On April 5, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a Key Opinion Leader (KOL) webinar discussing AWARE-1 data, the immunotherapeutic effects of pelareorep in breast cancer, and its synergistic activity with CAR T cells in solid tumors (Press release, Oncolytics Biotech, APR 5, 2021, sec.gov/Archives/edgar/data/1129928/000112992821000017/oncy_kolxpr.htm [SID1234577569]). The webinar will take place on Monday, April 12, 2021 at 2:00 pm ET.

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The webinar will feature presentations by Key Opinion Leaders Aleix Prat, M.D., Ph.D. (Clínic Barcelona) and Richard Vile, Ph.D., (Mayo Clinic). Dr. Prat’s portion of the presentation will focus on data from the AWARE-1 window-of-opportunity clinical trial evaluating pelareorep with and without atezolizumab (Tecentriq) in early-stage breast cancer, which will be presented at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Dr. Vile will then discuss the results of a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors (link to PR, link to poster).
During the event, Oncolytics’ management team will also give a corporate update and discuss the company’s upcoming milestones. Dr. Prat, Dr. Vile, and company management will be available to answer questions following the formal presentations.

To register for the event, please click here.

About the KOLs

Aleix Prat, M.D., Ph.D. is the Head of the Medical Oncology Department of the Hospital Clínic Barcelona (Spain), Associate Professor at the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Lab at IDIBAPS, and President of the governing board of the Spanish Breast Cancer Cooperative Research Group (SOLTI), which performs clinical trials of excellence in oncology. He was also named a member of the Executive Board of The Breast International Group (BIG) in 2018. BIG is an international non-profit organization that is linked to more than 3,000 hospitals and includes more than 10,000 experts and more than 56 cooperative groups from around the world.
Over his career, Dr. Prat obtained worldwide prestige as a research scientist in the field of breast cancer genomics and biomarker development. In 2008, he became a postdoctoral research associate (2008-2012) at the Lineberger Comprehensive Cancer Center (University of North Carolina at Chapel Hill, USA) in the Laboratory of Prof. Charles M. Perou, a world-renowned translational researcher in breast cancer. During this postdoctoral experience, he discovered and characterized a new molecular subtype of breast cancer, known as a Claudin-low (Prat et al. Breast Cancer Research 2010; Citations: 1,518). In addition, he contributed to the breast cancer portion of The Cancer Genome Atlas (Nature 2012; Citations: 4,661), which was a landmark molecular characterization study in the field of cancer research.

Richard Vile, Ph.D. is a world-renowned scientist and member of the Oncolytics Scientific Advisory Board with extensive experience studying pelareorep. As a recognized KOL, his research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo’s Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology. Dr. Vile received his B.A. in Biochemistry from the University of Oxford and his Ph.D. in Viral Vectors from the University of London.

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:
•Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

•Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

•Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

•Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

•Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue is collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day of their mastectomy. Data generated from this study are intended to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety, and tumor and blood-based biomarkers.
For more information about the AWARE-1 study, refer to View Source
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On April 5, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the signing of a merger agreement pursuant to which Sorrento will acquire ACEA Therapeutics, Inc. ("ACEA") (Press release, Sorrento Therapeutics, APR 5, 2021, View Source [SID1234577565]). The acquisition will include late clinical stage drug Abivertinib, clinical stage candidate AC0058, preclinical stage candidate AC0939, and ACEA’s extensive proprietary library of small molecules (over 1,000,000 compounds), which potentially have applications for numerous human disease indications, including non-small cell lung cancer (NSCLC), B cell lymphomas, systemic lupus, rheumatoid arthritis, multiple sclerosis and viral infections. These compounds are being actively studied in clinical trials and/or preclinical models to advance the most promising candidates rapidly to clinical stage development. Abivertinib, a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both a mutant form of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK), was originally identified from ACEA’s compound library. Abivertinib has the potential to improve outcomes in resistant prostate cancer, systemic lupus erythematosus, and various B cell lymphomas in addition to NSCLC, an indication for which a registrational/Phase 3 trial has been completed. It is currently being studied as a Phase 2 treatment for COVID-19-induced respiratory compromise in the US and Brazil. A second clinical candidate, AC0058, is a next generation BTK inhibitor, currently in a Phase 1b trial for Lupus patients in the US, which can potentially be expanded to other autoimmune diseases such as multiple sclerosis.

