On November 22, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months) (Press release, Can-Fite BioPharma, NOV 22, 2023, View Source [SID1234637898]).

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Liver Cancer designated as hepatocellular carcinoma (HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly for patients with advanced hepatic dysfunction known as disease stage Child Pugh B.

A patient with advanced HCC that was enrolled in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase III clinical study which is now enrolling patients in Israel, Europe and the US. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.

"We are currently enrolling patients for the pivotal Phase III clinical study and hope that if the interim analysis data will be positive, we will be able to get a conditional approval, and that patients who suffer from this devastating disease will enjoy our drug" stated Can-Fite CEO Motti Farbstein.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On November 21, 2023 Oncoteq AG, a clinical stage biotech company specializing in innovative cancer treatments, expands its pipeline with the in-licensing of the small molecule TEQ103 (formerly SERA2) from US biotech incubator, Systems Oncology (Press release, Cureteq, NOV 21, 2023, View Source [SID1234651624]). The agreement represents Oncoteq’s second in-licensing of a potential first-in-class or best-in-class cancer treatment following its transaction with Merck KGaA in 2022. The company will continue to seek opportunities with which to expand its growing oncology-focused pipeline.

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TEQ103 is a first-in-class selective estrogen receptor activator (SERA) that potentially offers a paradigm-shifting treatment approach for patients with breast cancer. TEQ103 utilises a novel mechanism directed towards estrogen receptor alpha (ER), a proven target for the treatment of patients with breast cancer. Through high-affinity binding to ER TEQ103 exerts lethal effects only in cells that have an activated stress response, so-called anticipatory unfolded protein response (aUPR), a feature absent in healthy cells. This pushes a normally protective cellular stress-response pathway into overdrive and rapidly and selectively kills ER-expressing cancer cells. Current ER- targeting ("endocrine") breast cancer treatments act to slow tumor growth by modulating or degrading ER or by lowering estrogen levels and lack selectivity for cancer cells.

Breast cancer is among the most frequent of cancers and annually more than an estimated 350,000 patients lose their lives to the disease. Given that around 80% of all breast cancers express ER, TEQ103 may represent a paradigm shift in treatment for a large group of breast cancer patients.

"We are thrilled by the opportunity to bring forward a potentially highly effective treatment for breast cancer, a disease still characterized by significant unmet medical needs despite recent advances in treatment. We are excited to progress this molecule as fast as possible to clinical testing, knowing that it could be a potential game changer for breast cancer patients in great need", says Mads Dalsgaard, Chief Executive Officer of Oncoteq.

Spyro Mousses, Chief Executive Officer of Systems Oncology, comments: "We are really impressed with the team at Oncoteq and their vision of how to take this molecule forward to a new groundbreaking breast cancer treatment. It is pleasure to hand over the future development to Oncoteq and have them build upon what we started, first and foremost to benefit patients"

TEQ103 is currently in pre-clinical development and Oncoteq will complete the non-clinical data package before advancing the molecule into clinical development in 2025. Oncoteq will firstly prioritize development of TEQ103 as treatment of breast cancer and could later expand to other indications, as the compound has potential as a treatment for several other cancers. Currently, the global market for breast cancer treatments has a value of approximately USD 25-30 billion annually, thus TEQ103 has significant potential not only for patients but also commercially.

Through the deal, Oncoteq obtains a world-wide exclusive license to develop and commercialize TEQ103 in exchange for upfront payment, milestones and royalties.

On November 21, 2023 BroadenBio reported that the company successfully completed the administration of the first patient in Phase I clinical trials of the independently developed, small molecule HPK1 inhibitor BB3008 at the Cancer Hospital Chinese Academy of Medical Sciences (Press release, BroadenBio, NOV 21, 2023, View Source [SID1234640207]). This clinical trial is led by Professor Jing Huang from the Cancer Hospital Chinese Academy of Medical Sciences, which aims to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral BB3008 tablets in patients with advanced solid tumors. Currently, no drug with the same target has been approved for marketing in the world, and all candidates are in the early clinical research stage.

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BB3008 is a highly potent and selective small molecule inhibitor of HPK1 that has been approved by China NMPA and the US FDA. It is currently undergoing phase I clinical trials in China for patients with advanced solid tumors regardless of cancer type. HPK1 is an intracellular immune checkpoint mainly expressed in immune cells (T cells, B cells, dendritic cells, macrophages, and etc.). It is a key negative feedback regulator of the T cell receptor (TCR) signaling pathway and inhibits the immune function of T cells. As a highly selective HPK1 inhibitor, BB3008 activates the anti-tumor function of T cells by blocking the HPK1-mediated negative feedback mechanism of TCR signaling, and breaks through the limitation of insufficient response rates of current immune checkpoint inhibitors. In preclinical studies, BB3008 showed significant tumor-growth inhibition efficacy in various syngeneic mouse tumor models, and synergic anti-tumor effect in combination with PD-1 antibody. BB3008 has good safety profiles, and no immune-related adverse effect has been observed in preclinical animal experiments.

