On October 25, 2024 Alterome Therapeutics, Inc., a biopharmaceutical company pioneering the development of next generation, small molecule targeted therapies for the treatment of cancer, reported that data from preclinical studies of ALTA3263, the Company’s potential best-in-class KRAS selective inhibitor, will be presented in a plenary oral session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium, taking place on October 23-25 in Barcelona, Spain (Press release, Alterome Therapeutics, OCT 25, 2024, View Source [SID1234647435]).

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"ALTA3263 induces deep and durable tumor regressions in preclinical models addicted to the most common KRAS mutations, G12D, G12V, and G12C," said Eric Murphy, Ph.D., co-founder and CEO of Alterome Therapeutics. "Mutant KRAS is a driver in approximately 1 out of every 5 cancers and ALTA3263 has the potential to be a robust treatment option for a wide range of KRAS mutant cancers based on its compelling preclinical profile."

Key Findings:

ALTA3263 is an oral, KRAS selective inhibitor designed to enable complete target coverage of the most common mutations including G12V and G12D.
ALTA3263 demonstrates potent KRAS ON-state inhibition, picomolar to low single digit nanomolar potency against cells harboring a diverse array of KRAS driver mutations, and is highly selective for KRAS versus the NRAS and HRAS isoforms.
ALTA3263 induced complete and sustained tumor regressions in 8 KRAS G12V/D/C/A mutant xenograft models, including complete responses in 2 patient-derived xenograft non-small cell lung cancer models, while being well-tolerated during prolonged daily oral dosing in mice.
Oral Presentation Details:

Title: ALTA3263: an oral, KRAS isoform-selective, dual ON/OFF state, non-covalent inhibitor induces regressions across KRAS G12V, G12D, and G12C cancer models
Session Title: Proffered Papers: New drugs on the Horizon
Session Type: Plenary Session 6
Date and Time: Friday, October 25 at 12:36-12:48 p.m. CEST
Speaker/Lead Author: Tim Sen Wang, Ph.D., Alterome Therapeutics

On October 25, 2024 Egle Therapeutics, a biotechnology company focused on advancing the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, reported that it will present at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting taking place in Houston, Texas from November 6th to 10th, 2024 (Press release, Egle Therapeutics, OCT 25, 2024, View Source [SID1234647434]).

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The presentation, entitled "Preferential tumor retention of EGL-001, a CTLA-4/CD25 antagonist fusion protein, to selectively deplete tumor Tregs and minimize peripheral toxicities: towards a first-in-human clinical study", will highlight the development and promising preclinical results of EGL-001, a humanized antibody designed to selectively target regulatory T cells (Tregs) within the tumor microenvironment. The data showcases EGL-001’s potential as single-agent and to enhance the effectiveness of immune checkpoint blockade therapies by depleting tumor-associated Tregs, leading to increased CD8+ T cell activation and anti-tumor responses in preclinical models.

The SITC (Free SITC Whitepaper) presentation will include key findings from studies in mouse models and cynomolgus monkeys, demonstrating the safety, tolerability, and efficacy of EGL-001, as well as its preferential tumor accumulation and rapid clearance from peripheral organs. These promising results leading Egle Therapeutics to conduct a first-in-human open-label, phase I/II trial evaluating the safety, tolerability, PK and preliminary activity of EGL-001 in patients with selected solid tumors, with the goal to address the critical need for more effective immunotherapies in cancer treatment.

Session Date Saturday, Nov. 9 ; Location: George R. Brown Convention Center – Level 1 – Exhibit Halls AB ; Poster Board Number: 674

On October 25, 2024 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid (also known as detalimogene, and previously EG-70) is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), reported that it has agreed to sell 6,758,311 of its common shares at a price per share of $8.90 (Press release, enGene, OCT 25, 2024, View Source [SID1234647433]). The financing is expected to close on October 29, 2024, subject to customary closing conditions. enGene anticipates the gross proceeds from the private placement to be approximately $60 million, before deducting any offering-related expenses.

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The financing included participation from new and existing investors, including Deep Track Capital, Cormorant Asset Management, Forbion, OrbiMed, Sphera Healthcare, Vestal Point Capital and Venrock Healthcare Capital Partners.

enGene intends to use the net proceeds from this financing to fund the continued development of detalimogene, pre-commercial activities, the potential expansion of the DDX platform, and for working capital and general corporate purposes. The proceeds from this financing, combined with current cash and cash equivalents, are expected to be sufficient to fund the current operating plan into 2027.

