On October 12, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported that it has selected OTX-2101 as the next Omega Epigenomic Controller (OEC) development candidate to advance into Investigational New Drug (IND)-enabling studies for the treatment of non-small cell lung cancer (NSCLC) (Press release, Omega Therapeutics, OCT 12, 2022, View Source [SID1234621977]).

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Omega scientists rationally engineered OTX-2101 to control the expression of the c-Myc (MYC) oncogene, a historically undruggable target in NSCLC. MYC is a master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a significant role in more than 50% of all human cancers. Genetic analysis has revealed that MYC overexpression is present in approximately 60% of NSCLC1. Preclinical data presented at the 2022 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting showed that OTX-2101 potently down-regulates MYC in multiple NSCLC cell lines. OTX-2101 effectively reduced tumor growth in vivo and was well tolerated in murine xenograft models, further supporting its clinical potential. IND-enabling activities for OTX-2101 are underway.

"NSCLC accounts for nearly 25% of cancer deaths worldwide and despite its high prevalence, treatment options are limited. Our approach to epigenomic programming has the potential to address NSCLC by targeting a key oncogene implicated in a broad segment of the patient population. In preclinical studies, OTX-2101 has demonstrated clear anticancer activity supporting its clinical potential and our overall approach to targeting MYC," said Thomas McCauley, Ph.D., Chief Scientific Officer of Omega Therapeutics. "We look forward to advancing OTX-2101 through IND-enabling studies and to continuing to leverage the power of our platform to realize the promise of epigenetics to treat disease."

The OTX-2101 clinical development program will utilize a lung tissue-targeting lipid nanoparticle (LNP) technology exclusively licensed from Nitto Denko Corporation ("Nitto"). This represents the first option exercised by the Company as part of an existing arrangement that provides Omega the option to exclusively license Nitto’s LNP technology for therapeutic development across multiple targets and tissue types.

"This milestone for OTX-2101, which comes on the heels of the MYCHELANGELO I trial initiation for OTX-2002 for the treatment of hepatocellular carcinoma, highlights the power of our OMEGA Epigenomic Programming platform to engineer candidate mRNA therapeutics customized to the biology of the disease," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "Our data-driven platform enables us to rapidly design novel medicines addressing the root cause of disease and tailor our delivery strategy to target the relevant cells and tissues. By leveraging both our internal development efforts and strategic external partnerships, we are able to accelerate clinical development of our OECs, with the goal of bringing innovative new therapies to patients sooner. We are excited to continue to deliver strong execution of our strategy, meet committed milestones, and establish a deep pipeline of promising candidates to treat a broad range of indications."

About OTX-2101
OTX-2101 is a first-in-class Omega Epigenomic Controller in development for the treatment of non-small cell lung cancer (NSCLC). OTX-2101 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. Genetic analysis conducted by others has revealed that MYC overexpression is present in approximately 60% of NSCLC1. Omega is currently evaluating OTX-2101 in Investigational New Drug (IND)-enabling studies.

On October 12, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that preclinical combination data of KRAS inhibitors and nab-sirolimus will be presented during a poster session at the upcoming 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, taking place October 26-28, 2022 in Barcelona, Spain (Press release, Aadi Bioscience, OCT 12, 2022, View Source [SID1234621976]). Nab-sirolimus is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

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KRAS is frequently mutated in non-small cell lung cancer (NSCLC) and other tumor types, with the KRAS G12C present in approximately 9% of NSCLC patients. The mTOR pathway is often activated in patients with the KRAS mutation and contributes to adaptive resistance to KRAS inhibitors. Aadi scientists conducted studies to determine the utility of a combination of the mTOR inhibitor nab-sirolimus and KRAS inhibitors, which could have synergistic potential in the treatment of KRAS mutated cancers.

Sotorasib (AMG510) is approved for the treatment of KRAS G12C-mutated locally advanced or metastatic NSCLC, and adagrasib (MRTX 849) is under review for the treatment of KRAS G12C-mutated NSCLC. This study investigated the antitumor activity of mTOR inhibitors nab-sirolimus or everolimus in combination with sotorasib or adagrasib in KRAS G12C-mutated cancer xenografts.

Results of these studies showed that combining nab-sirolimus with either of the KRAS G12C inhibitors significantly improved response against KRAS G12C mutant lung cancer and bladder cancer tumors in vivo and nab-sirolimus also showed significantly greater potency in the combination compared to everolimus. The nab-sirolimus combinations with sotorasib and adagrasib will be detailed in the upcoming poster.

"Increase in mTOR signaling can cause resistance to KRAS G12C inhibitors. Combination strategies that act through disease-driving pathways, like mTOR and KRAS, are critical to mitigating resistance and providing clinical benefit," said Neil Desai, Ph.D., Founder and Chief Executive Officer of Aadi Bioscience. "These preclinical results demonstrate that nab-sirolimus has the potential to be the preferred mTOR inhibitor in combination with the KRAS inhibitors and we look forward to exploring this approach in the clinic."

The details of the poster presentation are below:

Title: "KRAS G12C mutated NSCLC and bladder cancer xenografts treated with sotorasib and adagrasib in combination with mTOR inhibitors show improved antitumor activity of nab-sirolimus vs everolimus"
Abstract Number: 163
Session Title/Code: Combination Therapies/PP08
Date/Time: Thursday, October 27, 2022, 10am – 5pm
Authors: Shihe Hou, PhD, Jorge Nieva, MD, and Neil Desai, PhD

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.

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:

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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."

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]).

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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