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.

Alkermes to Participate in the Stifel 2022 CNS Days

On March 22, 2022 Alkermes plc (Nasdaq: ALKS) reported that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Stifel 2022 CNS Days on Tuesday, March 29, 2022 at 8:30 a.m. ET (1:30 p.m. BST) (Press release, Alkermes, MAR 22, 2022, View Source [SID1234610654]). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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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 [SID1234610559]).

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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.

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.

4SC AG provides results for financial year 2021 and outlook for 2022

On March 22, 2022 4SC AG (4SC, FSE Prime Standard: VSC) reported the financial results for the financial year ended 31 December 2021, presenting all material reporting period developments and provides an outlook for 2022 (Press release, 4SC, MAR 22, 2022, View Source [SID1234610605]). The full report is available at 4SC’s website.

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Key highlights of 2021

The key achievements of 4SC in 2021 are summarized below:

Signing of an agreement under which Immunic settled its remaining royalty obligation for Immunic’s lead program, IMU-838, for US-$17.25 million, payable 50% in cash and 50% in shares of Immunic Inc.’s common stock
Recruitment target of 190 patients reached in the RESMAIN study evaluating resminostat in cutaneous T-cell lymphoma (CTCL) and subsequently 80% of events reached for unblinding the study.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "On the positive side we hit our recruitment target of 190 patients in RESMAIN in 2021, meaning we are now in a position to expect to unblind the study in the first half of 2023. With respect to domatinostat, although we did achieve a great deal in terms of clinical progress, unfortunately the data from this pool of clinical studies did not justify further investment into the domatinostat program and this was discontinued early in 2022. Going forward we are now focused on resminostat and in obtaining an outcome to the RESMAIN study. We already achieved 80% of the events required to unblind the study and are confident we will see an outcome to RESMAIN in early 2023."

Business outlook for 2022

The focus of 4SC is now on completion of the RESMAIN pivotal study of resminostat in cutaneous T cell lymphoma (CTCL). In 2022 4SC expects to achieve 95% of the requisite number of events to unblind the study. Top-line data on the primary endpoint is expected in the 1H, 2023. Should the study be positive then the Company will proceed with preparation of the Marketing Authorisation Application for the EU and will file orphan drug applications in both the EU and US. 4SC will also seek scientific advice on potential routes to approval in the US.

Cash balance development in full year 2021 and financial forecast

4SC’s cash balance/funds were at €29,022 thousand on 31 December 2021. The average monthly operating cash burn in 2021 was €1,009 thousand, which was within the range of between €1,000 thousand and €1,500 thousand forecast since the Q1 announcement. Excluding the cash contribution received from the transaction with Immunic signed in Q1 2021, the average monthly use of cash from operating activities was €1,618 thousand.

Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC into the second half-year of 2023.

Whilst 4SC’s funds of € 29,022 thousand at the end of 2021 are a solid cash position entering 2022, it is also clear that the funding environment for small cap biotech companies deteriorated significantly in the second half of 2021 and as such management remains cautious as to 4SC’s ability to raise additional funds through further capital measurements and to generate income with business partners.

For 2022, 4SC is expecting an increase of average monthly use of cash from operations to between €1,500 thousand and €1,800 thousand. 4SC estimates the net loss to rise compared to 2021 as its ongoing clinical studies progress or will be completed in the course of 2022.

4SC expects to continue to report annual net losses, in the short to medium term future.