On October 13, 2022 Jacobio reported it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio’s KRAS G12C inhibitor JAB-21822 and Merck’s epidermal growth factor receptor (EGFR) inhibitor Erbitux (cetuximab) (Press release, Jacobio Pharmaceuticals, OCT 13, 2022, View Source [SID1234621975]).

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This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.

"Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck," said Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab.

About ERBITUX (cetuximab)

ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

On October 12, 2022 OSE Immunotherapeutics SA reported that three posters have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting which will be held in person and virtually in Boston, MA, November 8 – 12 (Press release, OSE Immunotherapeutics, OCT 12, 2022, View Source [SID1234646961]). The posters will feature the latest preclinical data on the Company’s pioneering drug discovery BiCKI and Myeloid platforms and including BiCKI-IL-7 (bifunctional therapy targeting PD-1 and IL-7) and CLEC-1 (new myeloid immune checkpoint). The Company was also invited for an oral presentation at the Macrophage-directed Therapies Summit of its CLEC-1 program (Boston, October 2022).

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POSTER PRESENTATION DETAILS AT THE SITC (Free SITC Whitepaper) 2022
BiCKI-IL-7v program
– Title: "IL7R TME expression correlates with immunotherapy response and is associated with Tcell stemness with decreased apoptosis" (poster #826)
Presentation date: November 11, 2022

– Title: "Anti-PD-1/IL-7v bispecific antibody promotes TCF1+ stem like T cells expansion and longlasting in vivo efficacy" (poster #1366)
Presentation date: November 11, 2022

CLEC-1 program*
– Title: "Blockade of the myeloid CLEC-1 checkpoint enhances antitumor responses and tumor antigen cross-presentation" (abstract #484)
Presentation date: November 11, 2022

ORAL PRESENTATION AT THE MACROPHAGE-DIRECTED THERAPIES SUMMIT 2022
– Title: "The C-type Lectin CLEC-1 is a Sensor of Cell Death Limiting Myeloid Cell Functions and Anti-Tumor Immunity"
Presentation date: October 4, 2022

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 [SID1234623229]).

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On October 12, 2022 Celyad Oncology (Euronext & Nasdaq: CYAD), a biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported an update on its strategic business model, clinical trial programs, and the related operational and organizational steps and cost-saving measures that it will undertake (Press release, Celyad, OCT 12, 2022, View Source [SID1234623188]).

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Update on Business Model

Celyad Oncology is increasingly focusing on maximizing its valuable intellectual property estate, through research and development efforts where the Company has the greatest expertise. The Company’s U.S. patents around allogeneic CAR T therapy and NKG2D-based therapies provide an avenue to develop intellectual property programs and to partner with outside parties around the licensing of these patents.

The Company continues to leverage the dynamic potential of the shRNA platform, including multiplexing shRNA where multiple genes can be modulated simultaneously, and its potential to serve as a backbone for armored CARs using the proprietary shARC (shRNA armored CAR) franchise which allows to increase the anti-tumor activity of CAR T cells. The Company is currently making progress in multiple discovery programs, including in dual targeting CARs with NKG2D capabilities and an undisclosed target, which could be used to decrease risk of relapse or resistance often observed with traditional single-targeting CAR T approaches.

"As we usher in Celyad 2.0, we are strengthening our efforts on our core assets, a research platform and our intellectual property that will provide long-term value for the Company." said Michel Lussier, interim CEO and director.

Update on Clinical Programs

CYAD-101 – Allogeneic TIM-based, NKG2D CAR T Candidate for Metastatic Colorectal Cancer (mCRC)

Based on a strategic, financial and medical review, taking into account the costs associated with the pursuit of the program and the delays to reach key medical milestones following the resolution of the previous Clinical Hold, the Company has decided to discontinue the development of CYAD-101
There were no new safety concerns leading to this decision
All patients currently on CYAD-101 trials will continue to receive their protocol-defined follow-up
CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T candidate for relapsed or refractory multiple myeloma (r/r MM)

Celyad Oncology continues to evaluate CYAD-211 in the IMMUNICY-1 Phase 1 trial which was developed to validate shRNA technology in the clinic. Data have shown safe use of shRNA to date, and its use as a technology to control Graft-versus-Host disease of allogeneic CAR Ts appears to be a viable approach
Clinical updates are expected by year end

On October 12, 2022, Statera Biopharma, Inc. (the "Company") reported that entered a Binding Memorandum of Understanding ("MOU") with Holobeam Technologies, Inc. ("HOLO"), pursuant to which the Company will acquire a minority interest of twenty-five percent in HOLO for $25 million via the issuance of the Company’s preferred stock or a combination of preferred stock and cash (the "Equity Investment") (Filing, 8-K, Cleveland BioLabs, OCT 12, 2022, View Source [SID1234622091]). In exchange, HOLO will provide a license to the Company to use their technology platform for the identification and treatment of diseases (together with the Equity Investment, the "Transaction"). Furthermore, HOLO will be provided two board seats on the board of directors of the Company upon the consummation of the Transaction. The MOU provides for an exclusivity period of sixty (60) days (the "Exclusivity Period") for negotiating and finalizing a definitive stock purchase agreement and technology license (the "Definitive Agreement"). The consummation of the Transaction is subject to certain closing conditions, including but not limited to the availability of at least $10 million on the balance sheet of the Company at the close of the Transaction for the development of HOLO’s technology and general working capital, approval of the Transaction by a majority of HOLO’s stockholders and the Company’s board of directors, receipt of a fairness opinion by HOLO from an investment bank of its choosing and other customary conditions.

The foregoing summary of the MOU does not purport to be complete and is subject to, and qualified in its entirety by, the MOU attached as Exhibit 10.1 to this Current Report on Form 8-K, which exhibit is incorporated herein by reference.

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