1stOncology™: Cancer Intelligence Service – Page 10510 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

MaaT Pharma Announces First Positive DSMB Safety Review for Phase Ib CIMON Trial Testing Its Microbiome Ecosystem Therapy Capsule Formulation in AML Patients

On December 22, 2020 MaaT Pharma reported that an independent Data Safety and Monitoring Board (DSMB) completed its first analysis of the ongoing Phase Ib CIMON clinical trial with MaaT033, the company’s capsule formulation of its lead biotherapeutic, MaaT013, in patients with acute myeloid leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS) following intensive chemotherapy (Press release, MaaT Pharma, DEC 22, 2020, View Source [SID1234573214]). The DSMB reviewed safety data from the first patient cohort treated with the first dose of MaaT033 and confirmed the absence of safety issues during the trial and recommended that the trial continue without modifications.

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!

Studies have shown that chemotherapy severely reduces the microbial species networks in the gut leading to disruption in its protective epithelial layer and immune system functionality, negatively impacting patient outcomes. MaaT033, which is characterized by high microbial species diversity and richness, has been designed to restore a functional gut microbiome and re-establish immune system homeostasis to improve outcomes for patients in an easy to administer capsule.

"The DSMB’s positive assessment supports our data compiled to date and our understanding of the safety of our microbiome ecosystem therapies in this patient population, and we look forward to continuing this trial with the next patient cohort and identifying a dose that will be utilized in the subsequent Phase II study," commented John Weinberg, MD, Chief Medical Officer at MaaT Pharma. "Our goal is to provide a convenient formulation that enables use in a broad group of patients and that complements our first product candidate MaaT013."

The CIMON trial (NCT04150393) is enrolling a total of 27 patients at 4 centers across France. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with AML or high-risk MDS who underwent intensive chemotherapy. Overall safety, tolerability, and dose regimen will be evaluated, as will the impact on the gut microbiome, to identify a recommended Phase II dose. The CIMON Phase 1b trial is expected to be completed in the fourth quarter of 2021.

Prof. Christian Recher, PU-PH, Head of the Hematology Department at the University Hospital of Toulouse, France, and coordinator of the CIMON trial added: "The treatment of hematological malignancies such as acute myeloid leukemia and myelodysplastic syndrome result in substantial negative changes in the content of patients’ gut microbiota. These microbiome changes increase the risk of poor outcomes, by allowing for negative effects such as gut or systemic infections or GvHD in patients who do go on to receive a hematopoietic stem cell transplant. Therefore, we believe that reconstituting the microbiome with a rich and highly diverse microbial therapy such as MaaT033 offers an opportunity to improve outcomes for these patients."

About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality in order to improve clinical outcomes as well as control adverse events related to conventional treatments for cancer. The capsule formulation eases administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory "Butycore" species, which characterize MaaT Pharma’s microbiome ecosystem therapies.

Ultimovacs ASA Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab

On December 22, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTI), reported the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company’s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab (Press release, Ultimovacs, DEC 22, 2020, View Source [SID1234573213]). The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.

"We continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer, but also by collaborating with clinicians like Professor Binder who can provide us with unique insights," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "Professor Binder and her team are well-recognized experts who will increase our understanding of UV1’s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination."

The FOCUS (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage.

"This clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach," commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle. "I am excited to apply my own insights as well as my team’s expertise to this trial with the goal of potentially providing head and neck cancer patients with better treatment options."

"We have continued to build momentum in our broad clinical development program with the start of the FOCUS study, representing the important opportunity to test UV1 in combination with pembrolizumab in a randomized setting for the first time," said Carlos de Sousa, Chief Executive Officer at Ultimovacs. "We welcome the funding provided by the Norwegian Research Council, which supports our ability as a small biotechnology company to conduct four Phase II trials in parallel and evaluate UV1 in different indications with more than 450 patients and as part of various treatment combinations."

Dr. de Sousa added: "Although we have signed our agreement with the lead investigator for our previously announced third Phase II clinical trial, we will need to wait for the investigator and the pharmaceutical partner to finalize the signature process for their agreement before we can provide full details, which we expect to do before year end."

About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs
As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials recruiting more than 450 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group, which will sponsor the trial. The fourth trial, FOCUS, is an investigator-sponsored, randomized clinical trial, enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, to evaluate the impact of adding UV1 to this regimen.

Horizon Therapeutics plc to Present at the 39th Annual J.P. Morgan Healthcare Conference

On December 22, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the 39th Annual J.P. Morgan Healthcare Conference (Press release, Horizon Therapeutics, DEC 22, 2020, View Source [SID1234573212]). Tim Walbert, chairman, president and chief executive officer, will present at 11:40 a.m. ET on Jan. 12, 2021.

