On April 5, 2022 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported that Roswell Park Comprehensive Cancer Center has joined its PROPHETIC study, launching a clinical site in Buffalo, New York (Press release, OncoHost, APR 5, 2022, View Source [SID1234611481]).

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The clinical trial site will use OncoHost’s precision oncology platform, PROphet, to conduct proteomic analysis on patients receiving immunotherapy for malignant melanoma, small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) to predict their treatment response. The expansion of OncoHost’s ongoing clinical trial initiative comes as the company’s diagnostic platform shows strong accuracy in host response analysis of late-stage lung cancer patients.

"With an increase in available treatment options, oncologists and patients find themselves facing a challenge in how to successfully identify treatment approaches that will yield the highest success probability," said Dr. Igor Puzanov, Professor of Medicine and Oncology at Roswell Park Center and PI of the study. "To maximize the likelihood of selecting the correct therapy combinations for each patient, clinicians rely on predictive biomarkers to guide individual treatment planning. Roswell Park is proud to help advance this work with our participation as a study site. We look forward to exploring the study’s ongoing development and eventual findings, with the hope of improving our patient outcomes as a result."

PROphet is a first-of-its-kind diagnostic platform that combines proteomic analysis with AI to predict patient response to immunotherapy and identify resistance associated processes. Recent results from the ongoing PROPHETIC study show that through analysis of one blood test pre-treatment, PROphet can predict patient response in non-small cell lung cancer (NSCLC) patients with high accuracy at three months, six months and one year. The platform also identifies potential drug targets, advancing the development of novel therapeutic strategies and providing clinicians with potential combinations to overcome treatment resistance.

"We are excited to partner with a prestigious and leading provider of cancer treatment, collaborating to gain a better understanding of patient response," said Dr. Ofer Sharon, CEO of OncoHost. "With Roswell Park joining our multicenter trial we can now expand recruitment, further developing our research base and improving on our current technology capabilities. We anticipate strong results from this study, which will eventually help us provide a premier tool for oncologists and physicians in the fight against cancer."

To date, OncoHost has opened over 35 clinical trial sites globally, expanding the study’s reach to new locations and providing a broader body of evidence-based research ahead of the U.S. PROphet launch later this year.

On April 5, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported it has received approval from Swissmedic, the Swiss Agency for Therapeutic Products, for the Company’s potentially pivotal study of Berubicin for the treatment of recurrent glioblastoma multiforme (GBM) (Press release, CNS Pharmaceuticals, APR 5, 2022, View Source [SID1234611480]). With approvals now received from both swissethics, the umbrella organization of the cantonal Ethics Committees (EC) in Switzerland, and Swissmedic, the Company can proceed with site initiation and patient enrollment in Switzerland.

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"With the necessary regulatory approvals in Switzerland now in place, our team is diligently working to bring clinical sites online and quickly and efficiently drive patient enrollment in this potentially pivotal study. We are sincerely grateful to the Swiss Competent Authority and Ethics Committee and their positive feedback on what we continue to believe is an incredibly important clinical program. We are laser focused on advancing Berubicin to unlock its greatest potential as a possible critical treatment option for this devastating disease. As long as the unmet medical need in GBM remains, we will continue our fight to bring hope to patients and families," commented John Climaco, CEO of CNS Pharmaceuticals.

Professor Michael Weller, MD, University Hospital Zurich and National Coordinating Investigator for the potentially pivotal study, added, "The data Berubicin has shown to-date demonstrates encouraging promise in treatment of GBM. Patients and families are desperate for a viable treatment option that provides benefit and I look forward to further exploring Berubicin’s potential. I am excited to be able to participate in this important clinical trial and join forces with CNS Pharmaceuticals in their effort to provide what could be an important, and crucial, treatment option."

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal global trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.

On April 5, 2022 Dialectic Therapeutics, Inc. (Dialectic), a Texas-based clinical stage biotechnology company focused on creating innovative new technologies to treat cancer, reported that the U.S. Food and Drug Administration (FDA) has granted fast track designation to DT2216 for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) (Press release, Dialectic Therapeutics, APR 5, 2022, View Source [SID1234611479]). DT2216 is Dialectic’s first generation compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD) technology platform.

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Fast Track designation is an FDA program that is intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition and provide opportunities for frequent interactions with the FDA.

