On May 24, 2023 InProTher, an early-stage biotechnology company developing effective immunotherapies targeting the Human Endogenous Retroviruses (HERVs), reported that it has raised EUR 6M Seed funding from private investors, with participation from the European Innovation Council (EIC) Fund (Press release, InProTher, MAY 24, 2023, View Source [SID1234632021]). The financing will enable InProTher to advance its lead drug candidate, IPT001, a first-in-class immunotherapy against solid tumors, into clinical development.

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Incubated at the BioInnovation Institute (BII) and seeded by the Novo Nordisk Foundation, InProTher was established to develop immunotherapies designed to overcome the limitations of cancer vaccines. InProTher is targeting the Human Endogenous Retroviruses (HERVs) to treat cancer. HERVS are well recognized as tumor specific antigens, but until now, have been undruggable. InProTher is targeting HERV tumor antigens with powerful technology that stimulates both arms of the immune system, the humoral and the cellular response. The Company delivers the immunogen by using Adenoviral and RNA vectors.

InProTher has generated robust pre-clinical, proof-of-concept data that demonstrates therapeutic potential for multiple oncology indications including pancreatic, ovarian, breast and prostate cancer. It plans to enter First-In-Human (FIH) trials in 2024.

To support its growth, InProTher has appointed Dr Hamina Patel, MD, as Chief Medical Officer, and Dr Sven Rohmann, MD, PhD, MBA as Chairman of the Board of Directors.

Jordi Naval, Chief Executive Officer of InProTher said: "InProTher is shifting the paradigm in cancer immunotherapy and is at an exciting phase of growth. Our aim is to unlock the full potential of immunotherapy in cancer. We believe InProTher can solve the limitations of current cancer vaccines, as our pre-clinical data has shown that our immunotherapy induces higher tumor control, survival rate and tumor efficacy, compared to other competing approaches. I am very pleased to welcome Sven and Hamina to InProTher. Their expertise and track record of success will be invaluable as we accelerate the development of our lead candidate into clinical development."

Hermann Hauser, the EIC Fund Board member commented: "The EIC Fund has established itself as a strong force in EU deep-tech investments. This unique form of financing via EIC combining grants and equity is proving itself highly attractive to Europe’s most promising start-ups."

Dr Sven Rohmann, newly appointed Chairman added: "I am thrilled to have joined the Board of Directors of InProTher at this time of company expansion. The Company is working on cutting-edge technology at the forefront of cancer immunotherapies, and I look forward to taking this technology into clinics."

Dr Patel has over 20 years of experience in the pharmaceutical industry with proven track record of leadership roles in clinical development, oncology and global commercialization, having previously held positions as Director of Drug Development, Oncology, at Johnson and Johnson, where she helped build a broad and differentiated portfolio of indications for the cancer drug VELCADE. Dr Rohmann is experienced in General Management and leadership and has a track record in raising funds for SMEs and public companies. He has extensive international experience in M&A, business and corporate development, clinical development, strategic marketing and portfolio management in small- and large-scale Venture Capital Financing at Merck, Novartis and MPM Bio IV NVS Strategic Fund.

The Seed round of EUR 6M includes private investors and a convertible loan from EICF. InProTher is planning to raise an additional Series A to finance the pivot from preclinical to clinical development.

On May 24, 2023 BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as BioRay) reported that the Investigational New Drug (IND) application for the clinical trial of its proprietary BRY812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors, has been accepted by the China National Medical Products Administration (NMPA) (Acceptance No. CXSL2300366) (Press release, BioRay Pharmaceutical, MAY 24, 2023, View Source [SID1234632020]).

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LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity. Its involvement in the homeostatic metabolism of zinc in cells and its role in promoting cell growth make it a key factor in tumor metastasis and the epithelial-mesenchymal transformation (EMT) process.

BRY812 is a LIV-1 targeting ADC developed on BioRay’s CysLink technology platform where highly stable conjugation is created through irreversible chemistry. By binding to LIV-1 on the surface of tumor cells, the ADC-target complex enters the tumor cell’s lysosome through endocytosis, releasing small molecule toxins that selectively kill tumor cells. In pre-clinical pharmacological studies, BRY812 demonstrated significant antitumor activity in various tumor models. Compared to other ADCs targeting the same pathway, BRY812 has higher stability in circulation by eliminating payload exchange, delivering toxins more selectively to tumor tissue, which resulted in a superior safety profile in pre-clinical toxicology studies. Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay’s BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.

Dr. Haibin Wang, CEO of BioRay, stated, "Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805. We are committed to finding better therapeutic options for patients living with cancers and immune-mediated diseases. We will continue the research in exploring innovative targets, technologies and therapeutic modalities, including ADCs.

