Cytel appoints first CMO, propelling expansion of analytics and innovation available to clinicians in drug development

On March 22, 2022 Cytel Inc. reported that it has appointed Albert Kim, MD, PhD, as its first Chief Medical Officer (CMO), driving expansion of the advanced analytics capabilities available to clinicians looking to streamline therapeutic development. Dr Kim brings more than 21 years of interdisciplinary experience in medicine and drug development across a range of therapeutic modalities, and has held senior leadership roles at both Novartis and Pfizer (Press release, Lifescience Newswire, MAR 22, 2022, View Source [SID1234610592]). The appointment will fortify Cytel’s strategic consulting capabilities to support efficient navigation of uncertainties in product development.

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The appointment will also help direct the evolution of the Solara clinical trial strategy platform towards greater insight and collaboration across the full ecosystem of clinical development stakeholders. Solara facilitates clinical trial strategy by applying high throughput screening approaches to study design selection. Leveraging massive, cloud based computational power enables deeper exploration of a larger opportunity space that enables clinicians, statisticians and other stakeholders to identify optimal design options. To accelerate the delivery of new therapies to patients, the ability to quickly optimize clinical trial design, extract insights from scarce information, and foresee roadblocks is crucial. For 35 years, Cytel has pioneered a unique blend of quantitative insight and powerful software tools that has made this possible for pharmaceutical companies across the globe. The hire of physician-scientist Dr Kim marks the latest step in this journey.

"Innumerable challenges can hinder clinical development success, not least the potential communications gaps between statisticians and clinicians," said Joshua Schultz, CEO of Cytel. "Empowering and connecting teams that speak different scientific languages makes navigating hurdles in clinical research dramatically more efficient. Dr Kim, with his multi-domain expertise, will be an accelerating force as Cytel expands our application of advanced analytics to the entire product development team — from patient recruitment to market access."

Dr Kim has rich expertise in cardiovascular disease, translational medicine, and drug development. After receiving degrees from Harvard and UCLA, completing residency at Brigham and Women’s Hospital, and undertaking further specialty training at Mass General Hospital and UCSF, he achieved board certification in internal medicine, cardiology, and clinical cardiac electrophysiology.

Most recently, he was Vice President, Clinical Research Head for Pfizer’s Internal Medicine Research Unit. His roles at Pfizer and at Novartis saw him lead early and late phase programs for common and rare diseases. Dr Kim has contributed to development efforts for several candidate medicines utilizing different therapeutic modalities and has authored a body of work including numerous publications in leading medical journals. He was also a medical reviewer in the Division of Cardiac Devices at the FDA.

"The pace of development in today’s biotherapeutics landscape is incredibly demanding and involves many uncertainties and risks. Making difficult decisions with limited information is par for the course," said Dr Kim, CMO of Cytel. "Cytel’s quantitative thought leadership and renowned tools have enabled sponsors to better analyze and understand their data and make confident decisions quickly. I am delighted to join such a talented team and add my perspective to help an even broader audience benefit from Cytel’s capabilities and platforms such as Solara."

Launched in late 2020, Solara is a first-in-class digital development platform that harnesses the power of simulation-driven clinical trial design for multiple stakeholders. Using massive cloud computation, the platform can test thousands of trial designs against varied business scenarios in minutes rather than months, combining this with visualizations for shared context across technical and strategic considerations (e.g., statistical, clinical, and commercial specialists). In addition to its scenario visualization capabilities, Solara use cases have demonstrated numerous trial design improvements including markedly shorter trial durations and ~10-20% reductions in cost.

To learn about the powerful capabilities of Solara or to discover more about Cytel’s renowned consulting services, please visit www.cytel.com/software/solara.

Lantern Pharma Announces Extension of Existing Share Repurchase Program

On March 22, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that its Board of Directors has authorized an extension through July 31, 2022 of Lantern’s existing share repurchase program to acquire up to $7 million of the Company’s common stock (Press release, Lantern Pharma, MAR 22, 2022, View Source [SID1234610591]).

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Since the initiation of the share repurchase program in November 2021, a total of 475,157 shares of common stock have been repurchased pursuant to Lantern’s share repurchase program. Total expenditures for share repurchases from the time of initiation of the share repurchase program through March 21, 2022 were approximately $3.4 million, including purchase fees. Lantern is authorized to purchase up to an additional $3.6 million of the Company’s common stock pursuant to the repurchase program. As of December 31, 2021, Lantern had cash, cash equivalents and marketable securities of approximately $70.7 million.

The Company may purchase common stock on the open market, through privately negotiated transactions, or otherwise, in compliance with the rules of the United States Securities and Exchange Commission and other applicable legal requirements. The timing, amount of shares repurchased and prices paid for the stock under the repurchase program will depend on market conditions as well as corporate and regulatory limitations, including blackout period restrictions. The repurchase program does not obligate the Company to acquire any particular amount of shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion.

Kintara Therapeutics to Present at the Maxim Group 2022 Virtual Growth Conference

On March 22, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announces that President and CEO Robert Hoffman will participate at the Maxim Group 2022 Virtual Growth Conference, which is being held on March 28-30, 2022 (Press release, Kintara Therapeutics, MAR 22, 2022, View Source [SID1234610588]).

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Mr. Hoffman will present a corporate overview which will become available on Monday, March 28, 2022 at 9:00 a.m. ET.

Investors can view the presentation by registering for the conference here and also request a one-on-one meeting with management to be arranged following the conclusion of the conference.

