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Targovax and Oslo University Hospital announce collaboration to test TG mutant RAS vaccination in multiple myeloma

On May 10, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical trial collaboration agreement with Oslo University Hospital (OUS) to run a phase 1/2 study testing polyvalent mutant RAS vaccine TG01 in multiple myeloma (MM) following standard of care (SoC) therapy (Press release, Targovax, MAY 10, 2022, View Source [SID1234614005]).

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Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers and remain a major unmet medical need with few good treatment alternatives. Targovax was recently awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG mutant RAS cancer vaccine program. These grants include funding towards several clinical studies, of which the first to open will be a TG01 phase 1/2 trial in MM patients with relevant KRAS and NRAS mutations (approx. 15-20% of MM patients) to be run in Oslo, Norway.

The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated MM patients who continue to have measurable disease after completion of SoC treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response. OUS will sponsor and be responsible for running and funding the trial, with Dr. Schjesvold as the principal investigator. Targovax will provide TG01 drug supply, scientific support and financial contribution.

Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population. Prior data clearly demonstrates the capability of TG01 to induce robust anti-RAS T-cell responses and eliminate residual disease in cancer patients, and suggest that TG vaccination could be a valuable tool to deepen and prolong responses in multiple myeloma. Being a Norwegian product makes it particularly interesting, and we very much look forward to collaborating with Targovax to test this concept in practice at our center."

Earlier in 2022, Targovax announced a collaboration with Agenus to utilize their proprietary vaccine adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix and Mosquirix vaccines. QS-21 should further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. The OUS trial will be the first study in patients of TG01 adjuvanted by QS-21.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "Following promising data from the first generation TG01 vaccine in pancreatic cancer, we have focused on enhancing our mutant RAS platform and establishing a cost-efficient, collaborative development plan to bring the program forward. We are now ready to bring TG01 back into the clinic in a new and improved format and are excited to work with Dr. Schjesvold and his team to assess the potential of TG01 in multiple myeloma. This trial will be the first step in a broader exploratory program with multiple collaboration partners aimed at testing TG01 vaccination in various RAS mutant cancer types and treatment combinations."

Step Pharma Strengthens Clinical Development Team Ahead of First in Human Studies

On May 10, 2022 Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective oral treatment of cancer, reported that it has strengthened its clinical development team with the appointment of Dr. Brian Schwartz as Chief Medical Officer and Dr. Maureen Higgins as Vice President and Head of Clinical Operations, as it continues to advance STP938, its lead CTPS1 inhibitor, towards clinical studies in haematological malignancies (Press release, Step Pharma, MAY 10, 2022, View Source [SID1234614004]).

Dr. Brian Schwartz brings more than 25 years of experience in drug development in the pharmaceutical and biotechnology industries, in areas including oncology, haematology and rare diseases. Dr. Schwartz previously served for twelve years at ArQule, where he was Chief Medical Officer and Head of Research and Development and led clinical development of the BTK inhibitor ARQ 531 before the company’s $2.7 billion acquisition by Merck in 2020. His previous roles also include CMO and Senior Vice President, Clinical and Regulatory Affairs at Ziopharm, where he oversaw the development of new cancer drugs. Earlier in his career, he held leadership roles at Bayer Healthcare and Leo Laboratories. Alongside his role at Step Pharma, Brian will continue to act as a consultant to other biotech companies, and also serve on the boards of Mereo BioPharma, Enlivex, Cyclacel Pharmaceuticals and Infinity Pharmaceuticals.

Dr. Schwartz, who practiced medicine prior to his career in the biopharmaceutical industry, holds a medical degree from the University of Pretoria, South Africa, and completed a fellowship at the University of Toronto, Canada.

Dr. Maureen Higgins has 30 years of experience in clinical research in project management, clinical operations, and business development within both the pharmaceutical and CRO sectors. Dr. Higgins was previously VP for Project Management at Precision for Medicine. Prior to that, she served as Director for Project Management at Chiltern Oncology, overseeing studies and leading project managers in the conduct and delivery of early phase oncology studies, and as Project Director at PRA Health Sciences, UK, where she project-managed early- and late-phase oncology, and neurology studies. She was also Director for Business Development at CroMedica and an Internal Business Consultant at Quintiles, where she also served as Head of Operations in South Africa.

Dr. Higgins holds a B.Sc. in Biology from Bristol Polytechnic, a Ph.D. in Molecular Developmental Genetics from the University of Edinburgh, where she also completed her post-doctoral fellowship in Molecular Biology and an MBA from Strathclyde Graduate Business School.

Andrew Parker, Chief Executive Officer of Step Pharma, commented: "On the eve of Step Pharma progressing into the clinic with STP938, we are delighted to have made such strong clinical operations appointments in Brian and Maureen. Step Pharma are the world leaders in CTPS1 inhibition, a novel approach that we believe could allow us to selectively target cancer cells, not only in our core focus of haematological cancers but in a combination setting in solid tumours as well."

Dr. Brian Schwartz, Chief Medical Officer, commented: "Researchers have been trying to target pyrimidine synthesis for decades to treat cancer without success, but with Step Pharma’s CTPS1 approach I believe we have the breakthrough. I am delighted to be joining such an experienced team at this pivotal time for the company."

Dr. Higgins, VP, Head of Clinical Operations, commented: "Step Pharma is the world leader in CTPS1 research and with its strong scientific heritage, outstanding team and high-quality investors has the clear recipe for success. I am excited to support the company take the next important clinical step in its development."

Ingenium Therapeutics applies for domestic phase 2 of Memory-NK cell therapy

On May 9, 2022 Ingenium Therapeutics reported that it has applied to the Ministry of Food and Drug Safety for phase 2 clinical trials of ‘Memory-NK’ cell therapy for relapsed acute myeloid leukemia (AML) (Press release, Ingenium Therapeutics, MAY 9, 2022, View Source [SID1234643521]).

This phase 2 will be conducted at three medical institutions in Korea, including Asan Medical Center in Seoul, Samsung Medical Center, and St. Mary’s Hospital in Seoul. The goal is to complete clinical trials and receive conditional approval in 2024.

According to the company, chimeric antigen receptor T cell (CAR-T) treatment is commercially available for lymphocytic leukemia, but there is currently no specific treatment for relapsed AML. Accordingly, it is expected that Memory-NK treatment will provide an innovative treatment method.
Ingenium’s Memory-NK cell therapy product is expected to have strong anti-cancer properties due to its high expression level of surface-activated receptors and high levels of ‘interferon gamma (IFN-r)’. It was said that cell viability was also high, overcoming the problem of short in vivo survival period, known as a limitation of existing NK cell treatments.

Ingenium said that it confirmed the therapeutic efficacy and safety of Memory-NK cells in a clinical trial conducted by researchers on about 100 patients with recurrent AML. It was said that the anti-cancer treatment potential was also confirmed in animal test models of solid cancers such as lung cancer, liver cancer, and colon cancer. Ingenium plans to formulate and conduct clinical trials of Memory-NK for the treatment of solid tumors in the future.

In addition, basic research on ‘CAR-NK’ and ‘NK engager’ is also being conducted to increase the effectiveness of Memory-NK. Preclinical research is also underway for a self-developed peptide (IGTN13) that has been shown to increase the anti-cancer effect of NK cells. We plan to begin clinical trials of additional candidate substances sequentially within two years.

Ingenium completed ‘Pre-Series A’ funding worth 5.7 billion won in March. We plan to recruit investors for Series A by September.

STROMACARE HAS RAISED € 1.500.000

On May 9, 2022 StromaCare reported a fundraising of €1,500,000 from Sham Innovation Santé (Advised by Turenne Groupe), Kréaxi, and Crédit Agricole Création (Press release, Stroma Care, MAY 9, 2022, View Source [SID1234640990]).

