On January 10, 2022 Pyramid Biosciences, Inc., a clinical-stage biotechnology company developing a portfolio of precision therapies targeting a wide range of diseases, reported the appointment of Brian Lestini, MD, PhD as Chief Executive Officer (Press release, Pyramid Biosciences, JAN 10, 2022, View Source [SID1234598535]). Dr. Lestini joined Pyramid Biosciences in March 2021 as the Chief Medical Officer, overseeing the advancement and expansion of the company’s clinical pipeline of novel targeted medicines. Pyramid Biosciences’ lead program, PBI-200, currently in Phase 1 clinical trials, is an orally-active, CNS penetrant TRK inhibitor targeting a variety of genetically defined cancers, including primary and metastatic brain cancers.

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Dr. Lestini will succeed co-founder and current CEO Kollol Pal, PhD, MBA. Dr. Pal will continue to serve as the Company’s Chief Scientific Officer, where he will lead all pre-clinical development activities. "I would like to thank Dr. Pal for his pioneering leadership," said Dr. Lestini. "Pyramid Biosciences has grown immensely over the past seven years under Dr. Pal’s stewardship, and I’m excited to help the company take the next step in our growth and achieve Dr. Pal’s vision of bringing Pyramid’s precision oncology therapies to underserved patients throughout the world."

"Dr. Lestini’s successful track record of bringing drugs through development to global approval will be invaluable to Pyramid Bio as we move forward in our clinical development process," said Dr. Pal. "I’m looking forward to continuing to grow our Company’s pipeline by focusing my efforts on developing new, innovative therapeutic targets for precision oncology."

An experienced leader in early- and late-stage oncology clinical development, Dr. Lestini oversaw development and commercialization strategies for checkpoint inhibitor therapies including OPDIVO (nivolumab) and relatlimab (anti-LAG3 checkpoint inhibitor), a novel immune-oncology agent applied to a wide range of cancers, at Bristol-Myers Squibb (NYSE: BMY). Dr. Lestini also served as the Head of Global Medical Affairs at Bristol-Myers Squibb for three hematology products: OPDIVO (nivolumab), SPRYCEL (dasatinib), and EMPLICITI (elotuzumab). Prior to joining Bristol-Myers Squibb, Dr. Lestini led early-stage clinical development programs at Hoffmann-La Roche (OTCMKTS: RHHBY).

Dr. Lestini is a board-certified pediatric hematologist-oncologist. He received his medical degree (MD) and Doctor of Philosophy (PhD) degree from Case Western Reserve University and completed his fellowship training at the Children’s Hospital of Philadelphia.

On January 10, 2022 Arsenal Biosciences, Inc., a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, reported that Bristol Myers Squibb (NYSE:BMY) has exercised an option to initiate a new program, expanding its strategic collaboration with ArsenalBio to discover and advance next-generation T cell therapies for the treatment of solid tumors (Press release, Arsenal Bio, JAN 10, 2022, View Source [SID1234598534]).

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"The decision by Bristol Myers Squibb to expand our collaboration and add another program is a testament to the strength of our partnership and the promise of ArsenalBio’s proprietary technology," said Ken Drazan, M.D., Co-Founder, Chairman and Chief Executive Officer, ArsenalBio. "We look forward to continuing this fruitful relationship and working together to advance next-generation T cell therapies so we can ultimately achieve our mission – help more patients defeat cancer."

Under the collaboration, ArsenalBio is discovering and building preclinical candidates against multiple targets, and Bristol Myers Squibb has the option to obtain an exclusive worldwide license to develop and commercialize preclinical candidates. Through the terms of the agreement, Bristol Myers Squibb has exercised an Expansion Option to initiate a new program, triggering an additional undisclosed financial milestone payment to ArsenalBio. Following exercise of a subsequent License Option, Bristol Myers Squibb is solely responsible for developing and commercializing the licensed candidates. ArsenalBio will remain eligible to receive additional payments associated with collaboration expansion, regulatory and sales milestones, as well as potential royalties on sales of approved products.

"We are pleased to continue our partnership with ArsenalBio as we work to advance the next generation of cancer therapies leveraging their unique therapeutic platform," said Teri Foy, Senior Vice President, Research and Early Development Immuno-Oncology and Cell Therapy, Bristol Myers Squibb. "Unlocking the promise of cell therapy with application to solid tumors is a key aspect of our R&D strategy at BMS as we strive to help more patients across a broad range of cancers."

Through the multi-year collaboration, ArsenalBio continues to deploy its full stack of synthetic biology compositions to build programmable cell therapy product candidates based on its PrimeR logic gates, CARchitecture chimeric antigen receptor libraries, multi-target gene expression controls, and CITE mediated nonviral manufacturing. Combined, these integrated circuit-modified T cells offer the promise of significantly improved outcomes for patients.

