On July 24, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the acceptance by the European Medicines Agency (EMA) of a Type II Variation Application for regulatory review for the use of XTANDI (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients (Press release, Astellas, JUL 24, 2019, View Source [SID1234537690]).

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Assessment by the EMA means the Committee for Medicinal Products for Human Use (CHMP) will evaluate the Type II Variation Application for enzalutamide and provide a Scientific Opinion on whether the medicine may be authorised for this new indication, following 90 days of assessment.1

"When prostate cancer begins to spread to other parts of the body, it can be an acutely distressing time for patients. As well as the emotional burden this places on them, daily life can be impacted by debilitating symptoms of progressing cancer, such as pain," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "We look forward to the CHMP’s opinion as we continue to address the unmet medical need for men with advanced prostate cancer by providing additional treatment options across the disease continuum."

The Type II Variation Application is based on data from both the pivotal Phase 3 ARCHES trial, and the Phase 3 ENZAMET trial, investigating enzalutamide in men with mHSPC.2,3

The data from the ARCHES trial were presented in an oral session at the 2019 Genitourinary Cancers Symposium in San Francisco (Abstract #687), and demonstrated that enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression by 61% versus placebo plus ADT in men with mHSPC (n=1,150; HR=0.39 [95% CI: 0.30-0.50]; P<0.0001). In the ARCHES trial, enzalutamide demonstrated a safety profile which was consistent with previous trials in castration-resistant prostate cancer (CRPC). Grade 3–4 adverse events (AEs) (defined as severe/disabling or life-threatening) were similar for patients receiving both enzalutamide plus ADT and those who received placebo plus ADT (23.6% vs. 24.7%).2

Data from the ENZAMET trial, organised by the international research group Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) Ltd, demonstrated a 33% decrease in the risk of death in men with mHSPC receiving enzalutamide plus ADT compared to those who took a conventional non-steroidal antiandrogen (NSAA) plus ADT (n=1,125; HR=0.67 [95% CI: 0.52-0.86]; P=0.002). Overall survival (OS) at 3 years was 80% for patients receiving enzalutamide plus ADT versus 72% receiving NSAA plus ADT. AEs during the follow-up period were consistent with the stage of disease, the age of the patients, and known safety profiles of the trial regimen. The incidence of seizure and fatigue were higher with enzalutamide plus ADT and treatment discontinuation due to AEs was more frequent among patients taking enzalutamide than with NSAA plus ADT.3 Astellas provided funding and support for the ENZAMET trial.

Enzalutamide is currently approved in Europe for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and adult men with metastatic castration-resistant prostate cancer (mCPRC) in whom chemotherapy is not yet clinically indicated, or following disease progression on or after docetaxel therapy.4 In the U.S. and Japan enzalutamide is indicated for the treatment of CRPC.5,6

On July 23, 2019 Oncoceutics, Inc., reported a collaboration with the National Cancer Institute (NCI) funded Pediatric Preclinical Testing Consortium (PPTC) to enable tumor type selection for ONC201 clinical trials in pediatric oncology beyond diffuse midline gliomas (Press release, Oncoceutics, JUL 23, 2019, View Source [SID1234558336]).

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The PPTC program addresses key challenges associated with the development of new therapies for children with cancer by producing reliable preclinical data using genomically characterized patient-derived lines to inform indication prioritization for pediatric clinical trials. The program is funded by the NCI and agents are selected for evaluation through a competitive application process and review of submitted proposals by the PPTC steering committee.

ONC201 was selected for evaluation by the PPTC steering committee based on the promising preclinical and clinical results in adult and pediatric diffuse midline gliomas. The collaboration looks to build and expand on these findings through in vitro and in vivo testing in order to develop data to support the evaluation of ONC201 more broadly across pediatric cancers in the clinic. ONC201 efficacy will be evaluated in vitro with follow-on in vivo studies in preclinical models of pediatric glioblastoma, ependymoma, medulloblastoma, neuroblastoma, Ewing sarcoma and rhabdomyosarcoma. The PPTC studies will be conducted at the Children’s Hospital of Philadelphia for neuroblastoma, the Greehey Children’s Cancer Research Institute for sarcoma, and Ann & Robert H. Lurie Children’s Hospital of Chicago for brain cancers.

"We are excited to work with the prestigious NCI funded PPTC research group to enable the expansion of our pediatric oncology program for ONC201 beyond H3 K27M mutant gliomas" said Varun Vijay Prabhu, PhD, Associate Vice President of R&D at Oncoceutics. "This translational effort to evaluate ONC201 broadly in pediatric oncology is consistent with feedback from academic disease experts during our recent presention at FDA to the pediatric subcommittee of ODAC."

A webcast recording of the meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee that occurred on June 20, 2019 concerning the development of ONC201 for pediatric oncology can be viewed at the following link.

On July 23, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions, reported that based on favorable safety data in a 19-patient dose-escalation run-in study, the Data Safety Monitoring Board (DSMB) has recommended the continuation of the Company’s Phase 3 clinical trial with trans sodium crocetinate (TSC) in inoperable glioblastoma multiforme (GBM) patients (Press release, Diffusion Pharmaceuticals, JUL 23, 2019, View Source [SID1234538535]). In addition, the DSMB has recommended that the highest dose administered, 1.5 mg/kg of TSC, be used during the adjuvant treatment period of the Phase 3 INTACT trial. The INTACT (INvestigating Tsc Against Cancerous Tumors) trial is comparing standard of care (SOC) radiation therapy and chemotherapy plus TSC against SOC alone.

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The dose-escalation run-in study explored four doses of TSC: 0.25, 0.5, 1.0 and 1.5 mg/kg. Patients received SOC radiation therapy and temozolomide chemotherapy with an intravenous injection of TSC administered before those treatments. Adverse events seen were consistent with the natural history of newly diagnosed inoperable GBM patients.

The DSMB concluded that no adverse safety signal had been observed, and unanimously recommended continuing the study as planned using the 1.5 mg/kg dose of TSC during the adjuvant chemotherapy period.

"We are pleased this run-in study is consistent with our previous findings as to the safety of TSC," said David Kalergis, Diffusion’s chief executive officer. "We are hopeful these run-in safety data, along with compelling data from our Phase 2 study showing a nearly four-fold improvement in survival at two years with TSC when used with radiation therapy in the inoperable GBM patient subgroup, will attract the attention of potential partners for continuing the development of the GBM indication. GBM patients have a poor prognosis and limited treatment options. We believe TSC has great potential to improve these patients’ outcomes and extend survival."

About the INTACT Trial

The INTACT clinical trial is an open-label, randomized, controlled, Phase 3 safety and efficacy registration trial in inoperable GBM patients. It will screen 300 patients and enroll 264, with the expectation that results from 236 patients will be available for analysis. Enrolled patients will be randomized in a 1:1 ratio into control and treatment groups. Patients in the control group will receive SOC radiation and chemotherapy, including the standard temozolomide injections. Patients in the treatment group will receive injections of TSC prior to these SOC treatments. The SOC regimen for GBM is temozolomide plus radiation therapy for 6 weeks followed by 28 days of rest, followed by 6 cycles of high-dose temozolomide treatment.

The study will compare overall survival at two years between the two groups. Up to 100 clinical sites are expected to participate.

Further details about the trial protocol are available at www.clinicaltrials.gov.

On July 23, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported the pricing of an underwritten public offering of 7,142,858 shares of its common stock at a price to the public of $70.00 per share (Press release, Seattle Genetics, JUL 23, 2019, View Source [SID1234537705]). All of the shares are being sold by Seattle Genetics. The gross proceeds to Seattle Genetics from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be approximately $500 million. The offering is expected to close on or about July 26, 2019, subject to customary closing conditions. In addition, Seattle Genetics has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,071,428 shares of its common stock solely to cover overallotments at the public offering price, less the underwriting discounts and commissions.

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Seattle Genetics anticipates using the net proceeds from the offering to fund ongoing commercialization of ADCETRIS in the United States and Canada, to fund its activities in preparation for the potential commercial launch of enfortumab vedotin, if approved by the FDA, to fund its research and development efforts designed to further expand the ADCETRIS label and to advance its pipeline of product candidates, as well as for general corporate purposes, including working capital. Seattle Genetics may also use a portion of the net proceeds to in-license, acquire or invest in complementary products, technologies, businesses or other assets or pursue other strategic opportunities although at this time Seattle Genetics has no material agreements or commitments with respect to any new in-license or acquisition opportunity.

J.P. Morgan Securities LLC, SVB Leerink LLC and Goldman Sachs & Co. LLC are acting as joint book-running managers for the offering. Barclays Capital Inc., RBC Capital Markets, LLC and Guggenheim Securities, LLC are acting as co-managers for the offering.

A shelf registration statement relating to the shares was previously filed with and became effective by rule of the Securities and Exchange Commission. The offering is being made solely by means of a prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the Securities and Exchange Commission and will be available on the Securities and Exchange Commission’s website located at View Source A copy of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by facsimile at (212) 902-9316 or by email at [email protected].

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.

On July 23, 2019, Moleculin Biotech, Inc. ("Moleculin" or "Company"), reported that it entered into an At Market Issuance Sales Agreement (the "Agreement") with Oppenheimer & Co. Inc. (the "Agent") (Press release, Moleculin, JUL 23, 2019, View Source [SID1234537703]). Pursuant to the terms of the Agreement, the Company may sell from time to time through the Agent shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), with an aggregate sales price of up to $15.0 million (the "Shares"). The Company had previously been party to an At Market Issuance Sales Agreement with Roth Capital Partners, LLC and National Securities Corporation, which agreement was terminated in June 2019.

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Any sales of Shares pursuant to the Agreement will be made under the Company’s effective "shelf" registration statement (the "Registration Statement") on Form S-3 (File No. 333-219434), which became effective on August 21, 2017 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the "SEC").

Under the Agreement, the Company may sell Shares through the Agent by any method that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act").

Sales of the Shares, if any, may be made at market prices prevailing at the time of sale, subject to such other terms as may be agreed upon at the time of sale, including a minimum sales price that may be stipulated by the Company’s Board of Directors or a duly authorized committee thereof. The Company or the Agent, under certain circumstances and upon notice to the other, may suspend the offering of the Shares under the Agreement. The offering of the Shares pursuant to the Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $15.0 million, or sooner if either the Company or the Agent terminate the Agreement pursuant to its terms.

The Company will pay a commission to the Agent of 3.0% of the gross proceeds of the sale of the Shares sold under the Agreement and reimburse the Agent for certain expenses. The Company has also provided the Agent with customary indemnification rights. The Company is not obligated to make any sales of Common Stock under the Agreement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Schiff Hardin LLP relating to the legality of the shares of Common Stock issuable under the Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

The above disclosure shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.