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The acquisition will also include ACEA’s state of the art cGMP facility located in Quzhou, China, on a 23-acre campus with five buildings. This facility has successfully manufactured multiple batches of the active pharmaceutical ingredient (API) and final product in capsules for Abivertinib and AC0058 for clinical studies. The ACEA facility currently has capacity to manufacture up to 5,000 kg/year of APIs and 50,000,000 capsules of final drug product.

The ACEA next generation BTKi and other TKI small molecule drug candidates are highly synergistic with Sorrento’s broad biological product pipelines in therapeutic antibodies, antibody drug conjugates (ADCs), autologous chimeric antigen receptor-T (CAR-T) and allogeneic dimeric antigen receptor-T (DAR-T) cell therapies, oncolytic viruses and IL-2 immune modulators. The synergy will potentially enable Sorrento to develop many life-saving, combinational drugs for difficult-to-treat human illness in oncology, autoimmune and infectious diseases.

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated "The ACEA acquisition will bring us a step closer to developing into a major biopharmaceutical company and we look forward to welcoming the ACEA team into the Sorrento family."

As previously announced on October 16, 2020, Sorrento and ACEA entered into a letter of intent setting forth the terms and conditions by which Sorrento would acquire ACEA. In consideration for the acquisition, at the closing of the merger, ACEA’s equity holders will receive up to an aggregate of $38 million in shares of Sorrento common stock, subject to certain adjustments, based on a price per share calculated in accordance with the merger agreement. In addition to the foregoing consideration, and subject to the achievement of certain clinical and sales milestones (as described below), Sorrento will also pay the ACEA equity holders (i) up to $450,000,000 in additional payments, subject to the receipt of certain regulatory approvals and achievement of certain net sales targets with respect to the assets acquired in the merger and (ii) with respect to specified royalty-bearing products, five to ten percent of the annual net sales thereof, in each case in accordance with the terms of an earn-out agreement. The amount referenced in clause (i) of the preceding sentence includes the amounts that would have otherwise been due to ACEA under that certain License Agreement, dated July 13, 2020, which agreement will terminate in its entirety at the effective time of the merger.

The merger is expected to close in the second quarter of 2021, subject to customary closing conditions and regulatory approval. If the proposed merger is consummated, the issuance of the shares of Sorrento common stock would be made in accordance with an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to Section 4(a)(2) thereof and Regulation D and Regulation S thereunder. Such shares of Sorrento common stock would not be registered under the Securities Act and could not be offered or sold without registration unless an exemption from such registration is available. This press release does not constitute an offer to sell or the solicitation of an offer to buy, any shares of Sorrento common stock.

On April 5, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC) (the "Company"), reported that it will redeem all of its outstanding public warrants (the "Public Warrants") to purchase shares of the Company’s common stock, $0.0001 par value per share ("Common Stock"), that were issued under the Warrant Agreement, dated as of March 5, 2020 (the "Warrant Agreement"), by and between the Company and Continental Stock Transfer & Trust Company, as warrant agent (the "Warrant Agent"), and that remain outstanding at 5:00 p.m. New York City time on May 5, 2021 (the "Redemption Date") for a redemption price of $0.01 per Public Warrant (the "Redemption Price") (Press release, Vincerx Pharma, APR 5, 2021, View Source [SID1234577564]). Prior to the Redemption Date, the Company’s units, listed on the Nasdaq Capital Market under the symbol "LSACU," will each be separated into one share of Common Stock and one Public Warrant, and be traded on the Nasdaq Capital Market under the symbols "LSAC" and "LSACW," respectively.

