On November 30, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported preliminary dose-ranging data from the first two dose levels of the dose escalation part of the Phase 1b/2 study of Nana-val in patients with EBV+ recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) (Press release, Viracta Therapeutics, NOV 30, 2022, View Source [SID1234624620]). The data are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), which is taking place both virtually and in-person at the Palexpo Exhibition Centre in Geneva, Switzerland, from December 7 – 9, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1b/2 trial’s first two dose levels enrolled seven patients with EBV+ R/M NPC, six of whom were evaluable for response as of the abstract’s data cut-off date (September 15, 2022). At the time of enrollment, patients had received a median of two prior systemic therapies. All patients were refractory to their last therapy with bone (6/7), liver (5/7), and lung (3/7) metastases.

Key data reported in the abstract include:

Nana-val was well tolerated with no dose limiting toxicities (DLTs) reported. Most common Grade 1-2 AEs were fatigue, nausea, and increased creatinine (n=3 each).
Two of six evaluable patients achieved stable disease (SD) per RECIST v1.1 criteria.
Plasma EBV DNA titers decreased or remained stable in both patients achieving SD, while rising in patients with progressive disease.
"We initiated this study earlier this year, and this abstract reports the first preliminary data on our all-oral combination regimen in patients with advanced Epstein-Barr virus-positive NPC, where few treatment options are available," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "Starting with the recommended Phase 2 dose from our Phase 1b/2 study in lymphoma, the combination of nanatinostat and valganciclovir was thus far well-tolerated in the initial dose escalation cohorts, with no DLTs reported. Dose escalation continues as we evaluate optimizing the use of both agents in the solid tumor setting. We look forward to the advancement of this study to determine the recommended Phase 2 dose."

As previously reported, the Phase 1b/2 trial is currently progressing through its third dose escalation cohort, with enrollment in the third dose level completed. Further safety data from the third dose level will be presented in the abstract’s corresponding poster at ESMO (Free ESMO Whitepaper)-IO. Viracta recently amended the trial protocol to include additional dose levels in the Phase 1b dose escalation portion, which is designed to determine the optimal recommended Phase 2 dose (RP2D). The company anticipates initiating the Phase 2 randomized expansion portion of the Phase 1b/2 trial in the second half of 2023.

Additional details related to the abstract and upcoming poster, entitled, A Phase 1b/2 Study of Nanatinostat (Nstat) Plus Valganciclovir (VGCV) in Advanced Epstein-Barr Virus Positive (EBV+) Solid Tumors and with Pembrolizumab (PEM) in Recurrent/Metastatic Nasopharyngeal Carcinoma (R/M NPC), are shown below.

Presentation Number: 156P
Poster Session Date: December 8, 2022
Poster Session Time: 12:30 p.m. CET

The abstract is currently available for viewing on the congress website. A copy of the poster will be available on the "Events and Webcasts" section of the Viracta website following the conclusion of the congress.

About the Phase 1b/2 Trial of Nana-val in EBV+ R/M NPC and Other EBV+ Solid Tumors
This 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 are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (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.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma and gastric cancer.

On November 30, 2022 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that it has submitted an exploratory Investigational New Drug (eIND) application to the U.S. Food and Drug Administration (FDA) for a planned First-in-Human Phase 0 clinical trial (Press release, TransCode Therapeutics, NOV 30, 2022, View Source [SID1234624619]). The planned clinical trial is to evaluate TransCode’s lead therapeutic candidate, TTX-MC138, in cancer patients with advanced solid tumors. TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode believes that TTX-MC138 could be used as a treatment for many of these cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very excited to take this next step in the development of TTX-MC138 which we hope will bring us closer to introducing this first of its kind treatment for metastatic disease," said TransCode’s Chief Executive Officer and co-founder, Michael Dudley. "We are hopeful that the study conducted under the eIND will demonstrate successful delivery of our lead therapeutic candidate to metastatic lesions in patients with advanced solid tumors. The delivery of oligonucleotide therapeutics to sites other than the liver has remained a significant challenge for decades. Overcoming this challenge would represent an unprecedented step in unlocking therapeutic access to a variety of well documented genetic targets involved in a range of cancers and beyond."

