On April 18, 2023 BullFrog AI Holdings, Inc. (Nasdaq: BFRG) ("Bullfrog AI" or the "Company"), a digital technology company using machine learning to usher in a new era of precision medicine, reported an exclusive license agreement with Johns Hopkins University for prodrug compositions of mebendazole (Press release, Bullfrog AI, APR 18, 2023, View Source [SID1234635572]). The exclusive license was signed on October 13, 2022.

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The world-wide, royalty-bearing license includes the rights to commercialize N-substituted prodrugs of mebendazole that demonstrate improved solubility and bioavailability relative to the parent compound. The license covers prodrug compositions and use for treating disease as claimed in multiple US and worldwide patent applications.

"This asset is another key addition to our oncology development pipeline and provides us with an opportunity to demonstrate how our AI/ML technology can turn promising drug candidates into tangible therapies in a cost-effective and efficient manner," said BullFrog AI’s founder and CEO, Vin Singh, "We are extremely proud of our expanding relationship with Johns Hopkins. We look forward to working with strategic partners to advance the development and monetize this promising asset for the treatment of glioblastoma and possibly additional oncology indications."

On April 13, 2023 Kelun-Biotech, a subsidiary of China’s Kelun Pharmaceutical is collaborating with Panolos Bioscience, a South Korean biotech company, join forces to develop a dual-targeted immune-oncology drug named PKB01 (Press release, Kelun, APR 18, 2023, View Source [SID1234633690]). The partnership aims to combine Kelun-Biotech’s immunotherapy candidate with Panolos’ multiple specific drug generation platform. The focus will be on optimizing the candidate material for preclinical studies, with clinical trials planned for the following years.

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Panolos will acquire global development and commercialization rights for the candidate material, excluding China, and will secure a portfolio of immune-oncology pipelines with First-In-Class potential. Kelun-Biotech’s immunotherapy candidate material is an immune checkpoint inhibitor that targets immune checkpoint molecules expressed in immune and cancer cells. The specific target information for this candidate material has not yet been released.

The dual-targeted therapy PKB01 aims to suppress tumor growth by targeting VEGF family members and enhance immune activation by inhibiting immune checkpoint molecules. This therapy may also overcome drug resistance, a limitation of current monotherapy treatments. Panolos and Kelun-Biotech hope to develop next-generation dual-targeted anti-cancer drugs that combine the advantages of both companies’ technologies to help cancer patients.

In Apr 06, Kick off ceremony, Panolos CEO, Dr. Hyeseong Lim said "Our collaboration aims to revolutionize immuno-oncology and give new hope to cancer patients around the world. Created by the combination of Panolos’ αART platform and Kelun-Biotech’s proprietary information of anti-PD-1, PKB01 will have an unique opportunity to create a strong dual-target therapy that will overcome current treatment limitations. This close partnership will benefit both companies, and ultimately benefit all the patients we serve".

On April 18, 2023 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported a Premarket Approval (PMA) application for its Lumicell Direct Visualization System (DVS) has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Lumicell Diagnostics, APR 18, 2023, View Source [SID1234630292]).

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The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity. The New Drug Application (NDA) for LUMISIGHT was submitted to the FDA in March 2023.

"The PMA submission for our Lumicell Direct Visualization System is the culmination of years of hard work from all of our clinical trial investigators and the Lumicell team," said Kevin Hershberger, president and chief executive officer of Lumicell. "This major milestone brings us one step closer to revolutionizing the way breast cancer surgery is performed and delivering meaningful clinical benefits to surgeons and patients."

The Lumicell DVS submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (NCT03686215) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy.

"The current standard of care focuses on tissue that has already been removed instead of inside the patient where it matters," said Irene Wapnir, MD, professor of surgery at Stanford University School of Medicine and investigator of the INSITE clinical trial. "A device like the Lumicell DVS which can look inside the breast cavity for residual cancer could be a crucial tool to help improve patient outcomes."

About the Lumicell Direct Visualization System

The investigational Lumicell Direct Visualization System (DVS) is intended for use with the investigational LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS and LUMISIGHT are not commercially available.

On April 18, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME) (Paris:ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported the successful closing of a financing of €2 million (Press release, TME Pharma, APR 18, 2023, View Source [SID1234630291]). The financing extends the company’s cash runway into December 2023, sufficient to reach its next major inflection points and to allow further advance its ongoing GLORIA Phase 1/2 clinical study of NOX-A12 combination therapies in newly diagnosed brain cancer (glioblastoma) patients.

