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Provectus Biopharmaceuticals Establishes Research Collaboration with University of Nevada, Las Vegas to Investigate Small Molecule Immunotherapy Rose Bengal for Tissue Regeneration and Repair

On July 19, 2022 Provectus (OTCQB: PVCT) reported that the Company has initiated a new sponsored research program with Kelly Tseng, PhD, Associate Professor of Pathology and Lab Medicine, School of Life Sciences at the University of Nevada, Las Vegas (UNLV) to characterize the effects of Provectus’ pharmaceutical-grade rose bengal sodium (RBS) on vertebrate tissue regeneration and repair (Press release, Provectus Biopharmaceuticals, JUL 19, 2022, View Source [SID1234616769]). RBS is the lead member of a class of small molecules called halogenated xanthenes that is entirely owned by Provectus.

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The Tseng Lab at UNLV will assess the effects of RBS on animal development and tissue repair using the African clawed frog (Xenopus laevis), an established vertebrate model organism, and in vivo assays to evaluate key biological processes: embryo development, wound healing, and tissue regeneration.

Dr. Tseng is an expert in tissue regeneration and a leader in the regenerative biology and bioelectrical signaling fields. Her research group at UNLV seeks to elucidate the mechanisms of complex tissue regeneration in vertebrates using the highly regenerative clawed frog, with the goal of applying this knowledge to therapeutic strategies. Dr. Tseng has identified key factors that control limb and eye regeneration, and has also established a new model for studying embryonic eye stem cells.

She graduated from the Massachusetts Institute of Technology with a Bachelor of Science in Biology and Harvard University with a PhD, and was a Howard Hughes Medical Institute research fellow at Boston Children’s Hospital. Dr. Tseng’s work has been highlighted in books and media outlets including The New York Times.

Recent medical journal publications of hers include "From Cell Death to Regeneration: Rebuilding After Injury" (Front Cell Dev Biol 18;9:655048. 2021), "Studying in vivo Retinal Progenitor Cell Proliferation in Xenopus laevis" (Retinal Development. Methods in Molecular Biology, 2092:19-33. 2020), and "Using the Xenopus Developmental Eye Regrowth System to Distinguish the Role of Developmental Versus Regenerative Mechanisms" (Front Physiol 10:502. 2019).

ORYZON Enters Cooperative Research and Development Agreement (CRADA) with U.S. National Cancer Institute to Develop Iadademstat in Different Cancers

On July 19, 2022 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (Press release, Oryzon, JUL 19, 2022, View Source [SID1234616768]). Under the terms of the agreement, Oryzon and the NCI will collaborate on potential further clinical development of Oryzon’s clinical stage LSD1 inhibitor, iadademstat, in different types of solid and hematological cancers.

Dr. Carlos Buesa, President and CEO of Oryzon, said: "This research and development agreement with the NCI is, first, a strong validation of iadademstat, probably the most potent and selective LSD1 inhibitor currently in clinical development, and will also allow us to significantly expand our clinical development program for this compound."

Dr. Douglas V. Faller, Oryzon’s Global Chief Medical Officer said: "This collaboration with the NCI on the development of iadademstat will allow us to work with some of the world’s leading oncology researchers to further expand its therapeutic potential. This collaboration also dramatically expands our ability to conduct clinical trials in a wide number of indications, and in combination with other novel or established therapies such as immuno-oncology and molecularly-targeted agents."

Iadademstat is an orally active, highly potent and selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers. More than 100 cancer patients have been treated with iadademstat in several trials. In a still ongoing Phase IIa trial (ALICE trial) in elderly 1L acute myeloid leukemia (AML) patients (ALICE trial), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine. The company is now starting a Phase Ib trial of iadademstat in combination with gilteritinib in FLT3 mutant relapsed/refractory AML patients, which recently received IND approval by the FDA. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors, medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial, finalized), preliminary efficacy results have been reported. Iadademstat has recently received orphan drug designation from the FDA for SCLC and has now orphan drug status in the US for SCLC and AML.

xCures partners with Travera to support advanced carcinoma patients and their physicians

On July 19, 2022 xCures, Inc. reported their partnership with Travera, and the launch of a decentralized clinical trial that provides patients with advanced carcinoma a functional profile of their cancer cells (Press release, xCures, JUL 19, 2022, View Source [SID1234616766]). Advanced carcinoma patients often have malignant fluid drained to provide symptomatic relief. Travera’s unique technology takes advantage of this fluid to screen the response of the live tumor cells against approved anti-cancer therapies.

"We are excited to partner with Travera and leverage the application and clinical utility of their incredible technology," said Mika Newton, CEO of xCures. "This study will provide many important outcomes, giving patients and their physicians insight into the cancer’s response to various drugs from a screening panel, eventually helping clinical and treatment decision-making."

