On June 11, 2024 Ono Pharmaceutical, Co., Ltd. (Chairman and CEO: Gyo Sagara, "Ono") reported that it has successfully completed the tender offer, previously announced on April 30, 2024 to acquire all outstanding shares of common stock of a US biopharmaceutical company, Deciphera Pharmaceuticals, Inc. (Nasdaq: DCPH, CEO: Steven L. Hoerter, "Deciphera") for US$25.60 per share (total amount of approximately US$2.4 billion) net to the seller in cash, without interest thereon and less any applicable withholding taxes, through its wholly owned subsidiary, Topaz Merger Sub, Inc. ("Merger Sub"), established in the State of Delaware, United States, solely for the purpose of engaging in the transactions contemplated in the Merger Agreement (Press release, Deciphera Pharmaceuticals, JUN 11, 2024, View Source [SID1234644250]).

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The tender offer commenced on May 13, 2024, New York City time, and, as set forth below, expired at one minute after 11:59 p.m., New York City time, on June 10, 2024.

On June 11, 2024, following the completion of the tender offer, Merger Sub merged with and into Deciphera with Deciphera continuing as the surviving corporation and a wholly owned subsidiary of Ono. In connection with the acquisition, Deciphera shares ceased to be traded on Nasdaq as of the date of closing of the acquisition and shares of Deciphera’s common stock will be delisted from Nasdaq.

"We are very pleased to welcome Deciphera into the family," said Gyo Sagara, Chairman and CEO of Ono. "Through this acquisition, we will leverage Deciphera’s excellent research and development capabilities in the oncology field and its sales power in Europe and the United States, and work to further accelerate the expansion of our pipeline and global expansion, which are part of our growth strategies."

"We are excited to enter a new phase as part of the family of Ono Pharmaceuticals, that has as its mission to contribute to society through the discovery and development of innovative drugs, under the corporate philosophy "Dedicated to the Fight against Disease and Pain,"" said Steven L. Hoerter, President and CEO of Deciphera. "By fully leveraging the research and development capabilities and commercialization platforms of both companies, we look forward to significantly contributing to the growth of the Ono Group as a global specialty pharma company."

On June 11, 2024 Eilean Therapeutics AU Pty Ltd, a biopharmaceutical company dedicated to discovering and developing best-in-class and first-in-class small molecule inhibitors to target escape mutations in hematologic and solid malignancies, reported that it has joined The Leukemia & Lymphoma Society (LLS) in the groundbreaking collaborative Beat AML Master Clinical Trial (Press release, Eilean Therapeutics, JUN 11, 2024, View Source;lymphoma-societys-groundbreaking-beat-aml-master-clinical-trial-302168959.html [SID1234644270]).

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Eilean’s investigational agent, lomonitinib (ZE46-0134) has been selected for a new trial arm for patients with FLT3 mutated relapsed/refractory (R/R) acute myeloid leukemia (AML). Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways. Given the excellent safety profile (with no cytological changes) and ability to rapidly reach steady state, target engagement exposures in a healthy volunteer study, it is anticipated that lomonitinib will have a deeper response (i.e. more CR/CRh) and longer duration of response in R/R AML patients and eventually expand to be the best-in-class FLT3 inhibitor. This will be Beat AML’s first phase 1 sub study, as well as its first precision medicine study in patients whose AML has relapsed or not responded to previous therapies.

"The Beat AML Master Trial provides a unique opportunity to contribute to the advancement of science in AML and evaluate the potential of lomonitinib in FLT3 mutated relapsed refractory AML," commented Iain Dukes, Chief Executive Officer of Eilean Therapeutics.

Beat AML is among the first cancer clinical trials to be sponsored by a nonprofit. It brings together a broad global collaboration of the best and brightest clinicians, cancer centers, pharmaceutical companies, and operational and technology partners, all unified to fundamentally change the treatment approach to AML. The trial has generated impressive results, showing superior survival rates and better quality of life when patients receive targeted treatment matched to the genetic mutations or their blood cancer in place of standard-of-care chemotherapy treatment.

"This partnership with Eilean is exactly what LLS envisioned when we began the Beat AML trial," said Ashley Yocum, Ph.D., LLS executive research lead for Beat AML. "Working with partners like Eilean to evaluate their new and potentially breakthrough approaches to AML treatment in the Beat AML framework will speed the process of bringing new treatments to both newly diagnosed patients and those previously treated with other therapies."

About Lomonitinib
Lomonitinib is a highly potent and selective inhibitor of FLT3 ITD, TKD and other clinically relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are the most frequently identified mutations in AML. There are two main mechanisms of resistance to FLT3 inhibitors: the FLT3-ITD-F691L mutation deemed the "gatekeeper" mutation that confers resistance to all currently approved FLT3 inhibitors and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms.

