Sapience Therapeutics Announces Expansion of Phase 2 Study Arm with ST101 in Patients with Recurrent Glioblastoma (GBM) Based on Confirmed Partial Response (PR)

On June 2, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported interim clinical data, including a confirmed PR per mRANO (meaning >50% reduction in tumor measurements) in a glioblastoma (GBM) patient from its ongoing Phase 1-2 study in patients with advanced unresectable and metastatic solid tumors (NCT04478279) (Press release, Sapience Therapeutics, JUN 2, 2022, View Source [SID1234615448]).

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In the Phase 2 expansion portion of the ongoing Phase 1-2 study of ST101, 14 GBM patients have been enrolled to date. Of these 14 patients, one patient has a confirmed PR after 18 weeks of therapy, seven patients have not reached the first on-study assessment, and six patients progressed. In both the Phase 1 and Phase 2 portions of the ongoing study, ST101 has demonstrated a favorable safety profile, with manageable mild-moderate infusion related reactions as the most common adverse event. Based on the confirmed PR announced today, Sapience intends to expand the recurrent GBM cohort to enroll additional patients.

"ST101 is showing promising results in GBM with a PR, which we have confirmed with repeat scans per mRANO and using an independent radiology reviewer. The tumor shrinkage we are seeing is especially encouraging given the significant unmet medical need in this disease and its poor prognosis," said Fabio Iwamoto, Principal Investigator at Columbia University. "Our team at Columbia is thrilled to be a part of this work and to deliver meaningful therapeutic benefit to cancer patients."

Dr. Alice Bexon, Sapience’s Chief Medical Officer, added, "The confirmed response in GBM is very exciting news, which along with the continuing clinical benefit we are seeing from some of the Phase 1 patients, suggests that ST101 could make a major contribution to the treatment of cancer. Based on its novel mechanism of action, ST101 is the first in a new class of peptide therapeutics, and we look forward to advancing our Phase 2 study."

Data from the ST101 Phase 1 study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 5th, 2022, Abstract #3014.

About ST101 and the Phase 1-2 Study

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

SELLAS Life Sciences to Present at the JMP Securities Life Sciences Conference on June 15th

On June 2, 2022 ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that Angelos Stergiou, MD, ScD. h.c, President and Chief Executive Officer of SELLAS, will present at the JMP Securities Life Sciences Conference to be held at the Lotte New York Palace in New York City on Wednesday, June 15, 2022, at 11:00 a.m. ET (Press release, Sellas Life Sciences, JUN 2, 2022, View Source [SID1234615445]).

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For more information about the conference, or to schedule a one-on-one meeting with SELLAS management, please contact your JMP Securities representative directly, or send an email to KCSA Strategic Communications at [email protected].

Viracta Therapeutics Provides an Update on the Phase 1b/2 Trial of Nana-val in Patients with Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and Announces Upcoming Poster Presentation at the ASCO Annual Meeting

On June 2, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported that the Safety Monitoring Committee for the ongoing Phase 1b/2 study of Nana-val in patients with EBV+ solid tumors (VT3996-301) has reviewed safety data from the first dose cohort of patients with recurrent or metastatic nasopharyngeal cancer (RM-NPC) and has approved advancing to the next dose level. Newly enrolled patients will enter the trial’s second cohort and receive nanatinostat 30 mg orally, 4 days per week, in combination with valganciclovir 900 mg orally daily (Press release, Viracta Therapeutics, JUN 2, 2022, View Source [SID1234615444]). Preliminary safety and efficacy data from the trial are expected in the second half of this year.

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"Treatment options are limited for patients with RM-NPC, and we are very pleased with the progress thus far in this trial," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "We look forward to enrolling the next cohort which moves us closer to determining the recommended dose of Nana-val for evaluation in additional patients with RM-NPC and other EBV-positive solid tumors."

In addition, the company also announced an upcoming poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will summarize the design of the Phase 1b/2 trial in patients with EBV+ RM-NPC and other EBV+ solid tumors.

Presentation Details:
Poster Title: A Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients with Advanced Epstein-Barr Virus Positive (EBV+) Solid Tumors and in Combination with Pembrolizumab in Patients with Recurrent/Metastatic Nasopharyngeal Carcinoma (RM-NPC)
Session Title: Head and Neck Cancer
Session Date and Time: Monday June 6, 2022, 1:15 – 4:15 pm CDT
Poster Number: 93b
Presenter: A. Dimitrios Colevas, M.D., Stanford Cancer Institute

A copy of the ASCO (Free ASCO Whitepaper) poster will be available by visiting the Events and Webcasts page of the Viracta website following the conference’s conclusion. The poster’s corresponding abstract is currently available on the ASCO (Free ASCO Whitepaper) Annual Meeting Website.

About the Phase 1b/2 Trial
The Phase 1b/2 trial (NCT05166577) is an open-label, multinational trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) of Nana-val in patients with EBV+ RM-NPC. In Phase 2, up to sixty patients with EBV+ RM-NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

Alkermes Announces 2022 Alkermes Inspiration Grants® Program to Support Innovative Programs Focused on People Affected by Addiction, Serious Mental Illness or Cancer

On June 2, 2022 Alkermes plc (Nasdaq: ALKS) reported that the company will accept applications for its Alkermes Inspiration Grants program beginning on June 15, 2022 (Press release, Alkermes, JUN 2, 2022, View Source [SID1234615443]). Now in its sixth year, this competitive grant program will provide up to a total of $500,000 in grants to assist nonprofit organizations in their work to address the needs of people living with addiction, serious mental illness or cancer.

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"In addition to our work developing new medicines designed to address the real world needs of patients, we are committed to working toward positive change for people affected by addiction, serious mental illness or cancer," said Richard Pops, Chief Executive Officer of Alkermes. "This year, we have sharpened the focus of the Alkermes Inspiration Grants program to support innovative programs focused on unmet patient and caregiver needs, while continuing to prioritize efforts to address longstanding and widespread health disparities."

This year’s submissions will be evaluated based on the set of criteria outlined in the request for proposals, with a focus on people affected by alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder, melanoma or ovarian cancer. Proposals should include clearly defined needs, objectives, activity format, mode of delivery and intended audience, and be relevant to historically under-resourced or underrepresented communities. Alkermes seeks to support programs that have a broad reach within the U.S. and potential to lead to sustained impact. Grant recipients will be selected by a committee that includes senior leaders from Alkermes and individuals chosen to represent the perspectives of people with lived experience, caregivers and patient advocates.

Eligible U.S. 501(c)(3) nonprofit organizations may submit a grant application between June 15, 2022 and July 15, 2022. For more information on the Alkermes Inspiration Grants program, including submission instructions, additional eligibility guidelines, evaluation criteria and a link to the application portal, please visit View Source

Ayala Pharmaceuticals to Present at the 2022 Jefferies Global Healthcare Conference

On June 2, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that it will participate in a "Fireside Chat" presentation at the Jefferies Healthcare Conference, to take place June 8-10, 2022, in New York, NY (Press release, Ayala Pharmaceuticals, JUN 2, 2022, View Source [SID1234615442]). The company will also be available for one-on-one meetings with institutional investors at the conference.

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Details on the presentation can be found below:

A webcast of the presentation will be available on the "Events and Presentations" section of the Ayala Pharmaceuticals website.