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Enochian BioSciences Announces Receipt of Notice from Nasdaq Regarding Delayed Filing of Form 10-Q for the Period Ended September 30, 2022

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.

Propanc Biopharma Concludes PRP Could Become an Effective Chemosensitizer Agent Against Pancreatic Cancer

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."

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.

Promontory Therapeutics to Present Research on PT-112 in Advanced Non-Small Cell Lung Cancer at the ESMO Immuno-Oncology Congress 2022

On November 30, 2022 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, will present clinical data on lead therapeutic candidate, PT-112, in combination with avelumab, and its immunogenic cell death inducing effects in patients with advanced non-small cell lung cancer as a poster presentation at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress 2022 in Geneva, Switzerland, on Dec. 7-9 (Press release, Promontory Therapeutics, NOV 30, 2022, View Source [SID1234624612]).

Poster Session Details
Title: A phase 2a study of the novel immunogenic cell death (ICD) inducer PT-112 plus avelumab ("PAVE") in advanced non-small cell lung cancer (NSCLC) patients (pts)
Presentation Number: 125P
Session location: Foyer ABC, Palexpo Exhibition Centre
Session time: Thursday, December 8, 2022, 12:30 p.m. to 1:15 p.m. CET
Speaker/Lead Author: Martina Imbimbo, MD, Lausanne University Hospital, Switzerland

Abstracts will be published online on the ESMO (Free ESMO Whitepaper) website at 12:05 a.m. CET on Thursday, Dec. 1, 2022. Abstracts will also be published online in the ESMO (Free ESMO Whitepaper)-IO Congress 2022 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Immuno-Oncology and Technology (IOTECH).

For more information about PT-112 and Promontory Therapeutics’ clinical pipeline visit www.PromontoryTx.com.

About PT-112

PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The ﬁrst in-human study of PT-112 demonstrated an attractive safety proﬁle and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress and the Phase 2a dose confirmation cohort in non-small cell lung cancer (NSCLC) patients will be reported at ESMO (Free ESMO Whitepaper) IO 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and now includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal collaboration with the NCI.

Onxeo advances its second lead candidate OX425 for the treatment of solid tumors

On November, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX), hereafter "Onxeo" or the "Company", a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), reported the expansion of its pipeline of drug candidates with OX425, the optimized new compound of OX400 series sourced from its proprietary PlatON platform (Press release, Onxeo, NOV 30, 2022, View Source [SID1234624611]).

OX425 is a new-generation decoy oligonucleotide (ODN) with a well differentiated mechanism of action from PARP inhibitors as it drives PARP-1 hyperactivation and leads to exhaustion of the DNA damage response, ultimately killing cancer cells. In addition, it also leads to activation of the STING pathway. In preclinical proof-of-concept studies performed to date, OX425 demonstrated high antitumor activity while sparing healthy cells. It also showed the ability to mediate multiple immunostimulatory effects, standing out as promising option for potential combination with immunotherapy, especially in tumors that are not attackable by the immune system ("cold" tumors).

Like the other drug candidates sourced from platON, such as AsiDNA, OX425’s benefits from decoy agonist mechanism of action and does not induce tumor resistance to treatment. This profile represents a clear differentiation from other targeted therapies such as PARP inhibitors. Moreover, OX425 shows no activity on healthy cells, which should yield a favorable safety profile in the clinical setting.

Based on these promising results, Onxeo will complete the preclinical development with the objective to file an Investigational New Drug (IND) with the FDA in mid of 2023.

Dr. Shefali Agarwal, President and CEO of Onxeo, stated: "With the selection of OX425, we demonstrate once again our ability to source new drug candidates with distinctive properties based on the unique decoy mechanism of action which is the technological engine of our PlatON platform. OX425 showed robust antitumor activity during our preclinical studies in multiple solid tumor models from different indications. OX425 is thus positioned as an innovative monotherapy and an ideal candidate for partnering, particularly in combination with immunotherapies, and specifically in cold tumors."

OncoSec Announces Pricing of $3.5 Million Public Offering

On November 30, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the patient’s own immune system to target and eradicate cancer, reported the pricing of its "reasonable best efforts" public offering of 1,166,667 shares of common stock (or common stock equivalents) and Common Warrants to purchase 1,166,667 shares of common stock at a combined price of $3.00 per share, for aggregate gross proceeds of $3.5 million, before deducting placement agent fees and other offering expenses (Press release, OncoSec Medical, NOV 30, 2022, View Source [SID1234624609]).

The closing of the offering is expected to occur on or about December 1, 2022, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes, which may include operating expenses, research and development, and future acquisitions.

A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-268081) previously filed with the Securities and Exchange Commission (SEC) which became effective on November 30, 2022. The offering is being made only by means of a prospectus forming part of the effective registration statement. Copies of the preliminary prospectus and, when available, copies of the final prospectus, relating to the offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the offering may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.