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Warrants to purchase Common Stock that were issued under the Warrant Agreement in a private placement and still held by the initial holders thereof or their permitted transferees are not subject to this redemption.

Under the terms of the Warrant Agreement, the Company is entitled to redeem all the outstanding Public Warrants if the last sale price of the Common Stock is at least $16.50 per share for any 20 trading days within any 30-day trading period ending on the third business day prior to the date on which a notice of redemption is given. This share price performance target has been met. At the direction of the Company, the Warrant Agent has delivered a notice of redemption to each of the registered holders of the outstanding Public Warrants.

Each Public Warrant may be exercised by the holders thereof until 5:00 p.m. New York City time on the Redemption Date, to purchase one-half (1/2) of a fully paid and non-assessable share of Common Stock underlying such warrant, at the exercise price of $11.50 per whole share of Common Stock. Pursuant to the Warrant Agreement, a holder may exercise its warrants only for a whole number of shares. This means that only an even number of Public Warrants may be exercised at any given time by a holder. Any Public Warrants that remain unexercised following 5:00 p.m. New York City time on the Redemption Date will be void and no longer exercisable, and the holders of those Public Warrants will be entitled to receive only the redemption price of $0.01 per warrant. 6,563,767 Public Warrants were initially issued by the Company, exercisable for an aggregate of 3,281,883 shares of Common Stock at a price of $11.50 per share, representing a total of approximately $37.7 million in potential proceeds to the Company.

None of the Company, its board of directors or employees has made or is making any representation or recommendation to any holder of the Public Warrants as to whether to exercise or refrain from exercising any Public Warrants.

The shares of Common Stock underlying the Public Warrants have been registered by the Company under the Securities Act of 1933, as amended, and are covered by a registration statement on Form S-1 filed with, and declared effective by, the Securities and Exchange Commission (File No. 333-252589).

Questions concerning redemption and exercise of the Public Warrants can be directed to Continental Stock Transfer & Trust Company, 1 State Street, 30th Floor, New York, New York 10004, Attention: Compliance Department, telephone number (212) 509-4000.

No Offer or Solicitation
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any offer of any of the Company’s securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On April , 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported its participation in the 20th Annual Needham Virtual Healthcare Conference (Press release, MEI Pharma, APR 5, 2021, View Source [SID1234577563]). MEI Pharma will present a company overview and business update on Monday, April 12, 2021 at 12:45 p.m. Eastern Time.

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A live webcast of the presentation can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported it has entered into a definitive agreement to acquire Genosity Inc. ("Genosity"), a genomics company offering innovative software and laboratory solutions to enable development and deployment of complex sequencing based tests (Press release, Invitae, APR 5, 2021, View Source [SID1234577562]). The acquisition would bring Genosity’s specialized capabilities onto the Invitae platform to accelerate the time to market and decentralization of Invitae’s personalized oncology offerings, including somatic and germline offerings poised to help transform how cancer is diagnosed, treated and monitored.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Each individual cancer is unique. The way we diagnose and treat it must be as well," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Our goal is to move as quickly as we can toward the day where each cancer patient receives timely, comprehensive genetic information that is used to guide their care from diagnosis to monitoring for disease recurrence. Together with Genosity, we believe our combined novel capabilities and capacity will help us reach that day sooner for patients around the globe."

Genosity has built an industry-leading suite of highly specialized capabilities designed to support the use of next generation sequencing in oncology development and clinical care, ranging from basic research to clinical testing for regulated studies. The company currently works with Invitae on a number of projects and clinical trials. Becoming a part of Invitae is expected to provide important advantages for the development and launch of Invitae’s oncology products, which include three devices under development that have received breakthrough device designation from the U.S. Food and Drug Administration (FDA), including the capacity, speed, and efficiency required to serve mainstream medicine cost effectively both with central laboratory services and decentralized kitted products.

