On October 14, 2022 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on oncology, reported that it has received clearance from the US Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody being developed for patients with small cell lung cancer (SCLC) and other neuroendocrine cancers (Press release, Phanes Therapeutics, OCT 14, 2022, View Source [SID1234622036]). PT217 has recently been granted an orphan drug designation by the FDA for the treatment of SCLC.

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"This is the third program in our pipeline that has received IND clearance by FDA this year, which is an important milestone for Phanes and a record for a biotech company of our size. The opportunity to bring this potential first-in-class bispecific antibody to cancer patients who have such a high unmet medical need is at the core of what drives us as a company," said Dr. Ming Wang, Founder and CEO. "With a strong pipeline targeting both the adaptive and innate immunity and the bispecific antibody technology platforms we have built, Phanes is well positioned to make important impacts in delivering innovative cancer therapies."

The Phase I study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of PT217 in subjects with advanced or refractory cancers. Patients with the following tumor types will be eligible for screening: unresectable SCLC, large cell neuroendocrine cancer (LCNEC), neuroendocrine prostate cancer (NEPC) and gastroenteropancreatic neuroendocrine tumors (GEP-NET). Subjects must have progressed after standard therapy (at least one line of platinum-based chemotherapy with or without immune checkpoint inhibitor for SCLC) or standard therapy has proven to be ineffective, intolerable or was considered inappropriate.

SCLC is an aggressive pulmonary carcinoma hallmarked by high early mortality rates and significant morbidities throughout the disease’s progression. The 1-year survival of patients with SCLC is only 32.9%, with survival steadily decreasing with only 10.7% of patients surviving 3 years.

Phanes current clinical programs include: PT199, a differentiated anti-CD73 monoclonal antibody, enrolling at 3 US study sites and PT886, an anti-Claudin 18.2/anti-CD47 bispecific antibody, which is in study startup at The University of Texas MD Anderson Cancer Center, Houston, TX.

On October 14, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), an immunology company, reported a poster presentation at the SITC (Free SITC Whitepaper) 2022 Annual Meeting being held November 8-12, 2022 (Press release, Corbus Pharmaceuticals, OCT 14, 2022, View Source [SID1234622035]). The poster will share the updated preclinical validation of the drug candidate CRB-601.

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Poster Details:

Title: CRB-601, a selective integrin avβ8 blocking antibody, exhibits potent anti-tumor activity in anti-PD-1 resistant models

Authors: Daqing Wang, Vaishali Shinde, Maneesh Singh, Rachael Brake, and Andrew Kolodziej

Abstract Number: 815

Date / Time: November 10 – November 11, 9:00 am – 9:00 pm ET

CRB-601 is a potent and selective integrin αvβ8 blocking monoclonal antibody that can overcome tumor immune exclusion and enhance the activity of immune checkpoint inhibitors in vivo. Investigational New Drug (IND) enabling studies are currently underway with a plan to explore the anti-tumor activity of this agent clinically in 2023.

The CRB-601 abstract will be available on the SITC (Free SITC Whitepaper) website as of November 7th and the poster will be made available on the Company website on November 10th.

On October 14, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported that they are attending the BIO-Europe 2022 conference in Leipzig, Germany from October 24 – 26, as well as presenting at the BIO-Europe Virtual Conference from November 2 – 4 (Press release, Bold Therapeutics, OCT 14, 2022, View Source [SID1234622034]).

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Bold Therapeutics’ BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant cancers, giving BOLD-100 the potential to significantly improve outcomes in a wide range of both solid and liquid tumors in combination with other anticancer therapies ranging from traditional chemotherapies to targeted therapies to immuno-oncology agents. BOLD-100 is currently being studied in a multinational Phase 2 trial in the treatment of advanced gastrointestinal (bile duct, colorectal, gastric and pancreatic) cancers actively enrolling at 13 clinical sites: six in Canada; two in the U.S.; and five in South Korea.

