On June 15, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported that it has entered into an agreement with Sun Pharmaceutical Industries Limited and related entities ("Sun") resolving patent litigation related to Korlym, Corcept’s medication for the treatment of patients with Cushing’s syndrome(Press release, Corcept Therapeutics, JUN 15, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-settles-patent-litigation-sun [SID1234584024]). The litigation has been pending in the United States District Court for the District of New Jersey since 2019, shortly after Sun notified Corcept that it had submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) seeking approval to market a generic version of Korlym.

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In connection with the settlement, Corcept has granted Sun the right to sell a generic version of Korlym in the United States beginning October 1, 2034 or earlier under circumstances customary for settlement agreements of this type.

"It is gratifying to put this lawsuit behind us," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Litigation is a costly, time-consuming diversion from our efforts to grow our Korlym business and continue the development of our increasingly mature pipeline of selective cortisol modulators – including relacorilant, our planned successor to Korlym for the treatment of patients with Cushing’s syndrome."

The settlement agreement is subject to entry by the Court of a stipulation and order of dismissal related to the litigation. As required by law, Corcept and Sun will submit the agreement to the United States Federal Trade Commission (FTC) and the United States Department of Justice (DOJ) for review. Similar patent litigation brought by Corcept against two other companies that have filed ANDAs seeking approval to market generic Korlym remains pending.

About Korlym

Korlym modulates the effect of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness.

On June 15, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and Capsida Biotherapeutics Inc., a biotechnology company dedicated to developing breakthrough gene therapies using fully integrated adeno-associated virus (AAV) engineering, cargo development and manufacturing, reported a strategic partnership to research, develop, manufacture and commercialize in vivo gene editing therapies delivered with engineered AAV vectors for the treatment of familial amyotrophic lateral sclerosis (ALS) and Friedreich’s ataxia (Press release, CRISPR Therapeutics, JUN 15, 2021, View Source [SID1234584021]).

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Under the agreement, CRISPR Therapeutics will lead research and development of the Friedreich’s ataxia program and perform gene-editing activities for both programs, and Capsida will lead research and development of the ALS program and conduct capsid engineering for both programs. Capsida’s high-throughput AAV engineering platform generates capsids optimized to target specific tissue types and limits transduction of tissues and cell types that are not relevant to the target disease, potentially allowing for improved efficacy and safety. CRISPR Therapeutics and Capsida will each have the option to co-develop and co-commercialize the program that the other company leads. Following such option, the companies would equally share all research, development and commercialization costs and profits worldwide related to the collaboration product. As part of the collaboration, Capsida will also be responsible for process development and clinical manufacture of both programs and have the option to manufacture commercial products generated under the agreement.

"We are excited to enter this collaboration with Capsida. The combination of Capsida’s AAV engineering platform and CRISPR Therapeutics’ gene-editing platform has the potential to enable transformative gene-edited therapies for patients with neurological diseases," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "This new partnership is one more step in our overall strategy of bringing together innovative and complementary technologies to unlock the full potential of our core platform."

"Bringing together Capsida’s fully integrated, tissue targeting gene therapy platform with CRISPR Therapeutics’ leading gene-editing capabilities gives us the potential to develop first-in-class gene therapies for patients with severe neurological disorders and expand the reach of Capsida’s broadly enabling capabilities," said Robert Cuddihy, M.D., Chief Executive Officer of Capsida Biotherapeutics.

On June 15, 2021 VBL Therapeutics (Nasdaq: VBLT) reported an update on its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer (Press release, VBL Therapeutics, JUN 15, 2021, View Source [SID1234584020]).

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The Company was notified by the U.S Food and Drug Administration (FDA) that clearance of new VB-111 batches for use in the U.S. is currently pending the completion of a technical review by the Chemistry, Manufacturing, and Controls (CMC) group, which is evaluating the comparability of VB-111 manufacturing between different source sites. Until new batches are cleared, the Company anticipates a temporary shortage of study drug supply for the U.S. Accordingly, recruitment of new patients in the U.S. will be temporarily paused. Treatment will continue as usual for all U.S. patients currently enrolled. To-date, the study has enrolled approximately 75% of the planned 400-patients.

"Our team is working to provide the requested information to the FDA as quickly as possible," said Dror Harats, M.D., CEO of VBL Therapeutics. "Since receipt of the notification, we have submitted some of the requested information, and are preparing the remaining documentation, which we believe can be completed and submitted to the agency in the next two to three months. We do not expect a material change to our data readout timelines. We are in regular contact with the FDA and taking the steps necessary to minimize disruption to the trial in the U.S."

