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.

On July 23, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported an update on its strategic collaboration with Celgene Corporation (NASDAQ: CELG), originally established in July 2016 (Press release, Jounce Therapeutics, JUL 23, 2019, View Source [SID1234537692]). Under the terms of a new license agreement, Celgene has licensed worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Jounce retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs, as Jounce and Celgene have also entered into a mutual agreement to terminate their original strategic collaboration agreement.

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Under the terms of the new license agreement for JTX-8064, Jounce receives a $50.0 million non-refundable license fee and is eligible to receive from Celgene up to $480 million in development, regulatory and commercial milestone payments, as well as royalties on potential worldwide sales. Celgene will be responsible for all development and commercialization of JTX-8064.

"We are grateful for Celgene’s investment and support of Jounce over the past three years as it has helped us grow our diversified pipeline and further enhance our translational science platform. We are proud of the many accomplishments we have achieved under the original agreement with Celgene and remain committed to developing innovative immunotherapies for patients with cancer," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The discovery and development of JTX-8064 showcases the strength of our translational science platform, validating our approach to discovering novel immunotherapies for patients in need. We look forward to the advancement of JTX-8064 by Celgene. Most importantly, we retain full global rights to all of our other programs, including vopratelimab, giving Jounce greater flexibility to create value for patients and shareholders moving forward. In addition to our ongoing clinical development programs, we are also poised to expand our broader pipeline and advance additional novel immunotherapy programs based on our translational science platform."

"We are pleased to have collaborated with Jounce for the last three years, and to continue our relationship with the licensing of worldwide rights to JTX-8064, a novel macrophage program coming from Jounce’s innovative, translational science platform," said Robert Hershberg, executive vice president and head of business development of Celgene. "We look forward to advancing its development toward an IND filing."

Clinical Program Guidance:
Jounce is currently enrolling patients in the Phase 2 EMERGE clinical trial of vopratelimab in combination with ipilimumab in patients with non-small cell lung cancer or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies. Jounce expects to report preliminary efficacy data and biomarker relationships to clinical outcomes from EMERGE in 2020.

Jounce is also currently conducting a Phase 1 clinical trial of JTX-4014, its PD-1 inhibitor. This Phase 1 clinical trial is nearing completion, and Jounce remains on track to identify the recommended Phase 2 dose of JTX-4014 in 2019.

Revised Financial Guidance:
As a result of the changes to the Celgene strategic collaboration, Jounce now expects to record approximately $50.0 million in cash revenue in 2019 related to the license of JTX-8064 and approximately $98.0 million in non-cash revenue in 2019 representing the remaining recognition of the upfront payment received in July 2016.

Based on its operating and development plans Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $80.0 million to $95.0 million.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 5:00 p.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6684846. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO­Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical trial that we refer to as ICONIC. In the initial Phase 1/2 portion of ICONIC, vopratelimab was found to be safe and well-tolerated, both alone and in combination with nivolumab, an anti-PD-1 antibody. At the June 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we reported Response Evaluation Criteria in Solid Tumors, or RECIST, responses and other tumor reductions as determined by investigator assessment that were associated with an ICOS pharmacodynamic biomarker. We subsequently reported that these responses were durable, lasting six or more months and that all responders, as determined by investigator assessments, remained on study for more than one year. ICONIC also included dose-escalation Phase 1 portions to assess vopratelimab in combination with pembrolizumab, an anti-PD-1 antibody, and in combination with ipilimumab, an antibody that binds to CTLA-4 on certain T cells. This Phase 1 portion established the safety of vopratelimab in combination with each of ipilimumab and pembrolizumab.

About JTX-4014
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates. JTX-4014 is currently in Phase 1 clinical development, which is nearing completion.

About JTX-8064
JTX-8064 is an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) antibody and is the first candidate to emerge from Jounce’s Translational Science Platform efforts that focuses on tumor-associated macrophages. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supports the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.