On May 25, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), and myNEO N.V., a Belgium-based immunotherapy company, reported that they have entered into a research and option agreement (Press release, myNEO, MAY 25, 2022, View Source [SID1234640209]). Under the agreement, both companies aim to identify specific antigens found on the surface of tumors for the development of novel mRNA immunotherapies. To achieve this goal, myNEO will leverage its biological datasets and its integrated machine learning and bioinformatics platform to identify and validate specific antigen targets predicted to elicit a strong immune response.

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"We are translating our mRNA technology insights and learnings to create value in oncology," said Antony Blanc, Chief Business Officer and Chief Commercial Officer of CureVac. "myNEO’s state-of-theart predictive approach to analyze tumor and normal genetic data inputs from multiple sources, perfectly complements our mRNA technology as we advance the development of novel cancer vaccines. Through this collaboration, we prepare to build a strong pipeline in oncology and accelerate growth beyond our progress in prophylactic vaccines."

myNEO utilizes a broad range of underlying genomic alterations to identify constantly emerging, novel classes of antigens of defined tumor types. The immunogenicity of identified antigens is predicted using proprietary algorithms, machine and deep learning methods and an extensive database containing data on tumor specific mutations. Incorporating new ranking methodologies based on tumor cell antigen processing and presentation allows for selection of antigens with the highest confidence of success for potential clinical testing.

"CureVac is a front-runner in the mRNA technology ecosystem, and its use for the development of therapeutic cancer vaccines has shown great promise," said Cedric Bogaert, Chief Executive Officer and co-founder of myNEO. "We’re convinced that combining our innovative neoantigen target identification and selection methods with mRNA technology holds great potential for immunotherapies, and CureVac was the logical choice for us to further validate this avenue. Supplementing our own developments with this collaboration will allow us to benefit from CureVac’s years of experience and know-how, and to create a significant impact on the immunotherapy domain."

On May 25, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene fusions (Press release, Elevation Oncology, MAY 25, 2022, View Source;utm_medium=rss&utm_campaign=elevation-oncology-announces-fda-fast-track-designation-granted-to-seribantumab-for-the-tumor-agnostic-treatment-of-solid-tumors-harboring-nrg1-gene-fusions [SID1234615028]). Seribantumab is currently being evaluated in the ongoing Phase 2 CRESTONE study, for which initial data will be presented in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting on Tuesday, June 7, 2022.

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"There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of Fast Track designation in a tumor-agnostic setting is a significant step in addressing this unmet need," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "NRG1 fusions are a type of genomic alteration that causes unregulated cell growth and proliferation in a variety of solid tumors, and we look forward to working closely with the FDA as we continue exploring the potential of seribantumab to improve outcomes for patients whose tumor harbors this unique oncogenic driver."

Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. Additionally, the designation allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as a Rolling Review, which means a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab was granted Fast Track designation from the FDA for the tumor-agnostic treatment of patients whose solid tumors harbor NRG1 fusions and is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the Phase 2 CRESTONE Study

CRESTONE (Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions; NCT04383210) is a Phase 2 tumor-agnostic study evaluating seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States, Australia, and Canada. For more information visit www.NRG1fusion.com.

On May 25, 2022 Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, reported the first patient has been dosed in an open-label Phase 2 study evaluating ENV-101 (taladegib) in patients with advanced solid tumors harboring Patched-1 (PTCH1) loss of function mutations (Press release, Endeavor BioMedicines, MAY 25, 2022, View Source [SID1234615044]).

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"Dosing the first patient in the Phase 2 study of ENV-101 is a critical step for advancing medicines that treat cancer by attacking the genetic cause of disease," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor BioMedicines. "The clinical effects of ENV-101, a small molecule inhibitor of the Hedgehog signaling pathway for the treatment of cancer have been evaluated in nearly 200 participants so far. ENV-101 has so far demonstrated exceptional ability to inhibit this oncogenic pathway and induce regression of tumors dependent on it. We hope this trajectory will continue as the drug advances through this next stage of clinical development."

The multi-center study employs a two-stage design to evaluate the efficacy and safety of ENV-101, a potent Hedgehog (Hh) pathway inhibitor, in patients with histologically or cytologically confirmed refractory advanced solid tumors characterized by loss of function (LOF) mutations in the PTCH1 gene. Endeavor expects to enroll 44 adults who are 18 and older in the first part of the study. Patients will receive 200 mg of ENV-101 once a day in one arm of the trial, and 300 mg of ENV-101 once a day in the other arm. The primary endpoint of the trial is Objective Response Rate (ORR) – comprised of Complete Response (CR) and Partial Response (PR), measured by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) – as determined by an independent review through study completion. Confirmed CR or PR will be defined as a repeat assessment performed no less than 28 days after the criteria for response is first met.

