On October 24, 2023 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported that the company will be presenting 16 posters and exhibiting at booth 223 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual conference, taking place from November 1-5, 2023 in San Diego, CA (Press release, Biocytogen, OCT 24, 2023, View Source [SID1234636315]).

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The poster presentations will highlight 9 drug assets and 7 gene-edited humanized mouse models:

Bispecific Antibody-Drug Conjugate Assets

DM001: A novel bispecific ADC targeting TROP2 and EGFR with potent anti-tumor efficacy in PDX models
Poster number: 1152
Date: November 4th, 2023

Preclinical evaluation of fully human bispecific antibody-drug candidates targeting HER3 and the juxtamembrane region of MUC1
Poster number: 1165
Date: November 3rd, 2023

DM005, an EGFR х MET bispecific antibody-drug conjugate, showed robust anti-tumor activity in PDX models
Poster number: 1150
Date: November 4th, 2023

BSA01, a bispecific antibody-drug conjugate targeting EGFR and membrane-bound MUC-1-C, exhibits anti-tumor efficacy in vivo
Poster number: 1164
Date: November 4th, 2023

BCG022: A HER3×MET bispecific antibody-drug conjugate (BsADC) targeting key mechanisms of bypass resistance in multiple tumor types
Poster number: 1153
Date: November 3rd, 2023

A novel bispecific antibody-drug conjugate targeting PTK7 and TROP2, BCG033, demonstrates preclinical efficacy against triple-negative breast cancer xenografts
Poster number: 1163
Date: November 3rd, 2023

TCR-mimic Antibody Assets

Identification of fully human TCR-mimic antibodies targeting the KRAS G12V/HLA complex generated in HLA-transgenic RenMab mice
Poster number: 1168
Date: November 4th, 2023

Preclinical application of a fully human TCR-mimic antibody developed to target NY-ESO-1/HLA-A02
Poster number: 356
Date: November 4th, 2023

Fully Human Monoclonal Antibody Asset

Fc-competent fully human anti-TIGIT blocking monoclonal antibodies demonstrated potent anti-tumor efficacy in preclinical models
Poster number: 479
Date: November 3rd, 2023

Off-the-Shelf Mouse Models – Humanized Mice

Development of a preclinical CD98HC mouse model for therapeutic studies
Poster number: 13
Date: November 3rd, 2023

Generation and validation of humanized GARP/TGFB1 mice for testing novel anti-human GARP antibodies
Poster number: 18
Date: November 4th, 2023

Humanized CD200/CD200R mice as a tool for evaluating novel therapeutics
Poster number: 12
Date: November 4th, 2023

Humanized ICOS mice as a novel tool for predicting and monitoring T-cell-mediated immunotherapy response
Poster number: 11
Date: November 3rd, 2023

Humanized NKP46 mouse models for testing novel NK cell-based immunotherapies
Poster number: 17
Date: November 3rd, 2023

Preclinical CD3-based mouse models for evaluation of bi-specific T-cell engager antibodies
Poster number: 19
Date: November 3rd, 2023

Off-the-Shelf Mouse Models – Immunodeficient Target Humanized Mice

A novel B2m-deficient immunodeficient model expressing human IL-15 for preclinical evaluation of T cell and NK cell-based therapies
Poster number: 16
Date: November 4th, 2023

To explore licensing and collaboration opportunities for drug assets, fully human antibody/TCR discovery platforms, off-the-shelf animal/cell models, or preclinical pharmacology services, please visit booth 223.

On October 24, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-drug conjugate therapeutics for cancer, reported that management will be participating in one-on-one meetings with investors at the Wells Fargo 2023 Virtual Private Biotech Symposium on Wednesday, November 1, 2023 and at the Piper Sandler 35th Annual Healthcare Conference from November 28 – November 30, 2023 (Press release, ProfoundBio, OCT 24, 2023, View Source [SID1234636314]).

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"We look forward to participating in these conferences to discuss our emerging clinical data from SITC (Free SITC Whitepaper) and company growth plans with investors" said Baiteng Zhao, PhD, CEO of ProfoundBio. "This is an exciting time for ProfoundBio as we explore the potential for our innovative ADC technology platform in the clinical setting."

On October 24, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that it has entered into a definitive agreement with a single healthcare focused investor for the issuance and sale of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying class A warrants and class B warrants (Press release, Coeptis Therapeutics, OCT 24, 2023, View Source [SID1234636313]). The gross proceeds to the Company from the private placement are expected to be $2,000,000, before deducting the placement agent’s fees and other offering expenses payable by the Company. The private placement is expected to close on or about October 26, 2023, subject to the satisfaction of customary closing conditions.