On June 11, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics and Orano Med, a clinical stage radiopharmaceutical company developing targeted alpha therapies with lead-212 (212Pb), reported the debut of their lead Radio-DARPin therapy (RDT) candidate MP0712, targeting DLL3, in an oral presentation (Press release, Molecular Partners, JUN 11, 2024, View Source [SID1234644228]). The data presented today provide strong support for MP0712’s clinical development in small-cell lung cancer (SCLC) and other DLL3+ neuroendocrine tumors. MP0712 features 212Pb as a potent therapeutic payload. The data were presented today at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 Annual Meeting taking place June 8-11 in Toronto, Canada.

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"Three years ago, we started our venture into the radiotherapy space. We have made tremendous progress with our Radio-DARPins and are proud to present MP0712, our first RDT development candidate targeting DLL3 delivering and 212Pb to kill the tumor, in partnership with Orano Med," said Patrick Amstutz, Ph.D., Molecular Partners’ Chief Executive Officer. "We have made key learnings how to reduce kidney accumulation and increase tumor uptake. We are now exploiting the long-known DARPin advantages to a full pipeline of candidates addressing high medical need. Kudos to both the Orano Med and Molecular Partners team for advancing the science to make this happen."

"We are extremely excited with the first preclinical results of the MP0712 program, which confirm the potential of the combination between Molecular Partners’ targeting technology and 212Pb, an isotope perfectly suited for targeted alpha therapy. We eagerly anticipate advancing the drug’s development and initiating clinical trials to provide solutions for patients with unmet medical needs," said Julien Dodet, CEO of Orano Med.

MP0712 is the first high-affinity DLL3-targeting RDT combining the advantages of DARPins as small protein-based delivery vectors and the short-lived alpha particle-emitting radioisotope 212Pb. DLL3 is expressed in >85% of SCLC patients and in other neuroendocrine tumors, while its expression in healthy tissues is low, making it a priority target for radiopharmaceutical therapy. SCLC is an aggressive form of lung cancer, with a poor five-year survival prognosis and a high unmet need for patients.

The preclinical package presented at SNMMI includes in vivo data demonstrating strong and homogeneous tumor uptake of 212Pb-DLL3 RDT, as well as significant and durable inhibition of tumor growth at clinically-relevant doses. The safety results seen across the tested dosing levels in mice suggest a favorable safety profile and potential for clinical use. 212Pb-DLL3 RDT candidates were engineered by tuning their biophysical properties to achieve an optimal safety/antitumor activity profile in vivo. The selected lead candidate, MP0712, demonstrated a promising biodistribution profile in mouse xenograft tumor models, with close to 60% of injected dose detectable in the tumor and encouraging tumor to kidney ratios over two. The replicable DARPin learnings from the development of MP0712, as well as additional platform improvements, are being taken forward to the broader RDT portfolio.

The intrinsic properties of DARPins, such as small size, high affinity and selectivity, and a broad range of potential targets, make them ideal vector candidates for radiopharmaceutical therapeutics. Historically, small protein-based vectors faced challenges with kidney accumulation and toxicity, as well as suboptimal tumor uptake. Molecular Partners has evolved its RDT platform to address these limitations with its half-life extension technologies and surface engineering approaches, while preserving the advantages of the small protein format. In addition, Molecular Partners’ DARPin candidates have been clinically validated with over 2500 patients treated worldwide and multiple DARPin mechanisms have been demonstrated as biologically active in for different indications, contributing to validation of the drug class and Molecular Partners as leader in the field of DARPin engineering and development.

Details of the presentation summarizing the MP0712 preclinical data at the SNMMI 2024 Annual Meeting can be found below. The presentation will be made available on Molecular Partners’ website after the presentation.

Presentation Title: Lead-212 Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) shows promising preclinical antitumor efficacy and tolerability in small cell lung cancer (SCLC)
Session: IS09 Integrated Session: Radionuclides (CMIIT/RPSC);
Timing: 11 June 2024; 8:00–9:15 am EDT

On June 11, 2024 Incyte Corporation (Nasdaq: INCY) ("Incyte" or the "Company") reported the preliminary results of its modified "Dutch auction" tender offer to purchase up to $1.672 billion in value of shares of its common stock, which expired at 12:00 midnight, at the end of the day, New York City time, on June 10, 2024 (Press release, Incyte, JUN 11, 2024, View Source [SID1234644271]).

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Based on the preliminary count by Computershare Trust Company, N.A., the depositary for the tender offer, a total of approximately 29.8 million shares of Incyte’s common stock were properly tendered and not properly withdrawn at or below the purchase price of $60.00 per share, including approximately 14.8 million shares that were tendered through notice of guaranteed delivery. Incyte has been informed by the depositary that the preliminary proration factor for the shares to be purchased by Incyte pursuant to the tender offer is approximately 93.4 percent.

In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, the Company expects to purchase approximately 27.9 million shares of its common stock through the tender offer at a purchase price of $60.00 per share, for a total cost of approximately $1.672 billion, excluding fees and expenses relating to the tender offer. These shares represent approximately 12.4 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.

