Immunome to Present Poster Highlighting Preclinical Evaluation of IM-1021, a ROR1-Targeted Antibody Drug Conjugate, at the 36th EORTC-NCI-AACR Symposium

On October 18, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that it will present a poster highlighting preclinical evaluation of IM-1021, a ROR1-targeted antibody drug conjugate (ADC), at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 24, 2024 (Press release, Immunome, OCT 18, 2024, View Source [SID1234647271]).

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Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025.

Following the presentation, a copy of the poster will be made available in the "Events & Presentations" portion of Immunome’s website.

Poster Presentation Details:

Title: Preclinical evaluation of IM-1021, a ROR1-targeted antibody-drug conjugate with a novel topoisomerase I linker payload.

Presenter: Robert Lawrence, Director of Biology, Immunome

Date: October 24, 2024

bioAffinity Technologies Announces Pricing of $2.66 Million Registered Direct Offering & Concurrent Private Placement

On October 18, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, reported it has entered into a securities purchase agreement with institutional investors for the purchase and sale of 2,048,294 shares (the "Shares") of common stock in a registered direct offering at a price of $1.30 per share and, in a concurrent private placement, common warrants (the "Warrants") to purchase up to 2,662,782 shares of common stock at an exercise price of $1.50 per common share (Press release, BioAffinity Technologies, OCT 18, 2024, View Source [SID1234647270]). The Warrants are initially exercisable on the date that the Company’s stockholders approve the exercise of the Warrants and the issuance of the shares upon exercise thereof and will expire five years from the date of such approval.

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The closing of the offering is expected to occur on or about Oct. 21, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $2,662,782 excluding any proceeds that may be received upon the exercise of the Warrants and before deducting placement agent fees and other offering expenses payable by the Company.

WallachBeth Capital is acting as sole placement agent for the offering.

The Shares of common stock will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form S-3 (File No: 333-275608) previously filed with the U.S. Securities and Exchange Commission (SEC), under the Securities Act of 1933, as amended, and declared effective by the SEC on Nov. 27, 2023. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from WallachBeth Capital, LLC, via email at [email protected], by calling +1 (646) 237‑8585, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.

The private placement of the Warrants will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act and/or Regulation D thereunder. Accordingly, the securities issued in the concurrent private placement 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 and such applicable state securities laws.

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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

Evergreen Theragnostics opens CCK2-VIEW, a Phase II small cell lung cancer clinical trial, in the European Union

On October 18, 2024 Evergreen Theragnostics, Inc., a clinical-stage radiopharmaceutical company, focused on providing additional treatment options for cancer patients, reported opening of its trial of 68Ga-EVG321 for patients with small cell lung cancer in the European Union, after receiving approval by the European Medicines Agency (EMA) to start recruitment (EUCT ID # 2024-514584-25-00) (Press release, Evergreen Theragnostics, OCT 18, 2024, View Source [SID1234647269]).

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Radioligand Therapies have become an important treatment option for patients with several tumor indications and represent a rapidly expanding market. By combining the power of medical isotopes and the precision of targeted therapeutics, these types of medicines facilitate cell-specific ablation of a tumor target, localizing ionizing radiation to diseased tissues. They also allow for non-invasive, whole-body quantification of tumor targets, thereby identifying which patients will benefit from treatment. 68Ga-EVG321 targets CCK2R, which has been shown to be highly expressed in SCLC, and has the potential to facilitate robust, tumor-specific delivery.

"We are excited to begin recruitment for our trial in this very important patient population," commented James Cook, CEO of Evergreen Theragnostics. "The EMA response suggests not only the importance of developing novel treatments for patients with small cell lung cancer, but also the need for radioligand therapies to branch out into novel indications with urgency. This Phase II study also validates Evergreen Theragnostics’ innovative drug pipeline, which is built to deliver a suite of differentiated RLTs."

The CCK2-VIEW trial uses 68Ga-EVG321, a peptide-based Radioligand imaging agent administered to patients with small cell lung cancer. It is a multi-center, open label, non-randomized, Phase 2 imaging trial. Its goal is to quantify measurements of 68Ga-EVG321 radioactivity and its whole-body distribution in patients at several time points, forming the foundation for theragnostic applications targeting CCK2R.

"CCK2R represents a significant, untapped opportunity for radioligand therapy drug development," added Dr. Thomas Reiner, CSO for Evergreen Theragnostics. "We are looking forward to further expanding our clinical trial portfolio, including therapeutic trials with 177Lu-EVG321. If successful, a theragnostic 68Ga/177Lu-EVG321 pair could offer new hope to patients with small cell lung cancer.