Infinity Pharmaceuticals Announces the Date of Its Fourth Quarter and Full Year 2021 Financial Results Conference Call and Webcast

On March 22, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported that it will host a conference call on Tuesday, March 29th, 2022 at 4:30 p.m. ET to report its financial results for the fourth quarter and full year 2021 (Press release, Infinity Pharmaceuticals, MAR 22, 2022, View Source [SID1234610586]).

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Conference call & Webcast Details

A live webcast of the conference call can be accessed in the Investors/ Media section of Infinity’s website at www.infi.com and will be available on Infinity’s website for 30 days following the event.

Affini-T Therapeutics Completes $175 Million Financing Co-Led by Vida Ventures and Leaps by Bayer to Advance Groundbreaking T Cell Therapies for Solid Tumor Patients with Oncogenic Driver Mutations

On March 22, 2022 Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported the completion of an oversubscribed $175 million financing co-led by Vida Ventures and Leaps by Bayer, the impact investment unit of Bayer (Press release, Affini-T Therapeutics, MAR 22, 2022, View Source [SID1234610582]). Additional investors participating in the round include Humboldt Fund, The Parker Institute for Cancer Immunotherapy, Catalio Capital Management, Agent Capital, Alexandria Venture Investments, Erasca Ventures, Fred Hutchinson Cancer Research Center and other leading blue chip life science investors. With proceeds from this financing, the company will operationalize its platform discovery engine and seek to drive multiple oncogene driver programs into the clinic while pursuing complementary technology licenses to bolster its cell therapy platform. To enable and accelerate growth, the company has established a bi-coastal U.S. presence with research labs in Seattle, Washington and headquarters and manufacturing infrastructure in Boston, Massachusetts.

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Affini-T is committed to developing potentially life-changing medicines for patients with intractable solid tumor cancers, who represent a critical unmet need as current treatment options lack durability and efficacy. Its proprietary platform has the potential to deliver transformative therapies for patients with mutant variants of KRAS, the most prevalent oncogenic driver mutation in solid tumors. Treatment options are needed for these patients as KRAS mutations account for up to 30% of all cancers and are particularly frequent in cancers with high mortality rates including lung cancer, colorectal cancer and pancreatic cancer.

"By targeting oncogenic drivers like mutated KRAS, we strike at the core genetic mutations that enable tumors to grow and spread," said Jak Knowles, M.D., Co-Founder, President and Chief Executive Officer, Affini-T Therapeutics. "Our differentiated platform combines highly active TCRs with unique synthetic biology, allowing us to pioneer novel therapeutic approaches intended to eradicate solid tumors. With proven management, an unparalleled founding team of scientific innovators and leaders in immunology and cellular engineering, we look forward to bringing life-changing medicines to patients in need."

Differentiated Science to Cure Solid Tumor Patients

Affini-T’s proprietary platform is designed to select and engineer the right immune cells to orchestrate a durable and coordinated immune response. Its suite of novel synthetic biology switches can rewrite the rules of the tumor microenvironment, enhancing T cell function to increase durability, build persistent responses and augment tumor infiltration.

"Cell therapies have revolutionized the treatment of cancer, but challenges remain in making this powerful technology effective for a greater variety of cancers," said scientific co-founder Dr. Phil Greenberg, who leads Fred Hutch’s Program in Immunology and holds the Rona Jaffe Foundation Endowed Chair at Fred Hutch. "By collaborating with industry partners, we have the opportunity to move our promising discoveries in the lab closer to benefiting the lives of patients."

"We are delighted to welcome Affini-T as one of the first investments in our Vida III portfolio, representing cutting-edge innovation in cell therapy for solid tumors, which remains a holy grail," said Arjun Goyal, M.D., M.Phil., Co-Founder and Managing Director, Vida Ventures and co-founder of Affini-T. "Their validated discovery workflow has the potential to bring cures to the large, unmet KRAS patient population. We look forward to leveraging our deep cell therapy expertise to support Affini-T’s bold vision to power T cells to cure solid tumors for patients globally."

"Curing and preventing cancer is one of the core focus areas of Leaps by Bayer, as this disease still represents one of today’s most pressing health concerns," said Juergen Eckhardt, M.D., head of Leaps by Bayer. "This is especially true for some difficult-to-treat solid tumors such as pancreatic, lung or colorectal cancer. Addressing KRAS represents a unique opportunity in the development of therapies that promise to address previously untreatable and incurable cancers and we are very excited about the potential of Affini-T’s technology platform."

Industry-Leading Management Team and Scientific Advisors

Affini-T is led by a management team of biotech and pharmaceutical industry leaders with demonstrated track records of success. At its helm is Dr. Knowles, an industry veteran and entrepreneur who most notably was Co-Founder and Chief Executive Officer at Exonics Therapeutics, Co-Founder and Chief Business Officer at Metagenomi and Vice President, Venture Investments at Leaps by Bayer. Joining Dr. Knowles are Loïc Vincent, Ph.D., Chief Scientific Officer, Kim Nguyen, Ph.D., Chief Technical Officer and Kathy Yi, MBA, Chief Operating Officer.

Affini-T has also established a world-class scientific advisory board comprised of its scientific co-founders from Fred Hutch and key innovators in immunology, tumor microenvironment biology and cellular engineering including:

Jim Allison, Ph.D., Nobel Laureate, MD Anderson Cancer Center;
Pam Sharma, M.D., Ph.D., MD Anderson Cancer Center;
Rafi Ahmed, Ph.D., Emory University;
David Kranz, Ph.D., University of Illinois; and
Susan Kaech, Ph.D., Salk Institute.