Stromacare is developing a new therapy in oncology based on the immuno-modulation of the tumor stroma using a monoclonal antibody. The tumor stroma is a reaction of the tissue in which the tumor is growing, which inhibits the CD8 T cells and creates a physical barrier preventing access of immune system and therapeutic molecules to the tumor. An overexpressed protein is at the origin of this stromal barrier. Thanks to a specific antibody directed against this protein, we are able to reactivate CD8 T lymphocytes and modulate the stroma stiffness, allowing them to reach and act on the tumor and facilitate the action of other therapies. This new approach opens the way to considerable clinical developments, the stroma being common to all solid cancers.

The company leverages the results of proof of concept in animals carried out by the team led by Dr Ana Hennino, Laureate of the Béatrice Denys Foundation 2021, within INSERM-CRCL, the CNRS, the University of Lyon and the Leon Bérard Center. Her laboratory is internationally recognized for its work on the stroma and is considered as a pioneer in this field. It has been granted with several awards of excellence.

Stromacare has signed an exclusive worldwide license with Inserm Transfert covering a portfolio of three patent families and all the know-how developed.

Ana Hennino, co-founder and CSO announces: "We have shown that the use of this antibody is capable of significantly increasing the survival of animals with solid stromal cancer, alone and in combination with other therapies. Our purpose is now to go to the "First in Human" clinical phase in order to evaluate our product and offer an innovative therapy to cancer patients".

Pierre-Olivier Goineau, co-founder and CEO declares: "The work carried out by Ana is remarkable; it opens up truly innovative therapeutic perspectives in oncology. I would like to thank the funds and the business-angels who trusted us from this stage. Thanks to these new shareholders, this fundraising will be supplemented by "innovation" loans and will make it possible to develop the antibody and refine our regulatory preclinical plan as well as our clinical plan. »

Camille Darcissac (Turenne Groupe) states: "Laureate of our Béatrice Denys Foundation, we were quickly convinced by the relevance and robustness of the approach, targeting the tumor stroma, developed by Ana. The innovation brought by Stromacare is unique and bears considerable therapeutic promises for patients suffering from solid tumors. Combined with Pierre-Olivier’s extensive experience in biotech development, Stromacare has the necessary assets to conduct its preclinical development and prepare its clinical plan. »

Isabelle Bou Antoun (Chief Executive Officer of Kréaxi) adds: "Stromacare opens a promising new therapeutic avenue in the field of oncology, resulting from research work carried out within the Léon Bérard Center (CLB-Lyon). The quality and robustness of the science, supported by a very experienced team, convinced us to support this project with a major societal impact in the treatment of solid tumors".

Contact: [email protected] / www.stroma.care

Allogene Therapeutics Named 2022 Bay Area “Best Place to Work” by San Francisco Business Times and Silicon Valley Business Journal

On May 9, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the San Francisco Business Times and the Silicon Valley Business Journal ranked Allogene as the highest rated biotechnology company – and 12th company overall – on the 2022 Best Places to Work in the Bay Area list in the large company category (200-499 employees) (Press release, Allogene, MAY 9, 2022, View Source [SID1234616276]).

Winning organizations were selected from over 400 competing Bay Area companies that have created exceptional workplaces that their employees value highly. Results were based on a survey of employees measuring engagement and other workplace factors including: communication and resources, individual needs, manager effectiveness, personal engagement, team dynamics and trust in leadership.

"Our people are the heart and soul of Allogene, and this recognition is a testament to the One Allogene company culture we’ve worked so hard to build," said David Chang, M.D., Ph.D., President, CEO and Co-Founder of Allogene. "This award is especially meaningful because it stems from honest, voluntary employee feedback and truly illustrates our collective mission of developing life-saving products for patients with cancer."

On May 1, 2022, Allogene celebrated its four-year anniversary with its more than 300 employees who together continue to nurture its One Allogene culture. The Company, which is actively recruiting new employees, was also recently named a 2022 Best Place to Work by BioSpace. For more information, visit the Allogene Careers web site.