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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On October 12, 2022, LianBio ("LianBio") reported that its partner BridgeBio Pharma, Inc. ("BridgeBio") informed LianBio that Helsinn Healthcare SA, which holds the Truseltiq (infigratinib) New Drug Application ("NDA") in the United States, is permanently discontinuing distribution of the drug and anticipates requesting withdrawal of the NDA in the United States due to business reasons (Press release, LianBio, OCT 12, 2022, View Source [SID1234622047]). Due to the planned withdrawal of the NDA, BridgeBio informed LianBio that it intends to close the ongoing global Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma ("CCA"). Consequently, LianBio is terminating activities related to the PROOF-301 clinical trial in China and no longer plans to pursue development and commercialization of infigratinib in CCA indications in its licensed territories. LianBio intends to continue to support patients who are currently being treated with infigratinib in China under the special Named Patient Program in Hainan Province. LianBio expects to continue the ongoing Phase 2a proof of concept clinical trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 genetic amplification and other solid tumors with FGFR alterations.

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On October 12, 2022 Kineta, Inc. ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it will present a poster on the Company’s anti-CD27 agonist antibody program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Tumor Immunology and Immunotherapy, to be held on October 21-24, 2022 as an in-person event in Boston, Massachusetts (Press release, Kineta, OCT 12, 2022, View Source;utm_medium=rss&utm_campaign=kineta-to-present-anti-cd27-agonist-preclinical-program-at-aacr-conference-on-tumor-immunology-and-immunotherapy [SID1234621989]). Thierry Guillaudeux, Ph.D., Kineta’s Chief Scientific Officer, will be presenting new preclinical data on the company’s anti-CD27 agonist antibodies in development for the treatment of advanced solid tumors.

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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 [SID1234621980]).

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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 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, reported that, as disclosed on uspto.gov, the United States Patent and Trademark Office ("USPTO") has allowed U.S. Patent Application No. 17/720,619, titled "Use of Tivozanib to Treat Subjects with Refractory Cancer" (the "Application") (Press release, AVEO, OCT 12, 2022, View Source [SID1234621979]). AVEO expects to receive a Notice of Allowance for this Application. This Application will potentially issue as a patent in 2022 and will provide patent protection in the United States for the claimed methods of use of FOTIVDA into 2039.

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A Notice of Allowance is issued after the USPTO decides that a patent can be granted from a patent application. The majority of patent applications that receive a Notice of Allowance will issue as a U.S. patent once the issue fee is paid. However, a Notice of Allowance is not a guarantee of patent issuance.

"We are pleased by the progress we have made at the United States Patent and Trademark Office and the continued recognition of FOTIVDA to treat refractory advanced RCC in subjects who have received at least two prior anti-cancer therapies," said Michael Bailey, AVEO’s president and chief executive officer. "When issued, this patent is expected to provide a potential barrier for generic entry. It is part of our broader life cycle management strategy and is designed to extend the commercial opportunity of FOTIVDA, following a long development path and a relatively short exclusivity period since FOTIVDA’s approval by the U.S. Food and Drug Administration in March 2021."

If issued, AVEO plans to list this patent in the United States Food and Drug Administration’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations as it relates to FOTIVDA with an expiration date of November 5, 2039.

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.