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Shorla Oncology Announces U.S. Food and Drug Administration (FDA) Expanded Approval of JYLAMVO™ (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications

On October 29, 2024 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has expanded the approval of JYLAMVO (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) (Press release, Shorla Oncology, OCT 29, 2024, View Source [SID1234647498]). With this approval, JYLAMVO is currently the only oral liquid methotrexate on the market approved for both adult and pediatric indications.

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"For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills"

"This approval follows JYLAMVO’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of pediatric care in oncology and autoimmune diseases," said Sharon Cunningham, chief executive officer of Shorla Oncology. "We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the U.S. as we continue to develop innovative solutions for those with limited treatment options."

JYLAMVO was first approved by the FDA as the only oral liquid methotrexate to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis.

JYLAMVO has an orange flavor and comes with a dedicated dosing syringe.

"For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills," said Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology. "At Shorla, we are committed to continuity of supply of age-appropriate formulations for patients in need."

Rayna Herman, chief commercial officer of Shorla Oncology added, "In addition to its palatable formulation, JYLAMVO offers key differences over similar drugs, such as room temperature stability for three months after opening, which eliminates the need for refrigeration before dispensing and adds convenience for patients. We are excited to expand our portfolio of innovative therapies for underserved patient populations."

About JYLAMVO

JYLAMVO is an anti-inflammatory and cancer oral methotrexate solution approved by the U.S. Food and Drug Administration for use in adult and pediatric patients with rheumatological, dermatological and oncological diseases. JYLAMVO is an easy-to-administer, orange flavored solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation. JYLAMVO offers advantages because it remains stable at room temperature (68°F to 77°F) for 90 days and does not require cold chain storage pre-dispense.

Sensei Biotherapeutics to Present at Two Upcoming Scientific Conferences

On October 29, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that the Company will present at two upcoming scientific conferences (Press release, Sensei Biotherapeutics, OCT 29, 2024, View Source [SID1234647496]).

Conference and Presentation Details:

PEGS Europe: Protein and Antibody Engineering Summit, November 5-7, 2024, Barcelona, Spain

Title: Selectively Targeting VISTA in the Tumor-Microenvironment with SNS-101, a Conditionally Active Monoclonal Antibody
Presenter: Edward van der Horst, Ph.D., Chief Scientific Officer
Session: Antibody-Based Cancer Therapies
Date and time: Tuesday, November 5, 2024, 9:00 a.m. CET (Central European Time)

Society for Immunotherapy Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, November 6-10, Houston Texas

Title: Spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications
Presenter: F. Donelson Smith, Ph.D., Senior Director, Biologics Discovery & Early Development
Presentation Type: Poster
Abstract Number: 70
Date and Time: Saturday, November 9, 2024, 12:15–1:45 p.m. & 7:00-8:30 p.m. CST.
Location: Level 1-Exhibit Halls AB (George R. Brown Convention Center)

Revitope Enters into a License Agreement for Next-generation T Cell Engagement Technology

On October 29, 2024 Revitope Oncology Inc. (Revitope), a biotechnology company advancing a new class of precision cancer immunotherapies, reported that it has signed a license agreement providing Genmab A/S (Genmab) access to Revitope’s conditional TCE technology, TwoGATE (Press release, Revitope Oncology, OCT 29, 2024, View Source [SID1234647495]). Genmab is granted exclusive rights to utilize TwoGate for multiple drug target pairs during a multi-year research period, including the option to take up to three exclusive licenses for worldwide development and commercialization of the resulting products.

TwoGATE leverages the dual antigen binding requirement of a unique split paratope that assembles on the tumor cell surface to potently engage T cells with high precision, potentially addressing key areas of unmet need in the treatment of solid tumors.

"The unique blending of precision protein engineering in TwoGATE with target pairs that are exquisitely tailored to solid tumors with high unmet need, offers the potential to transform treatment of solid tumors by allowing TCEs to be dosed at levels that achieve significant efficacy without inducing systemic toxicities," said Werner Meier, Chief Scientific Officer of Revitope. "Genmab is the ideal partner to bring this potential to patients."

"We are thrilled to partner with Genmab, a leading biotechnology company," said Mark Clement, Chief Operating Officer of Revitope. "In deploying our cutting-edge TwoGATE technology platform together with Genmab’s robust antibody engineering and development capabilities, Revitope aims to strengthen Genmab’s pipeline, thereby aiding the transformation of cancer treatment."