As previously announced, on May 12, 2024, Incyte entered into a separate stock purchase agreement with Julian C. Baker (a member of Incyte’s Board of Directors), Felix J. Baker, and entities affiliated with Julian C. and Felix J. Baker, including funds advised by Baker Bros. Advisors LP (collectively, the "Baker Entities"), under which the Baker Entities agreed not to tender or sell any shares in the tender offer and instead agreed to sell to the Company, following completion of the tender offer, a pro rata number of shares at the same price per share as will be paid by the Company in the tender offer, such that the Baker Entities’ aggregate percentage ownership in the Company will be substantially the same as prior to the tender offer. As such, the Company expects to repurchase a total of approximately 33.3 million shares of its common stock through the tender offer and the stock purchase agreement at a price of $60.00 per share, for a total cost of approximately $2.0 billion, excluding fees and expenses. These shares represent approximately 14.8 percent of the Company’s total outstanding shares of common stock as of June 7, 2024.

The number of shares expected to be purchased in the tender offer and under the stock purchase agreement and the purchase price per share are preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the required one business day period. The final number of shares to be purchased in the tender offer and the final purchase price per share will be announced following the expiration of the guaranteed delivery period and the completion by the depositary of the confirmation process. Payment for the shares accepted for purchase pursuant to the tender offer, and the return of all other shares tendered and not purchased, will occur promptly following the completion of the confirmation process. The Company expects to fund the purchase of shares in the tender offer and pursuant to the stock purchase agreement with the Baker Entities, together with all related fees and expenses, with cash on hand.

The dealer manager for the tender offer is Goldman Sachs & Co. LLC. D.F. King & Co., Inc. is serving as information agent for the tender offer. Stockholders who have questions or would like additional information about the tender offer may contact D.F. King & Co., Inc. toll-free at (866) 864-4943.

On June 11, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that it will present data on its innovative OncoMimics approach to cancer therapy at the 2024 Annual Congress of the European Association for Cancer Research (EACR 2024), taking place June 10-13 in Rotterdam, Netherlands (Press release, Enterome, JUN 11, 2024, View Source [SID1234644253]). The presentation describes Enterome’s OncoMimics peptide-based immunotherapy, designed to harness the patient’s immune system to target and eliminate cancer cells.

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Dr. Alice Talpin, lead researcher, commented: "The OncoMimics approach offers a promising strategy to enhance cancer immunity by overcoming the limitations of current vaccines. Our preclinical and clinical data underscore the ability of OncoMimics peptides to elicit strong, durable immune responses, which could significantly improve patient outcomes."

Peptide-based immunotherapy offers significant potential against cancer by leveraging the body’s immune system to eliminate cancer cells, targeting tumor-associated antigens (TAAs) or tumor-specific antigens (TSAs). Enterome innovative OncoMimics therapies are based on the concept of molecular mimicry and cross-reactivity between commensal-derived synthetic peptides and tumor-associated antigens-derived peptides (TAAps) to evoke a CD8+ T cell response against tumors.

Based on this approach, Enterome has developed a pipeline of drug candidates for the treatment of cancer, including EO2463, which is demonstrating a favorable safety profile with encouraging early signs of efficacy in a Phase 2 clinical trial (EONHL1-20/SIDNEY) for indolent non-Hodgkin lymphomas, and EO2401, which has successfully completed a Phase 2 clinical trial (EOGBM1-18/ROSALIE) in patients with recurrent glioblastoma.

Highlights from the EACR 2024 poster presentation, entitled Innovative immunotherapy based on commensal-derived peptides for enhancing CD8+ T cell activation against Tumor-Associated Antigens:

In humanized HLA-A2 murine models, OncoMimics peptides (OMPs) trigger the expansion of cross-reactive OMP-/TAAp- specific CD8+ T cells with specific cytotoxic activity against tumor cells. Experiments conducted on HLA-A2+ healthy human peripheral blood mononuclear cells revealed a high prevalence of cross-reactive OMP-/TAAp-specific CD8+ T cells when stimulated in vitro. In addition, those cross-reactive CD8+ T cells exhibit cytolytic activity against target cells presenting homologous TAAs.

Abstract #1155 is published in an online supplement to Molecular Oncology (Volume 18, Issue S1, DOI: 10.1002/1878-0261.13683) and the Poster will be available on Enterome’s website following the session.

Poster #1155 Presentation details

Title: Innovative immunotherapy based on commensal-derived peptides for enhancing CD8+ T cell activation against Tumor-Associated Antigens

Presenting Author: Alice Talpin, PhD, Enterome researcher

Poster Session: Immunotherapy (odd Abstract Numbers)

Poster Board: P-285

Session Date and Time: June 12, 18:40 to 20:15 CET (poster displayed from 11:00 CET)