On June 10, 2022 Umoja Biopharma, Inc., an immuno-oncology company pioneering off-the-shelf, integrated therapeutics that reprogram immune cells to treat patients with solid and hematologic malignancies, and TreeFrog Therapeutics, a biotechnology company aimed at making safer, more efficient and more affordable cell therapies based on induced pluripotent stem cells (iPSCs), reported that they have entered into a collaboration to evaluate Umoja’s iPSC platform within TreeFrog’s C-Stem technology for scalable expansion and immune cell differentiation in bioreactors (Press release, Umoja Biopharma, JUN 10, 2022, View Source [SID1234615881]).

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"Together, the successful pairing of Umoja’s RACR engineered iPS cells and TreeFrog’s C-Stem technology could overcome several challenges facing ex vivo allogeneic therapies," said Ryan Larson, Ph.D., Vice President and Head of Translational Science at Umoja. "Two major industry-wide challenges include the ability to scale iPSC-based culture while maintaining cell health, quality, and efficient immune cell differentiation. TreeFrog’s biomimetic C-Stem technology is the perfect complementary development platform for our RACR technology, a pairing which could result in controlled, efficient iPSC expansion and differentiation into immune cells, with improved yields and quality. In addition to enhancing the differentiation and yield of immune cells within the manufacturing process, our RACR system should bring therapeutic benefit to patients, allowing for safe in vivo engraftment and persistence of tumor-killing cells without requirements for toxic lymphodepleting chemotherapy."

Umoja is developing an engineered iPSC platform that addresses many challenges associated with ex vivo cell therapy manufacturing, including limited scalability and manufacturing complexity. Umoja’s iPSCs are engineered with a synthetic rapamycin-activated cytokine receptor (RACR) to drive differentiation to, and expansion of innate cytotoxic lymphoid cells, including but not limited to natural killer (NK) cells in the absence of exogenous cytokines and feeder cells. TreeFrog’s proprietary C-Stem technology relies on the high-throughput encapsulation (>1,000 capsules/second) of hiPSCs within biomimetic alginate shells, which promote in vivo-like exponential growth and protect cells from external stress. In 2021, C-Stem was demonstrated to allow for unprecedented iPSC expansion in 10L bioreactors, while preserving stem cell quality. Also enabling direct in-capsule iPSC differentiation, C-Stem constitutes a scalable, end-to-end, and GMP-compatible manufacturing platform for iPSC-derived cell therapies.

Frédéric Desdouits, Ph.D., Chief Executive Officer at TreeFrog added "Our primary goal is to bring the benefits of the C-Stem technology to patients as fast as possible, either through in-house programs or strategic alliances with cell therapy leaders. Partnering with Umoja is an important step forward in immuno-oncology. Besides scale-up and cell quality, the in vivo persistence of allogeneic therapies remains a critical challenge in the industry. We believe Umoja’s platform will allow for safer and more efficient allogeneic cell therapies in immuno-oncology. We look forward to rapidly advancing this joint approach to clinic and contributing to the future of off-the-shelf cancer treatments."

On June 10, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, and Mardi Dier, the company’s Chief Financial Officer, will present at the Goldman Sachs Global Healthcare Conference on Thursday, June 16, 2022, at 10:00 AM PDT in Palos Verdes, CA (Press release, Ultragenyx Pharmaceutical, JUN 10, 2022, View Source [SID1234615880]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On June 10, 2022 Step Pharma, a world leader in CTPS1 inhibition for the targeted treatment of cancer, reported that it is presenting encouraging data in three posters for its first-in-class, highly selective, orally bioavailable CTPS1 inhibitor STP938 at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress being held June 9-17, 2022 in Vienna, Austria (Press release, Step Pharma, JUN 10, 2022, View Source [SID1234615879]).

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The data presented demonstrate the high specificity of CTPS1 inhibition achieved with STP938, with inhibition of human neoplastic T cell growth shown both in vivo and in vitro. Moreover, inhibition of CTPS1 by STP938 shows anti-proliferative activity in multiple myeloma through the induction of replication stress and demonstrates synergistic activity when combined with ATR inhibition.

These data support Step Pharma’s belief in STP938’s targeted cytotoxic potential in haematological cancers. STP938 displays favourable preclinical safety and pharmacological properties and is due to progress into first in human clinical studies in the second half of 2022.

Philip Beer, Head of Research and Translational Medicine at Step Pharma, commented: "Our promising findings demonstrate the importance of CTPS1 for cancer cell proliferation and the potential of STP938 as a targeted therapy for the treatment of cancers with high unmet clinical need. CTPS1 plays a crucial role in neoplastic cells, where inhibiting its activity could have a significant impact in a number of different cancers, either as monotherapy or in combination with existing or novel cancer drugs. We look forward to progressing this exciting new therapy into the clinic."

Andrew Parker, Chief Executive Officer of Step Pharma, said: "Our deep understanding of the pathways and CTPS1 biology has led to the development of STP938, a targeted therapy with predicted superior safety and efficacy profiles compared to existing treatments. We believe that this highly selective treatment has the potential to kill cancer cells without affecting immune cell differentiation and therefore could represent a significant step change in the way we treat cancer."

