On June 30, 2021 Genomic Testing Cooperative, a first-in-class diagnostic company based on a cooperative business model (Co-Op) using the most recent advances in NGS technology, reported a collaboration with Elevation Oncology to enhance identification of patients with any solid tumor harboring an NRG1 fusion who may be eligible for enrollment in the Phase 2 CRESTONE study (Press release, Genomic Testing Cooperative, JUN 30, 2021, View Source [SID1234584507]).

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GTC’s business is based on a cooperation model and has partnerships with multiple Co-Op members, all offering identical menus as GTC. This identification of patients with tumors harboring an NRG1 fusion is extended to all Co-Op members laboratories including Anthology Diagnostics in Edison, NJ and Key Genomics Laboratory at the John Theurer Cancer Center. Patients identified at these sites may be eligible for referral into the CRESTONE study.

"Our goal is to provide comprehensive actionable molecular profiling so patients and their treating physicians can personalize therapy and select the proper treatment that has the potential of improving outcome," stated Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer "The Co-Op model allows us to enable all members of the Co-Op to update their offering and make testing for NRG1 fusion available to their patients."

"We believe that comprehensive biomarker testing of DNA and RNA is critical to give each patient their best chance of getting matched with a precision medicine," said Shawn Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "We are pleased to add Genomic Testing Cooperative to our growing community of collaborators, who share our vision of profiling every patient’s tumor to identify genomic driver alterations that may be actionable."

The Solid Tumor Profile Plus offered by GTC combines the analysis of DNA with RNA to provide comprehensive evaluation of cancer that includes detection of single nucleotide variation, copy number variation, expression and fusion. This includes testing of abnormalities in 434 DNA genes and 1408 RNA genes.

Under the terms of the agreement, GTC will help Elevation Oncology identify patients with advanced solid tumors that harbor an NRG1 fusion for participation in Elevation Oncology’s CRESTONE trial. Eligible patients will be referred to active clinical trial sites in Elevation Oncology’s Phase 2 CRESTONE trial of seribantumab in adult patients with recurrent, locally advanced or metastatic solid tumors that harbor an NRG1 fusion.

Patients and physicians can learn more about the CRESTONE study at www.nrg1fusion.com or on www.ClinicalTrials.gov under the NCT number NCT04383210.

On June 30, 2021 FairJourney Biologics S.A. (FJB), leaders in the discovery and optimization of antibodies, reported the launch of "THE ANTIBODY SERIES" – a 1-day conference bringing together top experts in the antibody field to explore the latest innovation within antibody drug discovery (Press release, FairJourney Biologics, JUN 30, 2021, View Source [SID1234584506]). The conference is being launched in Porto, Portugal, celebrating FairJourney Biologics’ inauguration of their new purpose built, state-of-the-art facilities. Online registration to the event has been made available free for a limited period here: Online Registration.

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THE ANTIBODY SERIES takes place on September 9th 2021 (8:45 am BST) and will play host to a panel of influential and international speakers ranging from Biotechs, Universities and Nobel Prize Laureate including:

Sir Gregory Winter, Winner of the 2018 Chemistry Nobel Prize
Hans Clevers (Principle Investigator at Hubrecht Institute)
Ton Logtenberg (University Medical Center Utrecht)
John McCafferty (CSO of IONTAS)
Maria Pajuelo (CSO of FJB)
Daniela Teixeira (COO FJB)
Teresa Barata (Head of Protein Production and Characterization at Flow Eighteen38)
Allan Jensen (VP of Lundbeck)
Mihri Tuna (CSO of Adaptate)
Tatiana Novobrantseva (CSO of Verseau)
Tim Van Hauwermeiren (CEO argenx)
Hans De Haard (CSO argenx)
THE ANTIBODY SERIES will be broadcast live from Porto to enable audiences globally the chance to participate and watch the conference, with the in-person event attended by notable invitees across Industry and Academia.

António Parada, CEO of FairJourney Biologics commented: "We believe our customers and clients will benefit greatly from the decades of experience, innovation and insight each speaker brings to this new event. Having such a diverse panel of speakers, from leading industry to academia, including Nobel Laureate at our first event is truly encouraging and we look forward to sharing this special event with our community and growing the platform."

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.

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"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.

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]).

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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.

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.

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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.