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Rigel Doses First Patient in Phase 1b Study of R289 for the Treatment of Lower-Risk Myelodysplastic Syndromes

On December 15, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it dosed the first patient in its Phase 1b study of R289, an IRAK1/4 dual inhibitor, in patients with lower-risk myelodysplastic syndromes (MDS) who are refractory or resistant to prior therapies (Press release, Rigel, DEC 15, 2022, View Source [SID1234625321]).

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"R289’s dual inhibition of IRAK1 and IRAK4 has the potential to provide a more robust suppression of the pro-inflammatory environment that causes lower-risk MDS by blocking inflammatory cytokine production," said Wolfgang Dummer, M.D., Ph.D., Rigel’s chief medical officer. "The initiation of our Phase 1b study demonstrates our continued ability and commitment to bringing innovative, investigational candidates for hematology-oncology indications into the clinic. We believe R289 may represent a promising new approach to treating patients with lower-risk MDS and look forward to investigating R289 further in this Phase 1b study."

Rigel’s open-label, Phase 1b study of R289 is expected to enroll approximately 22 patients with lower-risk MDS who are refractory or resistant to prior therapies (NCT05308264). The primary objective of the study is safety, with secondary and exploratory objectives to assess preliminary efficacy and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of R289. The safety and efficacy data from this Phase 1b study, along with the safety and PK/PD data from the completed first-in-human (FIH) study in heathy volunteers, are intended to be used to determine the recommended Phase 2 dose for future clinical development of R289 targeting lower-risk MDS.

About R2891
R289 is a prodrug of R8351, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients2.

Philogen to attend the JP Morgan on January 9-12, 2023 in San Francisco

On December 15, 2022 Philogen reported its attendance at JP Morgan 2023 (Press release, Philogen, DEC 15, 2022, View Source [SID1234625320]).

Prof. Dr. Dario Neri, CEO and CSO of Philogen, and Dr. Emanuele Puca, Investor Relations and Business Development, will be available for meeting to explore novel collaboration opportunities.

PDS Biotech Completes First Stage of Enrollment in Checkpoint Inhibitor Refractory Arm of Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer

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."

NantHealth, Inc. Announces 1-For 15 Reverse Stock Split

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).

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.

Moleculin Reports 80% Overall Response Rate in Final Cohort of Phase 1 Single Agent Trial of Annamycin for the Treatment of Acute Myeloid Leukemia (AML)

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.

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.