The study (TraveraRTGx) will run as a hybrid decentralized research trial utilizing a CLIA-approved test, meaning that the results will be communicated to the physicians and their patients. It will be open to anyone with carcinoma and malignant fluid (pleural effusion, ascites, etc.), most commonly patients with breast cancer, lung cancer, or abdominal cancers. When patients enroll in the study, xCures will work with treating physicians and institutions to ensure the excess fluid is properly stored and sent to Travera, where cancer cells in the fluid will be screened against candidate drugs relevant to the specific patient or cancer type.

"We are thrilled to partner with xCures and expand the clinical applications of our unique screening technology based on cancer cells’ growth response to candidate drugs," states Clifford Reid, Travera’s CEO." Tumor cells in this often discarded malignant fluid can provide critical information about which drugs to prescribe."

Advanced carcinoma patients and their caregivers interested in the study can register and learn more at View Source

Wugen Receives U.S. FDA Fast Track and Rare Pediatric Disease Designations for WU-CART-007 for the Treatment of R/R T-ALL/LBL

On July 19, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation and Rare Pediatric Disease Designation (RPDD) for WU-CART-007, the company’s off-the-shelf CAR-T cell therapy (Press release, Wugen, JUL 19, 2022, View Source [SID1234616765]). WU-CART-007 is currently being explored for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL).

"We are very pleased to have received both fast track and rare pediatric disease designations, which re-affirm the great unmet need for new treatment options for people with R/R T-ALL/LBL," said Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen. "Earlier this year, we dosed the first patient in our ongoing Phase 1/2 trial of WU-CART-007 for R/R T-ALL/LBL and are currently in the dose escalation phase of the study. We look forward to working closely with the FDA as we continue to advance WU-CART-007 through clinical development."

The FDA’s Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, the purpose is to get important new drugs to the patient earlier. Features of Fast Track Designation include opportunities for more frequent interactions with the FDA review team and, if supported by clinical data, eligibility for Priority Review.

A rare pediatric disease designation is granted for drugs intended for the prevention or treatment of rare diseases that primarily affect individuals under 18 years old, with recipients of this designation potentially qualifying for a priority review voucher if certain conditions are met. The priority review voucher may be redeemed, transferred, or sold.

WU-CART-007 is currently being evaluated for safety and efficacy in patients with R/R T-ALL/LBL in a global, open-label, first-in-human, Phase 1/2 study (NCT#04984356).

About WU-CART-007

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356.

VBL Therapeutics Announces Top-Line Data from Phase 3 OVAL Trial of Ofra-Vec in Patients with Platinum-Resistant Ovarian Cancer

On July 19, 2022 VBL Therapeutics (Nasdaq:VBLT), a biotechnology company developing targeted medicines for cancer and immune-inflammatory diseases, reported top-line data from the Phase 3 OVAL clinical trial of ofra-vec (ofranergene obadenovec; VB-111) in platinum-resistant ovarian cancer (Press release, VBL Therapeutics, JUL 19, 2022, View Source [SID1234616764]). The trial did not meet the primary endpoints of achieving a statistically significant improvement in progression-free survival (PFS) or overall survival (OS).

The OVAL trial demonstrated that patients randomized to the combination of ofra-vec and paclitaxel had a median PFS of 5.29 months, versus 5.36 months for the paclitaxel control arm (HR=1.03). The interim overall survival analysis was also not significantly different between the two study arms (median OS 13.37 months in the treatment arm versus 13.14 months in the control arm; HR= 0.97) and did not support study continuation.

"Given the urgent unmet need for those fighting platinum-resistant ovarian cancer, we are deeply disappointed that the top-line data indicate that ofra-vec did not improve progression free survival or overall survival," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "Based on this outcome, we plan to discontinue the OVAL trial and will review the data from our ongoing Phase 2 trials in metastatic colorectal cancer and recurrent glioblastoma multiforme to determine next steps with the ofra-vec program. We extend our deepest gratitude to all the patients, families and healthcare professionals who participated in this trial."

As VBL evaluates next steps with the ofra-vec program, it continues to move the VB-601 program forward towards a first-in-human clinical trial, expected to begin in the fourth quarter of 2022. The Company anticipates that its current cash on hand will be sufficient to fund planned operations for at least the next 12 months.

About the OVAL Phase 3 Clinical Trial

OVAL (VB-111-701/GOG-3018) was an international, Phase 3, randomized, double-blind, placebo-controlled, clinical trial comparing a combination of ofra-vec (ofranergene obadenovec; VB-111) plus paclitaxel to placebo plus paclitaxel in 409 adult patients with recurrent platinum-resistant ovarian cancer. The two primary endpoints of the trial were progression free survival (PFS) and overall survival (OS). OVAL was conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.