On April 14, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported a license agreement for use of a proprietary Bio-Techne antibody by Xencor, Inc., a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, for its therapeutic development pipeline (Press release, Bio-Techne, APR 14, 2021, View Source [SID1234578017]).

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Bio-Techne is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne is a preferred partner for many pharma and biotech companies who are developing antibody-based therapeutics for a variety of pathologies. Having access to a robust portfolio of antibodies for these coveted targets, as well as an extensive collection of unreleased monoclonal antibody libraries available for screening in novel applications, makes these valuable partnerships possible. This is Bio-Techne’s third licensing agreement with Xencor, a leader in protein engineering in the immuno-oncology field. Under the terms of this agreement, Bio-Techne grants Xencor access to a proprietary Bio-Techne antibody for use with their proprietary XmAb protein engineering technology, which is revolutionizing the development of new cancer therapeutics such as bispecific antibodies and engineered cytokines.

"We are extremely excited about this agreement with Xencor. Our goal for antibody development is to create highly specific antibodies against important therapeutic targets. This additional licensing agreement with Xencor is a perfect example of the value our vast antibody portfolio brings to the biopharma industry," stated Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "We are proud of our long history of being the partner of choice for therapeutic antibody discovery and our innovative antibody discovery platform that is harnessed by our pharma customers to fast-track their therapeutic programs. With this license agreement, Bio-Techne will increase its presence as a key player in the development of the next generation of immunotherapies."

On April 14, 2021 PsiOxus Therapeutics, Ltd. (PsiOxus), a clinical stage oncology company ​re-programming ​the tumor microenvironment to overcome the central challenge of resistance to therapy, and bluebird bio, Inc. (Nasdaq: BLUE) reported that preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, bluebird bio, APR 14, 2021, View Source [SID1234578016]). The study, "T-SIGn cancer gene therapy and anti-EGFR CAR-T cells synergize in combination therapy to clear A549 lung tumor xenografts", assessed anti-tumor synergy between PsiOxus’ T-SIGn vectors and an anti-epidermal growth factor receptor (EGFR) chimeric antigen receptor (CAR)-T cell therapy from bluebird bio in xenograft lung tumors.

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"We are encouraged by these results showing synergistic activity between our T-SIGn vector and bluebird bio’s CAR-T therapy in primary and metastatic solid tumors and are particularly excited by the ability of a single IV cycle of T-SIGn to enable an otherwise non-effective dose of CAR-T cells to clear both primary and metastatic tumors," said John Beadle, M.D., Chief Executive Officer, PsiOxus. "These data validate the potential of our T-SIGn platform to reprogram the tumor microenvironment such that CAR-T cells are recruited, activated and sustained within solid tumors to yield efficacy. We look forward to further evaluating our T-SIGn vector programs in combination with T-cell therapeutics that otherwise fail to meet their true potential to treat solid cancers."

"Cracking the solid tumor code will likely require layers of technology to reach the types of deep and durable response we aspire to as a field," said Philip Gregory, chief scientific officer, bluebird bio. "This collaboration between bluebird and PsiOxus is an example of this layered strategy, combining the power of two orthogonal anti-tumor approaches to achieve a synergistic impact on tumor control and clearance."

"Although it’s early in development, we believe that this is one of the most robust data sets so far showing that an IV administered therapy is able to rewire the tumor microenvironment to enable recruitment and activation of CAR-T cells and expand the efficacy of CAR-T therapies to solid tumors, including metastases," said Brian Champion, Ph.D., Chief Scientific Officer, PsiOxus. "Results of this study validate the mechanistic foundation of our T-SIGn platform and provide a blueprint of what can be achieved as we evaluate our T-SIGn vectors in combination with additional cell therapy approaches."

The study showed that when injected intravenously into mice with established human tumor xenografts, PsiOxus’ armed T-SIGn vectors reprogrammed the tumor microenvironment to a proinflammatory state. When this was followed three days later by a dose of bluebird bio’s anti-EGFR CAR-T cells, two T-SIGn vectors armed with different T-cell recruitment and activation transgenes, NG-347 and NG-641, synergistically yielded anti-tumor activity. The anti-EGFR CAR-T cells demonstrated no tumor efficacy when dosed alone at the same dose and also failed to synergize with the unarmed T-SIGn vector, demonstrating that the synergy was driven by the T-SIGn vectored transgene expression within the tumor. Transcriptional analysis showed that PsiOxus’ NG-347 T-SIGn vector reprogrammed the tumor microenvironment leading to enhanced activation of CAR-T cells through robust CAR-T and innate immune cell recruitment and activation, resulting in increased efficacy against both primary and metastatic tumors.