Financial Terms

Revitope will receive an upfront payment of USD $9 million and, on a target pair-by-target pair basis, is eligible to receive option-exercise fees and development, regulatory and commercial milestone payments up to USD $600 million -if all three options are triggered- plus tiered, single-digit royalties on commercial sales.

Allogene Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ALLO-316, an AlloCAR T™ Investigational Product for Adult Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

On October 29, 2024 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 for the treatment of adult patients with CD70 positive advanced or metastatic renal cell carcinoma (RCC) (Press release, Allogene, OCT 29, 2024, View Source [SID1234647491]). The RMAT designation was based on clinical data from the TRAVERSE trial indicating the potential of ALLO-316 to address the unmet need for patients with difficult-to-treat RCC who have failed multiple standard RCC therapies, including an immune checkpoint inhibitor and a VEGF-targeting therapy. The ongoing development of ALLO-316 continues to advance the scientific understanding and applicability of the Dagger technology as the next-generation allogeneic platform to maximize the potential of a single infusion of "off-the-shelf" CAR T product in solid tumors.

"The RMAT designation for ALLO-316 highlights the transformative potential of our AlloCAR T platform to offer new hope for heavily pretreated patients with renal cell carcinoma who have exhausted standard treatment options," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer. "This important milestone moves us closer to fulfilling the promise of "off-the-shelf" CAR T therapy—delivering faster, more reliable, and widely accessible treatments. We remain optimistic about the future of ALLO-316 and its potential to be an important advancement for patients."

The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic RCC. Initial results from the TRAVERSE trial were presented in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, Florida, in 2023. The Company will present updated Phase 1 data from the TRAVERSE trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting.

The RMAT designation is intended to accelerate the development and review of promising investigational products, including cell therapies. To qualify, a product must be designed to treat, modify, reverse, or cure a serious or life-threatening disease, with preliminary clinical evidence suggesting it can address unmet medical needs. The RMAT designation offers several key advantages, including early and frequent interactions with the FDA to discuss potential surrogate or intermediate endpoints, as well as strategies to meet post-approval requirements, potentially streamlining the path to market approval.

About ALLO-316 (TRAVERSE)
ALLO-316, an AlloCAR T investigational product, targets CD70 which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. ALLO-316 utilizes the Dagger technology to optimize CAR T cell expansion and persistence to maximize the potential efficacy in solid tumors with a one-time infusion. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In March 2022, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to ALLO-316, and in October 2024 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-316 based on its potential to address the unmet need for adult patients with CD70 positive advanced or metastatic RCC who have failed standard RCC therapies.

Plus Therapeutics Showcases Leptomeningeal Metastases Programs at the 2024 SNO Annual Meeting in Houston, Texas

On October 29, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that it will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24, 2024 in Houston, Texas (Press release, Plus Therapeutics, OCT 29, 2024, View Source [SID1234647492]).

Data presentations and symposium include:

Presentations:

Title Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection (CTNI-63)

Presenter
Andrew Brenner, M.D., Ph.D.

Date/Time Friday, 22 November 2024, 7:30-9:30 p.m. CST

Location Hall B3

Title CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment helps in clinical management of breast cancer and Non-Small Cell Lung cancer patients having Leptomeningeal Disease (BIOM-70), (FORESEE Study, NCT05414123)

Presenter
Priya Kumthekar, M.D.

Date/Time Sunday, 24 November 2024, 10:15-11:45 a.m. CST

Location Grand Assembly B; Abstract Session – Clinical Trials – Non-Immunologic

Title The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor (BIOM-69)

Presenter
Arushi Tripathy, M.D., University of Michigan Medical School (Neurosurgery PGY-4)

Date/Time Friday, 22 November 2024, 7:30-9:30 p.m. CST

Location Hall B3

LM Educational Symposium:

The Company will be hosting an educational symposium titled, "Novel Targeted Radiotherapies to Manage Leptomeningeal Metastases" on Saturday, November 23, 2024, at 12:45pm-1:45 p.m. CST at the George R. Brown Convention Center, Room 351. Speakers include:

Priya Kumthekar, M.D., Associate Professor of Neurology and Hematology/Oncology, Northwestern University Medical School (Moderator)
Jonathan Yang, M.D., Ph.D., Associate Vice Chair for Clinical Research and Developmental Therapeutics, Department of Radiation Oncology, Director of Clinical Research, NYU Langone Health’s Perlmutter Cancer Center
Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe and convenient manner. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).