"This is an important milestone in the development of DT2216, our lead APTaD compound. This, along with FDA’s recent decision to grant orphan drug designation, underscores our belief that DT2216 could be a promising therapeutic for T-cell lymphoma patients" said Dr. David Genecov, Dialectic’s President and Chief Executive Officer. "There is a critical unmet need for people diagnosed with this rare cancer, in which current approved therapies have relatively low response rates."

Normal T-cells require BCL-XL expression to survive thymic selection during their development. After thymic selection BCL-XL normal T-cells no longer express BCL-XL. However, many T-cell lymphomas re-express BCL-XL as a mechanism of their neoplastic transformation and permits their continued survival as a malignancy. Studies have demonstrated the importance of BCL-XL in T-cell lymphoma survival. Dialectic has shown that DT2216 is an effective treatment for T-cell lymphoma in preclinical studies.

About DT2216 and the APTaD Technology Platform
DT2216 is currently being investigated in a Phase 1 clinical trial designed as an open-label, first-in-human, dose escalation study in patients with histologically or cytologically confirmed advanced or metastatic solid tumors and hematologic malignancies who are no longer responsive to approved or accepted standard-of-care interventions. Patients in the Phase 1 trial will receive a single intravenous (IV) infusion of DT2216 twice weekly for at least 4 weeks, with each cycle consisting of 28 days. Additional information about the clinical trial is available at ClinicalTrials.gov (NCT04886622).

In preclinical studies DT2216 selectively induces the degradation of B-cell lymphoma extra-large, or BCL-XL, in cancer cells and either stimulates the return of cellular apoptosis or sensitizes the cells to be more susceptible to chemotherapy, and thus cellular destruction. DT2216 has been shown to be effective in various in vitro models of hematologic and solid tumors as a single agent and in combination with other chemotherapeutic agents. Further, these preclinical studies show cancer cells are less likely to develop resistance to DT2216 compared to other chemotherapy drugs. DT2216 accomplishes this with less impact on platelets.

As with BCL-XL, there are many other significant proteins associated with cancer that cannot be targeted with current therapies. Our proprietary APTaD technology platform is a novel approach that can be applied to the broader BCL family and other protein targets. Our current research and preclinical efforts are focused on developing next generation APTaD candidates to address this high unmet need.

On April 5, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2022 financial and operating results on Wednesday, May 4, 2022, before the U.S. financial markets open (Press release, Regeneron, APR 5, 2022, https://www.prnewswire.com/news-releases/regeneron-to-report-first-quarter-2022-financial-and-operating-results-and-host-conference-call-and-webcast-on-may-4-2022-301518076.html [SID1234611478]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
Participants may access the conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On April 5, 2022 Lytix Biopharma AS (Lytix), a clinical-stage company with an in situ vaccination technology platform targeting cancer indications, reported that the first patient has been dosed in Verrica Pharmaceuticals Inc.’s Phase II study evaluating LTX-315 for the treatment of basal cell carcinoma (skin cancer) (Press release, Lytix Biopharma, APR 5, 2022, View Source [SID1234611477]). This triggers a USD 1 million milestone payment to Lytix in accordance with the licensing agreement between the parties.

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Verrica Pharmaceuticals Inc ("Verrica") has an exclusive worldwide license agreement with Lytix to develop and commercialize LTX-315 for dermatologic oncology conditions.

"We are delighted to see Verrica doses the first patient in its Phase II trial evaluating LTX-315 as a non-surgical treatment option for patients with basal cell carcinoma. Non-melanoma skin cancers, including basal cell and squamous cell carcinomas, are the most common form of cancer in the U.S., with over 5 million diagnoses each year, and there is a high unmet need for new treatments. We look forward to following the development of our novel oncolytic molecule as a potential new treatment for non-melanoma skin cancer," said Øystein Rekdal, CEO of Lytix Biopharma.

LTX-315 is a first-in-class oncolytic molecule representing a new and superior in situ therapeutic vaccination principle, and in August 2020, Lytix licensed LTX-315 to Verrica for the treatment of dermatologic oncology indications.

Under the terms of the agreement, Lytix is entitled to receive an upfront payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of up to USD 111 million, including the mentioned milestone. In addition, Lytix is entitled to receive tiered royalties based on worldwide annual sales. There are approximately 3-4 million patients diagnosed with basal cell carcinomas in the U.S. each year, with a high unmet need for new treatment options.

To view the full announcement from Verrica, please visit View Source