MorphoSys Commences Cash Tender Offer for All Outstanding Shares of Constellation Pharmaceuticals

On June 16, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys") reported that it is commencing a cash tender offer to purchase all outstanding shares of Constellation Pharmaceuticals, Inc., (NASDAQ: CNST) ("Constellation") for $34.00 per share, net to the seller in cash, without interest, and subject to any applicable withholding of taxes(Press release, MorphoSys, JUN 17, 2021, View Source [SID1234584118]). The tender offer is being made pursuant to the previously announced merger agreement, dated June 2, 2021 between MorphoSys and Constellation.

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The tender offer is scheduled to expire at one minute past 11:59 p.m. New York City Time, on July 14, 2021, unless extended or earlier terminated, in each case in accordance with the terms of the merger agreement. The tender offer is subject to various conditions including a minimum tender of at least a majority of outstanding Constellation shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary conditions. The transaction is expected to close in the third quarter of 2021, as previously announced.

MorphoSys filed today with the U.S. Securities and Exchange Commission (the "Commission") a tender offer statement on Schedule TO, including an Offer to Purchase and related Letter of Transmittal, which includes the terms of the tender offer. Additionally, Constellation filed a Schedule 14D-9 with the Commission containing the recommendation of its Board of Directors that Constellation shareholders tender their shares into the tender offer. The Schedule TO, Schedule 14D-9, Letter of Transmittal and other tender offer documents can be obtained free of charge at the website maintained by the Commission at www.sec.gov or by contacting the information agent for the tender offer, Innisfree M&A Incorporated as described in the tender offer documents.

Advisors

Goldman Sachs Bank Europe SE acted as financial advisor to MorphoSys and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Constellation and Wachtell, Lipton, Rosen & Katz as its legal advisor.

Turning Point Therapeutics Granted FDA Orphan Drug Designation for TPX-0022 in Gastric Cancer

On June 17, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that TPX-0022, the company’s inhibitor of MET and the associated cancer signaling pathways of SRC and CSF1R, has been granted orphan drug designation by the Food and Drug Administration (FDA) for the treatment of patients with gastric cancer, including gastroesophageal junction adenocarcinoma (Press release, Turning Point Therapeutics, JUN 17, 2021, View Source [SID1234584135]).

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"Aberrant signaling and genomic alterations in MET-driven gastric cancers are associated with a poor prognosis for patients, creating a high unmet need for therapies to target the molecular drivers of the disease," said Mohammad Hirmand, M.D., chief medical officer. "We are pleased to receive this designation for TPX-0022 as we work to develop it as a potentially differentiated option for patients affected by MET-driven gastric cancer."

There are currently no approved MET inhibitors for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma.

TPX-0022 is a potent inhibitor of the MET tyrosine kinase and has the potential to modulate the tumor microenvironment to augment its therapeutic effect. Initial clinical data presented from the ongoing Phase 1 SHIELD-1 study in October 2020 showed TPX-0022 has been generally well-tolerated and demonstrated clinical activity in patients with MET-amplified gastric cancer.

Orphan Drug Designation is granted by the FDA to assist in the development of drug candidates that may offer therapeutic benefits for diseases with a prevalence of fewer than 200,000 patients annually. Benefits of the designation may include the opportunity for accelerated approval, discounts on registration fees, tax credits for qualified clinical trials and eligibility for 7 years of market exclusivity post-regulatory approval.

Mevion to Advance First Compact System to MEVION S250i

On June 17, 2021 Mevion Medical Systems reported the upgrade of the MEVION S250 Proton Therapy System at the S. Lee Kling Proton Therapy Center at Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, MO, to a MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning and FLASH capabilities (Press release, Mevion Medical Systems, JUN 17, 2021, View Source [SID1234584157]). Originally installed and treating patients since 2013, the MEVION S250 was the first compact proton therapy system in the world.

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"This upgrade strengthens our commitment to provide the most up to date proton technology to cancer centers and their patients," said Tina Yu, CEO of Mevion. "We are delighted to continue a collaboration with our longest clinically operational collaborator for many years to come."

The S. Lee Kling Proton Therapy Center features two independent Mevion proton therapy systems, each with its own dedicated compact accelerator. The system upgrade will enable the center to offer Mevion’s industry leading HYPERSCAN Pencil Beam Scanning on both systems. HYPERSCAN enables faster and sharper delivery of therapeutic radiation to tumors while sparing healthy tissue. FLASH*, a non-invasive, ultra-high dose rate technique delivering treatments in less than one second, may dramatically improve the cancer-fighting benefits of therapeutic radiation by shortening treatment courses and lessening side effects.

The purchase agreement with Barnes-Jewish Hospital was signed in December 2020 and received Certificate of Need Approval in March 2021. The upgraded room is scheduled to be put into service in 2022.

As the leading supplier of compact proton therapy systems in the United States, Mevion has been selected by more leading cancer centers, including NCI-Designated Cancer Centers, and has treated over 6,000 patients worldwide. Mevion’s leading-edge clinical capabilities, combined with its compact, affordable design, and industry-leading ramp-up time, have changed the landscape of proton therapy.

*FLASH Therapy is currently under preclinical research and is not yet available for commercial sale or clinical use.

Synlogic Enters Research Collaboration with Roche for Development of Novel Therapy to Treat Inflammatory Bowel Disease

On June 17, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that it has entered into a research collaboration agreement with Roche for the discovery of a novel Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD)(Press release, Synlogic, JUN 17, 2021, View Source [SID1234584099]). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic medicine addressing an undisclosed novel target in IBD.

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"Our mission is to develop Synthetic Biotic medicines that benefit patients in meaningful ways," said David Hava, Ph.D., Synlogic’s Chief Scientific Officer. "We are excited to expand our efforts in inflammation, working to address the unmet needs of patients with inflammatory bowel disease."

"We are excited to work with Synlogic and explore the potential of a new modality for the treatment of IBD," said James Sabry, Global Head, Roche Pharma Partnering. "Synlogic and Roche share a commitment to advancing innovative science and delivering transformative medicines to patients living with inflammatory disease."

At the conclusion of the research period, Roche will have the exclusive option to enter a licensing and collaboration agreement for further development and commercialization of the program.

Learn more about Synlogic’s programs and pipeline by visiting View Source

PROCESSA PHARMACEUTICALS ENTERS INTO A LICENSING AGREEMENT WITH OCUPHIRE PHARMA, INC., FOR THE DEVELOPMENT OF RX-3117

On June 17, 2021 Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) reported that it has entered into a licensing agreement with Ocuphire Pharma, Inc. (NASDAQ: OCUP) to license in RX-3117(Press release, Processa Pharmaceuticals, JUN 17, 2021, View Source [SID1234584119]). RX-3117 is an oral, anticancer agent with an improved pharmacological profile relative to gemcitabine and other nucleoside analogs. Rx-3117 has a family of patents extending into 2036 as well as U.S. Food and Drug Administration (FDA) Orphan Designation for the treatment of Pancreatic Cancer. Processa will evaluate the potential benefit of RX-3117 for patients with such cancers as pancreatic or non-small cell lung cancer.

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Under the terms of the agreement, Processa has an exclusive worldwide license (excluding China), to develop, manufacture, use, commercialize and sublicense RX-3117.

Processa will be developing biomarker assays to identify those patients who will most likely benefit from this targeted therapy. Prior to conducting a pivotal trial, Processa will first conduct a Phase 2b trial in 2022 to assess the correlation of the biomarker measurements with the clinical benefit-risk of RX-3117 in patients with pancreatic cancer or non-small cell lung cancer.

We are excited to expand our oncology portfolio, while providing an important solution for patients with pancreatic and non-small cell lung cancer," said Dr. David Young, Chief Executive Officer of Processa Pharmaceuticals. "The asset aligns with our mission to identify and bring to market better and safer drugs for patients who need treatment options to improve their survival and/or quality of life. From our Phase 2b trial, we expect to obtain biomarker data that will identify patients who will benefit the most from this drug while significantly increasing the probability of a successful Phase 3 trial.

"The RX-3117 program is a legacy asset from our merger with Rexahn Pharmaceuticals last year, and outside our core ophthalmology competency. We are very pleased to establish this partnership with Processa which has the expertise needed to further develop RX-3117. The economic terms of the license will be 75% attributed to the holders of the Rexahn Contingent Value Rights and 25% attributed to Ocuphire," said Mina Sooch, Chief Executive Officer for Ocuphire Pharma.