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that as of the tender offer expiration, a total of 18,471,314 shares had been validly tendered and not validly withdrawn, representing approximately 83.8% of the outstanding shares.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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On May 31, 2022 M2GEN reported that continues to partner with our Oncology Research Information Exchange Network (ORIEN) members to enable breakthrough scientific research that advances patient care (Press release, M2Gen, MAY 31, 2022, View Source [SID1234615263]). ORIEN researchers are showcasing several projects at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that utilize M2GEN’s rich longitudinal clinico-genomic Avatar data, and feature collaborations with scientists across ORIEN and M2GEN. These projects highlight research discoveries across four key areas: gastrointestinal cancers, developmental therapeutics, immunotherapy, and gynecologic cancers.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Learn more about how ORIEN investigators are collaborating with fellow Network members and M2GEN to leverage the expansive clinical and molecular Avatar database, for the research being featured at ASCO (Free ASCO Whitepaper) 2022:

On Saturday, June 4, during ASCO (Free ASCO Whitepaper)’s Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary poster session:

Gudbjorg Jonsdottir, M.D., of the University of Iowa Holden Comprehensive Cancer Center will present a poster entitled "The impact of HRD in patients with pancreatic adenocarcinoma who undergo surgical resection: an updated analysis" (Abstract: 4132, Poster: 118, Full Text).
Summary: Utilizing data from 311 pancreatic cancer patients in the ORIEN Avatar database, Dr. Jonsdottir determined that patients with one of 18 genetic mutations in the homologous recombination repair (HRR) pathway, which is involved with repairing DNA, had improved survival if treated with platinum-based chemotherapy compared to those who were not.
On Sunday, June 5, during ASCO (Free ASCO Whitepaper)’s Developmental Therapeutics—Immunotherapy poster session:

Ahmad Tarhini, M.D., Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "Predictors of immunotherapeutic benefits in patients with advanced malignancies treated with immune checkpoint inhibitors utilizing "real-world" data" (Abstract: 2618, Poster: 273, Full Text)
Summary: Of 1,214 patients with 27 cancer types in the ORIEN Avatar database treated with immune checkpoint inhibitor (ICI) therapies, Dr. Tarhini found that there was a significant increase in overall survival if the ICI was given as the first treatment. Furthermore, for patients with melanoma, Dr. Tarhini identified six patterns of gene expression that correlated significantly with improved survival on ICIs.

Payman Ghasemi Saghand, Ph.D., of the H. Lee Moffitt Cancer Center & Research Institute will present a poster entitled "A deep learning approach utilizing clinical and molecular data for identifying prognostic biomarkers in patients treated with immune checkpoint inhibitors: An ORIEN pan-cancer study" (Abstract: 2619, Poster: 274, Full Text)
Summary: Utilizing ORIEN Avatar data for 522 cancer patients treated with immune checkpoint inhibitor (ICI) therapy, Dr. Saghand developed a machine learning algorithm correlating survival outcomes to specific gene expression patterns. The algorithm aims to predict the genes that are associated with resistance to ICI therapy; future work will determine the mechanism behind this genetic resistance.

Kevin Chua, M.D., of the Rutgers Cancer Institute of New Jersey will present a poster entitled "Comparing Rate of Immunotherapy Treatment Change Due to Toxicity by Gender" (Abstract: 2656, Poster: 310, Full Text)
Summary: Utilizing clinico-genomic data from 447 patients treated with immunotherapies in the ORIEN Avatar database, Dr. Chua analyzed differences between treatment courses in female and male patients. He found that female patients were on immunotherapies for a shorter overall period, but there was no difference in treatment discontinuation rates due to adverse side effects.
On Sunday, June 5, during ASCO (Free ASCO Whitepaper)’s Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology poster session:

Daniel Spakowicz, Ph.D., of The Ohio State University will present a poster entitled "Pan-cancer analysis of exogenous (Microbial) sequences in tumor transcriptome data from the ORIEN consortium and their association with cancer and tumor microenvironment" (Abstract: 3113, Poster: 105, Full Text)
Summary: Utilizing RNA-sequencing data, Dr. Spakowicz analyzed the microbiomes of 2,892 tumors collected from patients in the ORIEN Avatar database and 2,720 patient samples in The Cancer Genome Atlas. The tumor microbiome was found to correlate better with the type of cancer than the level of oxygen in the tumor microenvironment, suggesting that the tumor microbiome is dependent on location.

