2seventy bio and JW Therapeutics Announce Intent To Expand Strategic Partnership to Accelerate the Research and Development of T Cell-based Immunotherapies and Autoimmune Therapies

On September 12, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, and JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, reported their intention to expand their strategic alliance (Press release, 2seventy bio, SEP 12, 2023, View Source [SID1234635093]). The expansion, based on the partnership that was established last year, builds upon the companies’ translational and clinical cell therapy development platform originally designed to more rapidly explore T cell-based immunotherapy therapy products in Greater China. Specifically, the companies intend to add up to two additional candidates from the 2seventy portfolio, one in solid tumor indications using T-cell receptor (TCR) based technology and a second in autoimmune disease using a CAR T cell approach.

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"Since our partnership was established, our companies have built a deeply collaborative and successful approach to progressing cell therapy candidates," said Steve Bernstein, chief medical officer, 2seventy bio. "At the time, our primary goal was to build a collaboration with a focus on our potency-enhanced MAGE-A4 solid tumor program that could demonstrate our collective capabilities to rapidly test, learn and progress our innovative cell therapy programs to the clinic. We’re excited to have done just that, with this initial program running ahead of schedule and on track to initiate an investigator-initiated study in China by the end of this year. Given the progress with MAGE-A4, today’s announcement is a natural evolution, doubling down on the success to date by extending our collaboration into additional programs in solid tumors and autoimmune disease."

As announced in October 2022, the initial focus of the collaboration was 2seventy bio’s potency enhanced MAGE-A4 TCR program in solid tumors which is being developed as part of a collaboration with Regeneron. Over the last 10 months, JW Therapeutics has successfully progressed this candidate and is on track to initiate an investigator-initiated study in China by the end of 2023 and well ahead of the original timeline. In addition to the pace of development, the significantly better cost structure of preclinical and early clinic development performed through JW Therapeutics’ internal and external development network provides additional rationale for further collaboration. To this end, the intent of the expanded collaboration is to add two new programs: an additional solid tumor program and 2seventy’s first autoimmune disease (AID) targeted CAR T cell program.

2seventy’s AID program is a natural extension of its’ internal expertise in CAR T cell research and significant clinical experience in both B-cell targeted and plasma cell-targeted CAR T cells in oncology – the two antibody secreting cell types in the body that play a role in the pathobiology of autoimmune disorders. 2seventy’s construct has been designed to achieve the breadth and depth of target cell elimination necessary to potentially provide a superior outcome for patients suffering from the plethora of antibody-mediated autoimmune diseases.

"From the start of our collaboration with 2seventy bio last year, we knew that there was the potential of working on other assets in China so we are excited to announce the intended expansion of our partnership," said Dr. Mark J. Gilbert, Chief Medical Officer, JW Therapeutics. "Our work together has proven that combining our companies’ strength and capabilities carries significant advantages including world-class translational research, process development and clinical development. We look forward to building upon our success, incorporating 2seventy’s advanced technology and collaborating with their highly-experienced team to accelerate the development of potential new medicines with breakthrough therapeutic value to serve more patients in China and possibly worldwide. This is testament to the highly versatile application and effectiveness of our end-to-end platform that successfully expedite our as much as third party R&D processes."

Collaboration between Cytea|Bio, EFS Besancon (PIBT) and Bionoveo

On September 12, 2023 CYTEA|BIO reported its collaboration with EFS Besançon (PIBT) and Bionoveo (Press release, CYTEA BIO, SEP 12, 2023, View Source [SID1234635092]). This partnership is aimed at propelling the development and manufacturing of our state-of-the-art cell therapy products. These groundbreaking therapies signify a novel category of medical progress, harnessing the potential of allogeneic natural killer (NK) cells sourced from human umbilical cord blood (UCB) armed with a chosen monoclonal antibody (mAb), expertly designed with a high-affinity Fc region.

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Alan Cookson, the CEO of CYTEA|BIO, remarked, "Through this collaboration, our commitment lies in advancing the realm of cell therapy and addressing a pressing, unmet medical necessity for patients grappling with glioblastoma. At the forefront of our inaugural clinical trial stands our flagship product, CYT-102, holding the promise of enhanced treatment outcomes and renewed hope."

This collaboration marks a milestone where expertise converges, aspirations align, and medical innovation takes center stage. Together, we are venturing into uncharted territories, guided by our dedication to scientific excellence and patient well-being. The synergy between CYTEA|BIO, EFS Besançon, and Bionoveo resonates with the potential to redefine medical standards and reinvigorate the lives of countless individuals.