Bold Therapeutics presented initial data from this Phase 2 trial at the 2022 American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022. In addition to demonstrating that BOLD-100 was safe and generally well-tolerated, this data showed remarkable outcomes in the treatment of 3rd line or later treatment-resistant metastatic colorectal cancer (mCRC) in combination with FOLFOX – including in patients that had previously failed on FOLFOX alone. Subsequent data has both expanded and strengthened these advantages. Consequently, Bold Therapeutics expects to receive a Breakthrough Therapy Designation in the treatment of 3rd line or later treatment-resistant metastatic colorectal cancer (mCRC) and potentially other gastrointestinal cancer indications as well. Bold Therapeutics expects to present this robust data set at a major cancer conference in early 2023. In the interim, Bold Therapeutics is meeting with interested investors as well as potential development and commercialization partners and is willing to share the full clinical data set under confidentiality.

On October 14, 2022 DiaCarta, Ltd. ("DiaCarta" or the "Company"), a precision molecular diagnostics company and developer of novel oncology and infectious disease tests, and HH&L Acquisition Co. (NYSE: HHLA.U, HHLA, HHLA WS) ("HH&L"), a publicly traded special purpose acquisition company ("SPAC"), reported that they entered into a definitive business combination agreement (the "Business Combination Agreement") that is expected to result in DiaCarta becoming a publicly listed company (the "Transaction" or "Business Combination") (Press release, DiaCarta, OCT 14, 2022, View Source [SID1234622033]). The Transaction is expected to provide DiaCarta with access to the approximately $414 million cash from HH&L’s IPO proceeds held in trust, assuming no redemptions by HH&L’s shareholders and prior to the payment of transaction expenses, and potential additional financing to catalyze DiaCarta’s growth. The Transaction implies a pre-money equity value of $460 million for DiaCarta on a fully diluted basis and is expected to close in the first quarter of 2023. The Transaction positions DiaCarta to capitalize on significant future growth within existing and new markets.

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HH&L is led by Kenneth W. Hitchner, Richard Qi Li and a management team with significant experience in identifying and investing in attractive growth opportunities in the global healthcare industry, and Fenglai Fang, Chairman of HOPU Investments, serves as an adviser.

Upon closing of the Transaction, the combined company will be listed on the New York Stock Exchange. The combined company will continue to be based in Pleasanton, California, and led by Aiguo (Adam) Zhang, Founder and Chief Executive Officer of DiaCarta, and other key members of DiaCarta’s management team.

On October 14, 2022 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported an hour-long webinar to be held today, October 14 at 1 p.m. Eastern time featuring case studies presented by leading neuro-oncologists who have used the company’s CNSide assay in the management of patients with confirmed or suspected central nervous system metastasis (Press release, Biocept, OCT 14, 2022, View Source [SID1234622032]).

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About the Speakers

Priya U. Kumthekar, MD is a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist from Northwestern University and is serving as the principal investigator for Biocept’s FORESEE clinical study. She is dedicated to patient care and moving the study of brain tumors forward primarily through her leadership on clinical trials. Dr. Kumthekar serves in leadership roles with the National Clinical Trials Network, particularly with the Alliance for Clinical Trials, and was named as the Alliance’s national Executive Officer of Neuro-Oncology in 2016. In this role, she oversees the conception and development of clinical trials from early phase through registration studies. Dr. Kumthekar is board certified in neurology and is a member of the American Board of Psychiatry and Neurology. She received her medical degree from Northeastern Ohio University. She previously was Chief Resident at Northwestern University, McGaw Medical Center and has led numerous trials involving primary and secondary brain tumors.

Seema A. Nagpal, MD is a board-certified neuro-oncologist and has served as Clinical Associate Professor at Stanford University since 2012. She treats patients with primary brain tumors and metastatic disease to the brain and nervous system. Her research concentrates on clinical trials for patients with late-stage central nervous system cancer and she has a special interest in leptomeningeal disease, a devastating complication of lung and breast cancers. In collaboration with Stanford scientists, including breast and lung oncologists, Dr Nagpal’s work is focused on more sensitive disease detection and the improvement of patient outcomes. She previously was a neuro-oncology fellow at Stanford hospitals and clinics, and a neurology resident at the University of California San Francisco. She received her medical degree from the University of Pennsylvania.