"The successful administration of BB3308 for the first patient means that BB3008, as a clinical drug candidate, has entered the global competition for clinical development on the innovative target HPK1. I would like to express my sincere thanks to the team of Professor Jing Huang from the Cancer Hospital Chinese Academy of Medical Sciences for their strong support, and I am also grateful to the company’s team for their devotion," said Xingmin Zhang, M.D., Ph.D., founder and Chief Executive Officer of BroadenBio. "We look forward to efficiently promoting the clinical research of BB3008 continuously with everyone’s joint efforts and benefiting cancer patients as soon as possible."

On November 21, 2023 Lantern Pharma Inc. ("Company") reported to have entered into separate Securities Purchase Agreements with Bios Fund I QP, LP and Bios Fund I, LP (the "Bios Entities") pursuant to which the Company agreed to purchase from the Bios Entities a total of 145,348 shares (the "Shares") of Company common stock, at a purchase price of $3.44 per share, for a total purchase price of $499,997.12 (Filing, 8-K, Lantern Pharma, NOV 21, 2023, View Source [SID1234637960]). The agreements contain customary representations, warranties, and covenants for agreements of such nature. The transactions under the agreements are expected to close prior to November 30, 2023.

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The Bios Entities are part of a related family of investment partnerships under common control, which collectively beneficially own approximately 14.7% of the Company’s issued and outstanding shares of common stock. The Company was advised by the Bios Entities that their motivation to sell the Shares (i) did not relate to the activities or operations of the Company and (ii) was for the purpose of generating working capital for the operations of the Bios Entities and ensuring adequate liquidity.

On November 21, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the expansion of its $ 20 m beLAB1407 BRIDGE partnership with Bristol Myers Squibb to include the Universities of Bristol and Glasgow as well as Queen Mary University of London (Press release, Evotec, NOV 21, 2023, View Source [SID1234637933]).

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beLAB1407 was launched in 2021 with the Universities of Birmingham, Dundee, Edinburgh and Nottingham as founding partners to identify and advance novel and breakthrough drug discovery opportunities across therapeutic areas. Under the expanded beLAB1407 agreement, the Universities of Bristol and Glasgow as well as Queen Mary University of London will benefit from access to funding, expertise and drug discovery and development platforms spanning multiple disease areas and modalities.

beLAB1407 is one of Evotec’s global portfolio of BRIDGE partnerships. BRIDGEs provide an integrated fund and award framework to validate exciting academic projects in collaboration with Pharma companies and/or venture investors to develop first-in-class therapies that can form the basis of new biotech companies or out-licensing transactions.

Dr Thomas Hanke, EVP Head of Academic Partnerships at Evotec, commented: "UK universities are sources of proven high-quality research to elucidate new therapeutic targets, platforms and candidates. Each of our new university partners brings an impressive biomedical research track record to the table and -through beLAB1407- we look forward to supporting them building strong translational foundations for projects with the potential to yield first-in-class therapies that can positively impact patient care."

Professor Jeremy M. Tavaré, Pro Vice-Chancellor and Executive Dean, Faculty of Health and Life Sciences at the University of Bristol said: "Bristol is a leading University in terms of the depth and quality of its biomedical research and the number of new ventures that are formed to accelerate its translation towards patient benefit. We are excited to be joining the beLAB1047 consortium which will enable us to access world-leading capabilities to support and accelerate the development of potential new therapies and better position these for onward investment."

Uzma Khan, Vice Principal of Economic Development and Innovation at the University of Glasgow said: "The University of Glasgow is delighted to be joining the beLAB1407 consortium which will significantly enhance our ability to generate positive impact in the context of drug discovery and on patient care. This initiative is a hugely important addition to our innovation eco-system in Scotland for biomedical research. It will provide our researchers with access to valuable pharmaceutical industry expertise along with resources that can support the translation of disease-related scientific discoveries into value propositions that can attract investment for further pre-clinical and clinical development."

Dr Phil Clare, Chief Executive Officer, Queen Mary Innovation, commented: "We’re delighted to be joining this exciting partnership, sharing expertise to discover new drugs and bringing them to patients through creating spinouts. Queen Mary University of London is home to one of Britian’s biggest research and teaching hospitals, making us an ideal partner in turning academic research into real world impact."