. Riccitelli, Biocept’s Chairman, and Interim President and CEO. "We believe that serial quantitative monitoring with our CNSide assay can have a tremendous impact on the success of many therapeutic clinical trials, and we are pleased to support these important research efforts aimed at providing new treatments for patients with limited time and options."

CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method, paired with assays to identify actionable molecular treatment targets. The assay answers three key questions that may help inform treatment decisions: Is there tumor? Is there a target for treatment? Is there a trend to treatment response? Because genetic changes can occur as metastatic cancer spreads to the central nervous system, the evaluation of cerebrospinal fluid provides a unique opportunity to identify biomarkers such as HER2 and EGFR in patients with metastatic breast, lung, and other cancers, to help guide therapy selection. In addition, the quantitative tumor cell count assay can be used in a serial fashion to more effectively monitor the response to therapy than other current methods.

A recording of the presentation, titled "A Novel CSF Assay to Help Diagnose, Manage, and Follow Response to Therapy in Patients with Leptomeningeal Metastasis," will be available on the Biocept website after the conference concludes.

On February 22, 2022 BostonGene reported its publication, "Conserved pan-cancer microenvironment subtypes predict response to immunotherapy," has been selected by Cancer Cell as one of ten research articles that represent cutting-edge areas of cancer research and oncology in 2021 (Press release, BostonGene, FEB 22, 2022, View Source [SID1234608830]).

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The manuscript describes a transcriptomic-based tumor classification platform that identified four unique tumor microenvironment subtypes across 20 different cancers, predicting prognosis and response to immune checkpoint blockade. BostonGene also created a personalized tumor map to visually depict the key molecular and immune characteristics of each tumor. The microenvironment classification platform and tumor map provide a clinically useful and robust methodology for response prediction and incorporate precision medicine strategies across varied cancer types.

"We are thrilled to be recognized by Cancer Cell for our innovative multi-platform analytics combined with cutting-edge software to improve patient outcomes," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings underscore the power of integrated analysis to uncover unique and clinically applicable characteristics of the tumor microenvironment, and we are committed to enabling doctors to personalize therapy for cancer patients."

The research results provided the foundation to launch BostonGene Tumor PortraitTM Tests, which are designed to reveal key drivers of each tumor, including immune microenvironment properties, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies.

On February 22, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that Dr. Klaus Wagner has been appointed as Chief Medical Officer (Press release, Boundless Bio, FEB 22, 2022, View Source [SID1234608829]).

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"We are excited to have Klaus join at this pivotal time as we advance the first ecDNA therapeutics towards the clinic," said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "Klaus brings extensive experience in oncology drug development from both industry and clinical research settings. Over the course of his career, he has developed a deep understanding of how cancer targeted therapies and immunotherapies perform in the clinic. His leadership over Boundless Bio’s clinical development will bring significant value to our ecDNA-directed therapeutic (ecDTx) programs and importantly, help us bring new treatment options to patients with oncogene amplified cancer."

Dr. Wagner comes to Boundless Bio previously serving as Executive Vice President and Chief Medical Officer at Inhibrx, Inc. At Inhibrx, Dr. Wagner built and led an integrated clinical development organization responsible for advancing four therapeutic candidates, including three oncology programs, from pre-IND into the clinic. Dr. Wagner previously served as Medical Oncologist at Banner MD Anderson Cancer Center and as Adjunct Assistant Professor in the Department of Thoracic, Head & Neck Medical Oncology at MD Anderson Cancer Center, where he led molecularly targeted therapy and cancer immunotherapy trials in non-small cell lung cancer as a local principal investigator. Before that, Dr. Wagner trained at MD Anderson Cancer Center as a fellow in Medical Oncology. Prior to that Dr. Wagner’s scientific work at Genentech, Inc. and the Genomics Institute of the Novartis Research Foundation focused on cancer drug discovery and predictive biomarker development. Dr. Wagner was a scholar of the German National Academic Scholarship Foundation. Dr. Wagner received his M.D. and Ph.D. from the Friedrich-Alexander University of Erlangen in Germany.

"It is a privilege to join Boundless Bio, a company founded on interrogating a fundamental and important area of cancer biology, ecDNA that appears to play a significant role in the poor prognosis and treatment challenges associated with oncogene amplified cancers," said Dr. Wagner. "In my career as a scientist and clinician, I have always been excited to bring innovative treatments to patients with high unmet needs cancer. There are very few therapies that effectively address oncogene amplification. Boundless Bio’s pipeline is uniquely tailored to develop treatments for these patients."

On February 22, 2022 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that management will host a conference call to discuss its fourth quarter and full year 2021 financial results and provide a business update on Tuesday, March 1, 2022 at 8:30 a.m. ET (Press release, Epizyme, FEB 22, 2022, View Source [SID1234608828]).

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To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 4082815. A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the call.

On February 22, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported the initiation of dose expansion cohorts of the Phase 1/1b study evaluating BCA101 in patients with head and neck squamous cell carcinoma (HNSCC), squamous cell carcinoma of the anal canal (SCAC) and cutaneous squamous cell carcinoma (cSCC) (Press release, Bicara Therapeutics, FEB 22, 2022, View Source [SID1234608827]).

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BCA101 is a bifunctional antibody designed to target a TGF-β trap to EGFR-positive tumors by inhibiting epidermal growth factor receptor (EGFR) and disabling TGF-β directly at the site of the tumor, ideally achieving superior anti-tumor efficacy with an improved therapeutic window.

"This is the first-in-human trial of the first bifunctional molecule targeting EGFR and TGF-β. We are pleased that the observed safety, pharmacokinetic, pharmacodynamic and efficacy profiles of BCA101 to date have enabled us to declare a recommended dose for expansion," said Liviu Niculescu, M.D., Chief Medical Officer of Bicara Therapeutics. "The results thus far from this early clinical study have been very encouraging in our efforts to offer new potential treatment options to patients with cancer, and we are grateful to the study’s patients, their families, and investigators whose trust, time, dedication and hard work have been crucial in reaching this milestone."

The dose expansion arm of the study follows the successful completion of a Phase 1/1b open-label, multicenter dose escalation study of BCA101 in patients with EGFR-driven advanced solid tumors that identified a recommended dose. It will assess the efficacy, safety and tolerability of BCA101 at 1500mg intravenously weekly in three initial expansion cohorts. BCA101 will be administered in combination with the immune checkpoint inhibitor pembrolizumab as first-line therapy in patients with unresectable, recurrent or metastatic HNSCC and as second-line therapy in patients with advanced SCAC who have received prior chemotherapy. A third cohort of patients with advanced or incurable cSCC who have received previous anti-PD-1 therapy will be treated with BCA101 as a single agent. Data from the dose escalation part of the study will be presented at a future scientific conference later in 2022.

"While these are early clinical trials, we have observed an intriguing efficacy signal for BCA101 in both the preclinical and interim phase 1 clinical data, including among those with highly refractory cancers," said Dr. Glenn J. Hanna, Assistant Professor of Medicine at Harvard Medical School, principal investigator of the BCA101 study. "We look forward to evaluating the efficacy of BCA101 in the selected expansion cohorts and to subsequently exploring ways to bring this potential therapeutic option to our patients."

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b clinical trial of BCA101, initiated in July 2020, has enrolled cohorts of patients in a dose-escalation study with BCA101 as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor and a recommended dose for expansion has been declared. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.