While NG-347 is a preclinical program in the IND enabling phase, NG-641 is already being evaluated in the clinic and PsiOxus plans to develop it both as a monotherapy and in combination with checkpoint inhibitors.

"This preclinical data opens up an additional valuable combination option for NG-641 to enable the effective treatment of a wide range of solid tumors with CAR-T or other cell therapies," concluded Brian Champion, Ph.D., Chief Scientific Officer, PsiOxus.

The poster, "T-SIGn cancer gene therapy and anti-EGFR CAR-T cells synergize in combination therapy to clear A549 lung tumor xenografts", is available to registered participants of the AACR (Free AACR Whitepaper) Virtual Annual Meeting 2021 and can be downloaded from the PsiOxus website.

On April 14, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a provider of enterprise solutions that help transform complex data into actionable insights, reported the signing of a new financing that will include the issuance of $137.5 million aggregate principal amount of new senior unsecured convertible notes due 2026 (the "2026 Notes") in a private transaction, with the common stock that may be issued upon a conversion to be registered under the Securities Act of 1933, as amended (the "Securities Act") (Press release, NantHealth, APR 14, 2021, View Source [SID1234578015]). As part of the transaction, the company will enter into an agreement to extend the maturity of its existing subordinated note to October 2026. The company intends to use the proceeds of the 2026 Notes to retire its existing convertible notes due December 2021 (the "2021 Notes") and further invest in initiatives to grow its business.

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The 2026 Notes will be issued to two existing NantHealth investors: certain funds managed by Highbridge Capital Management, LLC ("Highbridge"), a current holder of the company’s 2021 Notes, and Nant Capital, LLC, an affiliated entity owned by the company’s majority equity investor and holder of the company’s subordinated notes. The investors will purchase $137.5 million in aggregate principal amount of the 2026 Notes. The parties expect the 2026 Notes financing transaction to close on or before April 27, 2021.

In addition, each of Highbridge and Cambridge Equities, LP (also an affiliate owned by the company’s majority shareholder), have agreed to convert $5 million ($10 million in total) of their holdings of the 2021 Notes to shares of NantHealth common stock on April 14, 2021.

"This transaction provides several immediate benefits to NantHealth, including enhancing our financial flexibility and funding our growth initiatives," said Ron Louks, NantHealth’s Chief Operating Officer. "Not only does this financing address the upcoming maturity of our 2021 Notes, but importantly provides us with the resources to invest in our established businesses, NaviNet and Eviti, and accelerate the expansion of our recently acquired OpenNMS business. We thank our financing partners, Highbridge and Nant Capital, for their continued support."

Jonathan Segal, Co-Chief Investment Officer of Highbridge, said, "We are very pleased to increase our investment in NantHealth. Last year, NantHealth made a strategic decision to expand beyond healthcare by providing enterprise solutions to help businesses in other industries. We believe this financing will help NantHealth achieve this goal and continue further product expansion."

The 2026 Notes will bear interest of 4.5% that will be payable semiannually, unless earlier converted to the company’s common stock, redeemed or repurchased in accordance with their terms. The final terms of the 2026 Notes, including the interest rate, initial conversion rate, and other terms, will be disclosed in the company’s filings with the U.S. Securities and Exchange Commission (SEC).

A Special Committee of the NantHealth Board of Directors, consisting of the independent directors, undertook a thorough review of the transaction and unanimously recommended that NantHealth proceed with the transaction.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the 2026 Notes, nor shall there be any sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On April 14, 2021 Vascular Biogenics Ltd. ("VBL Therapeutics" or the "Company") (NASDAQ: VBLT), reported the closing of its underwritten public offering of 6,901,790 ordinary shares, and, to certain investors in lieu thereof, pre-funded warrants to purchase 8,050,000 ordinary shares in an underwritten public offering, at a price to the public of $1.90 per ordinary share and $1.89 per pre-funded warrant (Press release, VBL Therapeutics, APR 14, 2021, View Source [SID1234578014]). The pre-funded warrants allow investors that have restrictions on their ability to own Company stock above a designated ownership threshold (such as 4.99% or 19.99%) to invest additional capital. In practice, the pre-funded warrants are the equivalent to ordinary shares without voting rights. All of the securities in the offering were sold by VBL Therapeutics.

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The gross proceeds to the Company from the public offering, before deducting underwriting discounts and commissions and offering expenses payable by VBL Therapeutics, were approximately $28.3 million. VBL Therapeutics intends to use the net proceeds from the offering for working capital and other general corporate purposes.

Guggenheim Securities, LLC acted as bookrunning manager for the offering. Oppenheimer & Co. Inc. also acted as a joint bookrunner. Roth Capital Partners and JonesTrading Institutional Services LLC acted as co-managers.