VBL recently amended the primary endpoint of OVAL based upon requested changes by the Company that were reviewed by the FDA. OVAL now includes a second, separate primary endpoint, of progression free survival (PFS), in addition to the original primary endpoint of the trial, overall survival (OS). Successfully meeting either primary endpoint is expected to be sufficient to support BLA submission.

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies.

About VB-111 (ofranergene obadenovec)
VB-111 is an investigational anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that is designed to use a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US, for prolongation of survival in patients with recurrent glioblastoma. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970)

On June 15, 2021 Enlivex Therapeutics Ltd., (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the European Patent Office has issued European patent No. 3,258,943 covering AllocetraTM, the Company’s immunotherapy product candidate. The new patent’s title is "COMBINATION IMMUNE THERAPY AND CYTOKINE CONTROL THERAPY FOR CANCER TREATMENT", and is expected to provide added intellectual property protection for therapeutic compositions of AllocetraTM and CAR-T immunotherapies for inhibition or reduction of cytokine storms associated with CAR-T therapies for cancer (Press release, Enlivex Therapeutics, JUN 15, 2021, View Source [SID1234584019]).

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Oren Hershkovitz, PhD, CEO of Enlivex, stated, "We are pleased to have this patent granted in Europe, which adds to existing AllocetraTM patents in various countries around the world. Specifically, this new patent further strengthens our existing intellectual property portfolio covering the use of AllocetraTM for cancer therapy."

AllocetraTM is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On June 15, 2021 Caris Life Sciences, a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine, and Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported a strategic collaboration to jointly identify oncogenic fusions and mutations that are driver alterations (Press release, Elevation Oncology, JUN 15, 2021, https://elevationoncology.com/caris-life-sciences-and-elevation-oncology-announce-joint-discovery-and-development-collaboration-focused-on-oncogenic-fusions-and-driver-mutations/?utm_source=rss&utm_medium=rss&utm_campaign=caris-life-sciences-and-elevation-oncology-announce-joint-discovery-and-development-collaboration-focused-on-oncogenic-fusions-and-driver-mutations [SID1234584018]). Together, Caris and Elevation Oncology will discover and develop therapeutics targeting these newly identified alterations.

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Under the terms of the agreement, Caris and Elevation Oncology will jointly evaluate potential targets, some of which are not currently actionable by an existing therapeutic, identified on an ongoing basis by analyzing Caris’ Whole Transcriptome Sequencing (WTS) and Whole Exome Sequencing (WES) data. The companies can then elect to initiate a novel drug discovery program for those targets, or pursue licensing or product acquisitions, while retaining exclusive access to all targets selected by the parties.

"Caris is dedicated to advancing precision oncology for patients. We are thrilled to build upon our strategic relationship with Elevation Oncology and deepen the connection between molecular diagnostics and clinical development," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. "By pairing our unique insight into potential genomic driver alterations gained through Caris’ market-leading molecular profiling capabilities with Elevation Oncology’s strength in executing innovative clinical oncology programs in genomically-defined populations, we aim to further close the gap between target identification and clinical investigation for potential new therapeutics."

"Through this collaboration between Elevation Oncology and Caris, we hope to demonstrate how biopharmaceutical and molecular medicine companies can work hand in hand to realize visions that are shared across the precision oncology community," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "At Elevation Oncology, we believe every cancer patient deserves the opportunity to be matched with an actionable, purposely selected therapeutic that is precisely targeted to their tumor’s unique genomic biomarkers. In Caris, we have found a collaborator who both shares this vision as a leader in genomic testing and who can provide real-world insights into emerging or underserved genomically-defined patient populations. Together, we believe we are pioneering a platform to accelerate the development of precision therapeutics and build toward a future where patients have the option of a matched therapy for every driver alteration – no matter how rare."

Caris Molecular Intelligence, the company’s proprietary, comprehensive tumor profiling approach assesses all 22,000 genes in both DNA and RNA, and proteins – unique to an individual’s cancer – to reveal a molecular blueprint in order to guide more precise and individualized treatment decisions. Caris’ CODEai is the most comprehensive data solution in the industry, with cancer treatment information and clinical outcomes data for over 244,000 patients covering over 1,000,000 data points per patient. The analysis of oncogenic fusions and mutations that are driver alterations for assessment under the collaboration will be conducted on both the historical dataset that has been compiled by Caris, and on an ongoing basis from the future tumor profiling data routinely generated from Caris’ platforms over the term of the agreement.

Therapeutics selected by the parties, and subsequent companion diagnostics, will be developed on a cost-sharing basis with revenue being shared on any approved therapeutics.