"Genosity, under the insightful leadership of Marc Grodman, MD, has been able to develop solutions which enable broader adoption of genomic testing. Our laboratory services, end-to-end software solutions and data management platform are an ideal fit as Invitae develops best-in-class options for MRD-based cancer monitoring," said Robert D. Daber, Ph.D., president and chief technology officer of Genosity. "In Invitae we have found a like-minded partner focused on making genomics more affordable and accessible worldwide."

Maximum flexibility to accelerate the future of cancer care worldwide

Invitae is currently developing its Personalized Cancer MonitoringTM (PCM) platform as an in vitro diagnostic (IVD) intended for regulatory submission. PCM analyzes a patient’s unique genetic profile of their specific cancer and uses it to monitor their blood to detect cancer recurrence early when it is most curable. Invitae’s PCM test, if approved for use, will be augmented by Genosity technology and capabilities to distribute PCM globally, increasing accessibility and reducing turnaround time. With this capability, we believe Invitae will be uniquely able to meet the needs of cancer patients worldwide, whether their clinicians send out to a central testing service or rely on tests that are completed locally by in-house laboratories.

In January 2020, Invitae received Breakthrough Device Designation from the FDA for PCM.

Transaction Terms

Under the terms of the agreement, Invitae will acquire Genosity for approximately $200 million, consisting of (i) approximately $120 million in cash and (ii) approximately $80 million in shares of Invitae common stock (based upon a trailing average closing price prior to the date of closing but subject to certain potential adjustments), with such stock and cash consideration subject to reduction based upon certain debt and transaction expenses of Genosity determined at closing.

The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter, subject to customary closing conditions including the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In connection with the transaction, Invitae will grant restricted stock units ("RSUs") having a value of up to $15 million to certain continuing employees of Genosity. These RSUs will be granted under Invitae’s 2015 Stock Incentive Plan (the "2015 Plan"), which is being amended to create an additional pool of shares of Invitae common stock to be used exclusively for the grant of inducement awards in compliance with New York Stock Exchange Rule 303A.08 ("Rule 303A.08"). These RSUs were approved by the Invitae Board of Directors and will be granted as an inducement material for continued employment following the acquisition of Genosity in reliance on the employment inducement exemption under Rule 303A.08. These RSUs will vest annually over three years and, in certain instances, the number of RSUs that vest on each vesting date will be calculated based upon a trailing average closing price prior to the date of closing of the Genosity acquisition.

Advisors

Cowen served as exclusive financial advisor to Genosity in connection with the acquisition.

Other Inducement Grants for Previous Transaction

Unrelated to the Genosity transaction, Invitae reported inducement grants in connection with the addition of certain assets and key personnel from a small organization called IntelliGene Health Informatics, LLC. which was focused on specialized software capabilities and technologies and will augment Invitae’s oncology offerings.

In connection with Invitae’s acquisition of assets from IntelliGene Health Informatics, LLC ("IntelliGene") for approximately $2.7 million, Invitae granted RSUs having a value of up to $6.225 million to certain employees and consultants of IntelliGene who continue as employees of Invitae. These RSUs were granted under the 2015 Plan, which was amended to provide for an additional pool of shares of Invitae’s common stock to be used exclusively for the grant of inducement awards in compliance with Rule 303A.08. These RSUs were approved by the Invitae Board of Directors and were granted as a material inducement for continued employment following the acquisition of assets from IntelliGene in reliance on the employment inducement exemption under NYSE Rule 303A.08. These RSUs vest in two installments at 12 months and 24 months following the acquisition of IntelliGene assets. The number of RSUs that vest on each vesting date will be calculated based on the volume-weighted average trading price of the company’s common stock on the NYSE for a trailing 20 trading day period prior to the grant date or, in certain situations, the vesting date.