On January 10, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported its participation in the 40th Annual J.P. Morgan Healthcare Conference (Press release, Affini-T Therapeutics, JAN 10, 2022, View Source [SID1234598533]). Jak Knowles, M.D., Co-Founder, President and Chief Executive Officer, will present an overview of the company at 2:00 pm Eastern Time on Wednesday, January 12, 2022.

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On January 10, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported an update to the corporate presentation that its Chief Executive Officer and President, Alan H. Auerbach, presented at the virtual H.C. Wainwright BioConnect Conference, which began at 7:00 a.m. EST on Monday, January 10, 2022 (Press release, Puma Biotechnology, JAN 10, 2022, View Source [SID1234598532]). The updated presentation includes, among other things, the Company’s preliminary estimate that it sold approximately 3,454 bottles of NERLYNX in the United States in the fourth quarter of 2021. This preliminary estimate is subject to completion of the Company’s customary closing and review procedures and could change based on that process. The updated slides will be available on the Investors section of Puma’s website at View Source

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On January 10, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported certain unaudited preliminary performance results for the fourth quarter and full-year 2021 (Press release, Castle Biosciences, JAN 10, 2022, View Source [SID1234598531]).

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"At Castle, we are committed to providing innovative, clinically actionable tests to improve patient outcomes in diseases with high unmet need," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We accelerated investments in our growth initiatives throughout 2021 and saw the positive impact of these decisions. Despite diagnoses of cutaneous melanoma being down by approximately 11% in 2021 compared to 2019 pre-COVID levels, we delivered 25% more DecisionDx-Melanoma reports in 2021 than 2020.

"We believe the foundation of our success rests on evidence development, which supports clinician adoption and reimbursement of our commercial tests, as well as advancement of our pipeline. In 2021, we made excellent progress with our research and development plans, including the publication of 15 peer-reviewed articles. Since Castle began operations, we have analyzed data from more than 15,000 patients across our skin cancer studies and anticipate analyzing and presenting results from an additional 20,000 patients in 2022 in cutaneous melanoma alone."

Preliminary, Unaudited Fourth Quarter Ended December 31, 2021, Highlights

Delivered 8,242 total gene expression profile test reports in the fourth quarter of 2021, compared to 5,157 in the same period of 2020:
DecisionDx-Melanoma test reports delivered in the quarter were 5,635, compared to 4,246 in the fourth quarter of 2020, an increase of 33%. While third-party data for December is still finalizing, data through November suggests that diagnoses of melanoma were down 9% in the fourth quarter of 2021 compared to historical pre-COVID fourth quarter 2019 levels.
DecisionDx-SCC test reports delivered in the quarter were 1,265, compared to 428 in the fourth quarter of 2020, an increase of 196%.
myPath Melanoma and DecisionDx DiffDx-Melanoma (Castle’s comprehensive diagnostic offering) aggregate test reports delivered in the fourth quarter of 2021 were 904, compared to 73 in the fourth quarter of 2020 (Nov. 2–Dec. 31, 2020).
DecisionDx-UM test reports delivered in the quarter were 438, compared to 410 in the fourth quarter of 2020, an increase of 7%.
Preliminary, Unaudited Year- Ended December 31, 2021, Highlights

The Company expects to meet or exceed the top end of previously guided range of $89-93 million for full-year 2021 revenue.
Total gene expression profile test reports delivered in 2021 were 28,118, compared to 18,185 in the same period of 2020, an increase of 55%:
DecisionDx-Melanoma test reports delivered in 2021 were 20,328, compared to 16,232 in the same period of 2020, an increase of 25%. While third-party data for December is still finalizing, data through November suggests that diagnoses of melanoma were down 11% in 2021 compared to historical pre-COVID 2019 levels.
DecisionDx-SCC test reports delivered in 2021 were 3,510 compared to 485 in 2020 (Aug. 31-Dec. 31, 2020).
myPath Melanoma and DecisionDx DiffDx-Melanoma aggregate test reports delivered in 2021 were 2,662, compared to 73 in 2020 (Nov. 2–Dec. 31, 2020).
DecisionDx-UM test reports delivered in 2021 were 1,618, compared to 1,395 in the same period of 2020, an increase of 16%.
Year-end 2021 cash and cash equivalents are expected to be approximately $330 million.
Castle Biosciences has not completed the preparation of its financial statements for the fourth quarter or full-year 2021. The preliminary, unaudited information presented in this press release for the quarter and year-ended December 31, 2021, is based on management’s initial review of the information presented and is subject to adjustment based on the completion of the Company’s end-of-period reporting processes and related activities, including the audit by the Company’s independent registered public accounting firm of the Company’s financial statements. As such, any financial information contained herein may differ materially from the information reflected in the Company’s financial statements as of and for the year-ended December 31, 2021. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of and for the quarter and year-ended December 31, 2021. Accordingly, undue reliance should not be placed on this preliminary information.