On May 24, 2023 Valo Health, Inc. ("Valo"), the technology company focused on transforming the drug discovery and development process using human-centric data and artificial intelligence, reported that its founder and CEO, David Berry, will present at the Jefferies Global Healthcare Conference on June 7, 2023, at 2:30-2:55 pm ET in New York. Valo is also hosting 1×1 meetings with investors on June 7 (Press release, Valo Health, MAY 24, 2023, View Source [SID1234632019]).

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On May 25, 2023 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported positive Phase Ia data on the oncolytic virus BT-001 for the treatment of solid tumors (Press release, Transgene, MAY 24, 2023, View Source [SID1234632015]).

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Treatment with single agent BT-001 in 18 patients has now been completed with no safety concerns reported. Patients had at least one accessible superficial lesion and were studied in three dose-escalating cohorts. BT-001 stabilized the injected lesions in eleven patients in total: two at the 106 pfu dose (n=6), five at 107 pfu (n=6) and four at 108 pfu (n=6). Furthermore, objective antitumor activity, defined as decrease of injected lesion size of 50% or more, was observed in one patient in the 106 pfu cohort (n=6) and one patient in the 107 pfu cohort (n=6).

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform encoding BioInvent’s anti-CTLA-4 antibody to elicit a strong and effective anti-tumoral response. The drug is currently being evaluated in a Phase I/IIa clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) against solid tumors.

Previously reported Phase I data confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumor activity.

Based on these results, the independent Safety Review Committee (SRC) has now approved initiation of the combination part of the trial with pembrolizumab. The first patient in this Phase I part B is expected to be enrolled in H2 2023.

"These data are a further positive indication of the efficacy of BT-001 against solid tumors. While the advanced disease setting of this first in human trial did not allow long-term monitoring of patients, the effect on injected lesions has the potential to translate into the induction of a systemic immune response, antitumor effect and ultimately clinical benefit in combination with pembrolizumab. There were no safety concerns and antitumor activity was observed even at the lowest dose. We are looking forward to investigating BT-001 further in combination with pembrolizumab," commented Martin Welschof, CEO of BioInvent and Dr. Alessandro Riva, Chairman of Transgene.

On May 24, 2023 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), reported that the United States Patent and Trademark Office recently issued a patent to Cantex Pharmaceuticals, Inc. that covers claims related to the use of azeliragon as a potential treatment of glioblastoma multiforme (GBM) (Press release, vTv Therapeutics, MAY 24, 2023, View Source [SID1234632014]). Azeliragon is a small molecule inhibitor of the receptor for advanced glycation end products (RAGE) discovered by vTv and licensed to Cantex Pharmaceuticals. Cantex has ongoing azeliragon clinical trials in metastatic pancreatic cancer, neoadjuvant therapy of breast cancer, and hospitalized COVID patients to prevent acute kidney injury, and will soon initiate FDA-approved clinical trials of azeliragon in newly diagnosed glioblastoma, and in brain metastases in combination with stereotactic radiosurgery. Earlier this year, Cantex received Food and Drug Administration Orphan Drug Designation for azeliragon for the treatment of glioblastoma.

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On June 22, 2021, vTv and Cantex entered into a licensing agreement under which Cantex obtained exclusive worldwide rights to develop and commercialize azeliragon. Under the terms of the agreement, the companies will allocate downstream profits under a tiered arrangement if successfully developed and launched.

Prior to the Cantex agreement, vTv was developing azeliragon for the treatment of Alzheimer’s disease. Through these efforts, vTv generated a significant body of clinical data supporting the safety and tolerability profile of azeliragon. Evidence suggests that RAGE—ligand interactions play a vital role in cancer, as well as in a range of inflammatory diseases.

"We would like to congratulate Cantex on receipt of this important addition to the azeliragon patent estate covering its use as a potential therapy for GBM. Coupled with the Orphan Drug Designation granted for this indication in early 2023, Cantex is building robust protections around this novel small molecule RAGE inhibitor, aimed at maximizing the commercial opportunities for azeliragon should its clinical development be successful," said Paul Sekhri, President and Chief Executive Officer of vTv Therapeutics. "We will be closely following the ongoing GBM study as well as Cantex’s development efforts in other indications where RAGE is implicated."

About Azeliragon
Azeliragon is an orally administered small molecule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the glioblastoma microenvironment. By preventing interaction of RAGE with these ligands, azeliragon may inhibit glioblastoma and overcome its resistance to effective treatment. Azeliragon was originally under development for Alzheimer’s disease by vTv Therapeutics from whom Cantex licensed it. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex is also developing azeliragon for the treatment of brain metastasis, pancreatic cancer, and breast cancer. In addition, a phase 2/3 trial is currently enrolling hospitalized COVID-19 patients, evaluating the efficacy of azeliragon in the prevention of acute kidney injury.