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 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported that it will be hosting a conference call and webcast to discuss updated data from its lead clinical program in KRAS-mutated metastatic colorectal cancer on Tuesday, January 18, 2022, at 5:00 PM ET (Press release, Cardiff Oncology, JAN 10, 2022, https://www.prnewswire.com/news-releases/cardiff-oncology-to-host-conference-call-and-webcast-to-discuss-updated-data-from-lead-clinical-program-in-kras-mutated-metastatic-colorectal-cancer-being-presented-at-the-2022-american-society-of-clinical-oncology-gastrointestina-301456944.html [SID1234598551]).

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The conference call and webcast will include data that will be featured in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI). ASCO (Free ASCO Whitepaper)-GI is taking place January 20-22, 2022, both virtually and in-person at the Moscone West Building in San Francisco, California.

On January 10, 2022 LUMICKS, a next generation life science tools provider, reported that two major centers of excellence in cancer immunology have adopted LUMICKS’ z-Movi Cell Avidity Analyzer instrument (Press release, LUMICKS, JAN 10, 2022, View Source;utm_medium=rss&utm_campaign=z-movi-cell-avidity-analyzer-fred-hutch-oxford-university [SID1234598450]).

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The first placement is at Fred Hutchinson Cancer Research Center ("Fred Hutch") in Seattle, Washington, USA, a leading research institute dedicated to the eradication of cancer. The instrument is housed at the Immune Monitoring Core Facility and serves multiple immuno-oncology and cell therapy research groups from the Center to accelerate immunotherapy development for cancer treatments.

The second z-Movi is placed at the University of Oxford, in Oxford, UK, in the lab of Prof. Tim Elliott, a world leader in the field of antigen presentation and T cell biology. The teams of Prof. Elliott and Prof. Persephone Borrow are using the instrument to investigate a broad range of T cell–target interactions including the potency and longevity of T cells in solid tumors.

"The z-Movi Cell Avidity Analyzer provides an excellent platform for quantitating the avidity of interactions occurring between T cells and cognate antigen-presenting target cells during the induction and effector phases of an immune response." said Prof. Elliott and Prof. Borrow. "This enables dissection of attributes of both T cells and their interaction partners that influence the response to viral infections and cancer."

"We are delighted that our z-Movi instrument will be adopted into the workflows at Fred Hutch and University of Oxford, two institutions devoted to the development of promising immunotherapeutic strategies," said LUMICKS CSO Dr. Andrea Candelli. "At LUMICKS, we are focused on developing new technologies that help cancer researchers discover new therapies. We believe that cell avidity measurements provide unique insights into the mechanism of action of cell therapy products, ultimately leading to higher success rates for novel cancer immunotherapies."

On January 10, 2021 Cerus Corporation (Nasdaq: CERS) reported preliminary product revenue for the fourth quarter and full-year 2021, provided product revenue guidance for 2022 and provided an update on its INTERCEPT Blood System for Cryoprecipitation offering, which is used to produce INTERCEPT Fibrinogen Complex (Press release, Cerus, JAN 10, 2022, View Source [SID1234598469]).

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Cerus’ unaudited preliminary product revenue for the fourth quarter of 2021 totaled $39.9 million, representing an increase of 41% over the $28.2 million recognized during the fourth quarter of 2020. The Company expects its unaudited preliminary full-year 2021 product revenue to be $130.9 million, exceeding the Company’s most recent 2021 product revenue guidance range of $127-$129 million. The preliminary product revenue results have not been audited and are subject to change.

"Cerus’ commercial momentum during the first three quarters of 2021 carried on during the fourth quarter, continuing the Company’s growth trajectory. Strong uptake of INTERCEPT platelets in the fourth quarter of 2021 was again led by U.S. blood center adoption and growing hospital demand. I am pleased to report yet another record quarter and the corresponding positive impact on patient access to INTERCEPT-treated blood components," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "With the INTERCEPT Blood System for platelets being adopted so rapidly in the U.S. market, I am proud to say that on a run-rate basis, more than half of platelets in the U.S. are now treated with our technology, helping us realize our mission of making pathogen inactivation the standard of care globally. In this age of pandemic preparedness and awareness, we believe 2022 will see a continuation of our positive trajectory and result in another record year for product revenues for the Company."

The Company expects full-year 2022 product revenue will be in the range of $157-$164 million, representing strong growth of approximately 20%-25% compared to preliminary unaudited 2021 full-year product revenue of $130.9 million.

"In addition to the commercial momentum that we expect will continue in 2022, we have several exciting initiatives on tap that we believe will extend our leadership position in transfusion medicine globally," continued Greenman. "We remain committed to balancing these investments in these initiatives in the future with the financial discipline necessary to potentially achieve cash flow breakeven."

Finally, Cerus is beginning the nationwide launch early for INTERCEPT Fibrinogen Complex after one of the Company’s blood center production partners, Gulf Coast Regional Blood Center, received its Biological License Application (BLA) approval from U.S. Food and Drug Administration (FDA).

"As the launch of INTERCEPT Fibrinogen Complex continues in 2022, I am pleased to announce that we have made strides to expand access to this new product across the U.S.," added Greenman. "The receipt of the first BLA approval was sooner than we expected and we are excited about IFC’s potential to drive growth for us over the next several years."

Cerus will provide complete fourth quarter and full-year 2021 financial results and host a call to discuss both 2021 results and 2022 expectations in late February.

On January 10, 2022 Moderna Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Carisma Therapeutics Inc., a biopharmaceutical pioneer in engineered macrophage-based therapeutics, reported that the two companies have entered into a strategic collaboration agreement to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer (Press release, Moderna Therapeutics, JAN 10, 2022, View Source [SID1234598486]).

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"We are excited to begin this collaboration with Carisma to further expand our oncology pipeline with a differentiated in vivo cell-therapy approach," said Stephen Hoge, President of Moderna. "This exemplifies our strategy to partner with companies with deep biological expertise while leveraging Moderna’s core mRNA and LNP capabilities to further expand the reach of Moderna’s technology."

"Moderna’s deep expertise in mRNA and LNP technologies opens up a potentially game-changing opportunity for engineered macrophages," said Steven Kelly, President and Chief Executive Officer of Carisma. "In vivo delivery directly to monocytes and macrophages enables an off-the-shelf therapeutic approach that uses the patients’ own cells to provide a truly personalized treatment. By combining Carisma’s expertise in engineered macrophage biology and Moderna’s pioneering in vivo mRNA delivery technologies, we are excited about the potential of this novel therapeutic approach for treating cancer. We are thrilled to be working with Moderna."

About the Collaboration

Under the terms of the agreement, Carisma will receive a $45 million up-front cash payment and an investment by Moderna in the form of a $35 million convertible note. Carisma will receive research funding and is eligible to receive development, regulatory, and commercial milestone payments, plus royalties on net sales of any products that are commercialized under the agreement. Carisma will be responsible for the discovery and optimization of development candidates while Moderna will lead the clinical development and commercialization of therapeutics resulting from the agreement. Moderna has the option to nominate up to twelve targets for development and commercialization.