On March 23, 2020 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported that it has entered into an underwriting agreement with Aegis Capital Corp. under which the underwriter has agreed to purchase on a firm commitment basis a minimum of 500,000 shares of common stock of the Company, at a price to the public of $12.22 per share (the "Public Price"), representing a 5% discount to the closing price per share (Press release, Cel-Sci, MAR 23, 2020, View Source [SID1234555767]). The closing of the offering is expected to occur on or about March 26, 2020, subject to customary closing conditions.

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Aegis Capital Corp. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 45-day option to purchase up to 15% of the offering at the Public Price. The use of proceeds will be to fund the continued development of Multikine, LEAPS and for other general corporate purposes.

The shares of common stock described above are being offered by CEL-SCI pursuant to a "shelf" registration statement on Form S-3 (File No. 333-226558) filed with the Securities and Exchange Commission (SEC) and the accompanying prospectus contained therein. The offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained on the SEC’s website at View Source or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 23, 2020 InterVenn Biosciences reported it has added a colorectal cancer/advanced adenoma diagnostic panel to its proprietary glycoproteomic analysis platform (Press release, InterVenn Biosciences, MAR 23, 2020, View Source [SID1234555766]). These new indications are the latest for the company which has already demonstrated capabilities in ovarian, pancreatic, prostate, renal, hepatocellular, nasopharyngeal, and lung cancer, and in non-alcoholic steatohepatitis (NASH) liver disease and idiopathic lung fibrosis. InterVenn’s blood test for ovarian cancer is currently being validated in a multicenter, international prospective clinical trial, V.O.C.A.L., to demonstrate its utility and value as a clinical decision-making tool.

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"One in every 25 Americans will be diagnosed with colorectal cancer at some point in their lifetime, making this the third-leading cause of cancer-related deaths. As many as 60 percent of these deaths could be avoided with early intervention based on improved screening. The availability of a readily accessible, simple blood test, supplementing and guiding the use of screening colonoscopies, could radically increase the numbers of patients in whom colorectal cancer is prevented, or detected at a curable stage," said Klaus Lindpaintner, Chief Scientific and Medical Officer of InterVenn Biosciences.

The addition of a colorectal cancer/advanced adenoma diagnostic panel follows similar highly promising results the company has seen in its use of glycoproteomics in other indications. InterVenn has demonstrated that combining proteomics with glycomics, along with relevant phenotypical annotation data and powerful, high-precision, scalable data processing, and bioinformatics engine affords critical advances in biomarker and target discovery and utilization that have not been possible using conventional technologies. A pilot study at InterVenn’s new South San Francisco laboratory has now demonstrated the platform’s capability to detect colorectal cancer with very high accuracy (98 percent sensitivity and 91 percent specificity). Moreover, the test performs similarly well (98 percent sensitivity and 85 percent specificity) in the detection of advanced adenomas, an unprecedented accomplishment in testing performance. InterVenn’s colon cancer testing panel will be part of the company’s portfolio of offerings as it works with partners towards commercialization both in the U.S. and globally.

"InterVenn works with multiple top-tier institutional and industry partners for every indication to ensure that the data and results we publish are of the highest quality. Our industry partners are excited about moving forward with us to co-develop our colorectal cancer and advanced adenoma test, and we look forward to working hand in hand with them to bring this test to the market and to patients and health care providers as quickly and widely as possible," said Aldo Carrascoso, Chief Executive Officer of InterVenn Biosciences.

InterVenn’s application of glycoproteomics leverages the power of ultra-high-pressure- liquid-chromatography and mass-spectrometry for the generation of high-resolution, accurate-mass data on post-translational protein modifications, coupled with the prowess of artificial intelligence and machine learning technology to streamline the analysis of clinically relevant data. Importantly, InterVenn’s robust workflows and algorithms ensure that the laboratory-related variabilities inherent in any clinical study are minimized – from sample collection, sample processing, all the way to mass spectrometry instrument measurements – and that the results are reproducible. OpenPIP, the company’s AI-enabled mass spectrometry analysis software, which the company has made available to the scientific community at large as a public-domain tool, dramatically reduces the time and cost of analyzing mass spectrometry data while increasing data quality by eliminating observer-based bias.

To find out more about InterVenn Biosciences and how the company is leveraging artificial intelligence and mass spectrometry to the transformation of medical technology, visit View Source For all general and media inquiries about InterVenn Biosciences, please contact Andrea Vuturo at [email protected].

On March 23, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi) (Press release, Hoffmann-La Roche, MAR 23, 2020, View Source [SID1234555765]). Venclexta/Venclyxto (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile of these medicines.

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"Acute myeloid leukaemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "These data validate the benefit that this Venclexta/Venclyxto-based combination can bring to patients and we look forward to discussing the results with health authorities."