The company believes that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. In multiple preclinical murine models of triple-negative breast cancer (TNBC), treatment with low-dose chemotherapy and TTX-MC138 eliminated pre-existing local metastases in 100% of treated animals representative of stage II/III metastatic cancer. In a more aggressive model representative of stage IV metastatic cancer, treatment with low-dose chemotherapy and TTX-MC138 resulted in elimination of distant metastases in 65% of animals treated. In a murine model of pancreatic adenocarcinoma, TTX-MC138, administered as monotherapy, resulted in complete responses, manifested as regression without recurrence, in 40% of treated animals. In addition to murine models of cancer, TTX-MC138 was successfully delivered and demonstrated preliminary efficacy in a case study of spontaneous feline mammary carcinoma.

TransCode’s Chief Technology Officer and co-founder, Dr. Zdravka Medarova, said, "Demonstrating the feasibility of delivering TTX-MC138 to malignant lesions in humans could unlock the potential of a wide array of RNA-targeted therapeutics, since the TTX platform permits a modular drug design, centered around the same delivery vehicle but with different payloads in terms of the sequence, design, and mechanism of action of the nucleic acid that is being delivered.

A Phase 0 clinical trial is an exploratory study conducted under an Investigational New Drug application. Exploratory IND studies usually involve very limited human exposure to a therapeutic candidate; their primary purpose is to evaluate the candidate’s safety and mechanism of action. In TransCode’s planned clinical trial, up to 12 patients will be given a single dose of radiolabeled TTX-MC138 followed by noninvasive positron emission tomography-magnetic resonance imaging (PET-MRI). The trial is intended to quantify the amount of radiolabeled TTX-MC138 delivered to metastatic lesions and the pharmacokinetics and biodistribution of the therapeutic candidate in cancer patients. The trial could yield critical data regarding therapeutic dose, timing, and potential safety and could inform later stage clinical trials. This trial is not intended to demonstrate any therapeutic effect.

The eIND application includes data, reports and overview summaries of numerous studies that characterize the pharmacology, pharmacokinetics, and toxicology of the clinical trial version of TTX-MC138 both in vitro and in vivo. Additionally, the application describes the chemistry, manufacturing and control (CMC) production of the drug substance and drug product to be used in the trial. The main purpose of the eIND application is to provide FDA with extensive nonclinical data supporting an acceptable safety profile of a therapeutic candidate to be administered to humans. The FDA is expected to review this application and determine the acceptability of the data before TransCode can begin dosing patients. As with FDA review of Investigational New Drug (IND) applications submitted for Phase 1 clinical trials, an eIND becomes effective 30 days after receipt by the FDA unless FDA, within the 30-day time period, raises concerns or questions about the content of the eIND or clinical trial design.

On November 30, 2022 SQZ Biotechnologies (NYSE: SQZ) reported the strategic prioritization of its clinical portfolio to concentrate on the development of its second-generation enhanced Antigen Presenting Cells (eAPC) cell therapy program, focused on HPV16 positive recurrent, locally advanced, or metastatic solid tumors (Press release, SQZ Biotech, NOV 30, 2022, View Source [SID1234624618]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In connection with the prioritization decision, the company announced that Armon Sharei, PhD, Chief Executive Officer at SQZ Biotechnologies, will step down from his role as CEO and the Board of Directors, effective immediately. The Board has appointed Howard Bernstein, MD, PhD, former Chief Scientific Officer and current director, as Interim Chief Executive Officer. Dr. Bernstein, along with Chief Medical Officer, Marshelle Smith Warren, MD, will oversee the advancement of the eAPC program and clinical trial.

"The Board and I would like to sincerely thank Armon for his vision and leadership at SQZ over the past decade and his willingness to remain available to advise the company and the Board," said Bernard Coulie, MD, PhD, Chairman of the Board at SQZ Biotechnologies. "As we move into our next chapter, I have great confidence in the company’s ability to bring the eAPC program to clinical readout next year and am excited to explore the program’s full potential. The company will benefit from having a highly-experienced leader in drug development, like Howard, step in at this critical time. His deep institutional knowledge of SQZ from his time as Chief Scientific Officer and director will help the company realize the potential opportunity of the eAPC cell therapy program."

