On June 22, 2023 Circio Holding ASA (OSE: CRNA), reported that the first multiple myeloma (MM) patient has been dosed with mutant RAS cancer vaccine TG01 at Oslo University Hospital (OUS) (Press release, Circio, JUN 22, 2023, View Source [SID1234632842]). The study is led by multiple myeloma expert Dr. Fredrik Schjesvold in a clinical collaboration between OUS and Circio. OUS is the study sponsor, with Dr. Schjesvold as the principal investigator, in collaboration with project lead Dr Hanne Norseth and Research medical student Hedda Monsen. Circio will provide TG01 drug supply, scientific support and a financial contribution.

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Mutations in the RAS genes are commonly found in pancreatic cancer, colon cancer myeloma and lung cancer but outside of lung cancer there are no RAS-targeted therapies available for these patients. TG01 is a mutant RAS therapeutic cancer vaccine adjuvanted by QS-21 STIMULON, which targets the seven most commonly found RAS mutations. TG01 has previously demonstrated robust immune responses and survival benefit in resected pancreatic cancer combined with standard of care chemotherapy.

In this study, TG01 vaccination will be tested as a monotherapy in 20 KRAS or NRAS mutated myeloma patients who have either high risk smoldering myeloma or have evidence of disease after completion of standard of care (SoC) therapy. The treatment period is 12 months. In the first 3 months TG01 is given every other week, and thereafter it is given once every second month for 9 months. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can delay the disease progression and enhance the clinical response.

Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "There are no targeted therapy options available for RAS-mutated multiple myeloma patients which continue to have a clear need for better and more tolerable treatments. I believe the TG01 vaccine has the potential to eliminate residual disease and delay recurrence following standard of care treatment, and we look forward to work with Circio to test this therapeutic concept at our center."

Margrethe Sørgaard, VP and Head of Clinical Development of Circio Holding ASA, added: "Having the first patient dosed in Dr. Schjesvold´s study in multiple myeloma is an important milestone for the TG program. It is the first time the TG01 cancer vaccine will be tested in this indication, and the first time the new and enhanced vaccine format of sub-cutaneous single-injection TG01 adjuvanted by QS-21 STIMULON has been administered to a patient in Europe. We firmly believe that TG01 can bring targeted clinical benefit, with a favorable safety profile, to this underserved area of RAS-mutated multiple myeloma."

About TG01 mutant RAS vaccine

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. Circio 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.

About Agenus, QS-21 STIMULON
Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body’s immune system to fight cancer and infections. In March 2022, Circio announced a collaboration with Agenus to utilize the proprietary adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 STIMULON has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and as a component of the commercial Shingrix*, Mosquirix* and Arexvy* vaccines. QS-21 STIMULON is expected to further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses.

On June 22, 2023 Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, and Cimeio Therapeutics, a biotechnology company that is reinventing cell therapy through its leadership in the emerging field of epitope shielding, reported a research collaboration to combine their respective technologies, including Prime Medicine’s Prime Editing platform and Cimeio’s Shielded Cell and Immunotherapy Pairs (SCIP) platform (Press release, Cimeio Therapeutics, JUN 22, 2023, View Source [SID1234632841]).

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The goal of the research is to improve the safety and effectiveness of hematopoietic stem cell (HSC) transplants to treat genetic diseases, acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS), as well as enable the in vivo selection of edited HSCs to potentially remove the need for transplantation entirely.

HSC transplant offers a potentially curative approach for many debilitating and life-threatening diseases, including malignancies such as AML and rare genetic diseases like Gaucher’s and Hurler’s, though its clinical utility is limited by the current need for myeloablative conditioning regimens and the risk of post-transplant progression of malignant disease. Cimeio’s SCIP platform combined with Prime Editing may significantly improve the accessibility, eligibility and outcomes for patients who could benefit from HSC transplant. These combined technologies may also enable selection of in vivo edited HSCs, which could allow for the treatment of genetic diseases without a transplant.

Under the terms of the agreement, Prime Medicine will develop a Prime Editor for Cimeio’s CD117 shielding variant that will then be evaluated by both companies. CD117 is a receptor tyrosine kinase expressed on normal HSCs and on leukemia cells, and therefore is an attractive target for an antibody-based conditioning therapy for patients needing a stem cell transplant, or for patients with AML or MDS needing new treatment options.

If the research collaboration is successful, the companies will grant exclusive license options to each other for their technology. Prime Medicine will receive an exclusive option to license Cimeio’s cell shielding technology for CD117-shielded HSC transplant, as well as in vivo editing of CD117-shielded HSCs, for genetic diseases, not including Sickle cell disease. Cimeio will receive an exclusive option to license Prime Medicine’s Prime Editing technology for its CD117-shielded allogeneic HSC product for use in AML and MDS, and, potentially, a second shielding protein for use in AML and MDS. If the companies exercise their exclusive license options, they will each be eligible to receive economics on net sales of licensed products. Specific financial terms were not disclosed.

Cimeio’s proprietary investigational immunotherapies are designed to selectively deplete diseased HSCs, while its novel CD117 protein variant, which can be introduced into HSCs using Prime Editing, has the potential to protect the healthy transplanted HSCs from depletion, allowing them to engraft while maintaining the normal function of the CD117 receptor. Because the edited HSCs are shielded, the diseased HSCs can be more gradually depleted, which could reduce toxicity and increase safety. The immunotherapies can also be administered post-transplant with the potential to boost engraftment or treat minimal residual disease.

Prime Editing is uniquely suited to introduce these novel protein variants into HSCs by virtue of its versatility, precision and efficiency, without causing double strand breaks and with minimal off target editing. Because Prime Editing can be multiplexed (i.e., multiple Prime Edits can be made with a single administration), rare genetic diseases such as beta thalassemia, immunodeficiencies and bone marrow failure syndromes may be corrected by Prime Editing at the same time as cell shielding, offering the possibility of autologous transplant for these patients without toxic conditioning.

"We believe Prime Editing is an incredibly powerful technology that could impact the care and treatment of a wide range of diseases. To fully exploit the potential of our technology, we are committed to collaborating with partners who can meaningfully expand our reach, accelerating our efforts to deliver important new medicines to patients worldwide," said Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine. "Through this partnership, we are gaining access to a promising platform technology, which, when combined with Prime Editing, may allow many more patients to benefit from the potentially curative power of HSC transplant and, for the first time, make feasible in vivo treatment of many genetic diseases. We are delighted to collaborate with the Cimeio team, which includes experts in the fields of cell therapy, gene editing and HSC transplant, and look forward to working closely together to evaluate the synergistic potential of our technologies."

At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, Cimeio presented results from a preclinical study demonstrating proof-of-concept for its CD117-shielded cells. The data showed that its shielded cells expressing a genetically engineered variant of CD117 were fully functional in vitro and contributed to engraftment in vivo, similar to unmodified HSCs expressing the wild-type receptor. Mice transplanted with a mix of human HSCs expressing either wild-type CD117 or the Cimeio shielded CD117 variant showed a selective depletion of wild-type CD117 cells following treatment with Cimeio’s antibody directed against wild-type CD117, while those cells expressing the shielded CD117 variant were spared.

"Our recently disclosed data continues to show that our unique shielding technology and paired immunotherapies have the potential to deliver transformative therapies for patients with many types of diseases," said Thomas Fuchs, Chief Executive Officer of Cimeio Therapeutics. "Through this collaboration, we are bringing together industry leading protein engineering and genome editing, with the potential to deliver safer, curative therapies for patients. Our aim is to eliminate the need for toxic chemotherapies and radiation, and enable new therapeutic approaches post-transplant. Our goal is to reinvent HSC transplant as a more effective and practical option for many more patients facing debilitating and fatal diseases. We look forward to partnering with the extremely talented team at Prime Medicine to advance our novel CD117 program."

On June 22, 2023 Starpharma (ASX: SPL, OTCQX: SPHRY) today announces that an investor presentation by Chief Executive Officer, Dr Jackie Fairley, will be broadcast at 10:00 am EDT on Thursday, 22 June 2023 (12:00 am AEST on Friday, 23 June 2023), as part of the OTCQX’s Virtual Life Sciences Investor Forum (Press release, Starpharma, JUN 22, 2023, View Source;mc_eid=bf52dd3418 [SID1234632830]).

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The Life Sciences Investor Forum is a leading, virtual investor conference that provides a forum for public companies to present to retail and institutional investors as well as advisors.

