On May 17, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that it has received clearance from the FDA for its investigational new drug application (IND) for Abivertinib (Fujovee) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castrate resistant prostate cancer (mCRPC) at multiple centers in the United States (Press release, Sorrento Therapeutics, MAY 17, 2022, View Source [SID1234614735]). The MAVERICK study will be conducted in a partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with both abiraterone-naïve and abiraterone-progressing mCRPC. The MAVERICK trial will be conducted as an open-label study of Abivertinib with abiraterone in up to 100 participants harboring the adrenal-permissive HSD3β1 allele (heterozygous or homozygous). The primary objective of the study is to evaluate the efficacy of Abivertinib with abiraterone via an assessment of 6-month radiographic progression-free survival (rPFS) and the primary endpoint is the 6-month rPFS defined as a percent of subjects alive and without progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases. Participants will remain on treatment until radiographic progression, unacceptable toxicity, intercurrent illness or other reasons (such as subject withdrawal).

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Extragonadal androgen production requires the activity of 3β-hydroxysteroid dehydrogenase isoenzyme-1 (3β-HSD1) encoded by the HSD3β1 allele and an identified single nucleotide polymorphism (SNP) can create an adrenal-permissive phenotype that allows for more rapid development of mCRPC resulting in earlier castration resistance and shortened overall survival. Increased BTK expression has been observed in various solid tumors, including prostate cancer, and it is believed that the interplay between BTK inhibition and 3βHSD is responsible. BTK inhibition has been shown to inhibit androgen production, particularly from extragonadal precursor steroids, in preclinical models. In addition to selectively targeting both mutant forms of EGFR (T790M and exon 19 and 21 mutations), Abivertinib irreversibly binds to the BTK receptor, preventing phosphorylation of the receptor. Abivertinib is an oral capsule taken twice daily and has been well tolerated across multiple cancer types in doses up to 300 mg twice daily.

The global market for CRPC for 2021 was $2.7 billion, with the U.S. accounting for 67% ($1.83 billion), and a CAGR of 4.15%, projected to reach $4.56 billion, with the U.S. projected to account for 68% ($3.08 billion) by 2031(1).

On May 17, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Intermountain Healthcare reported that Galleri, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, will be offered as a complement to existing single cancer screenings to help advance the delivery of cancer care through early detection (Press release, Grail, MAY 17, 2022, View Source [SID1234614769]). Starting this month, Intermountain will offer the Galleri test to eligible health system patients at elevated risk for cancer, such as adults over 50 years old or with additional risk factors. In addition, the test will be available to eligible employees and their families who are enrolled in a company-sponsored health plan.

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"When it comes to cancer, we promote proactive measures through preventive screening wherever possible because it leads to better outcomes," said Dr. Naresh Agarwal, associate chief medical officer for primary care at Intermountain Healthcare. "The continuing partnership with GRAIL provides us with additional resources to detect cancer in its early, more treatable stages, directly aligning with our commitment to help people live the healthiest lives possible."

Early detection is known to improve cancer outcomes, yet, today, most cancer is detected too late because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers. The Galleri test is the first-of-its-kind multi-cancer early detection blood test available. Using advanced genomics and machine learning, in a clinical study, the Galleri test was able to detect signals across more than 50 types of cancer, more than 45 of which lack recommended screening tests, with a low false positive rate of less than 1%. The test also can determine where in the body the cancer signal comes from with high accuracy.

Intermountain, the largest private employer in Utah, is a not-for-profit health system with 33 hospitals and more than 3,800 physicians. The system serves residents with hospitals and clinics in seven states and additional operations across the western United States.

"We are pleased to be expanding our partnership with Intermountain, a recognized leader in healthcare innovation, to expand its cancer screening capabilities with MCED," said Josh Ofman, MD, MSHS, president and chief medical officer at GRAIL. "Intermountain is a partner in the interventional PATHFINDER study evaluating the implementation and performance of the Galleri test in a clinical care setting and we’re grateful for their ongoing commitment to continuing to build the body of clinical evidence for the Galleri test. We applaud Intermountain’s forward-thinking approach to patient care so that, together, we can make progress against this devastating disease."

Initial results from PATHFINDER were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), demonstrating that the performance of the Galleri test was consistent with findings from previous observational studies and underscoring the potential real-world ability of the Galleri test to find deadly cancers earlier. Final results from PATHFINDER will be presented at a medical meeting later this year.