Data from the VIALE-A study will be shared with global health authorities and presented at an upcoming medical meeting. Venclexta has previously been granted accelerated approval by the US Food and Drug Administration (FDA) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly-diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions, based on response rates from the M14-358 and M14-387 studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.

About the VIALE-A study
VIALE-A (NCT02993523) is a phase III, randomised, double-blind, placebo-controlled multicentre study evaluating the efficacy and safety of Venclexta/Venclyxto plus azacitidine, a hypomethylating agent, compared to placebo plus azacitidine, in 431 people with previously untreated acute myeloid leukaemia who are ineligible for intensive chemotherapy. Two-thirds of patients received 400 mg Venclexta/Venclyxto daily, in combination with azacitidine, and the remaining patients received placebo tablets in combination with azacitidine. The primary endpoints of the study are overall survival, and rate of complete remission (CR) and CR with incomplete blood count recovery (CRi). Secondary endpoints include event free survival, CR and CR with partial haematologic recovery (CRh), transfusion independence and patient-reported outcomes.

About acute myeloid leukaemia
Acute myeloid leukaemia (AML) is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow.1 AML is the most common type of aggressive leukaemia in adults.2 It has the lowest survival rate of all types of leukaemia.2 Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.3,4 Approximately 20,000 people in the US and 18,000 in Europe are diagnosed with AML each year.5,6

About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the US, Venclexta has been granted five Breakthrough Therapy Designations by the US Food and Drug Administration: one for previously untreated chronic lymphocytic leukaemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On March 23, 2020 Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, reported the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that GEN-1 be designated as an orphan medicinal product for the treatment of ovarian cancer (Press release, Celsion, MAR 23, 2020, View Source [SID1234555764]). GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an interleukin-12 (IL-12) DNA plasmid vector encased in a non-viral nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1 previously received orphan designation from the U.S. Food and Drug Administration and is currently being evaluated in a Phase I/II clinical trial (the OVATION 2 Study) for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer.

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The OVATION 2 Study combines GEN-1 with the standard of care for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer who will undergo standard neoadjuvant chemotherapy followed by interval debulking surgery. The OVATION 2 Study is a randomized Phase I/II study designed to evaluate the safety of 100 mg/m² of GEN-1 in the Phase I portion, followed by a continuation at the safe dose in the Phase II portion in an open-label, 1:1 randomized design.

"EMA’s orphan drug designation for GEN-1 recognizes the urgent need for new therapies to treat ovarian cancer, an aggressive, rapidly progressing disease with few effective treatment options," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We are pleased to receive a positive opinion from EMA COMP as this Designation carries multiple benefits and represents another important milestone for our clinical program to treat late-stage ovarian cancer."

As established by the EMA, Orphan Medicinal Product Designation (the "Designation") by the European Commission provides for scientific advice and certain regulatory assistance during the product development phase, direct access to centralized marketing authorization and certain financial incentives for companies developing new therapies intended for the treatment of a life-threatening or chronically debilitating condition that affects no more than five in 10,000 people in the European Union (EU).

Benefits for the Designation are manifold and include:

10 years of market exclusivity (in which other industry sponsors are prevented from entering the market with a similar product for the same therapeutic indication);
EMA protocol assistance for sponsors on the conduct of the tests and trials necessary to demonstrate their quality, safety and efficacy, or regulatory assistance;
EMA advice will be free or given in return for reduced fees;
Access to a centralized procedure allowing immediate marketing authorization in all Member States and facilitating the availability of medicines to all patients in the EU;
Eligibility for a reduction of regulatory fees associated with pre-authorization inspections, as well as, marketing authorization application fees and certain other fees for qualifying companies.

On March 23, 2020 UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, reported promotions for key members of the Executive Leadership Team (Press release, UroGen Pharma, MAR 23, 2020, View Source [SID1234555763]). These appointments will better position the Company for its next growth phase with the anticipated approval and launch of its first product candidate, UGN-101 (mitomycin gel) for instillation, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). In December 2019, the U.S. Food and Drug Administration accepted for filing and granted priority review for the Company’s UGN-101 application and assigned a Prescription Drug User Fee Act (PDUFA) action date of April 18, 2020.

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Effective April 1, 2020, the following individuals will be promoted to the following roles:

Jeff Bova, Chief Commercial Officer
Marina Konorty, PhD, Executive Vice President, Research & Development and Technical Operations
James Ottinger, RPh, Executive Vice President, Regulatory Affairs and Quality
Elyse Seltzer, MD, Chief Development Officer
"I am delighted to announce the promotions of these outstanding colleagues and to see firsthand how they will continue to help transform the Company with their expanded responsibilities. UroGen’s accomplishments to date have been a direct result of their tireless efforts, and I look forward to continuing to work with this talented and experienced team as we together embark on the most transformational time for our company," said Liz Barrett, President and Chief Executive Officer of UroGen. "We are rapidly approaching potential approval and commercialization of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer. With this team, I’m confident in our ability to deliver on the promise of our RTGel platform and advance our pipeline of product candidates for patients in areas of unmet need."