The CEO’s pre-recorded presentation will provide an overview of Starpharma’s business including:

Recent progress across Starpharma’s internal clinical DEP programs including for both the Phase 2 DEP cabazitaxel and DEP docetaxel (monotherapy) trials, which have completed recruitment and treatment of patients, as well as the DEP irinotecan Phase 2 trial.
The latest preclinical results for Starpharma’s HER2-targeted DEP antibody-drug conjugate (ADC), which utilised the active metabolite of irinotecan, SN-38, showed significantly greater anti-tumour activity and improved survival compared to the marketed ADC, Enhertu, in a HER2+ human cancer xenograft model.
An overview of Starpharma’s partnership with AstraZeneca and the clinical development of AZD0466, which utilises Starpharma’s DEP technology to deliver and widen the therapeutic window of a Bcl-2/xL inhibitor and is the subject of two global Phase 1/2 clinical trials recruiting patients with advanced blood cancers at over 40 sites globally.
Regulatory and commercial progress for Starpharma’s in-market products, including Viraleze and VivaGel BV.
The presentation is appended and will also be made available on Starpharma’s website

On June 21, 2023 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), reported its founding with a $23 million seed financing led by F-Prime Capital with Omega Funds (Press release, ARTBIO, JUN 21, 2023, View Source [SID1234637907]). ARTBIO was founded in 2021 by Roy Larsen, Øyvind Bruland, Radforsk, and F-Prime Capital to create highly targeted cancer therapies by pairing the optimal alpha-emitting isotope Pb212 with ligands against proven tumor-specific targets. ARTBIO is also creating an entirely new approach to ART manufacturing to overcome production and distribution challenges. In early 2022, Emanuele Ostuni, formerly Head of Europe for Cell and Gene Therapy at Novartis Oncology, joined ARTBIO as CEO to start building its world-class team and advance its proprietary technology, while securing additional funding from F-Prime Capital and Omega Funds.

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The financing enables ARTBIO’s ongoing clinical development of its lead program AB001 for the treatment of prostate cancer. The funds will enable the company to advance a differentiated pipeline, further develop its AlphaDirectTM Pb212 isolation technology, and expand its distributed manufacturing network.

"Our unique approach combines Pb212 best in class properties with rationally designed ligands against tumor-specific targets to unlock the full therapeutic potential of alpha radioligand therapy," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Many cancer patients still have few or no treatment options. We focus on ARTs with Pb212 because they can selectively deliver lethal energy to tumors in an optimal timeframe, resulting in better outcomes for patients and easier management by health care professionals. We are equally focused on building a distributed manufacturing ecosystem to maximize the potential of these therapies through a footprint tailored to the short half-life of Pb212."

A New Approach for Alpha Radioligand Therapy (ART)
ARTBIO’s unique approach is underpinned by a deep understanding of cancer biology and the infrastructure needed to effectively design, manufacture and distribute ARTs.

There are four distinct pillars of development:

The ideal alpha-emitter profile: Pb212 has a short half-life that matches the properties of the small molecule carriers used by ARTBIO, delivering most of its energy into the tumor quickly.
A differentiated pipeline of ARTs: ARTBIO has one asset in clinical development, with additional assets in rapid pre-clinical development, each focusing on addressing unmet medical needs.
Distributed ART manufacturing ecosystem: The company is building an end-to-end distributed manufacturing network for reliable and fast delivery of therapeutic candidates to the bedside.
Proprietary Pb212 isolation technology: ARTBIO’s AlphaDirectTM technology delivers highly pure Pb212 from widely available raw materials.
An Expert Leadership Team
ARTBIO has assembled a world-class team of talented professionals spanning multiple disciplines and categories.

"ARTBIO’s team is highly skilled and passionate, bringing together a unique combination of expertise in the radioligand space, drug development and oncology," said Ted W. Love, M.D., Chairman of the Board at ARTBIO. "I believe that ARTBIO’s approach represents the future of radioligand therapy that will radically advance cancer care."

