On September 30, 2024 Regor Pharmaceuticals (USA) ("Regor") reported that it has entered into a definitive purchase agreement whereby Genentech, a member of the Roche Group, will acquire a portfolio of next-generation CDK inhibitors from Regor for the treatment of breast cancer (Press release, Regor Therapeutics, SEP 30, 2024, View Source [SID1234646951]).

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Under the terms of the agreement, Regor will receive an upfront cash payment of $850 million and is eligible to receive additional cash payments based on the achievement of certain predetermined development, regulatory and commercial milestones. Genentech will be responsible for clinical development, manufacturing and commercialization worldwide. Regor will continue to manage the two ongoing Phase 1 trials to their completion: Regor will also advance its other distinct assets, unrelated to this deal, in oncology, metabolic diseases and auto-immunity.

"Genentech is well-positioned to bring these novel therapeutics to their full potential to benefit patients with breast cancer around the world," said Xiayang Qiu, Ph.D., founder and CEO of Regor. " We are proud of the strong data we have generated to date. We look forward to bringing more innovative therapies to patients around the world."

The proposed transaction is expected to close in the fourth quarter of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.

BofA Securities, Inc. is acting as the exclusive financial advisor to Regor on this transaction, and Cohen, Tauber Spievack & Wagner PC and DLA Piper are its legal advisors.

On September 30, 2024 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that its partner Asieris Pharmaceuticals (SSE: 688176) communicated that international multicenter Phase III clinical study data for its non-surgical treatment candidate Cevira (APL-1702) for cervical High-Grade Squamous Intraepithelial Lesion (HSIL) has been published by the 27th Chinese Society of Clinical Oncology (CSCO) Annual Meeting as a poster, focusing on the analysis of different age subgroups regarding the six-month pathological regression rate and HPV clearance rate (Press release, Asieris Pharmaceuticals, SEP 30, 2024, View Source [SID1234646948]).

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This Phase III clinical trial is a prospective, randomized, double blind, placebo controlled, multi-center clinical study, which has reached its primary efficacy endpoint and exhibited good safety.

Furthermore, the study results included the pathological regression rate (defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue) at the 6th month across different age subgroups. Both the "≥20 and <30 years" subgroup and the "≥30 and <40 years" subgroup showed an increase of 15% to 20% in the pathological regression rate in the APL-1702 group compared to the placebo control group. No cervical cancer events were reported, suggesting a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years.

Regarding HPV clearance rate, in the "≥20 and <30 years" age group, the APL-1702 group showed enhancements in the overall HPV clearance rate, HPV16-positive clearance rate, and HPV16/18-positive clearance rate compared to the placebo control group. The patients’ number in the "<20 years" and "≥40 years" age groups were limited, thus the results in these age groups require a validation study with a larger sample size. Overall, APL-1702 not only facilitates the regression from HSIL to LSIL but also demonstrates the ability to induce clearance of high-risk HPV infections.

On September 30, 2024 Aktis Oncology, a clinical-stage biotechnology company pioneering the discovery and development of novel targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, reported the successful closing of an oversubscribed and upsized $175 million Series B financing (Press release, Aktis Oncology, SEP 30, 2024, View Source [SID1234646945]). The financing was led by RA Capital Management, and co-led by RTW Investments and Janus Henderson Investors. A select syndicate of additional new investors joined the financing, including funds and accounts advised by T. Rowe Price Associates, Inc., Avidity Partners, and an undisclosed life sciences-focused investment fund. All existing institutional investors participated, as well as existing strategic investors Bristol Myers Squibb, Eli Lilly and Company, and MRL Ventures Fund, the therapeutics-focused corporate venture fund of Merck & Co., Inc.

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Aktis Oncology also announced that three abstracts, including one oral presentation, have been accepted for presentation at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, October 23-25, 2024.

"The overwhelming support from high caliber investors underscores the progress we have made on our pipeline, platform, and supply chain capabilities, exemplified by the significant opportunity for AKY-1189, our first-in-class miniprotein alpha radioconjugate targeting Nectin-4 in development for several tumor types," said Matthew Roden, PhD, President and Chief Executive Officer of Aktis Oncology. "With over $300 million in cash, we are well-positioned to prosecute several opportunities to expand the benefit of this exciting modality into new patient populations."

In conjunction with the financing, Andrew Levin, MD, PhD, Partner and Managing Director at RA Capital Management, will join the Aktis Oncology Board of Directors. Lauren Lee, PhD, from RTW Investments, and Vish Sridharan, MD, from Janus Henderson Investors, will join as Observers to the Board of Directors.

"Aktis has leveraged its unique technology platform, experienced team, robust supply chain and radiopharmaceutical development capabilities to generate a promising and differentiated pipeline of next-generation radiopharmaceuticals," said Andrew Levin, MD, PhD, Partner and Managing Director at RA Capital Management. "We are pleased to support Aktis through the next stage of its growth as it seeks to bring new options to patients with cancer."

On September 30, 2024 BioAI, an emerging biotech company applying multimodal artificial intelligence (AI) to novel biomarker discovery, development, and diagnostics, reported a strategic partnership with Arbele, a biopharmaceutical company dedicated to developing novel immunotherapeutic platforms for gastrointestinal cancers (Press release, ARBELE, SEP 30, 2024, View Source [SID1234646944]).

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The collaboration aims to leverage BioAI’s PredictX platform to develop AI-based models using Arbele’s clinical trial data, with a focus on colorectal cancer (CRC) biomarker screening. The goal is to create a companion diagnostic test for Arbele’s drug assets, enhancing patient selection through advanced AI technology.

"By joining forces with Arbele, we are excited to apply our novel AI platform and expertise to accelerate the development of innovative treatment options for gastrointestinal cancers," said Thomas Colarusso, CEO of BioAI. "This partnership underscores our commitment to revolutionizing personalized medicine through cutting-edge machine learning."

Arbele’s CEO & Founder, Dr. John Luk, commented, "BioAI’s machine learning capabilities offer a transformative approach to biomarker identification and patient stratification. This collaboration is a critical step in improving outcomes for patients with high mortality cancers."

The initial phase of the partnership will focus on developing a prototype machine learning classifier model for quantifying CDH17 expression patterns in CRC samples, using a combination of H&E (hematoxylin and eosin) and IHC (immunohistochemistry) stained images. This initiative aims to standardize and improve the pathologic assessment of treatment response biomarkers to facilitate more effective patient selection for Arbele’s specific therapeutic programs. Both companies expect that this collaboration will pave the way for future advances in precision medicine, ultimately benefiting patients with gastrointestinal cancers.

On September 30, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial (Press release, Merus, SEP 30, 2024, View Source [SID1234646939]).

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Merus has confirmed through feedback with the U.S. Food and Drug Administration (FDA) that petosemtamab 1500 mg every two weeks is appropriate for further development in HNSCC as monotherapy, and in combination with pembrolizumab.

"Based on our strong phase 2 clinical data reported previously for petosemtamab in HNSCC both as monotherapy and in combination with pembrolizumab, I continue to be confident that petosemtamab has the opportunity to become a new standard of care across r/m HNSCC and potentially beyond," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Our recently announced alignment with the FDA on phase 3 dose, and excellent execution to date has allowed us to promptly initiate our registration trials in 1L and 2/3L HNSCC."

More details of the trial can be found at clinicaltrials.gov.

About LiGeR-HN1
LiGeR-HN1, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab, compared to pembrolizumab in 1L PD-L1+ r/m HNSCC patients. The trial is open to adult patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.2 HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.