Novartis First Quarter 2022

On April 26, 2022 Novartis reported its first quarter financial results 2022 (Presentation, Novartis, APR 26, 2022, View Source [SID1234613001]).

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GT Medical Technologies Announces the Presentation of Clinical Data on GammaTile® Therapy in the Treatment of Recurrent Glioblastomas at the 2022 American Association of Neurological Surgeons Scientific Meeting

On April 26, 2022 GT Medical Technologies, Inc. reported that new data on the company’s innovative GammaTile Therapy for patients with operable brain tumors will be presented via an oral, live presentation at the 2022 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Philadelphia, PA (Press release, GT Medical Technologies, APR 26, 2022, View Source [SID1234613000]). The abstract will provide the first report of clinical outcomes for recurrent glioblastoma patients treated with FDA-cleared GammaTile Therapy. Impressive clinical outcomes were reported, with a Median Local Control of 81% at 12 months and Median Overall Survival reaching 37 months in MGMT methylated patients. The safety profile was comparable to patients undergoing repeat surgery without GammaTile treatment.

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GammaTile Therapy is a bioresorbable 3D-collagen tile embedded with Cesium-131 sources that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting remaining tumor cells, sparing healthy tissue. "There is no established standard of care today for patients with recurrent glioblastoma. This abstract, along with other studies and clinical publications, supports that GammaTile Therapy should be considered for all patients with operable recurrent glioblastomas," says Matthew Likens, President and CEO of GT Medical Technologies. "Patients receiving GammaTile Therapy have the benefit of prolonged survival without sacrificing quality of life. Our company purpose is to improve the lives of patients with brain tumors, and Dr. Chen’s early clinical experience at University of Minnesota advances this purpose."

The abstract will provide a report of clinical outcomes for recurrent GBM patients treated with FDA-cleared GammaTile.

The abstract, titled GammaTile Brachytherapy in the Treatment of Recurrent Glioblastomas, earned lead author Clark C. Chen, MD, PhD, M Health Fairview neurosurgeon and the head of the University of Minnesota Medical School Department of Neurosurgery, the prestigious Brainlab Neurosurgery Award. This award is presented at both the annual meetings of AANS and the Congress of Neurological Surgeons (CNS) and is given to a neurosurgeon with a high-scoring abstract relating to central nervous system tumors.

"The treatment of recurrent glioblastoma remains a major challenge in our field, without consensus for a standard of care. Our published results suggest clinical benefit from GammaTile treatment and warrant consideration in this setting, especially given the highly favorable safety profile," said Dr. Chen. "Recapitulation of our results in a larger, multi-institution cohort has the potential to redefine the standard of care for recurrent glioblastoma patients."

The abstract will be presented on Monday, May 2nd at 4:16 PM in the Tumor Abstract Session in Philadelphia. This will be the first in-person AANS meeting since 2019. Read the abstract here.

Jubilant Therapeutics Inc. Doses First Patient in Phase I/II Trial Evaluating JBI-802, dual inhibitor of LSD1 and HDAC6, in patients with advanced solid tumors

On April 26, 2022 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the dosing of the first patient in a Phase I/II clinical trial of JBI-802 in patients with advanced solid tumors (Press release, Jubilant Therapeutics, APR 26, 2022, View Source [SID1234612999]). JBI-802 is a first-in-class, small-molecule, orally administered dual inhibitor of LSD1 and HDAC6 that has demonstrated synergistic anti-tumor activity in animal models.

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The Phase I/II trial is an open label, two-part dose escalation and expansion study designed to define the safety and tolerability, explore predictive biomarkers and assess preliminary activity of JBI-802 in more than 100 study participants with advanced solid tumors. More information on the clinical trial can be found at NCT05268666.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "We have come a long way from drug discovery to first-in-human dosing. We look forward to making a difference in patients’ lives. Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties."

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-802, effectively modulates two validated oncology targets with similar affinity and quick on/off exposure kinetics, leading to synergistic anti-tumour activity with a reduced risk of thrombocytopenia. This is our first internally developed product candidate to enter clinical development. Other advancing programs include an oral brain penetrant inhibitor of PRMT5, JBI 778, and an oral brain penetrant PDL1 inhibitor, JBI 2174, for neurological cancers among others."

About JBI-802

JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone and a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.

TC BioPharm to Participate in Upcoming Conferences

On April 26, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported that the company will be participating in several upcoming conferences (Press release, TC Biopharm, APR 26, 2022, View Source [SID1234612998]).

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TC BioPharm Co-founder and Executive Chariman, Michael Leek will participate in the Allogeneic Cell Therapies Summit, at the Hilton Boston Northshore between 9-11 May, 2022. Michael is scheduled to co-present the workshop on Supply Chain Management for Multicentered Clinical Trial Set-up (May 9) and chair sessions on Supply/Storage and Manufacturing (May 10 and 11 respectively).

He will also be speaking at the Advanced Therapies Conference at ExCel in London, May 24-25. The conference will explore the hottest topics in the advanced therapy medicinal products (ATMP) space alongside a faculty of industry leading speakers, whilst showcasing the latest technologies and advancements in the industry.

This June, Dr. Leek will be featured at the Next Generation CAR & T Cell Therapies 2022. The event takes place June 14-16, 2022 at the Mark Hopkins Hotel in San Francisco, California. Dr. Leek is scheduled to present and co-chair a workshop on on June 14th at 2:15 pm in a session entitled; TC Biopharm Case Study: Phase 3 Studies of Our Lead Product in Blood Cancers.

