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,

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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?

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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, Celsion Corporation ("Celsion") reported that entered into an At the Market Offering Agreement (the "Agreement") with H.C. Wainwright & Co., LLC, as sales agent ("Wainwright"), pursuant to which Celsion may offer and sell, from time to time, through Wainwright shares of common stock, par value $0.01 per share, of Celsion having an aggregate offering price of up to $ 7,500,000 (the "Shares") (Filing, 8-K, Celsion, MAY 25, 2022, View Source [SID1234615027]). Celsion intends to use the net proceeds from the offering, if any, for general corporate purposes, including research and development activities, capital expenditures and working capital. Pending the application of the net proceeds, Celsion intends to invest the net proceeds in short-term, investment grade, interest-bearing securities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Celsion is not obligated to sell any Shares under the Agreement. Subject to the terms and conditions of the Agreement, Wainwright will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of The Nasdaq Capital Market, to sell Shares from time to time based upon Celsion’s instructions, including any price, time or size limits or other customary parameters or conditions Celsion may impose.

Under the Agreement, Wainwright may sell Shares by any method deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

The Agreement may be terminated by Wainwright or Celsion at any time upon notice to the other party, or by Wainwright at any time in certain circumstances, including the occurrence of a material adverse change in Celsion. Unless earlier terminated, the Agreement will automatically terminate upon the issuance and sale of all of the Shares subject to the Agreement through Wainwright on the terms and subject to the conditions set forth in the Agreement.

Celsion will pay Wainwright a commission of 3.0% of the aggregate gross proceeds from each sale of Shares and has agreed to provide Wainwright with customary indemnification and contribution rights. Celsion has also agreed to reimburse Wainwright for legal fees and disbursements, not to exceed $35,000 in the aggregate, in connection with entering into the Agreement.

The foregoing summary of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is attached as Exhibit 10.1 hereto and incorporated herein by reference.

The purchasers in and placement agent for the Company’s January 2022 preferred stock offerings provided consents under their respective purchase and placement agent agreements for the At the Market Offering program.

The Shares will be issued pursuant to Celsion’s previously filed and effective Registration Statement on Form S-3 (File No. 333-254515), the base prospectus dated March 30, 2021, filed as part of such Registration Statement, and the prospectus supplement dated May 25, 2022, filed by Celsion with the Securities and Exchange Commission. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy Shares, nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On May 25, 2022 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that it will host a key opinion leader (KOL) webinar on HM43239 and luxeptinib and their roles in the treatment of acute myeloid leukemia (AML) on Thursday, June 2, 2022 at 4:30 pm Eastern Time (Press release, Aptose Biosciences, MAY 25, 2022, View Source [SID1234615026]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The call will feature KOLs Brian Druker, M.D., of the Oregon Health & Science University, Naval G. Daver, M.D., of The University of Texas MD Anderson Cancer Center, and Brian Andrew Jonas, M.D., Ph.D., of the University of California, Davis, who will discuss the current treatment landscape and unmet medical need in treating patients with acute myeloid leukemia AML, as well as their experiences with Aptose’s investigational therapies.

The Aptose leadership team also will provide a data update on their two potential treatments for patients with AML and B cell malignancies: HM43239, an oral genotype-agnostic small molecule inhibitor of a constellation of kinases operative in myeloid malignancies, and luxeptinib, an oral inhibitor of kinases operative in lymphoid and myeloid malignancies.

A question and answer session will follow the formal presentations. To register for the event, please click here.

Brian Druker, M.D., has devoted his career to improving the lives of cancer patients. For his contributions to medical research, Dr. Druker was nominated for the Lasker-DeBakey Clinical Medical Research Award in 2009. Dr. Druker is most well-known for his role in developing Gleevec for patients with chronic myeloid leukemia (CML). Dr. Druker’s other career milestones include being named a Howard Hughes Medical Investigator in 2002, becoming a member of the National Academy of Sciences in 2007, winning the Japan Award in 2011, and being elected to the American Academy of Arts and Sciences in 2012. Dr. Druker received his Doctor of Medicine from the School of Medicine at the University of California, San Diego, completed his residency in internal medicine at Washington University in St. Louis, Missouri, and did an oncology fellowship at Dana-Farber Cancer Institute at Harvard Medical School.

From his earliest days, Dr. Druker was a dedicated researcher, winning the President’s Undergraduate Research Award at the University of California, San Diego. He is the recipient of a Lifetime Achievement Award from the Leukemia & Lymphoma Society, the Medal of Honor from the American Cancer Society and many other awards.

Naval G. Daver, M.D. is an Associate Professor in the Department of Leukemia at MD Anderson. He completed his medical school from Grant Medical College and Sir J group of Hospitals Mumbai, followed by a residency and fellowship in hematology-oncology from Baylor College of Medicine. He is a clinical investigator with a focus on molecular and immune therapies in AML and Myelofibrosis and is principal investigator on >25 ongoing institutional, national and international clinical trials in these diseases. These trials focus on developing a personalized therapy approach by targeting specific mutations or immune pathways expressed by patients with AML, evaluating novel combinations of targeted, immune and cytotoxic agents, and identifying and overcoming mechanism of resistance. He is especially interested in developing monoclonal and bispecific antibodies, immune checkpoint and vaccine based approaches in AML, MDS, and myelofibrosis and is leading a number of these trials at MD Anderson. Dr. Daver has published >150 peer-reviewed manuscripts and is on the editorial board of numerous hematology specific journals. He has also authored numerous abstracts at national and international conferences.

Brian A. Jonas, MD, PhD, FACP is an Associate Professor and clinician scientist in the Division of Hematology and Oncology at UC Davis Comprehensive Cancer Center (UCDCCC), where he specializes in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (ALL), and other hematologic malignancies. He received his medical degree and PhD in biochemistry and molecular biology from UC Davis School of Medicine and completed his internship, residency, and a fellowship in hematology and oncology at Stanford University School of Medicine. Dr. Jonas leads the UCDCCC clinical and translational research program in AML, MDS, and ALL, with an emphasis on early drug development. He is PI on several clinical trials, including multiple investigator-initiated trials and ETCTN trials. He chairs the UCDCCC Hematological Malignancies Working Group and is Chair of the UCDCCC Data and Safety Monitoring Committee. He serves on the National Comprehensive Cancer Network panels for AML, MDS and ALL.

On May 25, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that Lisa Anson, Chief Executive Officer, and Peter Collum, Chief Financial Officer, will be presenting in-person at the Jefferies Global Healthcare Conference in New York on Wednesday 8 June 2022 at 9:30am ET / 14:30 GMT (Press release, Redx Pharma, MAY 25, 2022, View Source [SID1234615024]). Alongside the presentation, the Company will also be available for one-to-one meetings.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The presentation will be webcast live and can be accessed via the following link: View Source Following the event, a recording will be made available on the investor section of the Company’s website at: View Source