The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available following the event.

Cyclacel Pharmaceuticals Announces at-the-market $7 Million Strategic Investment by Fundamental Investor Acorn Bioventures

On December 22, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported it has entered into a definitive securities purchase agreement with Acorn Bioventures, LP, a biotech-focused fundamental investor (Press release, Cyclacel, DEC 22, 2020, View Source [SID1234573211]).

Under the agreement, Acorn Bioventures has agreed to purchase in a registered direct offering 485,912 shares of common stock and 237,745 shares of newly designated Series B Preferred Stock (convertible into shares of common stock at a ratio of 1:5), and in a concurrent private placement, warrants to purchase 669,854 shares of common stock, for aggregate gross proceeds of approximately $7 million. The offering is priced at-the-market pursuant to the rules of The Nasdaq Stock Market. The warrants will be exercisable beginning twelve months following the date of issuance, will expire on the five-year anniversary of the date of issuance, and have an exercise price of $4.13 per share.

Cyclacel intends to use substantially all of the net proceeds of approximately $6.9 million from the registered direct offering and concurrent private placement to rapidly advance clinical development of CYC140, a Polo-like-kinase 1 (PLK1) inhibitor.

"We are very pleased to support Cyclacel as they continue to progress clinical development of their clinical-stage assets for patients with various types of cancer," commented Anders Hove, MD and Isaac Manke, PhD, of Acorn Bioventures. "Cyclacel’s value proposition focuses on fadraciclib, a CDK2/9 inhibitor, which has shown promising clinical activity and safety profile in patients with advanced cancers and CYC140, a PLK1 inhibitor. Extensive preclinical data support clinical investigation of CYC140 in a broad range of liquid and solid tumors."

"Acorn’s philosophy is centered on achieving long-term investment returns after evaluating the scientific and clinical merits of novel medicines," said Spiro Rombotis, President & Chief Executive Officer of Cyclacel. "We are excited by the prospect that our two internally-discovered molecules, fadraciclib and CYC140, can move forward in parallel. Our clinical development program will evaluate both agents across a broad spectrum of hematological and solid tumor types with the aim of offering novel alternatives to patients with unmet medical needs."

The common stock is being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-231923), previously filed with the Securities and Exchange Commission ("SEC") on June 3, 2019 and declared effective on June 21, 2019. Such shares of common stock are being offered only by means of a prospectus supplement. A prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained, when available, on the SEC’s website at View Source or by contacting Cyclacel Pharmaceuticals, Inc.

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from registration requirements of the Act and such applicable state securities laws.

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

SCYNEXIS Announces Closing of $85 Million Public Offering of Common Stock, Pre-Funded Warrants and Warrants

On December 22, 2020 SCYNEXIS, Inc. (Nasdaq: SCYX) reported the closing of its previously announced underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, DEC 22, 2020, View Source [SID1234573210]). The shares and warrants were sold at a public offering price of $6.25 per share and accompanying warrants, and the pre-funded warrants were sold at a public offering price of $6.249 per pre-funded warrant and accompanying warrants. The total gross offering proceeds to SCYNEXIS from this offering were $85.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants were offered by SCYNEXIS.

At closing, SCYNEXIS issued 8,340,000 shares of its common stock, pre-funded warrants to purchase 5,260,000 shares of common stock, and two series of warrants to purchase an aggregate of 13,600,000 additional shares of its common stock. The pre-funded warrants were issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of SCYNEXIS common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants were issued separately. The Series 1 warrants to purchase up to 6,800,000 shares of common stock have a one-year term and an exercise price of $7.33 per share, and the Series 2 warrants to purchase up to 6,800,000 shares of common stock have a three-and-a-half-year term and an exercise price of $8.25 per share. The pre-funded warrants and the warrants in each series are exercisable immediately. The warrants were certificated and are being delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. served as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (NASDAQ: NHLD), acted as co-lead managers for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC acted as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on September 11, 2020, and was declared effective on October 1, 2020. The offering was made only by means of a preliminary and final prospectus supplement and accompanying prospectus. Copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, or by telephone at (212) 518-9658, or by email to [email protected]; or Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Avenue, 6th floor, New York, NY 10022; mail: [email protected]. The final terms of the offering were disclosed in the final prospectus supplement filed with the SEC.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

In connection with the offering SCYNEXIS terminated its Controlled Equity OfferingSM Sales Agreements with Cantor Fitzgerald & Co. and Ladenburg Thalmann & Co. Inc.