On September 24, 2019 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage oncology company targeting the epigenetic causes of cancers, reported that the Safety Review Committees overseeing the Phase 1/2 clinical study of Seclidemstat in Ewing sarcoma and the Phase 1 study of Seclidemstat in patients with advanced solid tumors (AST) have approved the advancement of each study to the fourth level dosing cohort (Press release, Flex Pharma, SEP 24, 2019, View Source [SID1234539734]).

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The Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma and Phase 1 AST clinical trial are designed as open-label dose-finding studies to determine the maximum tolerated dose (MTD) and initial safety profile of Seclidemstat. Seclidemstat is administered daily as an oral tablet, with each cohort receiving an increased dose of study medication. This MTD, as determined by the Safety Review Committee, will then be used to treat a larger group of patients to confirm the safety profile for Seclidemstat and capture additional information regarding pharmacokinetics and potential preliminary efficacy.

David Arthur, President and Chief Executive Officer of Salarius, stated, "Clearance from the Safety Review Committees to proceed to the higher dosing cohort is an important milestone in the ongoing clinical trials. Ultimately, our goal with these studies is to pinpoint the optimal dose of Seclidemstat, which, in addition to determining the safety parameters of the drug, will enable us to obtain key pharmacokinetic information and, potentially, initial efficacy data. Based on current projections we are on track to reach maximum tolerated dose early next year and report early patient data from both studies in 2020."

The Ewing sarcoma study opened patient enrollment in Q3 2018 and is currently enrolling patients of 12 years of age or older at leading cancer centers in the U.S., including Johns Hopkins All Children’s Hospital, Children’s Hospital of Los Angeles, Moffitt Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. Most recently, the Sarcoma Oncology Center in California was added, bringing the total number of active clinical trial sites to six. The Safety Review Committee recently cleared the third dose level (300 mg Seclidemstat twice-daily), and the fourth dose level is currently enrolling (600 mg Seclidemstat twice-daily). Based on the first 3 dose levels, the pharmacokinetic profile (i.e., how the drug is distributed in the body following administration) appears to be dose proportional.

In June 2019, the Advanced Solid Tumor study began enrolling patients with advanced or recurrent solid tumors including, but not limited to, breast, ovarian and prostate cancer. All study patients had received standard of care therapies but continued to experience progression of their disease. Similar to the Ewing sarcoma study, the Safety Review Committee has cleared the 300 mg dose twice-daily and the 600 mg twice-daily dosing group is currently enrolling patients across the two active sites, HonorHealth in Arizona and the Sarcoma Oncology Center in California.

On September 24, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company has dosed the first patient in a Phase 1/2 clinical trial of CPI-0209 (Press release, Constellation Pharmaceuticals, SEP 24, 2019, View Source [SID1234539733]).

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CPI-0209 is a second-generation EZH2 inhibitor that has been designed to achieve comprehensive target coverage through extended on-target residence time and enhanced potency compared with first-generation EZH2 inhibitors. These features lead to faster onset of action than first-generation EZH2 inhibitors as well as robust anti-tumor activity in models of multiple cancer types.

"We recognized that a best-in-class molecule with enhanced potency and residence time may help to access the full potential of EZH2 inhibition in cancer," said Dr. Patrick Trojer, Chief Scientific Officer. "We believe that CPI-0209 can deliver on this need, and we are eager to learn more about CPI-0209 in the clinic. We have seen impressive pre-clinical activity of CPI-0209 and are excited to take the first steps toward bringing CPI-0209 to patients."

Constellation has utilized its epigenetics platform, including expertise in translational science, to identify novel, targeted patient contexts that may be responsive to inhibition by next-generation EZH2 inhibitors. For instance, in xenografts derived from bladder cell lines harboring ARID1A mutations, once-daily treatment with CPI-0209 achieved regression at well-tolerated doses – activity that was superior to that from the chemotherapeutic agent cisplatin, a standard of care in bladder cancer. At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Bladder Cancer meeting on May 19, 2019, Constellation presented a poster with supporting data from these studies.

The Phase 1 dose escalation phase of the clinical trial will study CPI-0209 monotherapy in advanced, relapsed solid tumor patients. After determining the recommended Phase 2 dose (RP2D) for the monotherapy, we will pursue expansion arms in selected tumor indications as well as combination therapy development, employing a biomarker strategy that includes assessment of ARID1A.