Additionally, Dr. Leek and Co-founder and Chief Operating Officer, Angela Scott will be speaking at the Onco Cell Therapy Summit. This seminar will be held June 29-30 at the Hynes Convention Center in Boston, Massachusetts. Michael Leek’s seminar is entitled: Using banked unmodified allogeneic gamma-delta T cells to treat cancer, while Angela Scott will speak to; Manufacture of GMP-grade frozen allogeneic cell therapies for phase 2/3 clinical studies’. The Onco Cell Therapy Summit (OCTS) is the only industry-led meeting covering the full range of autologous and allogeneic cell product advancements.

Pheast Raises $76M in Series A Funding to Train the Immune System to Feast on Cancer

On April 26, 2022 Pheast Therapeutics, a company developing novel checkpoint therapies to fight cancer, reported it has raised $76 million in Series A funding round led by Catalio Capital Management and ARCH Venture Partners (Press release, Pheast Therapeutics, APR 26, 2022, View Source [SID1234612997]). Alexandria Venture Investments and Risk and Reward (R2) also participated. Pheast plans to use the funds to expand its management, scientific, and administrative teams, as well as towards R&D to advance its pipeline of innate immune checkpoint inhibitors towards the clinic.

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Pheast is led by scientific experts Dr. Amira Barkal, MD, PhD, Dr. Irving Weissman, MD, Dr. Ravi Majeti, MD, PhD, and Dr. Roy Maute, PhD. Drs. Weissman and Majeti were co-founders of Forty Seven Inc. (acquired by Gilead in 2020) and were instrumental in the discovery of CD47 as a "don’t eat me" signal and critical to the advancement of CD47-targeting clinical programs to treat multiple hematologic malignancies. Drs. Barkal and Weissman uncovered the role of CD24 as a "don’t eat me" signal and promising target for immunotherapy of solid tumors.

"While cancer immunotherapy has revolutionized the treatment of some tumors, many cancers, including ovarian and breast, have seen lackluster responses to existing immunotherapies, and patients are in dire need of new options," Dr. Amira Barkal, MD, PhD, Principal Founder, Scientific Director, and Interim CEO at Pheast. "With the help of this funding, we will be much better equipped to increase and expand our research efforts, and in doing so, hopefully bring meaningful responses for treatment-resistant cancers closer to reality."

"Pheast’s exceptional leadership and differentiated approach to leveraging macrophage checkpoints to develop life-changing cancer therapies have quickly positioned the company as a leader in the immunotherapy space," said George Petrocheilos co-founder and managing partner of Catalio.

"This investment is emblematic of Catalio’s strategy to identify and back breakthrough biomedical technology companies led by world-renowned, serial scientists with proven track records of launching category-defining businesses," said Dr. Jacob Vogelstein, co-founder and managing partner of Catalio, who will also be joining Pheast’s Board of Directors.

Spun out of Irv Weissman’s lab at Stanford University, Pheast is a pre-clinical stage immuno-oncology company focused on targeting immune evasion pathways to activate the innate immune system to fight cancer. However, unlike most cancer immunotherapies, which to date have focused on augmenting adaptive immune responses by targeting T-cells, Pheast’s approach is pioneering in the cancer immunotherapy space for three main reasons:

Pheast is focused on enhancing the innate immune response to cancer by targeting macrophage checkpoints, also called "don’t eat me" signals;
Pheast is targeting an entirely new signaling axis through their CD24 pipeline which has shown promise in animals for treating ovarian cancer, breast cancer, and other solid tumors;
Pheast’s team is developing therapeutic strategies to combine macrophage checkpoint inhibitors with existing anti-cancer therapies including existing immunotherapies, tumor-targeting antibodies, and chemotherapies.
The company’s primary program targets the surface protein CD24, a "don’t eat me" signal commandeered by many cancers, including ovarian and breast cancer, in order to avoid detection and clearance by intra-tumoral macrophages. Pheast is also leveraging its proprietary discovery platform to enable the development of additional novel tumor-specific cancer immunotherapies.

"The first macrophage checkpoint inhibitor discovered was CD47, a molecule upregulated by all cancers to block macrophages from eating and killing cancer cells, but later shown to be a general inhibitor of other disease-causing cells. By discovering how CD47 blocks macrophage eating, we developed general principles to discover other ‘don’t eat me’ signals, and we uncovered CD24 as a major ‘don’t eat me’ component of at least most ovarian and breast cancer cells" said Irv Weissman, co-discoverer of both molecules. "I have come to think about macrophages as micro-computing cells, each counting the sum of the ‘don’t eat me’ signals and ‘eat me’ signals coming from attached cancer cells, then acting if the ratio of ‘eat me’ to ‘don’t eat me’ is such that eating dominates. Our goal is to determine, with precision, how to assess the eat me and don’t eat me signals for each cancer, and to tip the balance to remove each human cancer. We are building the team to excel at achieving this goal."

"Through their research into macrophages and CD24, Pheast has already demonstrated that blockade of CD24 signaling can lead to impressive results in animal models of some of the most difficult-to-treat and aggressive malignancies, including ovarian cancer and breast cancer," said Dr. Steven Gillis, Managing Director at ARCH Venture Partners. "ARCH is excited to be a part of the Pheast team’s journey and we look forward to future developments at the company."