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The transaction involves: 1) a €1 million equity financing at the price of €1.04161 per share from a group of new investors, 2) a drawdown of €1.08 million under agreement with Atlas Special Opportunities, LLC (ASO) by issuing 1,100 convertible bonds, 3) the conversion of €2 million (~48%) outstanding convertible bonds held by ASO into newly issued shares at a conversion price of €1.04161 per share, 4) a soft lock-up of all shares issued through this transaction for a 6-month period, and 5) a lock-up of all remaining convertible bonds for a 6-month period.

Moreover, the company will not draw any further tranches from the ASO convertible bond vehicle and the agreement with ASO is terminated other than with regard to already issued convertible bonds. TME Pharma is also studying options to be able to repurchase the remaining convertible bonds, as allowed under the agreement, to prevent conversion to shares.

"We are very pleased to announce the details of a successful transaction concluded with a group of new investors and Atlas, which extends our cash runway into December 2023," said Aram Mangasarian, CEO of TME Pharma. "This innovatively-structured transaction represents the first step in the commitment we made to our shareholders to end reliance of the company on convertible bond financing. By removing the pressure of convertible bonds, we hope our exceptional therapeutic assets will be able to reach a valuation on the market that reflects their therapeutic potential. We estimate the addressable market for first line glioblastoma to be $2.5 billion per year. We would like to thank Atlas for their support in facilitating the transaction and welcome our new investors who showed their confidence in TME Pharma through this latest financing. This will enable us to maintain our focus on our goal of developing novel therapies for cancer patients and bringing them to market."

The convertible bond agreement with ASO was initially entered on April 23, 2020, and amended on October 14, 2020, December 29, 2021, May 19, 2022, and April 17, 2023.

The characteristics, terms and conditions and dilution resulting from the transaction may be found in the Annex to this press release.

On April 18, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported the peer-reviewed publication of original research article in this month’s issue of Molecular Cancer Therapeutics (volume 22, issue 4), a renowned American Association of Cancer Research (AACR) (Free AACR Whitepaper) journal that publishes translational research studies focused on the discovery and preclinical development of therapeutic agents for oncology (Press release, MAIA Biotechnology, APR 18, 2023, View Source [SID1234630290]). The preclinical study, entitled "Activating an Adaptive Immune Response with a Telomerase-Mediated Telomere Targeting Therapeutic in Hepatocellular Carcinoma," showed highly potent anticancer activity of THIO in multiple HCC preclinical models.

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The study revealed the anti-tumor immune response role of THIO as a telomerase-dependent telomere targeting therapeutic in HCC models. THIO induces telomere damage and activates the cGAS-STING pathway, which is a major intracellular signaling pathway that plays a role in innate immune responses. THIO enhances the cross-priming capacity of dendritic cells (DCs), which are antigen presenting cells of the adaptive immune system and activates tumor specific T cells. Observed potent anticancer activity is taking place in CD8-positive T cell dependent manner. Moreover, the study showed a potential role of immunogenic protein molecule HMGB1 (high-mobility group box 1, which are released during cancer cell death), in THIO induced T cell activation. In addition, the study demonstrated enhanced efficacy and durability of complete tumor regression when THIO is followed by administration of immunotherapies (an anti-PD-1 or anti-PD-L1) and anti-VEGF (anti-vascular endothelial growth factor, one of the major anti-angiogenic drug target) in advanced, resistant HCC tumors providing a strong scientific rationale for a clinical trial in HCC.

"The knowledge gained from this study will help support our understanding of the compound’s mechanism of action and its broad therapeutic utility. Moreover, this publication strengthens our scientific rationale already included in our current clinical development plan for THIO-102, a Phase 2 clinical study in multiple solid tumor indications, including HCC," said MAIA’s Chief Scientific Officer Sergei Gryaznov, Ph.D.

"The findings from our study provides solid rationale for THIO to be evaluated as a treatment of liver cancer, as our Company already holds the US FDA Orphan Drug Designation for this clinical indication. This published evidence supports our strong belief that THIO, especially in combination with immune checkpoint inhibitors and other standard of care agents, may be clinically studied for treatment of various forms of cancer," added Vlad Vitoc, M.D., MAIA’s Chief Executive Officer.

The full results are available in Molecular Cancer Therapeutics and online here.