Full details of the posters are:

Poster Presentation: CTP synthase 1 (CTPS1) is a novel target in T cell cancers, with small molecule inhibition inducing death of neoplastic human T cells in vitro and inhibition of their growth in an in vivo xenotransplant model

Authors: Philip Beer, Hélène Asnagli, Norbert Minet, Eef Hoeben, Andrew Parker, Alain Fischer, Sylvain Latour

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform

Session title: Lymphoma Biology & Translational Research

Poster presentation: CTPS1 is a novel therapeutic target in myeloma – selective small molecule inhibition delivers single agent activity and synergises with ATR inhibition

Authors: Christina Pfeiffer, Philip Beer, Hélène Asnagli, Arnold Bolomsky, Alexander Grandits, Anja Schneller, Julia Huber, Niklas Zojer, Martin Schreder, Andrew Parker, Heinz Ludwig

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform

Session title: Myeloma and other monoclonal gammopathies – Biology & Translational Research

Poster Presentation: Selective small molecule inhibition of CTP synthase 1 (CTPS1) suppresses T cell proliferation and cytokine release, highlighting a novel therapeutic target for graft-versus-host disease

Authors: Philip Beer, Andrew Parker, Hélène Asnagli

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform

Session title: Stem cell transplantation – Experimental

On June 10, 2022 The SHINE Technologies reported that gearing up for this year’s SNMMI Annual Meeting, June 11-14 in Vancouver, British Columbia (Press release, Shine Medical Technologies, JUN 10, 2022, View Source [SID1234615878]). Leading molecular-imaging and nuclear-medicine professionals from every corner of the industry will come together to share in-depth views of the latest research and development, as well as share insights into practical clinical applications.

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After two years of holding virtual events, we’re excited to attend SNMMI’s first in-person conference since 2019. This year’s theme is "Advancing Precision Imaging and Therapy."

We’ll be sharing progress on our diagnostics and therapeutics divisions during exhibit hours. Our proprietary isotope production processes create molybdenum-99 and non-carrier-added lutetium-177 used in tens of thousands of daily procedures to diagnose and treat heart disease and late-stage cancer. Our contribution to these markets will increase access to life-saving capabilities, including improving industrial equipment safety and diagnosing and treating cancer, heart disease, and other illnesses.

We are already producing lutetium-177 on a small scale for preclinical and clinical trials, and our process was validated for Good Manufacturing Practice earlier this year. We plan to continue to scale production of Lu-177 on the way to our large-scale production facility going online in 2024.

Our large-scale molybdenum-99 production facility is expected to be the largest facility in the world dedicated solely to producing medical isotopes. It is slated to go online late next year.

Chris Vessell, SHINE’s new General Manager of the Therapeutics Division, will be in attendance.

"I am excited to bring my experience to such a talented, visionary team at SHINE," said Vessell. "Their technology and vision for the future will be a game-changer as the company continues to pioneer new methods of nuclear medicine and delivers cancer therapies that make immeasurable differences for patients and their families."

If you want to say "hi" to Chris, or learn how SHINE Technologies is working to help improve medical outcomes through fusion technology, stop by and see us at Booth No. 36 at the show. If you have any questions in advance, send us a note at [email protected] or visit our virtual booth.

On June 10, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that preclinical data from its ROR1-targeting cell therapy programs will be highlighted in a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (Press release, Oncternal Therapeutics, JUN 10, 2022, View Source [SID1234615875]). Oncternal’s collaborators from the Karolinska Institutet in Stockholm, Sweden, have conducted a series of preclinical studies evaluating T cells as well as Natural Killer cells expressing Oncternal’s ROR1 CAR containing the antigen binding region of zilovertamab. The ROR1 CAR mediated target recognition and cell activation when expressed in either T cells or NK cells. Also, ROR1 CAR-T cells demonstrated dose-dependent anti-tumor activity in a mantle cell lymphoma mouse model.

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Poster Title: Preclinical Evaluation of Zilovertamab-Based Anti-ROR1 Chimeric Antigen Receptors in NK and T Cells
Abstract Number: P1435
Session Title: Gene therapy, cellular immunotherapy and vaccination – Biology & Translational Research
Session Date and Time: June 11, 2022 from 9:00am CEST
"Despite recent significant advances in treating hematological malignancies with current CAR-based cell therapies, certain limitations remain, such as treatment failures due to tumor antigen escape, and toxicities including induction of immunodeficiencies like B-cell aplasia. Patients are in need of more effective treatment options" said Evren Alici, M.D., Ph.D., Associate Professor and group leader of the Cell and Gene Therapy Group, HERM, Department of Medicine, Karolinska Institutet. "The ROR1-targeting cell therapies have shown strong activity in our lymphoma models. We are now working with our Oncternal colleagues to evaluate the therapies in models of other tumor indications. With our strong focus on NK cells, we are excited to further study ROR1 CAR-NK cells within our NextGenNK competence center."

"Based on the wide expression of ROR1 across tumor indications and its underlying importance in cancer biology as well as the safety and efficacy shown by zilovertamab in our clinical studies, we believe that targeting ROR1 using zilovertamab-based CAR cell therapy might offer a potentially effective treatment option for patients suffering from unmet medical needs, including heme malignancies and solid tumors" said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "In preclinical research, our zilovertamab-derived ROR1 cell therapies have demonstrated anti-tumor activity in a series of studies, including these presented here by our colleagues from the Karolinska Institutet. We are working closely with Professor Evren Alici and his team to evaluate our ROR1 cell therapies using T cells and NK cells, thus potentially laying the foundation for an off-the-shelf cell therapy program. Oncternal is proud to be an industry partner of the NextGenNK competence center located at the Karolinska Institutet. Near-term, we are looking forward to dosing the first patient with our autologous ROR1 CAR-T cell therapy, ONCT-808, in the coming months."

ONCT-808 is the Company’s lead autologous ROR1-targeted CAR-T cell therapy program candidate. The program is advancing towards an Investigational New Drug (IND) application submission expected in mid-2022.