As we embark on this remarkable journey, the path ahead may present challenges, yet it is illuminated by the prospect of reshaping the landscape of healthcare. Through relentless determination and collaborative spirit, we strive to make a lasting impact. The core of our endeavor remains rooted in compassion, guided by purpose, and driven by a commitment to improving lives. The future is promising, and we are poised to drive positive change.

Exai Bio Presents Data Further Validating its Liquid Biopsy Platform at the 2023 World Conference on Lung Cancer

On September 12, 2023 Exai Bio reported non-small cell lung cancer (NSCLC) data further validating that its novel RNA- and generative AI-based liquid biopsy platform detected early-stage disease with high accuracy (Press release, Exai Bio, SEP 12, 2023, View Source [SID1234635082]). The study of nearly 900 subjects demonstrated stage I sensitivity was 95% at 90% specificity. The use of Exai’s proprietary generative AI technology, derived from large independent datasets of tumor and blood samples, enhanced both sensitivity and specificity beyond what is achievable using standard machine learning techniques. The high detection of stage I tumors could have major clinical implications to enable earlier disease detection at initial diagnosis as well as molecular residual disease (MRD) monitoring.

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Today’s study also revealed the platform’s novel capability to subtype cancer biology using a routine blood draw. In a pilot sub-study including 100 NSCLC patients, cell-free RNA patterns were used to distinguish adenocarcinoma from squamous cell carcinoma. The accuracy of Exai’s prediction was equivalent to tissue subtyping, highlighting the potential to use a blood-based test in lieu of or in conjunction with surgical pathology. Beyond this initial technology demonstration, Exai’s platform enables further novel insights into cancer transcriptional activity for clinical monitoring as well as in accelerating drug development programs for the biopharmaceutical industry. These results will be presented today at the 2023 World Conference on Lung Cancer (WCLC).

Earlier lung cancer detection could lead to better treatment options and improved outcomes, however, finding small tumors and early-stage disease is still a major clinical challenge," stated Sandip Patel, Professor, Medical Oncology, University of California, San Diego. "Blood-based tests for the accurate and sensitive detection of lung cancer could significantly improve patient care, especially as new therapies are utilized in the neoadjuvant and adjuvant setting for treating non-small cell lung cancer."

"Over the past year, Exai has generated compelling evidence demonstrating that our innovative liquid biopsy platform can detect cancer at the earliest stages and shed insights into cancer biology," stated Pat Arensdorf, CEO of Exai Bio. "Based on strong results across multiple studies, we are actively developing a range of blood tests that aim to detect, define and monitor cancer at the earliest actionable stage for patients."

Exai’s platform uses the latest next generation sequencing techniques to generate a comprehensive profile of cell-free RNA and identify a novel category of cancer-associated, small non-coding RNAs, termed orphan non-coding RNAs (oncRNAs). OncRNAs are transcribed and actively secreted from cancer cells and are stable and abundant in the blood of cancer patients. Exai has created a catalog of hundreds of thousands of oncRNAs and tens of thousands of patient oncRNA profiles, spanning all major cancer subtypes. When combined with Exai’s proprietary artificial intelligence, this unique platform has several scientific and practical advantages over tests that focus on circulating tumor DNA (ctDNA) including sensitivity, specificity, and informative properties for active cancer biology.

Exai’s universal platform can be used across multiple cancer care settings such as screening and early detection, monitoring, molecular residual disease and therapy selection.

World Conference on Lung Cancer Presentation Details

Presentation Title: AI-Based Early Detection and Subtyping of Non-Small Cell Lung Cancer from Blood Samples Using Orphan Non-Coding RNAs

Session Title: Emerging Technologies in Lung Cancer Screening

Date: Monday, 9/11/23, 9:00 pm PDT

Authors: M. Karimzadeh, T. Cavazos, J. Wang, M. Multhaup, Y. Fang, J. Ku, J. Wang, X. Zhao, K. Wang, R. Hanna, O.I. Afolabi, A. Huang, D. Corti, K. Garcia, T. Joshi, D. Nguyen, Y. Kong, P. Arensdorf, K. Chau, A. Hartwig, H. Li, S. Patel, H. Goodarzi, L. Fish, F. Hormozdiari, B. Alipanahi

Imugene PD1-Vaxx Update

On September 12, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported an update on development of its PD1-Vaxx clinical drug candidate (Press release, Imugene, SEP 12, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/b84086de-66ea-1143-ed9d-b6751a178dfa/Imugene_PD1_Vaxx_Update.pdf [SID1234635074]).

