On July 1, 2019 Oncoceutics, Inc. reported a scientific publication in the journal Leukemiademonstrating selective and potent agonism of the G-protein coupled receptor (GPCR) GPR132 by ONC212, an imipridone derivative of ONC201 (Press release, Oncoceutics, JUL 1, 2019, View Source [SID1234558352]).

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GPR132 is an orphan GPCR previously shown to play a tumor suppressor role in acute leukemias that has not been targeted therapeutically. The article shows that ONC212 binds to and activates GPR132 at nanomolar concentrations. GPR132 expression and activation of the integrated stress response was associated with ONC212 anti-cancer effects in acute myeloid leukemia preclinical models. The preclinical efficacy was observed as a single agent and synergistic in combination with the Bcl-2 inhibitor ABT-199.

These findings are consistent with a previous publicationon ONC212 safety and efficacy in preclinical models of pancreatic cancer, which also exhibits elevated GPR132 expression. ONC212 is protected by a composition of matter patent and its future Phase I/II clinical trials in refractory AML is the subject of an alliance between MD Anderson and Oncoceutics.

"Whereas our clinical programs that are ongoing with ONC201 or will commence shortly with ONC206 focus on specific antagonistic effects on Dopamine Receptor D2, the referenced publication clearly indicates the translational potential of ONC212 as the first GPR132 agonist for oncology that is poised for clinical introduction," said Wolfgang Oster, MD, PhD, and Chief Executive Officer of Oncoceutics. "ONC212 adds another GPCR to our target list that have not been druggable so far and allows us to incorporate GPR132 as a predictive biomarker in the development program."

"ONC212 belongs to the group of orphan GPCRs that have been extremely challenging targets for drug development despite their frequent dysregulation in malignant diseases," said J. Silvio Gutkind, PhD, Associate Director of Basic Science at University of California, San Diego. "ONC212 is one of the first drug candidates discovered and developed by Oncoceutics to address this opportunity and it extends the utility of the imipridone platform into hematologic malignancies, as elegantly described in this manuscript."

On July 1, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (hereinafter "Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported the publication of an initiation report by KEPLER CHEUVREUX, a leading independent European financial services company specialized in research, execution and advisory services (Press release, Onxeo, JUL 1, 2019, View Source [SID1234537341]).

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KEPLER CHEUVREUX will now cover the ONXEO share on the stock exchange*.

The financial analysis published on June 28, 2019 by Kepler Cheuvreux is available on the website View Source, section "Research Public Access".

* This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country. ONXEO and KEPLER CHEUVREUX have agreed on a service for the production and distribution of financial analyses.

On July 1, 2019 Adaptive Biotechnologies Corporation (Nasdaq:ADPT) ("Adaptive"), a commercial-stage biotechnology company that reads and translates the genetic code of the adaptive immune system to develop personalized diagnostics and therapeutics to improve patient lives, reported the pricing of its initial public offering of 15,000,000 shares of common stock at a public offering price of $20.00 per share, before underwriting discounts and commissions (Press release, Adaptive Biotechnologies, JUL 1, 2019, View Source [SID1234537357]). The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Adaptive, are expected to be $300.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares of common stock are being offered by Adaptive. In addition, Adaptive has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions. Adaptive common stock is expected to begin trading on The Nasdaq Global Select Market on June 27, 2019, under the ticker symbol "ADPT." The offering is expected to close on July 1, 2019, subject to the satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC, J.P. Morgan and BofA Merrill Lynch are acting as joint lead book-running managers for the offering. Cowen and Guggenheim Securities are acting as book-running managers for the offering. William Blair and BTIG are acting as co-managers for the offering.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on June 26, 2019. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, or by telephone at (866) 471-2526, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204 or by email at [email protected]; or BofA Merrill Lynch, NC1-004-03-43; 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department, Email: [email protected].

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 1, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of CNS/LM from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma (Press release, Y-mAbs Therapeutics, JUL 1, 2019, View Source [SID1234537342]).

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As of the end of June 2019, all of the 18 planned omburtamab patients have been enrolled. The Company expects the study to remain open and continue enrolling patients until the product potentially becomes available on the market and believes it remains on target to file a biologic license application ("BLA") by the end of 2019 under the breakthrough therapy designation ("BTD") the Company previously received from the FDA. The Company has also previously received orphan drug designation ("ODD") and a rare pediatric disease designation ("RPDD") for omburtamab from the FDA, in each case for the treatment of CNS/LM from neuroblastoma. The RPDD qualifies the Company for receipt of a priority review voucher ("PRV") upon approval of omburtamab for the treatment of CNS/LM from neuroblastoma, if such approval occurs.

For naxitamab, more than 30 patients of a planned total of 37 patients in the Company’s Study 201 have been enrolled as of the end of June 2019. The Company expects the remaining patients to be included in the coming weeks and believes it remains on target for a BLA filing in 2019 under the BTD the Company previously received from the FDA for naxitamab in combination with GM-CSF for the treatment of relapsed/refractory high-risk neuroblastoma. The Company has also previously received ODD and a RPDD from the FDA for naxitamab, in each case for the treatment of relapsed/refractory high-risk neuroblastoma. The RPDD qualifies the Company for receipt of a PRV upon approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma, if such approval occurs.

"We are approaching an important milestone by reaching our initial patient recruitment goals for both compounds and focus on advancing these treatments to give children access," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We believe the two important BLA filings are on track in line with our timelines and previous guidance. We salute and thank health authorities, clinical sites and our staff for their combined efforts in moving these compounds forward towards registration. We hope to see both of these new and important cancer treatments on the market in 2020. We believe these new product candidates have the potential to become historic milestones for pediatric oncology."

On July 1, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada, will hold its second-quarter 2019 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, July 30 (Press release, Merck & Co, JUL 1, 2019, View Source [SID1234537343]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 4263838. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 4263838. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.