On October 29, 2024 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company dedicated to developing new generation therapies for unmet medical needs, reported highly promising early data from a preclinical study of its latest cancer treatment (Press release, Hoth Therapeutics, OCT 29, 2024, View Source [SID1234647497]). The preliminary results demonstrate that the treatment successfully stabilizes tumor growth with remarkable consistency across subjects, showing potential as an effective therapeutic option in oncology. This study was performed and took place under a sponsored scientific research agreement with NC State University.

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The study measured tumor volumes in treated and untreated subjects over the course of the experiment. Tumor volume measurements in the treated group exhibited minimal changes, suggesting that the treatment effectively inhibited tumor growth. Additionally, all tumors in the treated animals displayed remarkable consistency in volume, with standard deviation error bars barely visible—a strong indication of the treatment’s uniformity and reproducibility in suppressing tumor growth.

"These early findings are incredibly encouraging and demonstrate that our treatment has the potential to halt tumor progression consistently across subjects," said Robb Knie, CEO of Hoth Therapeutics. "The stability and low variability observed in tumor volumes among treated animals are indicative of a promising therapeutic effect, and we’re excited to move forward with further testing as we process additional tissue data."

Key observations from the initial data include:

Stabilized Tumor Growth: Tumor volumes in treated subjects remained remarkably stable over the course of the study, suggesting that the treatment may significantly inhibit tumor growth.

Consistency Across Subjects: Tumor sizes were highly consistent across all treated animals, as demonstrated by the minimal error bars on the graph. This uniform response highlights the treatment’s potential reproducibility and reliability.

Comparison with Untreated Controls: In contrast, untreated subjects showed greater variability and an increase in tumor volume, underscoring the potential efficacy of the treatment in slowing or halting tumor growth.
As Hoth Therapeutics advances this research, the company will continue analyzing additional tissue data to further validate these results. The company is committed to moving forward with the development of this promising treatment and exploring its full potential for patients in need of effective cancer therapies.

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.

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]).

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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)

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.

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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.

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.

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"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.