On December 15, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported the completion of enrollment in the first stage of the checkpoint inhibitor refractory group of its VERSATILE-002 Phase 2 study for the potential treatment of recurrent and/or metastatic human papillomavirus (HPV16)-positive head and neck cancer (Press release, PDS Biotechnology, DEC 15, 2022, View Source [SID1234625318]). 90% of HPV-associated head and neck cancers in the US are reported to be caused by HPV16, as reported in a study published in the Journal of Clinical Medicine.

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab (KEYTRUDA) in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). VERSATILE-002 is investigating two patient populations of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients has failed treatments including checkpoint inhibitor therapy (CPI refractory).

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. During PDS Biotech’s recent Head and Neck Cancer Key Opinion Leader (KOL) Roundtable, Dr. Weiss highlighted data observed from 17 patients, including an objective response rate of 41%, clinical benefit rate of 77%, and an overall survival rate of 87% at nine months.

"We are very pleased to have completed enrollment among checkpoint inhibitor refractory patients in this first stage for this group in our VERSATILE-002 Phase 2 study," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "This important milestone follows continued positive progress with the Phase 2 study, including data presented at ASCO (Free ASCO Whitepaper) 2022 and updated at our recent Head and Neck Cancer KOL Roundtable demonstrating the potential of PDS0101 in combination with pembrolizumab as a treatment for recurrent or metastatic HPV16-positive head and neck cancer. Currently, there are no approved therapies for CPI refractory head and neck cancer, with patients typically surviving less than a year. Our intent with VERSATILE-002 is to investigate the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer."

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On December 15, 2022 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported that the company has implemented a reverse stock split at a ratio of 1-for-15, which is expected to be effective 5 p.m. Eastern Time (ET) on December 15, 2022 (Press release, NantHealth, DEC 15, 2022, View Source [SID1234625317]). The company’s common stock is expected to begin trading on a split-adjusted basis at commencement of trading on Friday, December 16, 2022. The reverse stock split was approved by NantHealth’s stockholders on August 18, 2022 and is intended to increase the per share trading price of the company’s common stock, which the company expects will satisfy the minimum bid price requirement for continued listing on the Nasdaq Global Select Market (Nasdaq).

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Reverse Stock Split

The reverse stock split will reduce the number of shares of the company’s common stock from approximately 115,550,244 shares to approximately 7,703,350 shares, but will not change the authorized number of shares of common stock, which will remain at 750,000,000 shares. The company’s common stock will continue to trade on Nasdaq under the symbol "NH." In connection with the reverse stock split, the company’s CUSIP number will change to 630104305 as of December 15, 2022 at 5 p.m. ET.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive a fractional share will instead be entitled to receive cash in lieu of such fractional share from the company’s transfer agent, American Stock Transfer & Trust Company, LLC. Holders of the company’s common stock held in book-entry form or through a bank, broker or other nominee do not need to take any action in connection with the reverse stock split. Stockholders of record will be receiving information from the company’s transfer agent regarding their common stock ownership post-reverse stock split.

In addition, pursuant to their terms, a proportionate adjustment will be made to the per share exercise price and number of shares issuable under all of the company’s outstanding equity awards, and the number of shares authorized and reserved for issuance pursuant to the company’s equity incentive plans will be reduced proportionately.

On December 15, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported an update on its clinical programs evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases (Press release, Moleculin, DEC 15, 2022, View Source [SID1234625316]). These updates were recently presented during a reception for potential investigators held outside of the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans.

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Key updates made during the presentation were as follows:

Announced 80% overall response rate (ORR) in final cohort (n=5) of the European trial of Annamycin as a single agent for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) with one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response).
Of a total of 42 subjects in three of the Company’s Annamycin clinical trials, 100% demonstrated no signs of cardiotoxicity as confirmed by independent expert. All expert reviews included analysis of ejection fraction, echo strain and certain troponin levels intended to assess the potential for both acute and chronic heart damage.
In two of the Company’s Annamycin clinical trials, 32 subjects have been, as allowed by the trial protocol, safely treated above the current FDA lifetime maximum anthracycline dose (550 mg/m2) with up to 1800 mg/m2 of Annamycin treatment with no evidence of cardiotoxicity as confirmed by an independent expert.
Data so far have resulted from treatment with Annamycin as a single agent, however, based on additional preclinical animal data from sponsored research, Annamycin in combination with Cytarabine demonstrated a 68% improvement in the median overall survival (OS) compared to Annamycin as a single agent and a 241% increase in OS compared to Cytarabine alone. These data were recently presented at the 62nd Annual Meeting & Exposition of the American Society for Hematology (ASH) (Free ASH Whitepaper) under the title: "High Efficacy of Liposomal Annamycin (L-ANN or Annamycin) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model."1
Annamycin has been in two single agent Phase 1 clinical trials treating R/R/AML, one in the US and one in Europe. Annamycin is currently in two Phase 1b/2 clinical trials for the treatment of soft tissue sarcoma metastasized to the lungs, again one in the US and one in Europe. Furthermore, based on the preclinical and clinical data discussed above, the Company has begun screening in Poland for a Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of R/R AML. The Company is looking to expand this trial into other countries in Europe to potentially improve recruitment rates.

"Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic. We have continued to make significant progress across our clinical trial programs evaluating Annamycin in STS lung mets and AML. Based on the encouraging data seen to date, we are optimistic in Annamycin’s potential to treat a number of indications and remain committed to furthering its development," commented Walter Klemp, Chairman and CEO of Moleculin. "Additionally, we continue to receive encouraging feedback from our clinical staff and recently had the opportunity to meet with our current and potential investigators during the ASH (Free ASH Whitepaper) Annual Meeting. We intend to expand our Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of R/R AML beyond the borders of Poland. We have gained valuable insight in all of our ongoing development programs, and I believe we are well-positioned to successfully execute on our clinical development initiatives moving forward."

Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.

On December 15, 2022 MimiVax reported the published manuscript of the now completed Phase IIa study of SurVaxM, a cancer vaccine, in newly diagnosed glioblastoma (nGBM) in the Journal of Clinical Oncology, authored by researchers from several prominent US cancer centers (Press release, MimiVax, DEC 15, 2022, View Source;utm_medium=rss&utm_campaign=survaxm-glioblastoma-phase-2a-data-published [SID1234625314]). Glioblastoma is a rare disease with severe unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advancements in recent years. The current study found that 51% of nGBM patients receiving SurVaxM had survived at least 2 years and 41% had survived 3 years, considerably higher rates than has been seen historically from standard care.

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This multi-center, open label, single arm, phase IIa trial in adult patients with nGBM was approved by the institutional review boards at each of the participating hospitals [NCT02455557]. All participants signed an informed consent prior to participation and study related tests. Patients were enrolled and treated at the following institutions: Roswell Park Comprehensive Cancer Center (which also served as the central trial site), Beth Israel Deaconess Medical Center, Cleveland Clinic, Dana-Farber Cancer Institute and Massachusetts General Hospital.

Of 63 patients enrolled, 60 (95.2%) remained progression-free 6 months after diagnosis to successfully reach the study primary endpoint. Additional endpoints of median Progression Free Survival (mPFS) of 11.4 months and median Overall Survival (mOS) of 25.9 months, measured from first dose of SurVaxM. SurVaxM was shown to stimulate survivin-specific cytotoxic T-cells and produce anti-tumor antibody responses which correlated with survival. Patients with the strongest antibody responses had a mOS of 43.1 mos. SurVaxM appeared to be safe and well-tolerated and may represent a promising new therapy emerging for nGBM.

"These promising results seen in the Phase IIa study compare favorably to the historical contemporary outcomes seen in glioblastoma. Additionally, we are excited about the benefit that was seen in both in the methylated [temozolomide-sensitive] and unmethylated [temozolomide-resistant] patients. There has also been significant interest in the randomized Phase IIb ongoing study." –Manmeet Ahluwalia, MD, MBA; Fernandez Family Foundation Endowed Chair in Cancer Research, Chief of Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida.

A follow-up Randomized, Blinded Placebo-Controlled Phase IIb Clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 10 cancer centers across the USA (enrolling at Roswell Park Comprehensive Cancer Center, Miami Cancer Institute, Cleveland Clinic, Dana-Farber Cancer Institute, Overlook Medical Center, Norton Cancer Institute, Fred Hutchinson Cancer Center, Texas Oncology, NYU Langone and UCSF Medical Center). See clinical trials.gov for enrollment details and locations.

"We are finally starting to see immunotherapy having an impact upon difficult to manage diseases like glioblastoma and are excited to be able to contribute in a meaningful way to cancer care to provide hope for glioblastoma patients" –Michael Ciesielski, PhD; Chief Executive Officer, MimiVax

"Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma." J Clin Oncol, Dec. 15, 2022 Manuscript is available online for free open-access at: View Source

Trials for SurVaxM were graciously supported by Roswell Park Comprehensive Cancer Center and the Roswell Park Alliance Foundation.

On December 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for VAL-083 for the treatment of diffuse intrinsic pontine glioma (DIPG), a rare and highly-aggressive childhood brain cancer (Press release, Kintara Therapeutics, DEC 15, 2022, View Source [SID1234625312]).

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The FDA’s ODD program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people. ODD provides the sponsor of the drug with development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

"This is another important step for us in evaluating VAL-083 as a treatment for brain tumors in addition to our lead indication of glioblastoma," said Robert E. Hoffman, Kintara’s President and CEO. "We will continue with our clinical advancement of the drug candidate with our objective of delivering a much-needed new treatment that can benefit patients."