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Janux Therapeutics Announces First Patient Dosed with JANX007 in First-in-Human Phase 1 Clinical Trial in Patients with Prostate Cancer

On October 12, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported the first patient has been dosed in a Phase 1 clinical trial of JANX007 in subjects with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Janux Therapeutics, OCT 12, 2022, View Source [SID1234621974]). JANX007 is a prostate-specific membrane antigen (PSMA) directed T cell engager (TCE) and is the first product candidate utilizing Janux’s TRACTr platform to be administered in humans.

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"We are excited to begin clinical evaluation of our first product candidate. Importantly, JANX007 has the potential for tumor-selective T cell activation and tumor cell killing," said Wayne Godfrey, M.D., Chief Medical Officer at Janux. "Preclinical data have shown potent killing of tumor cells by JANX007, with less potential for systemic side effects from cytokine release when compared to an unmasked T cell engager."

The first patient was dosed at Sarah Cannon Research Institute (SCRI). Ben Garmezy, M.D., Assistant Director of Genitourinary Research and the principal investigator from SCRI at Tennessee Oncology, notes, "PSMA is a highly expressed target in prostate cancer, so the opportunity for this therapeutic candidate to address an unmet need in late-stage prostate cancer patients would be meaningful. We look forward to exploring the safety and activity of this approach with JANX007 in prostate cancer patients."

Janux is currently in the process of opening additional trial sites in the United States and Australia.

"The initiation of this first-in-human clinical trial represents a major milestone for Janux, as it marks the first therapeutic to be used in humans from our TRACTr platform," said David Campbell, Ph.D., President and CEO of Janux. "Our TRACTr platform is designed to generate tumor-specific immune responses to attack and kill tumors without harming the patient’s healthy tissues. We believe these characteristics have the potential to allow JANX007 to overcome the limitations that have beset previous T cell engagers in prostate cancer. Most importantly, this trial underscores our commitment to addressing critical unmet needs for cancer patients as we pursue our mission to discover and deliver innovative immunotherapies that transform cancer patients’ lives."

About the JANX007 Phase 1 Clinical Trial

The Phase 1 clinical trial is a multi-center, open-label dose escalation trial to evaluate ascending doses of JANX007 in patients with mCRPC. This trial will assess the safety, tolerability, pharmacokinetic, pharmacodynamic, and the preliminary efficacy of JANX007 as a single agent in adult subjects with mCRPC. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT05519449.

Perimeter Medical Imaging AI Hosts Two Poster Presentations at the College of American Pathologists 2022 Annual Meeting

On October 12, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) – a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs – reported that two poster presentations at the Annual Meeting of the College of American Pathologists 2022 (CAP22), which took place October 8 to 11, 2022 in New Orleans, LA (Press release, Perimeter Medical Imaging AI, OCT 12, 2022, View Source [SID1234621973]). The research presented validates the potential use of Perimeter S-Series OCT to intraoperatively image specimens across a variety of tissue types, such as breast, thyroid, kidney, liver, lung, colon, heart, pancreas, spleen, and adrenal glands:

Validation of Wide-Field Optical Coherence Tomography for Microstructural Analysis of Tissue From Multiple Organs (Poster No. 108)
Intraoperative Use of Wide-Field Optical Coherence Tomography to Evaluate Tissue Microstructure in the Oral Cavity and Oropharynx (Poster No. 170)
Andrew Berkeley, Perimeter’s Co-founder stated, "We were excited to present to leading pathologists at CAP22 with data that support the potential use of Perimeter’s OCT medical imaging technology across several tissue types, including the analysis of margins in head and neck surgery. This research helps demonstrate that Perimeter S-Series has the potential to be used in a variety of settings to help ‘bridge the gap’ between the surgeon’s need for immediate ‘real time’ info in the operating room with images that correlate to histological results, with a process that does not interfere with surgical procedures or final pathology."

CANbridge Pharmaceuticals to Participate in Upcoming Investor Conferences

On October 12, 2022 CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, reported that it will take part in two upcoming investor conferences (Press release, CANbridge Life Sciences, OCT 12, 2022, View Source [SID1234621972]).

The Jefferies London Healthcare Conference, November 15-17
The Morgan Stanley 21st Annual Asia Pacific Summit, Singapore, November 16-18
The company’s presentation will be available on the website in the Investor section.

In addition, the company announced that data from a pre-clinical development program in collaboration with UMass Chan Medical School will be presented at:

The ESGCT 29th Congress, in Edinburgh, Scotland, October 13, 3:30 PM BST

Title: Endogenous Human SMN1 Promoter-driven Gene Replacement Improves the Efficacy and Safety of AAV9-mediated Gene Therapy for Spinal Muscular Atrophy in Mice

Type: Oral presentation
Presenter: Guangping Gao, Ph.D., Co-Director, Li Weibo Institute for Rare Diseases Research, Director, the Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems and Penelope Booth Rockwell Professor in Biomedical Research at UMass Chan Medical School

ZAP Surgical Announces Rapid Global Expansion with the First ZAP-X Gyroscopic Radiosurgery Platform Installation in Poland

On October 12, 2022 ZAP Surgical Systems, Inc. reported that the University Hospital in Olsztyn, in collaboration with the University of Warmia and Mazury in Olsztyn, will become the first center in Poland and Eastern Europe to offer completely non-invasive brain tumor treatments with the ZAP-X Gyroscopic Radiosurgery platform (Press release, ZAP Surgical Systems, OCT 12, 2022, View Source [SID1234621971]). System installation has commenced, and first patient treatments are planned to begin in early 2023.

As a completely non-invasive outpatient treatment for select brain tumors and metastatic disease, stereotactic radiosurgery (SRS) is a proven alternative to historical surgical procedures. Unlike surgery however, the SRS procedure requires no incisions and is painless. In most cases patients immediately return to normal activities following SRS.

The recently unveiled ZAP-X radiosurgery system is renowned for its unique use of two axes of motion to direct radiation beams from hundreds of unique angles. This maneuverability allows clinicians to lower incidental radiation exposure to the brain and nearby organs at-risk, thus aiming to lower the potential for patient complications.

"To protect the healthy brain and preserve patient cognitive function, cranial radiosurgery requires exacting precision beyond that which is typical of conventional radiotherapy of the body," says Prof. Dr. Sergiusz Nawrocki, Head of the Department of Oncology and Radiotherapy Clinic at the University of Warmia and Mazury in Olsztyn, and Head of the University Medical College. "From the gyroscopic dual axes design, down to the smallest details, everything about ZAP-X is purpose-built for SRS, and will allow us to better focus high-intensity radiation on tumors while strictly controlling potential radiation exposure of critical structures such as the eyes and brain stem."

The ZAP-X system is the latest advance in surgical robotics and first new dedicated cranial radiosurgery platform in nearly half a century. Prior to ZAP-X, state-of-the-art SRS often required hospitals to house large quantities of costly and dangerous Cobalt-60 for radiosurgery beam generation. ZAP-X eliminates this requirement by using leading-edge linear accelerator technology.

ZAP-X is also the first and only radiation delivery system to eliminate the need for 2-3-million-pound concrete radiation treatment vaults, thereby allowing for exterior treatment suite windows for the first time ever. This breakthrough not only creates a more comfortable patient experience, but also brings world-class SRS to communities previously considered infeasible by significantly reducing healthcare system costs.

Calidi Biotherapeutics to Present Pre-Clinical SuperNova1 (SNV1) Data at the 2022 SITC Annual Meeting

On October 12, 2022 Calidi Biotherapeutics, Inc. (Calidi), a clinical-stage biotechnology company that is pioneering allogeneic cell-based platforms to revolutionize oncolytic virus therapies, reported a poster presentation highlighting pre-clinical data from the company’s SuperNova1 (SNV1) program at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place in Boston, Massachusetts and virtually, November 8-12, 2022 (Press release, Calidi Biotherapeutics, OCT 12, 2022, View Source [SID1234621970]).

Details of the poster presentation are below:

Title: SuperNova1 (SNV1), a novel oncolytic-cell based platform for cancer therapy
Abstract ID: 1137
Location: Poster Hall C
Date: November 10, 2022, 9:00 a.m. – 9:00 p.m. ET
Presenters: Duong H. Nguyen, Ph.D., Director of Translational Research and Innovation, and Antonio F. Santidrian, Ph.D., Senior Vice President, Global Head of Research and Development