1stOncology™: Cancer Intelligence Service – Page 8191 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Deciphera Announces First Patient Treated in Phase 1 Study of DCC-3116 in Patients with Advanced or Metastatic Tumors with a Mutant RAS or RAF Gene

On June 30, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported dose administration for the first patient in the Phase 1, multicenter, open-label, first-in-human study of DCC-3116 (Press release, Deciphera Pharmaceuticals, JUN 30, 2021, View Source [SID1234584503]). DCC-3116 is an investigational ULK kinase inhibitor designed to inhibit autophagy and is being studied as a single agent and in combination with trametinib, a U.S. Food and Drug Administration (FDA) approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.

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!

"Approximately one third of all cancers, including a high percentage of pancreatic, lung, colorectal, and melanoma cancers, are driven by mutations in RAS or RAF genes, representing what we believe to be one of the largest unmet medical needs in oncology," said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera Pharmaceuticals. "DCC-3116, a first-in-class, highly selective switch-control ULK kinase inhibitor, is designed to suppress autophagy and may offer a novel approach to targeting a broad array of cancers. We look forward to advancing our fourth active clinical development program generated from our switch-control kinase inhibitor platform and further evaluating the role of ULK kinase inhibition and its potential to represent a new treatment paradigm for cancers caused by RAS or RAF mutations."

Autophagy, a catabolic process in which cells recycle components to generate energy, is often upregulated in cancer cells when cells are stressed or damaged due to anti-cancer treatments. The ULK kinase initiates the autophagy pathway and provides a potential targeted approach to selectively inhibiting autophagy in cancers caused by RAS or RAF mutations. In preclinical studies, DCC-3116 was observed to potently and durably inhibit autophagy in RAS and RAF mutant cancer cell lines through the inhibition of ULK kinase. In addition, in preclinical studies, DCC-3116 also blocked the increase in autophagy induced by inhibitors of the MAPK pathway as a resistance mechanism. The Company’s in vitro and in vivo studies have demonstrated that DCC-3116 in combination with inhibitors of the MAPK pathway may block the growth of cancers caused by RAS or RAF mutations.

The clinical development plan for DCC-3116 will focus on documented RAS and RAF cancer mutations, which utilize autophagy for tumor growth and survival. The Phase 1, multicenter, open-label, first-in-human study will evaluate DCC-3116 as a single agent and in combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic tumors with a mutant RAS or RAF gene. Assuming positive results in the dose escalation phase, combination expansion cohorts are currently planned in patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS or BRAF mutations, non-small cell lung cancer (NSCLC) with KRAS, NRAS, or BRAF mutations, colorectal cancer (CRC) with KRAS, NRAS, or BRAF mutations, and melanoma with NRAS or BRAF mutations. Combination expansion cohorts are planned to evaluate DCC-3116 in combination with trametinib.

Cytovation Announces Clinical Collaboration with MSD to Evaluate its First-in-class Tumorolytic Agent CyPep-1 in Combination with KEYTRUDA

On June 30, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, reported that it has entered into a clinical trial collaboration and supply agreement with MSD to evaluate the safety and efficacy of CyPep-1 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy (Press release, Cytovation, JUN 30, 2021, View Source;utm_medium=rss&utm_campaign=cytovation-announces-clinical-collaboration-with-msd-to-evaluate-its-first-in-class-tumorolytic-agent-cypep-1-in-combination-with-keytruda [SID1234584502]).

Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort. Subsequently, clinical evaluation will proceed into a Phase II trial that will evaluate the efficacy and safety of the combination in up to 90 patients with advanced head and neck squamous cell carcinoma (HNSCC), melanoma, or triple-negative breast cancer (TNBC). Initial results from the safety study are expected early next year with the Phase II trial scheduled to start shortly thereafter.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "Early clinical data for CyPep-1 monotherapy have shown a strong safety profile and encouraging anti-tumor activity that are consistent with our preclinical data, where we have also seen a highly synergistic effect of CyPep-1 with checkpoint inhibitor therapy. We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CyPep-1

CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.

Celcuity Announces Launch of Follow-on Offering

On June 30, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Celcuity, JUN 30, 2021, View Source [SID1234584501]). As part of the offering, Celcuity expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Celcuity . The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Celcuity intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.

Jefferies and Cowen are acting as joint bookrunning managers for this offering. Canaccord Genuity is acting as the lead manager and Needham & Company is acting as the senior co-manager.

The shares are being offered by Celcuity pursuant to a registration statement on Form S-3 previously filed with and declared effective by the U.S. Securities and Exchange Commission. The offering is being made only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from the following: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, email [email protected], telephone: 833-297-2926.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, or any solicitation of an offer to buy, 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.

Alpine Immune Sciences to Collaborate with Merck on Immuno-Oncology Study to Evaluate ALPN-202 in Combination with KEYTRUDA® (pembrolizumab)

On June 30, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported a clinical trial collaboration and supply agreement with Merck (Press release, Alpine Immune Sciences, JUN 30, 2021, View Source [SID1234584500]). This collaboration will evaluate the safety and efficacy of Alpine’s ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The clinical trial, NEON-2, began dosing study participants in June 2021.

"We are extremely pleased to collaborate with Merck, one of the world’s leading immuno-oncology companies," said Stanford Peng, M.D., Ph.D., President and Head of R&D of Alpine. "Our prior preclinical studies demonstrated that the combination of ALPN-202 and a PD-1 inhibitor can be particularly advantageous, and this collaboration will greatly enable our ability to pursue this opportunity in the clinic. This study, in conjunction with NEON-1, ALPN-202’s ongoing first-in-human monotherapy trial, will provide insights across a broad spectrum of cancers and lines of therapy."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a monotherapy study of ALPN-202 in patients with advanced malignancies, and NEON-2 (NCT04920383), a study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, are currently enrolling.

Panbela Increases Previously Announced Bought Deal Offering of Common Stock to $10.0 Million

On June 30, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA) (the "Company" or "Panbela"), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 3,333,334 shares of common stock of the Company at a price to the public of $3.00 per share, less underwriting discounts and commissions (Press release, Panbela Therapeutics, JUN 30, 2021, View Source;utm_medium=rss&utm_campaign=panbela-increases-previously-announced-bought-deal-offering-of-common-stock-to-10-million [SID1234584498]). The closing of the public offering is expected to occur on or about July 2, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company has granted to the underwriter a 30-day option to purchase up to an additional 500,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The gross proceeds of the offering are expected to be approximately $10.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Panbela and assuming no exercise of the option to purchase additional shares. The Company intends to use the net proceeds of the offering for the continued clinical development of its initial product candidate SBP-101 and for working capital and other general corporate purposes.

The shares of common stock described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-255751) filed with the Securities and Exchange Commission ("SEC") and declared effective on May 11, 2021. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus, and the final prospectus supplement and accompanying prospectus, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail at [email protected] or by calling (212) 856-5711.

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation, or sale is unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.