Dr. Christopher Vaughn, M.D., Oncologist at Hematology Oncology Associates of Fredericksburg (HOAF) in Virginia, stated, "It is wonderful and exciting to bring potentially landscape-changing new therapeutic advances to our patient community. I fully appreciate the collaboration and support between the Endeavor team and HOAF’s research department. The Endeavor trial embodies the model for individualized therapy and for potentially better response rates with limited side effects for our patients."

"ENV-101 is for patients with tumor mutations in the Hedgehog pathway, which affect approximately 2% of all cancers, amounting to roughly 30,000-40,000 patients annually in the U.S. alone," said Dr. Srikanth Pendyala, Chief Medical Officer, Endeavor Biomedicines. "Mutations in this pathway can aberrantly activate downstream signaling resulting in proliferation, survival and metastasis of cancer cells. ENV-101 is intended to inhibit the activity of the Hedgehog pathway which may significantly benefit the lives of cancer patients with these mutations."

ENV-101: Targeting the Hedgehog Signaling Pathway in Oncology and Fibrosis

ENV-101 (taladegib), an orally available small molecule inhibitor of the Hedgehog signaling pathway, has already demonstrated preliminary clinical efficacy and safety in nearly 200 subjects enrolled across six completed studies. Initially targeted for a broad group of patients with basal cell carcinoma (BCC), Endeavor is now investigating precision therapy approaches for ENV-101 in multiple types of cancers driven by oncogenic driver mutations in PTCH1, as well as in idiopathic pulmonary fibrosis (IPF).

PTCH1 oncogenic driver mutations in the Hedgehog signaling pathway are found in approximately 2% of all cancers. Because of its prevalence across multiple types of cancer, Endeavor plans to enroll patients in a tumor agnostic study that includes any patient with oncogenic hedgehog mutations irrespective of tissue of origin. Endeavor is currently enrolling patients in an open label Phase 2 clinical trial in oncology (www.clinicaltrials.gov identifier NCT05199584).

For more information about our clinical trial please contact us at: [email protected] or call us at 858-727-3199.

On May 25, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that it will be participating in the 19th Annual Craig-Hallum Institutional Investor Conference being held virtually on Wednesday, June 1, 2022 (Press release, DiaMedica, MAY 25, 2022, View Source [SID1234615110]). Management will be available to participate in one-on-one meetings. Investors and attendees that would like to schedule a meeting with DiaMedica’s management can contact their Craig-Hallum representative to arrange a meeting.

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On May 25, 2022 EVERSANA reported to be attending this year’s DTx Europe Summit taking place 28-29 June 2022 in London, UK and online (Press release, EVERSANA, MAY 25, 2022, View Source [SID1234615029]). Schedule a meeting today to connect with digital therapeutic innovators,

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Join EVERSANA and other leaders in the industry, at the upcoming DTx Europe conference as we advance the conversation on:

Commercializing digital therapeutics by navigating the local regulatory pathways to approval
Advancing the adoption of companion apps
Securing broad payer coverage and reimbursement for digital therapies
Be sure to check out the following panel to hear from Martin Culjat, Senior VP, Regulatory Innovation & Digital Medicine, EVERSANA and other panelists discuss the need for innovation in policy of clinical trials.

Exploring a Need for Change of Clinical Trials in Digital Medicine
Tuesday, 28 June – 2:20pm BST

The current framework for clinical trials in digital health falls under an umbrella of one size fits all. There is an unwritten dichotomy between regularly updated software based digital health products and how regulatory frameworks are designed. This panel of experts will dive deep into discussing the need for innovation in policy of clinical trials.

What are the key challenges facing the European market in clinical trials today?
How can we utilise decentralised clinical trials to bring value to the DTx industry?
How do decentralized clinical trials compare to traditional studies?
Where can changes be made within the clinic to develop more efficient trials for DTx?
What changes must be made in regulation to accommodate for new digital medicine?
Companies are trying to innovate software fast in DTx but regulatory issues are getting in the way, how can we combat this?
How much of an algorithm can change for its regulatory classification to change?