Jeff Bova, Chief Commercial Officer

Mr. Bova joined UroGen in 2017 and most recently served as UroGen’s Senior Vice President of Commercial. He is an experienced pharmaceutical industry executive with extensive leadership experience across key commercial functional areas, including national sales, marketing, and managed care. Prior to UroGen, he spent 20 years at Bayer Healthcare, holding multiple senior-level leadership positions of increasing responsibility. Most recently at Bayer, Mr. Bova served as Vice President of Oncology Sales, where he led a field sales force of more than 200 in marketing well-known brands such as Xofigo, Stivarga, and Nexavar. He also previously served as Vice President of Marketing for Bayer’s prostate cancer franchise where he designed, developed, and led the highly successful launch of Xofigo. Mr. Bova holds a Master’s Degree in business administration from Xavier University and a Bachelor of Science in finance and marketing from the University of Cincinnati.

Marina Konorty, PhD, Executive Vice President, Research & Development and Technical Operations

Dr. Konorty joined UroGen as Chief Chemist in 2011 and most recently served as UroGen’s Senior Vice President of Research and Development and Head of Israeli Operations. In her role as Chief Chemist, Dr. Konorty was responsible for development of the RTGel reverse-thermal hydrogel technology platform, including optimization of its delivery properties and verifying its suitability as a drug carrier in humans. She has subsequently led development of the manufacturing processes and specifications associated with RTGel-formulated drug products for the UroGen clinical development pipeline. Prior to UroGen, Dr. Konorty served as Project Manager at TransPharma Medical, a medical device and drug delivery company. A published author with multiple patents, she holds a PhD in organic chemistry from the Weizmann Institute of Science and a Master of Science and Bachelor of Science in chemical engineering from the Technion Institute of Technology.

James Ottinger, RPh, Executive Vice President, Regulatory Affairs and Quality

Mr. Ottinger joined UroGen in 2017 and most recently served as Senior Vice President of Regulatory Affairs, and has been directly responsible for guiding the regulatory pathway for UGN-101’s potential U.S. FDA approval. He is an experienced pharmaceutical industry executive with more than 30 years of strategic regulatory experience, having supported the successful development, approval, and marketing of a number of new drugs throughout his career. Prior to joining UroGen, Mr. Ottinger served as Senior Vice President of Global Regulatory Affairs at Teva Pharmaceutical Industries, Ltd., where he was responsible for global regulatory oversight of Teva’s portfolio of branded, generic, and over-the-counter products. Earlier in his career, Mr. Ottinger led both regulatory affairs and quality assurance with Premier Research Group Limited, and regulatory positions of increasing responsibility at Wyeth Research (acquired by Pfizer, Inc.). He holds a Bachelor of Science in pharmacy from the Temple University School of Pharmacy and is a registered pharmacist in the State of Pennsylvania.

Elyse Seltzer, MD, Chief Development Officer

Dr. Seltzer joined UroGen in 2017 and most recently served as UroGen’s Senior Vice President of Clinical Development. She brings a strong track record in clinical development within the pharmaceutical industry. Prior to joining UroGen, Dr. Seltzer served as Chief Medical Officer of Nabriva Therapeutics, where she was a key member of the management team that took the company public, and was responsible for the clinical and regulatory strategy and implementation of the company’s clinical development of Xenleta (lefamulin) for community acquired pneumonia. Dr. Seltzer joined Nabriva from GlaxoSmithKline (GSK), where she was Vice President of Global Clinical Sciences and Operations. Prior to joining GSK, Dr. Seltzer served as Chief Medical Officer at Tengion, a regenerative medicine company, where she established and built the company’s clinical organization. Dr. Seltzer previously held senior clinical development roles at Centocor and Vicuron and began her industry career at SmithKline Beecham (now GSK). Before joining the pharmaceutical industry, she practiced consultative Infectious Diseases and HIV care. Dr. Seltzer holds an MD from the New York University School of Medicine, completed her Internal Medicine training at the University of Pennsylvania Medical Center and her Infectious Diseases Training at Yale New Haven Hospital.

As UroGen positions itself for the next stage of growth, Stephen Mullennix, who has served as Chief Operating Officer, will be departing the company to pursue other opportunities. Mr. Mullennix has played an important role building the foundation for operational and financial efficiencies as the Company prepared for commercialization. Mr. Mullennix’s responsibilities will be transitioned to Mr. Bova, Dr. Konorty, and Mr. Ottinger, in their expanded roles.