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Imugene announces the grant of a new patent (number 2019-553504) by the Japanese Patent Office. The granted claims protect Imugene’s immunotherapeutic PD1-Vaxx, a first-in-class programmed death-1 (PD1) vaccine, currently in clinical development for non-small cell lung cancer (NSCLC).

The patent titled "HUMAN PD1 PEPTIDE VACCINES AND USES THEREOF" will expire on 28 March 2038 and protects the composition of matter and method of treatment in cancer of Imugene’s PD1-Vaxx for the generation of a therapeutic antibody response against the PD1 checkpoint target.

Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction and produce an anti-cancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

Last week marked 1000 days cancer free for a patient with late-stage NSCLC who was recruited and dosed in December 2020. This week Professor Michael Boyer M.D., MBBS, FRACP, PhD, Chris O’Brien Lifehouse Hospital will present a trial-in-progress poster in person at the IASLC 2023 World Conference on Lung Cancer (WCLC 2023) in Singapore. The poster presentation can be downloaded from Imugene’s website, View Source

Imugene MD & CEO Leslie Chong said: "Attaining the key Japanese patent, on top of gaining protection in the USA this year, is a very important milestone. Recruitment in the Phase 1 PD1-Vaxx trial, as monotherapy or in combination with atezolizumab in adults with NonSmall Cell Lung Cancer, has increased markedly recently with strong interest from new clinical sites to participate in this innovative study".

ImmuneOnco completed IMM27M Phase I dose escalation and determined recommended Phase II dose

On September 11, 2023 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco", Hong Kong Stock Exchange stock code: 01541.HK) reported that IMM27M,an independently developed ADCC-enhanced CTLA-4 antibody, completed the phase I dose escalation patient enrollment and determined the recommended phase II dose (Press release, ImmuneOnco Biopharma, SEP 11, 2023, View Source [SID1234655690]). This is another milestone event in the company’s rapid development.

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The first patient was dosed in June 2022. The Phase I dose escalation trial of the IMM27M for solid tumors is progressing smoothly. Overall data showed that IMM27M was well tolerated, without dose-limiting toxicities (DLTs) occurring in all subjects across the seven dose groups of 0.1 mg/kg to 7.5 mg/kg. Among them, initial objective response (both obtained PR) was observed in 2 breast cancer patients after multiple lines of treatment at dose of 3 mg/kg and 5 mg/kg respectively; in addition, another subject with advanced melanoma achieved SD with 20% tumor size shrinkage at 2 mg/kg dose level. After reviewed clinical data, the Safety Review Committee (SRC) unanimously agreed that 5mg/kg Q3W should be RP2D used as monotherapy.

On August 17, the Phase II clinical research application for IMM27M combined with IMM2510 was accepted by the National Medical Products Administration (NMPA). Preclinical studies have shown that IMM2510 produces stronger synergistic anti-tumor activity than that of anti-VEGF combined with PD-L1 antibody. Repeated in vivo studies have demonstrated that IMM27M has strong anti-tumor activity and can be used in clinical studies in combination with a variety of drugs in the company’s pipeline. Dual immune therapy of CTLA4 combined with PD1/PD-L1 has been well established to have clear cut synergy. In addition, in March this year, the Phase II IND application for IMM27M combined with PD1 to treat different advanced solid tumors has been approved by CDE.

Dr. Tian, Wenzhi, founder and chairman of ImmuneOnco, said: "I am very pleased to see that our IMM27M completed the enrollment of patients in phase I dose escalation and determined the recommended phase II dose. IMM27M is an IgG1 antibody against CTLA-4. It has been genetically engineered to significantly enhance ADCC activity. Compared with similar molecule lpilimumab, the efficacy in animal models of IMM27M was much better at the same dose levels, and tumors can be eliminated at a lower dose (0.3 mg/kg). Repeatable in vivo studies showed that IMM27M had powerful anti-tumor activity. It can be also used in combination with a variety of drugs in the company’s pipeline. We believe that IMM27M have great value for clinical development. We will work closely with clinical experts and subjects to accelerate the clinical research of IMM27M and benefit cancer patients as soon as possible."

Dr. Lu, Qiying, chief medical officer/senior vice president of ImmuneOnco, said: "Today is a special day for our company that IMM27M completed the phase I dose escalation and determined the recommended phase II dose. IMM27M is a second-generation antibody against CTLA-4 with good safety and tolerability. No DLT was observed in any dose level of phase I study. 2 patients with hormone receptor-positive breast cancer who relapsed after multiple lines achieved PR. We will further evaluate the efficacy by combining antibodies with different targets, such as combination with PD-1, and IMM2510 (vEGF/PD-L1), are being actively explored in different solid tumors, and we look forward to bringing good news to the cancer patients."