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.

On October 14, 2022 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy (Press release, Novartis, OCT 14, 2022, View Source [SID1234622030]).

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"People at this advanced stage of disease have already received many different treatments and have few alternatives left," said Prof. Karim Fizazi, MD, PhD, VISION trial investigator and
Head of Medical Oncology at Gustave Roussy, first European cancer center based in Villejuif, France. "If approved in Europe, Pluvicto would represent a new type of precision medicine targeting a biomarker broadly expressed in prostate cancer patients4 and provide a therapeutic option with demonstrated potential to improve outcomes1. As a clinician this gives me hope for patients facing a very difficult situation."

The positive CHMP opinion is based on data from the Phase III VISION study, in which Pluvicto plus best standard of care (BSoC) demonstrated significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone1.

Results from the VISION trial demonstrated that participants treated with Pluvicto plus BSoC had a 38% reduction in risk of death and a 60% reduction in the risk of radiographic disease progression or death (rPFS) compared to BSoC alone1. In addition, approximately a third (29.8%) of patients with evaluable disease at baseline demonstrated an overall response (per RECIST 1.1) with Pluvicto plus BSoC, compared to 1.7% in the BSoC alone arm1. The most common adverse events (all grades) in the Pluvicto arm of the study were fatigue (43%), dry mouth (39%), nausea (35%), anemia (low red blood cell counts) (32%), decreased appetite (21%), and constipation (20%)1.

"This positive CHMP opinion for Pluvicto is an important step forward in our goal of bringing transformative innovation to more patients around the world," said Marie-France Tschudin, President, Innovative Medicines International & Chief Commercial Officer, Novartis. "If approved by the European Commission, Pluvicto would be the first and only commercial radioligand therapy for people with advanced prostate cancer in Europe. We are committed to exploring the potential of radioligand therapy to address unmet needs in prostate cancer, including in earlier stages of disease."

The CHMP’s positive opinion on Pluvicto in PSMA–positive mCRPC patients will be referred to the European Commission (EC), which will deliver a final decision in approximately two months. The decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein.

About Pluvicto (lutetium (177Lu) vipivotide tetraxetan)
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with mCRPC1. Pluvicto is a radioligand therapy combining a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope (a radioactive particle, in this case lutetium-177)1. Pluvicto delivers radiation to PSMA-positive cells and the surrounding microenvironment1. Pluvicto was approved by the FDA in March 2022.

Two additional Phase III trials in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore)11 and in the metastatic hormone-sensitive setting (PSMAddition)12. Novartis is also evaluating opportunities to investigate Pluvicto radioligand therapy in earlier stages of prostate cancer.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study that assessed the efficacy and safety of Pluvicto (lutetium (177Lu) vipivotide tetraxetan) (7.4 GBq administered by IV infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen standard of care (BSoC) in the investigational arm, versus BSoC in the control arm1. Patients with PSMA PET-scan positive mCRPC who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy, were randomized in a 2:1 ratio in favor of the investigational arm1. The alternate primary endpoints were rPFS and OS1. The study enrolled 831 patients1.

Novartis and Prostate Cancer
With more 1.4 million new cases and 375,000 deaths in 2020 alone, prostate cancer is the most frequently diagnosed cancer in 112 countries—more than half the world13.

At Novartis, we are harnessing the innovation of our world-class scientists, strategic partnerships, and one of the industry’s most competitive pipelines to explore the potential of new, targeted therapies and precision medicine platforms to address the greatest unmet needs in prostate cancer.

Through the bold science of targeted therapies, our goal is to reduce the global disease burden, extend the lives of patients with prostate cancer, and elevate current standards of care.

About Phenotypic Precision Medicine in advanced prostate cancer
More than 80% of patients with prostate cancer highly express a phenotypic biomarker4 called prostate-specific membrane antigen (PSMA)4-8, making it a promising diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy9. This differs from ‘genotypic’ precision medicine which targets specific genetic alterations in cancer cells10.

On October 14, 2022 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its third quarter 2022 financial results on Thursday, October 27, 2022 after the financial markets close (Press release, Vertex Pharmaceuticals, OCT 14, 2022, View Source [SID1234622029]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (877) 270-2148 (U.S.) or +1(412) 902-6510 (International) and reference the "Vertex Pharmaceuticals Third Quarter 2022 Earnings Call".

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.