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Ladenburg Thalmann & Co. Inc. is acting as exclusive placement agent in connection with the offering.

The warrants will have an exercise price $1.36 per share and exercise period commencing immediately upon the earlier of shareholder approval or six months from the issuance date, and a term of eighteen months (with respect to the class A warrants) and five and one-half years (with respect to the class B warrants).

The Company currently intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The securities were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and/or Rule 506(b) of Regulation D promulgated thereunder and have not been registered under the Act, or applicable state securities laws. Accordingly, the 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 Act and such applicable state securities laws.

Under an agreement with the investor, the Company is required to file an initial registration statement with the SEC covering the resale of the shares of common stock and the warrant shares issuable upon exercise of the warrants to be issued to the investor in the private placement no later than 20 days after today and to use best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after the filing of the initial registration statement in the event of a review by the SEC.

In connection with the Offering, the Company has also agreed to reduce the exercise price of warrants held by the healthcare focused investor to $1.36 and the exercise period commencing immediately upon the earlier of shareholder approval or six months from the closing date of the Offering.

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

On October 24, 2023 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") reported that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA) (Press release, BioRay Pharmaceutical, OCT 24, 2023, View Source [SID1234636312]). This marks BioRay’s first project to receive FDA IND approval.

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BR105 Injection is a humanized monoclonal antibody developed in-house, specifically targeting SIRPα. It can recognize common genotypes of SIRPα (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47, thereby abolishing the "don’t eat me" signal between macrophage and tumor cell. This activation enables macrophages to perform their tumor-phagocytosing function, achieving anti-tumor immunotherapy.

The efficacy of targeting CD47/SIRPα has been validated in various tumor models, and previous clinical studies suggest that targeting the CD47/SIRPα signaling pathway may have a broad spectrum of anti-tumor activity. CD47/SIRPα-targeted therapy has shown positive results in acute myeloid leukemia, lymphoma, head and neck squamous cell carcinoma, gastric cancer, and other malignancies.

Compared to CD47, the expression of SIRPα is more specific. By targeting SIRPα instead of CD47, BR105 exhibits enhanced safety profile intrinsically. Additionally, CD47 interacts with other proteins, such as TSP-1, SIRPγ, leading to a more complex signaling network and increased risks in corresponding targeted therapies. Therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway is a more promising strategy in oncology drug development. Currently, no medicine targeting SIRPα has been approved in the global market.

Phase I clinical trial of BR105 Injection is currently on-going in China, and preliminary result has confirmed its good clinical safety.

"Based on our global strategic layout of innovative drugs, the FDA IND approval of BR105 Injection as our first FDA approved clinical trial project is a significant milestone for BioRay. Currently, fierce competition exists in the global innovative drug discovery and development arena, where innovation is indispensable. BioRay continues to invest heavily in innovation and build a rich pipeline of innovative biopharmaceuticals," said by Dr. Wei Zhu, Chief Medical Officer of BioRay. "We look forward to transforming these pipelines and BR105 into best-in-class therapies in autoimmunology and immuno-oncology, benefiting an increasing number of patients both in China and overseas."

On October 24, 2023 Caris Life Sciences(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, reported a new agreement with Moderna (NASDAQ:MRNA) in support of Moderna’s oncology and novel therapeutics initiatives (Press release, Caris Life Sciences, OCT 24, 2023, View Source [SID1234636311]).

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Through this multi-year agreement, Moderna will leverage Caris’ vast library of de-identified, multi-modal data solutions derived from whole exome sequencing, whole transcriptome sequencing and protein analyses along with claims data to enhance development strategies for Moderna’s oncology pipeline, including facilitation of optimal clinical trial design, discovery of novel biomarkers and characterization of resistance mechanisms.

"Partnering with Caris Life Sciences will support Moderna’s oncology portfolio with clinico-genomics data from Caris’ industry-leading and comprehensive suite of integrated precision medicine capabilities," stated Praveen Aanur, MD, MPH, MBA, Vice President, Oncology Therapeutic Area Head of Moderna.

"We are thrilled to partner with Moderna to impact and advance the field of cancer treatment with mRNA medicines, with a common goal of improving patient lives," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "The aggregate strength of our combined molecular, data science and therapeutics technologies will support the predictive modeling of patient responses to therapies, and more generally, may help improve the probability of technical and regulatory success of Moderna’s innovative medicines."

As the pioneer in precision medicine and molecular profiling, Caris has created the largest clinico-genomic database coupled with cognitive computing to unravel the molecular complexity of disease. Caris was the first in the industry to provide Whole Exome Sequencing DNA coverage and Whole Transcriptome Sequencing RNA coverage (WES / WTS) for every patient.