The securities described were offered by VBL Therapeutics pursuant to a shelf registration statement on Form F-3 (No. 333-251821), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and a final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC. The final prospectus supplement is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these 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 14, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a second poster for the GP2 Phase III clinical trial design for recurring breast cancer at the 2021 AACR (Free AACR Whitepaper) Annual Meeting (Press release, Greenwich LifeSciences, APR 14, 2021, View Source [SID1234578013]). The Global Principal Investigator of the GP2 Phase III clinical trial, Dr. Mothaffar F. Rimawi of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, is the lead author of the poster and has recorded an audio track providing an overview.

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Poster Presentation CT256 from 2021 AACR (Free AACR Whitepaper) Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)

Poster Presentation CT256 from 2021 AACR (Free AACR Whitepaper) Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)

The AACR (Free AACR Whitepaper) published the Phase III trial design abstract on April 9, 2021 and the poster on April 10, 2021. The abstract can be viewed at the bottom of this press release and the full poster with audio can be accessed or downloaded on the Company website at View Source

Snehal Patel, CEO of Greenwich LifeSciences, commented, "At present, the Phase III trial is designed to treat up to 500 patients. The data read out for the interim analysis will be event driven and could be completed approximately halfway through the planned 5 year follow-up. The recently reported robust immune response data, which peaked after 6 months in the Phase IIb trial, will help to finalize the Phase III trial design, including the immune response monitoring strategy. We will also assess immune response in an open-label third arm across multiple HLA types to potentially expand the market for GP2. This immune response data could be reported before the interim analysis."

Updated Phase III Clinical Trial Design: The Company and the Baylor College of Medicine presented the updated design of the planned Phase III clinical trial to breast cancer key opinion leaders. The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center trial. The primary efficacy endpoints for the three arms of the Phase III trial are invasive Disease Free Survival (iDFS). The objective is to conservatively reproduce the Phase IIb trial results which demonstrated 100% iDFS with 5 years of follow-up in the HER2/neu 3+ population.

In addition to the trial design updates in the bullet points above, patients meeting all entry criteria will be randomized to receive either GP2 + GM-CSF or placebo. The Phase III trial design includes the use of saline in the placebo arm, instead of GM-CSF, which was used in the placebo arm of the Phase IIb trial. GM-CSF is not the standard of care and may cause immune responses in placebo patients.

Dr. Jaye Thompson, VP of Clinical and Regulatory Affairs, added, "It is critical that the study population and design in the protocol are carefully crafted so that the resulting data provides convincing evidence of safety and efficacy for the BLA submission. We have already engaged a statistician to design the interim analysis and have begun recruiting clinicians and clinical sites for participation in the Phase III trial."

AACR Abstract CT256

Title: A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer

Snehal S Patel1, David B McWilliams1, Christine T Fischette1, Jaye Thompson1, F Joseph Daugherty1, C Kent Osborne2 and Mothaffar F Rimawi2.

1Greenwich LifeSciences, Stafford, TX; 2Baylor College of Medicine, Houston, TX

Background: GP2 is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with an FDA-approved immunoadjuvant Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF, Sargramostim, Leukine) that stimulates an immune response targeting HER2/neu expressing cancers. In a prospective, randomized, single-blinded, placebo-controlled, multicenter Phase IIb clinical trial completed in 2018, no recurrences were observed in the HER2/neu positive adjuvant setting after median 5 years of follow-up, if the HLA 2+ patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338) in a pre-specified subgroup analysis. Furthermore, the GP2 immunotherapy elicited a potent immune response measured by local skin tests and immunological assays. Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to the GP2 immunotherapy. This Phase III trial aims to reproduce the Phase IIb study and will explore the use of GP2 + GM-CSF as adjuvant therapy to prevent the recurrence of breast cancer in HER2/neu positive and HLA 2+ patients, post-surgery and following the first year treatment with any trastuzumab-based therapy.

Trial Design: This Phase III trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo (Bacteriostatic Saline/WFI) will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years treatment plus 2 years follow-up for a total of 5 years following the first year treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

Eligibility Criteria: The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year treatment with trastuzumab-based therapy.

Trial Objectives:

To determine if GP2 therapy reduces recurrence in HER2/neu positive breast cancer patients.
To monitor the in vitro and in vivo immunologic responses to GP2 therapy and correlate these responses with the clinical outcomes.
To monitor for any unexpected adverse events and toxicities related to GP2 therapy.
Accrual: The target enrollment is up to approximately 500 patients.

Funding: This trial is supported by Greenwich LifeSciences.

About the AACR (Free AACR Whitepaper) Annual Meeting 2021

The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 48,000 members residing in 127 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research — from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy — and highlights the work of the best minds in research and medicine from institutions all over the world.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.