On September 24, 2019 BioNTech SE ("BioNTech"), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported that it has filed a registration statement on Form F-1 with the United States Securities and Exchange Commission (the "SEC") to offer 13,200,000 American Depositary Shares ("ADSs") representing its ordinary shares to the public (Press release, BioNTech, SEP 24, 2019, View Source [SID1234539732]). BioNTech also intends to grant the underwriters a 30-day option to purchase up to an additional 1,980,000 ADSs. The initial public offering price is expected to be between $18.00 and $20.00 per ADS, and BioNTech expects to raise approximately $250 million at the midpoint of the range. BioNTech has applied to list its ADSs on the Nasdaq Global Select Market under the symbol "BNTX."

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J.P. Morgan, BofA Merrill Lynch, UBS Investment Bank and SVB Leerink are acting as lead joint book-running managers for the offering. Canaccord Genuity, Bryan, Garnier & Co. and Berenberg are acting as joint book-running managers for the offering and Wolfe Capital Markets and Advisory, Kempen and Mirae Asset Securities are acting as co-managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the preliminary prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at (866) 803-9204, or by e-mail at [email protected]; BofA Securities, Inc., NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by e-mail at [email protected]; UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at (888) 827-7275, or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]. 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.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities law of any such state or jurisdiction.

On September 24, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported a strategic, multi-year drug discovery collaboration with Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Evotec, SEP 24, 2019, View Source;announcements/press-releases/p/evotec-and-takeda-enter-collaboration-agreement-to-discover-clinical-candidates-across-multiple-therapeutic-areas-5847 [SID1234539731]). Under the collaboration, the parties aim to establish at least five drug discovery programmes with the goal of Evotec delivering clinical candidates for Takeda to pursue into clinical development.

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"Collaborating with world-class drug discovery partners like Evotec is central to our model for discovering and developing transformative medicines," said Steve Hitchcock, Ph.D., Global Head of Research at Takeda. "Takeda has a long history of working with Evotec and is confident in Evotec’s capabilities."

The collaboration combines Evotec’s ability to effectively drive fully integrated drug discovery programmes with Takeda’s strategic insights into transformative therapeutic approaches in Takeda’s four core therapeutic areas: Oncology, Gastroenterology, Neuroscience and Rare Diseases, as well as Takeda’s development and commercialisation expertise. Evotec will leverage its industry-leading discovery platform to validate therapeutic hypotheses and advance small molecule programmes with Takeda having options to assume responsibility at lead series and upon Evotec delivering a pre-clinical candidate.

Under the terms of the collaboration, Takeda will pay Evotec a one-time, upfront fee to access its platforms. Additionally, Evotec is eligible to receive pre-clinical, clinical, and commercial milestones that can total in excess of $ 170 m per programme as well as tiered royalties on future sales.

Dr Craig Johnstone, Chief Operating Officer of Evotec, added: "We are pleased to enter into another collaboration with Takeda, whose values are aligned with Evotec’s, including a shared commitment to translating highest quality science into highly innovative medicines. We believe this collaboration will be very fruitful for both parties and we are excited to combine our resources and skills to produce novel therapies."

On September 24, 2019 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T cell enhancing therapeutics, reported that it has achieved a fifth milestone in its collaboration with Takeda Pharmaceutical Company Limited (Takeda) (Press release, Crescendo Biologics, SEP 24, 2019, View Source [SID1234539730]).

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Under the global, strategic, multi-target collaboration and license agreement with Takeda that was announced in October 2016, Crescendo’s proprietary transgenic platform and engineering expertise is used to identify and configure Humabody-based therapeutics against certain targets selected by Takeda.

Under the terms of the agreement, Crescendo has successfully delivered three novel oncology-targeted Humabody lead molecules. Takeda has taken exclusive licenses to both of the first two programmes in this highly productive collaboration.

Theodora Harold, CEO of Crescendo Biologics, commented:

"Reaching this fifth technical milestone marks our continued progress towards our joint goal with Takeda of creating the next generation of differentiated cancer therapies and provides strong validation of the work being done at Crescendo."