Emily Hoskins of The Ohio State University will present a poster entitled "Pan-cancer landscape of PD-L1 and PD-L2 structural variations" (Abstract: 3133, Poster: 125, Full Text)
Summary: PD-L1 and PD-L2 are proteins that are involved in suppressing the creation of new immune cells; cancer cells often produce increased amounts of these proteins to evade the immune system’s attack. Utilizing large datasets, including ORIEN Avatar whole-exome data, Emily Hoskins curated 514 cancer cases with structural variations in PD-L1 and PD-L2 that increased expression of these genes. Patients with these gene rearrangements may potentially respond better to therapies that block PD-L1 or PD-L2 activity.
Additionally, in the Gynecologic Cancer section of the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Proceedings, a supplement to the Journal of Clinical Oncology:

McKayla Riggs, M.D., of the University of Kansas Markey Cancer Center will publish an abstract entitled "DACH1 mutation frequency in endometrial cancer is associated with high tumor mutation burden in a nationwide cohort" (Abstract: e17634, Full Text)
Summary: From 691 endometrial cancer patients in the ORIEN Avatar database, Dr. Riggs found that those with mutations in DACH1 had overall tumor mutation burden and co-occurred with other genome destabilizing mutations. The researchers also found that DACH1 mutations were more prevalent in the local Appalachian region than elsewhere in the country. Their findings suggest DACH1 may be a candidate biomarker for future immunotherapy trials, particularly for endometrial cancers.
To inquire about partnering with M2GEN and the Oncology Research Information Exchange Network (ORIEN), or our rich longitudinal clinico-genomic ORIEN Avatar dataset, contact [email protected].

On May 31, 2022 InveniAI LLC, a global leader in applying Artificial Intelligence (AI) and Machine Learning (ML) to transform drug and target discovery and development, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported the achievement of the first milestone in disease model systems that triggered a milestone payment that has been received by InveniAI under the research collaboration between the companies (Press release, Kyowa Hakko Kirin, MAY 31, 2022, View Source [SID1234615262]).

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Yoshifumi Torii, Ph.D., Executive Officer, Vice President, and Head of R&D Division of Kyowa Kirin, added, "We are excited to achieve a successful outcome by leveraging InveniAI’s platform AlphaMeld that detected very early signals of association between targets/mechanism of action and clinical utility based on the platform’s analytics. We have since validated this program which, as predicted, has shown signals of efficacy in preclinical proof-of-concept studies for the treatment of a disease indication where current therapeutic options lack efficacy and have adverse effects. We are eager to test this very promising candidate for further studies. We also look forward to the selection of additional novel programs identified by InveniAI’s truly game-changing platform and believe that our collaboration will contribute to addressing enduring unmet medical needs."

"We are delighted with the progress of our synergistic collaboration with Kyowa Kirin and the advancement of an AI-identified target and associated clinical utility at unprecedented speed," said InveniAI’s President and Chief Executive Officer, Krishnan Nandabalan, Ph.D., "Our AI-powered drug and target discovery platform, AlphaMeld, has repeatedly demonstrated the ability to generate concepts that have been validated by our partners from preclinical to late-stage clinical success. The ability to translate data into meaningful efficacy, safety, and clinical endpoints is pushing the current probability of clinical success from 1 in 10 to 3 in 10 – a significant impact in today’s drug discovery and development paradigm," he added.

InveniAI and Kyowa Kirin have been collaborating since 2018 and have expanded the framework of their collaboration twice so far (2020 and 2021)*. This milestone achievement is the result of the first joint research to maximize the portfolio value that began in 2018. In addition to the above-mentioned projects, there are ongoing projects aimed at discovering new drug candidates in several disease areas.

About AlphaMeld
AlphaMeld is an Artificial Intelligence (AI) and Machine Learning (ML) powered platform that accelerates innovation for the discovery of targets, drugs, and healthcare products and technologies. The platform generates testable hypotheses by taking into account the ideal mode of pharmacotherapy (antibody, protein replacement, siRNA, mRNA, small molecule, cell and gene therapy, and gene-editing modalities), disease severity, gene ontology, disease pathways, proteinopathies, standard of care, emerging innovation, and enabling technologies while factoring in medical, scientific, strategic, and commercial considerations.