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.

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"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]).

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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.

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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).

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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.

On November 30, 2022 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Chief Scientific Officer and Co-Founder, Dr. Julian Kenyon MD, MB, ChB, has recently come to the conclusion that PRP could become an effective chemosensitizer agent against pancreatic cancer (Press release, Propanc, NOV 30, 2022, View Source [SID1234624613]). Chemotherapy activates certain growth factors, which directly activate cancer-associated fibroblasts (CAFs) to induce collagen deposits in pancreatic ductal adenocarcinoma, thus increasing tumor resistance and becoming unresponsive to treatment, according to Kim, et al., Nature Communications, journal, October 22, 2022. Pancreatic adenocarcinoma (PDAC) accounts for 80% of pancreatic cancers and has a 5-year survival rate of less than 8%. According to Dr. Kenyon, chemotherapy-induced fibrosis in PDAC highlights an "opportunity for a combinatorial therapeutic strategy to treat these resistant tumors."

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Cancer-associated fibroblasts (CAFs) are one of the abundant cell types in the external fibrous walls of tumors, which is the major source of the extracellular matrix within the tumor microenvironment (TME). Emerging evidence indicates that the dense collagen matrix increases resistance to standard anti-PDAC therapies. Furthermore, activated CAFs stimulate cellular signals that promote tumor growth through angiogenesis (blood vessel formation) and immunosuppression. As a result, various therapeutic targets have been identified to support CAF activation, reduce tumor resistance, and improve patient prognosis. Despite extensive efforts, none of these attempts has received FDA approval for the treatment of PDAC due to limited efficacy. One reason for the frustrating outcome could be due to the genetic variability of the CAF population within the TME, making genetic sequencing and targeting difficult. Therefore, the key is to target genetic variations which are less subject to mutation. Another option is to enforce CAFs to express different cellular signaling pathways, which re-educates the cell instead of targeting eradication, leading to decreasing the influence of the TME in drug uptake, immune evasion, tumor progression and further tumor dispersion.

"PDAC resistance to standard chemotherapy remains a significant challenge and consequently results in a poor prognosis for sufferers. Recent attempts to address this effect have focused on the inhibition of CAFs to prevent formation of fibrotic tissue, which contributes to tumor resistance, but with limited results due to genetic variability among patients," said Dr. Kenyon. "This is where PRP comes in. We recently confirmed PRP’s effects on the tumor microenvironment and its ability to alter the expression of CAFs and limit its ability to increase tumor resistance. PRP is a unique approach because, rather than target the genetic sequence to inhibit cellular signaling pathways, it re-educates these cells to overcome tumor resistance. This could have tremendous implications for PRP as a chemosensitizer agent with standard therapies to generate better clinical outcomes for PDAC patients. We look forward to providing further scientific data as we continue our joint research program with our partners at the Universities of Jaén and Granada in Spain."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers.