On June 17, 2021 KIYATEC, Inc. reported the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients(Press release, EurekAlert!, JUN 17, 2021, View Source [SID1234584121]). The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances, an open access clinical journal.

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A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict Glioma assay.

The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

"Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment," said Matthew Gevaert, PhD, CEO of KIYATEC.

Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

On June 17, 2021 Vor Biopharma (Nasdaq: VOR or the Company) reported that it will build-out an in-house clinical manufacturing facility in Cambridge, Massachusetts to support its development of potentially transformative engineered hematopoietic stem cell (eHSC) and chimeric antigen receptor T-cell (CAR-T) therapeutic candidates for patients with hematological malignancies(Press release, Vor BioPharma, JUN 17, 2021, View Source [SID1234584120]). Vor anticipates that the facility, located in the same premises as Vor’s current headquarters, will be operational in 2022.

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"Vor’s novel approach to cancer treatment demands an equally novel approach to cell therapy manufacturing. We are thrilled to construct our own manufacturing facility in our existing location, which will give us end-to-end oversight over drug product for our planned clinical trials and nicely complement our global supply chain," said Sadik Kassim, Ph.D., Chief Technology Officer at Vor. "With this new facility, our manufacturing teams will be seamlessly integrated within our wider organization, a crucial component of our strategy as we begin treating patients living with devastating blood cancers."

The facility has been designed to support clinical manufacturing for Vor’s cell therapy programs, including both eHSCs and CAR-T therapeutic candidates, and to be current Good Manufacturing Practice (cGMP) compliant. By integrating its internal research, process development, analytical development, manufacturing, and quality control testing capabilities under one roof, Vor aims to achieve flexible manufacturing capacity and to reduce the time and cost required to manufacture complex cell therapy clinical candidates.

In addition to leveraging its experienced manufacturing team, Vor plans to hire additional employees over the next few years to support the new in-house manufacturing operations. The planned build-out is consistent with Vor’s strategic plan and does not impact cash runway, which Vor believes is still sufficient to fund operations at least into the first quarter of 2023.

The new clinical manufacturing facility is part of a recently expanded lease agreement with Longfellow that increases Vor’s growing footprint in Cambridge.

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.

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.

On June 14, 2021 Intellia Therapeutics, Inc. ("Intellia") entered into Amendment #3 (the "Amendment") to its License and Collaborative Research Agreement (the "Collaboration Agreement"), dated as of December 18, 2014, with Novartis Institutes for Biomedical Research, Inc. ("Novartis")(Press release, Intellia Therapeutics, JUN 17, 2021, View Source [SID1234584115]). The Amendment amends Novartis’ rights with respect to all the CAR-T Therapeutic Targets (as defined in the Collaboration Agreement) that Novartis selected under the Collaboration Agreement, including (a) making Novartis’ license non-exclusive for such CAR-T Therapeutic Targets, (b) removing Novartis’ diligence and related reporting obligations for such CAR-T Therapeutic Targets, and (c) refining the scope of Novartis’ sublicense rights for such CAR-T Therapeutic Targets. Intellia agreed to pay to Novartis a one-time payment of $10.0 million within 30 days after the effective date of the Amendment.

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The foregoing summary is qualified in its entirety by reference to the Amendment filed as an exhibit to this Form 8-K. The Company has sought confidential treatment for certain portions of the Amendment.