About 68Ga-EVG321

68Ga-EVG-321 is intended to be a diagnostic agent targeted at CCK2R which enables the use of PET diagnosis for patient selection. This molecule is paired to its radiotherapeutic pair 177Lu-EVG321, which is designed to deliver Lutetium-177, a beta-emitting radioisotope, to solid tumors expressing CCK2R. CCK2R is a protein found on the surface of tumor cells in small cell lung cancer and other indications.

cTRL Therapeutics to Present Novel Data on cTRL Platform at SITC Annual Meeting 2024

On October 18, 2024 cTRL Therapeutics, a biotechnology company advancing next-generation cell therapies for solid tumors, reported two upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2024, taking place November 8-10 in Houston, TX (Press release, CTRL Therapeutics, OCT 18, 2024, View Source [SID1234647268]). These presentations will highlight the therapeutic potential of circulating tumor-reactive lymphocytes (cTRLs), isolated using cTRL’s proprietary IsoQore platform, as a transformative new treatment modality for solid tumors.

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Details of cTRL’s poster presentations at SITC (Free SITC Whitepaper) are as follows:

Title: Anti-tumor activity of circulating tumor-reactive lymphocytes (cTRLs) isolated from checkpoint-refractory melanoma patients that failed TIL manufacturing.
Abstract Number: 401
Date and Time: Friday, November 8, from 9:00 a.m. to 7:00 p.m. CST
Location: Exhibit Halls A & B, George R. Brown Convention Center
Title: Circulating tumor-reactive lymphocytes (cTRLs) isolated from colorectal cancer (CRC) patients are reactive against autologous tumors and show less exhaustion than tumor-infiltrating lymphocytes (TILs).
Abstract Number: 400
Date and Time: Saturday, November 9, from 9:00 a.m. to 7:00 p.m. CST
Location: Exhibit Halls A & B, George R. Brown Convention Center

LaNova Medicines Announces Initiation of Phase 1 Clinical Trial of Anti-PD-1/VEGF Bispecific Antibody LM-299 and Completion of $42 Million Series C1 Financing

On October 18, 2024 LaNova Medicines Limited ("LaNova" or "The Company"), a privately-held clinical-stage innovation-driven biotech specializing in ADCs and immuno-oncology, reported the initiation of its Phase 1 clinical trial of LM-299, an anti-PD-1/VEGF BsAb, in China for advanced solid tumors and the successful completion of its $42 million Series C1 financing (Press release, LaNova Medicines, OCT 18, 2024, View Source [SID1234647267]).

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Founded in September 2019, LaNova’s R&D engine is based on three proprietary platforms adept at tackling challenging targets and versatile modality development, which has so far enabled the in-house development of more than ten innovative programs, including monoclonal antibodies, ADCs and bispecific antibodies.

Following promising preclinical results demonstrating LM-299’s strong inhibition of tumor growth in hPBMCs-humanized mice and well tolerated safety profile in NHP GLP tox study, LaNova has initiated its first-in-human clinical trial in China for advanced solid tumors. LaNova is planning to initiate an additional Phase 1 clinical trial in the US and expects to submit an IND in the second half of 2024.

The completed Series C1 financing was led by Sino Biopharmaceuticals and included participation from new investors Pudong Innovation Investment and Zhangjiang Haoheng, and existing investors, Qiming Venture Partners and Shanghai Healthcare Capital. Zhong Lun Law Firm acted as the legal advisor for this round of financing.

LaNova has recently initiated its Series C2 financing round.

Proceeds will be primarily used to advance the clinical development of the Company’s pipeline, including lead candidates:

LM-302 (anti-CLDN 18.2 ADC): ongoing Phase III registrational clinical trial in China for gastric cancers, making it one of the top three candidates globally in terms of development progress for this target; US Phase II trial expected to start in H2 2025
LM-108 (anti-CCR8 mAb): ongoing Phase II clinical trials in China for multiple solid tumors, making it one of the top three most advanced projects worldwide targeting CCR8; US Phase II trial expected to start in H2 2024
LM-299 (anti-PD-1/VEGF BsAb): Phase I clinical trial in China is currently enrolling patients for advanced solid tumors
Dr. Crystal Qin, LaNova’s founder, chairwoman and CEO, stated: "Since its establishment, LaNova has been dedicated to original innovation, with a focus on the tumor microenvironment and the development of tumor-specific targeted ADCs and immune-modulating biologics. We have established a robust pipeline of differentiated innovative drugs, with independent intellectual property rights and profiles that are competitive on a global scale. We are thrilled to have initiated our Phase 1 trial for LM-299 and completed our series C1 financing round. We are especially grateful for the continued support and confidence of our new and long-standing investors during this challenging period for pharmaceutical investments. Proceeds from this financing will allow us to expedite the development of our late-stage clinical programs, LM-302 and LM-108, moving us closer to market approval. We will also accelerate the clinical development of LM-299, which is currently in Phase 1 clinical trials with best-in-class potential. We look forward to strengthening our partnerships across the industry and enhancing our self-sustainability through business development collaborations. Together, we aspire to bring China’s innovative drugs to a global stage, ultimately providing high-quality treatment solutions to more patients and promoting healthier lives worldwide."