On May 31, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-101 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) (Press release, TScan Therapeutics, MAY 31, 2022, View Source [SID1234615269]). The target of TSC-101 is the minor histocompatibility antigen HA-2, which is a lineage-specific antigen expressed on blood cells. TScan believes that TSC-101 is the first clinical program to target the HA-2 antigen. As previously announced, TScan’s IND for TSC-100, which targets the minor histocompatibility antigen HA-1, was cleared by the FDA in January 2022. TSC-100 and TSC-101 are designed to address different subsets of patients undergoing allogeneic HCT.

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Study start-up activities are now ongoing for all three arms of TScan’s umbrella Phase 1 clinical trial, which includes active treatment arms for TSC-100, TSC-101, as well as a control arm using current standard-of-care for HCT patients. TScan expects to enroll the first patient in the middle of the year.

"This marks TScan’s second IND clearance in our leukemia program. Our TCRs against both HA-1 and HA-2 antigens are aimed at reducing the risk of relapse following HCT, thereby enabling increased use of more tolerable conditioning regimens to allow more leukemia patients to be cured by transplantation," said David Southwell, President and Chief Executive Officer. "With the FDA clearance of TSC-101, we will now proceed with all components of our planned multi-arm Phase 1 clinical trial, with preliminary data from all three arms of the trial expected by the end of 2022."

"We look forward to fully opening the Phase 1 umbrella trial for our leukemia program," said Gavin MacBeath, Chief Scientific Officer. "The trial will include patients positive for either the HA-1 or HA-2 antigens, with remaining patients receiving standard-of-care in the control arm. Importantly, the INDs for TSC-100 and TSC-101 were based on our proprietary T-Integrate cell engineering platform, which includes our advanced non-viral vector and our in-house GMP manufacturing capabilities. We will use this same platform to develop enhanced TCR-T cell therapies for our solid tumor program, with IND filings beginning later this year."

Primary endpoints in TScan’s HCT trial include safety and dose-finding, and secondary and exploratory endpoints include relapse rate versus standard-of-care as well as quantitative biological readouts including minimal residual disease and kinetics of donor chimerism.

On May 31, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that it has appointed Marshelle Smith Warren, M.D. as Chief Medical Officer (Press release, SQZ Biotech, MAY 31, 2022, View Source [SID1234615267]). Dr. Warren will report to the CEO and lead the company’s clinical development, clinical operations, translational medicine, and regulatory affairs functions.

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"Marshelle has tremendous experience in cell-based therapeutic development and will provide complementary expertise as we seek to rapidly advance our clinical programs," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "Her proven leadership, extensive global clinical trial experience, and broad clinical development background will strengthen our ability to execute on our mission to drive patient impact across disease areas."

Dr. Warren brings over 25 years of clinical development industry experience to the company, including a particular focus on viral malignancies and T cell-directing therapeutics. Previously, she was Chief Medical Officer and Senior Vice President of R&D at Viracta Therapeutics, where she led the development of investigational therapeutics for the treatment of Epstein-Barr virus associated lymphoid malignancies. Her prior experience also includes clinical development positions at Allovir, Atara Biotherapeutics, Ionis, Gilead Sciences, Amgen, and AstraZeneca Pharmaceuticals. Dr. Warren has also recently served as a senior advisor on Phase 2 and Phase 3 clinical research programs for investigational T cell therapies targeting cancer, autoimmunity, and viral infections.

"I am very excited to be joining a dedicated team focused on developing a new generation of impactful cell therapies for diseases with significant unmet need," said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. "I look forward to supporting our clinical team and working with my fellow leaders at SQZ to realize the broad potential of our cell therapy platforms to benefit patients around the world."

During her career, Dr. Warren has made significant contributions to approved immunology products including blockbuster Enbrel (rheumatoid arthritis) and Accolate (asthma). She has led the development of successful investigational new

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drug applications for a range of therapeutic types and has overseen regulatory authority negotiations and advisory meetings.

Dr. Warren, who is board certified in internal medicine and clinical immunology, received a BS in biology with honors from Baylor University, and an MD from the University of Nebraska Medical Center College of Medicine. She performed her residency in internal medicine at St. Joseph’s Hospital in Colorado and completed a clinical immunology fellowship at the National Jewish Center for Immunology and Respiratory Medicine.

SQZ Biotechnologies’ cell therapy programs seek to generate activating or tolerizing target-specific immune responses with potential impact across many diseases. The company’s first disease targets include Human Papillomavirus positive solid tumors and celiac disease.

On May 31, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it has successfully acquired Checkmate Pharmaceuticals, Inc., deepening its commitment to immuno-oncology and adding a new modality to the company’s portfolio of potential combination-ready approaches for difficult-to-treat cancers (Press release, Regeneron, MAY 31, 2022, View Source [SID1234615266]).

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Checkmate’s lead investigational candidate, vidutolimod, is an advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9 (TLR9) agonist delivered in a virus-like particle (VLP) and has demonstrated clinical responses as a monotherapy in patients with PD-1 refractory melanoma.

"As we continue to deepen and expand our efforts in immuno-oncology, the acquisition of Checkmate adds a potentially best-in-class clinical asset, as well as a promising underlying technology platform in the VLP delivery system," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Our increasingly diverse portfolio enables strategic flexibility and creativity as we advance monotherapy and combination candidates for difficult-to-treat cancers. With Libtayo (cemiplimab) as our anti-PD-1 backbone and a differentiated scientific approach, Regeneron is well positioned to make meaningful progress for people with cancer."

The tender offer by Regeneron for shares of Checkmate expired one minute after 11:59 p.m., Eastern Time, on Friday, May 27, 2022. Broadridge Corporate Issuer Solutions, Inc., the depository and paying agent for the tender offer, advised Regeneron that as of the tender offer expiration, a total of 18,471,314 shares had been validly tendered and not validly withdrawn, representing approximately 83.8% of the outstanding shares. All of the conditions of the offer have been satisfied, and Regeneron has paid $10.50 per share (without interest) for all shares that were validly tendered, which is the same price as in the tender offer. Following its acceptance of the tendered shares, Regeneron completed its acquisition of Checkmate through a second step merger of Scandinavian Acquisition Sub, Inc. with and into Checkmate. As a result of the acquisition, Checkmate common stock have ceased to be traded on the Nasdaq Global Market.

Regeneron anticipates accounting for this transaction as an asset acquisition. Consequently, the total acquisition cost allocated to the acquired in-process research and development is expected to be expensed in the second quarter of 2022 and will be included in non-GAAP financial results. At this time, there is no change to Regeneron’s 2022 GAAP and non-GAAP financial guidance as a result of this transaction.

Wachtell, Lipton, Rosen & Katz is serving as legal advisor to Regeneron. Centerview Partners LLC served as financial advisor and Goodwin Procter LLP served as legal counsel to Checkmate.

On May 30, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAY 31, 2022, View Source [SID1234615265]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 23 May 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 13,456,381 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 25 May 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 11,716,818 B shares at an average share price of DKK 755.90 per B share equal to a transaction value of DKK 8,856,787,637.

On May 31, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported its participation at an upcoming investor conference (Press release, Nkarta, MAY 31, 2022, View Source [SID1234615264]):

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Cowen 3rd Annual Oncology Innovation Summit
June 2, 2022
11:00 a.m. ET – fireside chat

A simultaneous webcast of the event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.