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.

On October 14, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) (Press release, BeiGene, OCT 14, 2022, View Source [SID1234622028]).

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"BRUKINSA was designed to overcome limitations in efficacy and safety of first-generation Bruton’s Tyrosine Kinase inhibitors (BTKi). As a result, BRUKINSA became the only BTKi to demonstrate superiority versus ibrutinib in the largest head-to-head BTKi study in relapsed/refractory (R/R) CLL, in addition to demonstrating superior Progression-Free Survival (PFS) against bendamustine plus rituximab (BR) in treatment-naïve (TN) patients regardless of age, co-morbidities, mutation, or risk status," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "This recommendation demonstrates the focus and urgency with which we are delivering on our mission to accelerate development and broaden access to innovative medicines around the globe."

The CHMP recommendation is based on two global head-to-head Phase 3 clinical trials in which BRUKINSA demonstrated superior efficacy: ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in patients with R/R CLL and SEQUOIA (NCT03336333) comparing BRUKINSA to BR in patients with TN CLL. These two studies enrolled patients from a total of 17 countries, including the United States, China, Australia, New Zealand, and multiple countries in Europe.

Prof. Clemens Wendtner, Head of Hematology and Oncology at Munich Clinic, an academic teaching hospital of the University of Munich, Germany, commented, "BTK inhibitors have proven to be highly effective oral treatments for CLL; however, the burden of adverse events and discontinuations have a negative impact on patients’ prognosis. The findings from two large head-to-head Phase 3 trials of BRUKINSA in CLL demonstrated efficacy across lines of therapy in addition to consistently low rates of atrial fibrillation/flutter and discontinuation across trials. These clinical trial data suggest BRUKINSA has the potential to become a practice-changing treatment option for CLL."

"We are proud of the rapid progress we have made over the past year bringing BRUKINSA to the blood cancer community in Europe," noted Gerwin Winter, Senior Vice President, Head of Europe at BeiGene. "With this recommendation, we are looking forward to the opportunity to provide this important medicine to more people with hematologic malignancies in the European Union."

Following the CHMP positive opinion, the European Commission will consider BeiGene’s Marketing Application, with a final decision expected within 67 days of receipt of the CHMP opinion. The decision will be applicable to all 27 member states of the European Union (EU), plus Iceland and Norway. BRUKINSA is currently approved in the EU for the treatment of adult patients with WM who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemo-immunotherapy. Last month, CHMP issued a positive opinion recommending approval of BRUKINSA for the treatment of adult patients with MZL who have received at least one prior anti-CD20-based therapy.

In Europe, BeiGene has now obtained reimbursement for BRUKINSA for the treatment of WM in Austria, Belgium, Denmark, England and Wales, Germany, Ireland, Italy, Spain, and Switzerland, while additional EU countries are currently going through the reimbursement process.

About Chronic Lymphocytic Leukemia (CLL)

A slow-growing, life-threatening and incurable cancer of adults, CLL is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.i,ii,iii CLL is one of the most common types of leukemia, accounting for about one-quarter of new cases of leukemia.iv In Europe, the estimated incidence is 4.92/100,000 persons per year.v,vi

About BRUKINSA

BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,500 subjects in 35 trials across 28 markets. To date, BRUKINSA has received approvals covering more than 55 countries and regions, including the United States, China, the EU, Switzerland, Great Britain, Canada, Australia, and additional international markets.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology, and solid tumor targeted therapies, and immuno-oncology are key focus areas for the Company, with both monotherapies and combination therapies prioritized in our research and development. BeiGene currently has three licensed medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Switzerland, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis oncology products across designated regions of China.