On June 11, 2024 Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, reported its rare disease business has signed a strategic agreement with AGC Biologics (Press release, Essential Pharma, JUN 11, 2024, View Source [SID1234644255]). As a leading global biopharmaceutical contract development and manufacturing organisation (CDMO), AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB).

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Under the agreement, AGC Biologics will support the process development, scale-up and manufacturing as Essential Pharma plans to commence clinical activities and ongoing regulatory agency interactions over the coming months.

Simon Ball, Vice President of the rare disease business at Essential Pharma, commented: "This partnership is a tremendous milestone in the development of Hu14.18 and its path to commercialization. The prospect of building an inventory of Hu14.18 is very exciting. Ahead of us is a period of intense regulatory agency interaction, which will take place alongside late-stage clinical development, and we are a step closer to providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes."

"AGC Biologics is a global leader in contract antibody development and manufacturing," stated Emma Johnson, CEO of Essential Pharma. "This partnership will help us to accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, the majority of whom are young children. We look forward to working closely with AGC to deliver this potentially transformative therapy in an area of significant unmet need."

Christoph Winterhalter, CBO at AGC Biologics, said: "We are very pleased that Essential Pharma has chosen us to manufacture this innovative therapy. Our Copenhagen site has the expertise and experience in therapeutic antibodies to accelerate the late-stage development and manufacturing of Hu14.18. We look forward to partnering with Essential Pharma and working together to ensure the product meets the high level of quality, yield and all data packages needed to successfully master future clinical trials and regulatory agency submissions to supply patients across the globe with this life-saving product."

Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for the development of Hu14.18. A Phase II trial incorporating Hu14.18 into first-line therapy, and additionally within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study were published in the Journal of Clinical Oncology in December 2021 and are approaching five-year OS readouts.

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)

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 Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, reported that it selected Exothera S.A. ("Exothera"), a leading provider of nucleic acids and viral vector development and manufacturing services, for process development up to clinical Phases I/II manufacturing of its candidate AT-108, based on viral vector technology (Press release, Asgard Therapeutics, JUN 11, 2024, View Source [SID1234644248]).

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AT-108 is a first-in-class, off-the-shelf gene therapy that leads to personalized and potent anti-cancer immune responses. AT-108 reprograms cancer cells inside the patient’s body to become conventional Type 1 Dendritic Cells (cDC1s), a rare subset of immune cells, which are critical for effective anti-tumor immunity. These induced cDC1s present the individual’s specific cancer antigens to the immune system, triggering personalized and systemic anti-cancer immune responses.

Exothera will be entrusted with the development and scale-up of a manufacturing process for the drug candidate, including development of analytical methods, GMP-grade material production, and aseptic filling.

Exothera offers a full-service model for viral vector-based biotherapeutics thanks to state-of-the-art technologies, and one of the largest viral vector facilities in Europe (15 000 m² – 161 500 ft²).

Cristiana Pires, Co-founder and Chief Executive Officer of Asgard Therapeutics, said: Following our proof-of-concept studies supporting the lead candidate AT-108, we are very happy to reach process development phase and start CMC activities. We are looking forward to work with the very knowledgeable and skilled technical team at Exothera to progress our pioneering AT-108 towards clinical development.

Hanna Lesch, Chief Technology Officer at Exothera, mentioned: We are proud to support Asgard Therapeutics in bringing these revolutionary therapeutics closer to the patients. Over the years we gained extensive experience with virus-based therapeutics production – both in suspension and in fixed bed bioreactors – and we are confident that we will use this expertise to help Asgard Therapeutics achieve clinical phase success.

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