About Intermountain Healthcare

Based in Utah with locations in seven states and additional operations across the western U.S., Intermountain Healthcare is a nonprofit system of 33 hospitals, 385 clinics, medical groups with some 3,800 employed physicians and advanced practice providers, a health plans division called SelectHealth with more than 1 million members, and other health services. Helping people live the healthiest lives possible, Intermountain is committed to improving community health and is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes at sustainable costs.

On May 17, 2022 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.66 per share, payable on July 20, 2022 to shareholders of record of Quest Diagnostics common stock on July 6, 2022 (Press release, Quest Diagnostics, MAY 17, 2022, View Source [SID1234614784]).

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On May 17, 2022 Alloy reported that has more than 130 partners in the drug discovery ecosystem across academic, biotech, and large biopharma teams (Press release, Alloy Therapeutics, MAY 17, 2022, View Source [SID1234615175]). Early in our history, we connected with Dren Bio, Inc., an emerging biopharmaceutical company headquartered in Northern California that specializes in the discovery of therapeutic antibodies engineered to selectively deplete pathologic cells and other disease-causing agents. Dren Bio’s pipeline encompasses two distinct drug discovery programs. Their initial product candidates are currently in development for the treatment of a variety of oncology and autoimmune diseases.

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At the time we were introduced to the founders of Dren Bio, they were in the process of raising their first round of financing and were looking for an antibody discovery partner that was both affordable and agile. After considering multiple alternative solutions, the Dren Bio team ultimately selected Alloy for what they perceived as an accessible, transparent business model, notably one that did not include undue royalties for products that they discovered under our ATX-Gx license. After initially licensing the ATX-Gx mouse platform for use at one of our certified third-party service providers’ facilities, the team at Dren Bio eventually transitioned the work directly to Alloy, becoming one of the first customers for our Antibody Discovery Services offering that we launched in early 2020. Through close collaboration, our Alloy Discovery Services team was able to generate an antibody candidate that required no further optimization following initial discovery and characterization. From there, we made sure to remain responsive, offering materials and guidance to continue supporting the Dren Bio team’s internal efforts after shipment. Like all of our collaborations, we tried to treat the program like it was our own. Our CEO was never more than a text message away from Dren’s CEO if there were any questions.

"Alloy Discovery Services acted as a trusted partner and extension of our team, collaborating with us to optimize an antibody that has now become the lead product candidate for our Enhanced ADCC Program," said Nenad Tomasevic, PhD, Dren Bio ‘s Founder and CEO.
Dren Bio has had an incredible run, assembling a highly experienced executive leadership team, securing an impressive $1 billion partnership with Pfizer using its Targeted Myeloid Engager and Phagocytosis Platform, and most recently this year clearing its first clinical IND application with the FDA. Alloy’s relationship with Dren Bio is a shining example of our commitment to providing robust antibody discovery services to companies possessing novel insights into disease biology and that are passionate about developing therapeutic antibodies against today’s most exciting targets.

If you are an early stage biotech looking to explore an ATX-Gx license or run a full discovery campaign with our services group, you can connect with our business development team here to learn more.

On May 17, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the first patient has been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib (Press release, Calliditas Therapeutics, MAY 17, 2022, View Source [SID1234614701]).

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The trial is a randomized, placebo-controlled, double-blind, proof-of-concept Phase 2 study. It will investigate the effect of setanaxib 800 mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks (the standard treatment regimen for this immunotherapy), in approximately 50 patients with moderate or high CAF-density tumours. A tumour biopsy will be taken prior to randomization and then again after at least 9 weeks of treatment. Treatment will continue until unacceptable toxicity or progression, as is typical for oncology trials.

"Today marks an important milestone for Calliditas, with the enrolment of the first patient into our proof-of-concept study in SCCHN. We believe that a successful translation into the clinic of the promising pre-clinical observations of co-administration of setanaxib and check point inhibitors, could result in important new treatment approaches for patients with CAF rich solid tumors, and we look forward to working with our clinical trial sites, investigators and site staff to successfully execute the study," said CMO Richard Philipson.

Interim biomarker analysis is targeted for Q4 2022, and the study is expected to read out final data (including impact on tumour size) in 2023. Further details of this study can be found at www.clinicaltrials.gov, with the reference NCT05323656.