On May 31, 2022 ORPHELIA Pharma, the French biopharmaceutical company focused on developing and commercializing orphan medicines in oncology and neurology, reported the successful completion of the phase 1 study of KIMOZO, novel ready-to-use oral suspension of temozolomide, aimed at determining bioequivalence between KIMOZO suspension and temozolomide capsules (Press release, ORPHELIA Pharma, MAY 31, 2022, View Source;utm_medium=rss&utm_campaign=orphelia-reports-positive-results-of-the-bioequivalence-study-of-kimozo-oral-suspension-of-temozolomide [SID1234615249]).

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The abstract #368704 entitled "bioequivalence study of a novel liquid and ready-to-use temozolomide oral suspension and temozolomide capsules in patients with primary central nervous system malignancies" by Ducray et al., was selected by the Scientific Program Committee of the 2022 ASCO (Free ASCO Whitepaper) annual meeting. The data released online demonstrate the equivalence between KIMOZO oral suspension and temozolomide capsules.

"The positive results of the bioequivalence study are an important milestone in the development of KIMOZO", comments Caroline Lemarchand, Chief Pharmaceutical Development Officer at ORPHELIA Pharma. "KIMOZO is the first drinkable form of temozolomide that has been specifically developed to address the needs of young children with cancer", she adds.

"Temozolomide is part of the standard of care for the treatment of relapsed or refractory neuroblastoma, a devastating cancer that affects young children. KIMOZO is currently undergoing further clinical evaluation (TEMOkids trial, NCT04610736) and our goal is to make this pediatric formulation of temozolomide available to children in the shortest timeframe possible"; concludes Jeremy Bastid, Chief Development Officer at ORPHELIA Pharma.

About the bioequivalence study (NCT04467346)

The NCT04467346 bioequivalence study was an open label, randomized, crossover, 2-period study in 30 adult patients with primary CNS malignancies. The study objective was to evaluate primarily the bioequivalence between KIMOZO oral suspension and TEMODAL capsules, to define KIMOZO pharmacokinetic parameters and to assess the safety and tolerability including buccal tolerance of KIMOZO.

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 31, 2022 Pillar Biosciences, the leader in Decision Medicine, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and overall testing costs, reported that its abstract, "Reducing Pre-analytical Sample QC Failure Rates for Cancer Molecular Genetic Assays with SLIMamp Technology", has been published online in the Journal of Clinical Oncology, in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Pillar Biosciences, MAY 31, 2022, View Source [SID1234615283]). The company will also be showcasing its highly accurate and sensitive NGS genetic testing technology at booth #17157 June 4 through June 6, 2022.

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"There is a critical need for NGS tests that can accurately and rapidly identify somatic variants in cancer patients. Current NGS tests can have high failure rates which delay the return of actionable results to physicians, significantly impacting time to diagnosis and critical treatment decisions," said Randy Pritchard, CEO of Pillar Biosciences. "The findings from our study underscore the accuracy and reliability of our SLIMamp technology and demonstrate its ability to generate highly accurate results from lower quality samples that have failed other NGS tests. We are pleased that this study has been published online and look forward to demonstrating the capabilities of our NGS genetic testing solutions at ASCO (Free ASCO Whitepaper)."

In the study, 48 tumor samples failing one or more pre-analytical quality control (QC) sample parameters for whole exome sequencing (WES) from an accredited diagnostic genomics laboratory were sequenced using Pillar Bioscience’s oncoReveal Solid Tumor Panel. Results demonstrated that the panel achieved high sequencing coverage (>3,000X) for all 48 samples and was able to generate clinical reports for 45 samples (94%). 38 of these reports (79%) contained clinically actionable or significant variants that would not have otherwise been identified with currently available panels. The study showed that oncoReveal Solid Tumor Panel with Pillar Biosciences’ proprietary SLIMamp technology, was able to generate reliable, interpretable results for almost all of the samples that had failed pre-analytical QC for WES.

At booth #17157, Pillar Biosciences will also be featuring the company’s extensive portfolio of NGS genetic testing solutions, including the oncoReveal Dx Lung and Colon Cancer Assay, PillarHS Multi-Cancer Panel, Essential MPN Panel, Multi-Cancer with CNV and RNA Fusion Panel, and Myeloid Panel.

On May 31, 2022 Biond Biologics Ltd., a private, clinical-stage biopharmaceutical company developing novel immunotherapies for cancer and a platform enabling the intracellular delivery of biologics, reported that the company will be presenting a joint poster with Sanofi at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting taking place in Chicago, Illinois, June 3-7, 2022 (Press release, Biond Biologics, MAY 31, 2022, View Source [SID1234615301]). The poster presents pre-clinical translational data including potential patient enrichment biomarkers for SAR444881 (BND-22).

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The poster will be presented at:

Developmental Therapeutics—Immunotherapy

Date and Time: 06/05/2022, 8:00 AM – 11:00 AM

Abstract Title: Evaluation of pharmacodynamic and patient enrichment biomarkers for SAR444881, a first-in-class anti-ILT2 monoclonal antibody for cancer immunotherapy.

Abstract ID: 2571

About SAR444881 (BND-22),

Leukocyte Ig-like receptor B1 (LILRB1), also known as immunoglobulin-like transcript 2 (ILT2), is an inhibitory receptor expressed on various immune cells. ILT2 was shown to bind to classical and nonclassical MHC class I molecules and with the highest affinity to HLA-G. Inhibition of ILT2 signaling axis results in impairment of immune cell proliferation, differentiation, phagocytosis, cytotoxicity and cytokine secretion and may therefor serve as a novel target for anti-cancer immunotherapy. SAR444881 (BND-22) is a novel humanized IgG4 monoclonal antagonist antibody that selectively binds to ILT2, blocking its interaction with MHC I molecules, thus preventing the inhibition of ILT2 signaling.

"We previously demonstrated that SAR444881 has robust macrophage and lymphocyte-driven anti-tumor activity in in vitro and in vivo models. The poster presents a joint effort of Biond and Sanofi to explore the pharmacodynamic effect of ILT2 antagonism as well as to inform on combinatorial and patient enrichment strategies for SAR444881 clinical development", said Ilana Mandel, Ph.D., VP R&D at Biond Biologics.

On May 31, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported the acceptance of its Clinical Trial Application (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to allow expansion of its VERSATILE-002 study of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) to the UK (Press release, PDS Biotechnology, MAY 31, 2022, View Source [SID1234615250]). The MHRA is among several regulatory agencies that PDS Biotech is seeking approval from to expand the trial into various site outside of the United States PDS Biotech anticipates that enrollment in the UK could begin during the third quarter of 2022.

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"The acceptance of this CTA marks another important regulatory milestone for PDS Biotech. Initiation of our global expansion is a key advancement to expedite enrollment into the VERSATILE-002 clinical study," stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "Additionally, this expansion allows PDS to expose global regulators to our novel molecularly targeted immunotherapies."

Chris Curtis, Chief Executive Officer of the UK-based charity group, The Swallows, stated "The reported preliminary safety data of PDS0101 in combination with pembrolizumab is highly encouraging, and we are pleased that European patients will be able to enroll in this promising clinical study of an HPV-targeted immunotherapy with standard of care, pembrolizumab."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.