"As we navigate an unprecedented operating environment, we plan to be disciplined with our capital and pursue opportunities where we see great potential promise," said Howard Bernstein, MD, PhD, Interim Chief Executive Officer at SQZ Biotechnologies. "We have made the strategic decision to focus our efforts on advancing our eAPC clinical candidate with the aim of reaching a Phase 1/2 data readout for our highest-dose monotherapy cohort by the middle of next year."

The company will transition its first-generation Antigen Presenting Cells (APC) therapy to its second-generation enhanced Antigen Presenting Cells therapy and has initiated switching select APC sites to the eAPC clinical trial. At European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)—Immuno-Oncology (ESMO-IO) Congress 2022, the company will present the latest clinical data from the company’s Antigen Presenting Cells (APC) program clinical candidate, SQZ-PBMC-HPV, including high dose monotherapy and combination therapy. The company will also present initial cohort 1 data from its ongoing COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial at ESMO (Free ESMO Whitepaper)-IO.

Additionally, the company will pause its APC, Activating Antigen Carrier (AAC) and Tolerizing Antigen Carrier (TAC) programs. This portfolio prioritization allows the company to deliver data readouts for the SQZ eAPC program’s highest-dose monotherapy cohort, which the company anticipates in mid-2023. The company will continue to explore partnerships and collaborations for its earlier stage assets and programs, including TAC, as well as the company’s point-of-care manufacturing capabilities.

As part of the prioritization decision, the SQZ Biotechnologies Board of Directors approved a restructuring plan which includes a workforce reduction of approximately 60 percent. The company expects to incur total expenses of approximately $5 million as a result of the restructuring plan, consisting primarily of severance and other employee-related costs. The initial cost saving measures are expected to extend the company’s cash runway into 2024.

Additionally, Micah Zajic, Chief Financial Officer, has decided to step down from his role at SQZ Biotechnologies, effective December 31, 2022.

On November 30, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("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 the Company will present at the JMP Securities Hematology and Oncology Summit, a virtual investor conference being held from December 6-7, 2022 (Press release, Sellas Life Sciences, NOV 30, 2022, View Source [SID1234624614]). Angelos Stergiou, MD, ScD. h.c, President and Chief Executive Officer of SELLAS, will participate in a virtual fireside chat on Wednesday, December 7, 2022, at 3:20 p.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For more information about the conference, please refer to the conference website or contact your JMP Securities representative directly.

On November 30, 2022, Enochian BioSciences Inc. (the "Company") reported that it received a notice (the "Notice") from The Nasdaq Stock Market LLC ("Nasdaq") stating that because the Company has not yet filed its Form 10-Q for the period ended September 30, 2022 (the "Form 10-Q"), the Company remains in non-compliance with Nasdaq Listing Rule 5250(c)(1), which requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission (the "SEC") (Press release, Enochian BioSciences, NOV 30, 2022, View Source [SID1234624617]). As previously disclosed on Form 8-K filed with the Securities and Exchange Commission on October 21, 2022, on October 17, 2022, the Company previously received a notice from Nasdaq indicating that as a result of not having timely filed its Annual Report on Form 10-K for the period ended June 30, 2022 (the "Form 10-K"), the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As previously disclosed, the Company currently believes the delay in the filing of the Form 10-K and Form 10-Q is due to one issue resulting from the continued work being done by a third-party valuator on a company asset.

This notification has no immediate effect on the listing of the Company’s shares on Nasdaq. However, if the Company fails to timely regain compliance with the Nasdaq Listing Rule, the Company’s common stock will be subject to delisting from Nasdaq.

Under Nasdaq rules, the Company has 60 calendar days from the prescribed due date for filing the Form 10-K, or December 16, 2022, to either file the Form 10-Kor to submit to Nasdaq a plan to regain compliance with the Nasdaq Listing Rule. If the Company does not file the Form 10-K but submits a plan to regain compliance, and Nasdaq accepts the Company’s plan, then Nasdaq may grant the Company up to 180 days from the prescribed due date for filing the Form 10-K, or April 11, 2023, to regain compliance. If Nasdaq does not accept the Company’s plan, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel.