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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]).

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.

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."

IMM2510 of ImmuneOnco completed 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 IMM2510, a PD-L1/vEGF bispecific fusion protein independently developed by ImmuneOnco, completed Phase I dose escalation and determined the recommended Phase II dose (Press release, ImmuneOnco Biopharma, SEP 11, 2023, View Source [SID1234655689]). This is another important milestone of ImmuneOnco in its rapid development.

The preliminary results of the Phase I clinical trial of the IMM2510 demonstrate that the product have anti-tumor efficacy with tumor objective response observed in three different dose groups (3mg/kg, 10mg/kg, 20mg/kg). Among them, one PR was observed in each of the 3 mg/kg and 10 mg/kg dose groups in patients with lung squamous cell carcinoma who had failed PD1, and one PR was observed in thymic adenosquamous cell carcinoma (20 mg/kg). After discussion by the Safety Review Committee （SRC）, it was unanimously agreed that the RP2D be dose of 20mg/kg Q2W for monotherapy to enter Phase II development.

On August 17, the Phase II clinical research application of CTLA-4 antibody IMM27M combined with IMM2510, both are independently developed by the company, accepted by the National Medical Products Administration (NMPA). Preclinical efficacy studies demonstrated that IMM2510 produces stronger synergistic anti-tumor activity than that of anti-vEGF combined with PD-L1 antibodies. Repeatable in vivo studies showed 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. It has been well established that dual immunotherapy of anti- CTLA4 combined with anti-PD1/PD-L1 have clear cut synergy in patients.

In addition, the Phase II clinical-IND application for IMM2510 combined with chemotherapy for the treatment of different solid tumor indications such as non-small cell lung cancer and breast cancer has been accepted by CDE.

Dr. Tian, Wenzhi, founder and chairman of ImmuneOnco, said: "We are very pleased to see that our IMM2510 completed Phase I dose escalation and determined the recommended Phase II dose. IMM2510 is an antibody-receptor recombinant protein (mAb-Trap) that targets both PD-L1 and vEGF. It inhibits angiogenesis, shrinks tumors, and makes tumor cells more sensitive to immune responses. It also activates T cells, natural killer cells, and macrophages by blocking PD-L1/PD-1 interaction and inducing Fc-mediated ADCC/ADCP activity. There are currently four bispecific molecules targeting both vEGF and PD-L1 in the global pipeline, two of which do not have active IgG1 Fc fragments IMM2510 has an enhanced IgG1 Fc who has powerful ADCC effector functions. So, by angiogenesis inhibition and T cell activation, it modulates the tumor microenvironment and significantly improves treatment efficacy. Preclinical in vivo efficacy studies show that IMM2510 is more effective than that anti-vEGF combined with PD-L1 antibodies, by comparing with combination of two single agents, IMM2510 has a huge competitive advantage in reducing patient affordability. We will continue to promote the research on the IMM2510 and strive to bring good news to the cancer patients as soon as possible."

Dr. Lu, Qiying, chief medical officer/senior vice president of the company, said: "It is of great significance for our company today that IMM2510 has completed the patient enrollment in Phase I dose escalation and determined the recommended Phase II dose. There are preliminary positive efficacy signals in relapsed and refractory lung adenocarcinoma, lung squamous cell carcinoma and thymic cancer. For unmet clinical needs, we plan to further develop single drug and combinations of different treatment modes for multiple indications and explore the efficacy in solid tumors, including non-small cell lung cancer, triple-negative breast cancer, soft tissue sarcoma, liver cancer, etc. So far, the company has submitted a Phase II IND application of combination with chemotherapy for different indications, and a Phase II IND application of combination with IMM27 for different solid tumors. We have high hopes and expectations for IMM2510 and look forward to bringing good news to cancer patients."

Xspray Pharma and Bristol Myers Squibb Reach Settlement on Dasynoc™ Patent Litigation, Paving Way for Early Market Launch

On September 11, 2023 Xspray Pharma announced a resolution to its patent litigation with Bristol Myers Squibb (BMS) concerning its product, Dasynoc (Press release, Xspray, SEP 11, 2023, View Source [SID1234650015]). The settlement clears all pending claims, paving the way for Xspray to introduce Dasynoc to the market on September 1, 2024, pending final FDA approval. The launch may occur earlier under certain circumstances. The contested patents and their associated regulatory exclusivities expire on September 28, 2026.

The parties will proceed to file a dismissal with the United States District Court for the District of New Jersey, eliminating the need for any additional litigation on this matter.

"This settlement provides clarity on the launch date of our leading product, Dasynoc, benefiting the market. It also allows Xspray to shift its focus towards ensuring a successful product debut in 2024. Funds that were previously earmarked for litigation can now be redirected towards advancing Xspray’s future products" commented Per Andersson, CEO Xspray Pharma.