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."

On November 21, 2023 OSE Immunotherapeutics reported that the Company has entered into a collaboration with GenDx (a Eurobio Scientific Company, a key player in the field of specialty in vitro diagnostics) to develop and validate a companion diagnostic (CDx) test to support the confirmatory pivotal Phase 3 clinical trial of Tedopi cancer vaccine candidate in preparation in Non-Small Cell Lung Cancer (NSCLC) second line treatment (Press release, OSE Immunotherapeutics, NOV 21, 2023, View Source [SID1234637924]). GenDx, one of the pioneering companies in the HLA field, is developing and marketing innovative molecular diagnostics, in particular in the field of high-resolution HLA typing and related molecular diagnostic testing.

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Under the Master Collaboration Agreement, GenDx will develop and validate a companion diagnostic (CDx) unique test for a predictive immunological biomarker to identify patients with HLA-A*02 genotype (1) who are biological responders to Tedopi epitopes. The CDx test, based on a simple blood sample and Next-Generation Sequencing technologies (NGS), will support the enrolment of eligible NSCLC patient in the upcoming registration pivotal Phase 3 of Tedopi. The objective of this study will be to confirm the efficacy and safety of Tedopi in second line treatment post-immune checkpoint inhibitor (ICI) failure in HLA-A*02 positive NSCLC patients to support Tedopi’s registration in both United States and Europe.

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:

"We are very pleased to have initiated this collaboration with GenDx, the leading high-resolution HLA typing company. This companion diagnostic test is the first step to move forward in selecting HLA-A*02 eligible cancer patients and thus to accelerate the clinical development and regulatory registration of Tedopi as a precision medicine innovative treatment."

Maarten Penning, General Manager of GenDx, says: "In this project, our regulatory expertise, being one of the first IVDR (2) compliant companies, and our extensive knowledge of developing software and reagents for accurate high resolution HLA typing using NGS, come together in the development of a companion diagnostic assay for HLA-A*02. We are very happy to enter in this strategic collaboration with OSE, as we aim to contribute to improve the quality of life and survival of patients.".

In June 2023, OSE Immunotherapeutics had received €1.5 million in non-dilutive funding from Bpifrance – Direction Régionale de Nantes, as part of the "R&D Innovation Loan" program, to support the development of this companion diagnostic for the pivotal Phase 3 clinical trial of Tedopi in NSCLC second line treatment. This upcoming clinical is planned to be conducted in the United States and in Europe.

(1) NSCLC accounts for 85% of all lung cancers and the HLA-A*02 phenotype represents about 45% of the population. Based on selection of patients after ICI failure data, the targeted population for Tedopi in second line is hence considered as rare with high unmet medical needs. Up to 100,000 patients per year are estimated to potentially benefit from Tedopi in 7 major markets across the US, Europe, China and Japan. Tedopi has obtained an orphan drug status designation in the United States and is considered as a precision medicine in Europe for HLA-A*02 positive patients.

(2) IVDR = In Vitro Diagnostic Regulation

About HLA-A*02
The Human Leukocyte Antigen (HLA) system comprises a diverse family of genes and allelic variants crucial for the human immune system, existing in most human cell types and interacting with T cell receptors (TCRs) to activate T cells, inducing adaptive immune responses. HLA typing enables the identification of specific nucleotide sequences. HLA-A*02 is one of the most common Major Histocompatibility Class I molecules in humans (about 45% of the NSCLC patient population). HLA-A*02 system presents tumor antigens as A2 epitopes to T cells to facilitate the immune system to recognize tumor allowing a potent activation of the protective specific CD8+ T cells.