Leerink Partners, Piper Sandler & Co., Guggenheim Securities and Wells Fargo Securities are acting as placement agents to the Company in connection with the private placement.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. enGene has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the common shares issued in this private placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On October 25, 2024 Traverse Biotech, Inc., a privately held biotechnology company specializing in innovative immunotherapy solutions, reported that it will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting, taking place November 6-10, 2024, in Houston, TX (Press release, Traverse Biotech, OCT 25, 2024, View Source [SID1234647431]). The presentation will showcase preclinical results on TB-Bs1, Traverse’s T-cell engaging product candidate targeting ROR2-positive solid tumors.

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Poster Presentation Details:

Title: ROR2-targeted T-cell engager as a novel therapeutic approach in solid tumors
Abstract Number: 1065
Location: Exhibit Halls A-B, George R. Brown Convention Center
Date: Friday, November 8, 2024
Attending from Traverse Biotech:

Brandy Houser, Ph.D., Co-Founder & Chief Executive Officer
Jing Gong, Ph.D., Director of Strategy and Operations
About TB-Bs1
TB-Bs1 is a first-in-class T-cell Engaging (TCE) bispecific antibody built on the DuoBody platform targeting ROR2. ROR2 is a receptor that has been shown to cause cancer cell proliferation and that has also been identified as a negative prognostic indicator. ROR2 is a member of the receptor tyrosine kinase-like orphan receptor family associated with Wnt signaling. We and others have confirmed ROR2 protein expression in liquid and solid cancers, with TB-Bs1 demonstrating consistent cytotoxic activity against ROR2-positive cancer cell lines. In a humanized mouse model, TB-Bs1 significantly inhibited tumor growth in a dose-dependent manner with minimal adverse effects. These results highlight the potential of TB-Bs1 as a targeted immunotherapy for ROR2-positive cancers.

On October 25, 2024 RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, reported that the US Food and Drug Administration (FDA) has cleared its IND application for the Phase I/IIa Study of RXRG001 (SPRINX-1 Study) on October 25th, 2024 (Press release, RiboX Therapeutics, OCT 25, 2024, View Source [SID1234647430]). RXRG001 is the first-ever circular RNA therapy to receive FDA IND clearance. This important advancement marks a significant milestone as circular RNA drugs advance into the clinical development phase. The first-in-human SPRINX-1 study is designed to evaluate the safety and efficacy of RXRG001 in patients with radiation-induced-xerostomia (RIX) (dry mouth) and hyposalivation (low saliva secretion).

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Xerostomia and hyposalivation are common side effects of radiation therapy in head and neck cancer (HNC) patients. The incidence of HNC is increasing and has become the sixth most common malignant tumor worldwide. Radiation therapy, a main treatment for HNC, often results in damage to salivary glands and a significant decrease in saliva secretion, frequently leading to dry mouth, difficulties in chewing and swallowing, impaired oral health, and diminished quality of life. It has been two decades since the last xerostomia treatment was approved by the FDA. Patients reported that current treatments are ineffective, temporary, and costly. There is a significant unmet medical need to develop a new treatment for xerostomia and hyposalivation.

RXRG001 is a proprietary product developed using innovative circular RNA technology. In recent years, circular RNA has emerged as the next generation mRNA therapy due to its high protein expression efficiency, low immunogenicity, and manufacture stability. RXRG001 consists of the circular RNA coding human aquaporin 1 (hAQP1, a water channel protein of cell membrane), encapsulated in lipid nanoparticles (LNPs). RXRG001 increases saliva production by restoring water permeability via overexpression of hAQP1, therefore it alleviates dry mouth symptoms. Non-clinical studies demonstrated a favorable risk and benefit profile of RXRG001 in animal models. For instance, a single administration of RXRG001 led to a significant increased salivary flow which was sustained for about four weeks.

"RIX is a devastating life-long health issue for patients with HNC. Although radiation therapy improves patients’ survival, its damage to the salivary glands leads to an impaired quality of life of many cancer survivors," said Dr. Yizhen Xu, Chief Medical Officer of RiboX. "RXRG001 may offer a potential effective and sustained therapeutic option for RIX patients. We are excited to conduct clinical trials to further evaluate its efficacy and safety in patients."

"The FDA’s clearance of the IND application for RXRG001 is an acknowledgment of our innovative capabilities, robust technology, and competitiveness in the field of circular RNA therapeutics." Dr. Weiyi Zhang, Chief Executive Officer of RiboX, stated "RiboX will advance the clinical development of RXRG001, continue leveraging the unique advantages of circular RNA technology in therapeutic applications, and introduce more pioneering treatments to patients around the world."