The leadership includes:

Management Team

Emanuele Ostuni, Ph.D., Chief Executive Officer; Former Head of Europe for Cell & Gene Therapy for Novartis Oncology
Bharat Lagu, Ph.D., Sr. Vice President and Head of Discovery; Former Head of Drug Discovery at Mitobridge (acquired by Astellas)
Victor Paulus, Ph.D., Sr. Vice President and Head of Regulatory Affairs; Former SVP of Regulatory Affairs at Fusion and Advanced Accelerator Applications.
Vicki Jardine, M.D., Ph.D., Vice President of Clinical Development; Former Senior Clinical Development Leader (Alpha Radioligand Therapies) at Bayer
Gjermund Olsen, Director of Manufacturing; Former Head of Technology Development (Radiotherapies) at Bayer
Scientific Advisory Board

Øyvind Bruland, M.D.; ARTBIO SAB Chairman and Co-founder
Roy Larsen, Ph.D.; ARTBIO Co-founder
Oliver Sartor, M.D.; Director of Radiopharmaceutical Trials, Mayo Clinic
Richard P. Baum, M.D.; President of the International Centers for Precision Oncology (ICPO) Academy and a Consultant at the Advanced Center for Radiomolecular Precision Oncology (RPO) at Curanosticum Wiesbaden-Frankfurt
Dennis Benjamin, Ph.D.; Former Head of R&D at Seagen
Board of Directors

Ted W. Love, M.D.; Chairman of the ARTBIO Board; Chair of Biotechnology Innovation Organization’s (BIO) Board of Directors
Alex Pasteur, Ph.D.; Partner at F-Prime Capital
Otello Stampacchia, Ph.D.; Managing Director and Founder at Omega Funds
Roy Larsen, Ph.D.; ARTBIO Co-Founder, Founder of Sciencons
Anders Tuv, Partner at Radforsk
Susanne Schaffert, Ph.D.; ARTBIO Independent Director; Former President of Novartis Oncology and Advanced Accelerator Applications
Emanuele Ostuni, Ph.D.; Chief Executive Officer of ARTBIO
Martin Taylor, Ph.D.; Senior Associate at F-Prime Capital (Observer)
Francesco Draetta; Partner at Omega Funds (Observer)
"ARTBIO is a global company that was incubated in Europe, where there has been much innovative development in the radioligand therapy space," said Alex Pasteur, Ph.D., Partner at F-Prime Capital. "Roy and Øyvind are serial entrepreneurs responsible for developing the only alpha particle emitting radiopharmaceutical product currently on the market. We look forward to working with this team to support the development of their pipeline and advance their vision of creating alpha radioligand therapies that are accessible, effective, and safe for patients around the world."

On June 21, 2023 Swedish biotechnology company NEOGAP Therapeutics, which is developing personalised immunotherapy, announces its acquisition of the remaining 30 per cent of the shares in its subsidiary, TCER Oncology AB (Press release, Neogap Therapeutics, JUN 21, 2023, View Source [SID1234636607]). This acquisition will broaden NEOGAP’s patent portfolio and strengthen the company’s pipeline of potential drug candidates, further consolidating NEOGAP’s position in the field.

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Previously, NEOGAP owned 70 per cent of the shares in TCER Oncology AB. During the second quarter of this year, the remaining 30 per cent was acquired from Rolf Kiessling and Stina Wickström in exchange for NEOGAP shares. This means that Rolf Kiessling and Stina Wickström, both prominent researchers in the company’s field, are now shareholders in NEOGAP, further enhancing the company’s scientific expertise. Rolf Kiessling is well-known for his discovery of NK cells, which have had significant implications in cancer research and the development of cancer therapies.

The acquisition not only expands NEOGAP’s patent portfolio but also enhances the company’s pipeline of potential candidates for future preclinical and clinical development.

In recent years, NEOGAP has enjoyed a successful academic collaboration with Rolf Kiessling and Stina Wickström to investigate how the company’s EpiTCer beads can be used to stimulate dendritic cells and activate tumour-specific T cells in the patient’s blood. The collaboration has yielded fruitful results, leading to a patent application and the publication of their findings in the reputable scientific journal, Frontiers.

As a result of the acquisition, the patent rights now transfer from NEOGAP’s subsidiary, TCER Oncology, to NEOGAP.

"We are delighted to acquire the remaining shares in TCER Oncology and extend a warm welcome to Rolf Kiessling and Stina Wickström as valued shareholders in NEOGAP. This acquisition marks an important milestone, fortifying our standing in personalised immunotherapy. It allows us to expand our patent portfolio and pipeline of potential drug candidates while further developing our innovations in the field. We look forward to continuing to drive progress and deliver groundbreaking scientific breakthroughs in cancer treatment," says Samuel Svensson, CEO of NEOGAP.