HOOKIPA Pharma to Present at Kempen Life Science Conference

On April 14, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate and host 1:1 meetings at the virtual Kempen Life Science Conference, taking place April 21, 2021 (Press release, Hookipa Pharma, APR 14, 2021, View Source [SID1234578019]).

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Additional information will be available within the Investors & Media section of HOOKIPA’s website at View Source

Moleculin Awarded New Rare Pediatric Disease Designation from U.S. FDA for WP1066 for the Treatment of Ependymoma

On April 14, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPD) to its p-STAT3 inhibitor, WP1066, for the treatment of ependymoma (Press release, Moleculin, APR 14, 2021, View Source [SID1234578018]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Ependymoma is a rare type of tumor that can form in the brain or spinal cord. Ependymoma begins in the ependymal cells in the brain and spinal cord that line the passageways where the fluid (cerebrospinal fluid) that nourishes your brain flows. Ependymoma can occur at any age, but most often occurs in young children.

"The FDA’s recognition of the high prevalence and unmet needs in the treatment landscape for ependymoma, especially in pediatric patients is a significant milestone as we continue to advance and expand the WP1066 development program. We currently have Orphan Drug Designation for WP1066 for the treatment of brain tumors, as well as RPD designation for three other pediatric indications, and believe that ependymoma represents another important rare indication. We continue to be encouraged by the data WP1066 has demonstrated to date and believe it has the potential to be an effective therapy for pediatric patients with ependymoma," commented Walter Klemp, Chairman and CEO of Moleculin.

The Rare Pediatric Disease Priority Review Voucher program, which was created as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, is intended to incentivize the development of new therapies for rare pediatric diseases. Under the FDA’s rare pediatric disease designation program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a "rare pediatric disease," which is defined as a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and affects fewer than 200,000 people in the U.S. Subject to FDA approval of WP1066 for the treatment of ependymoma, Moleculin would be eligible to receive a voucher that may be redeemed to receive priority review for a subsequent marketing application for a different product candidate or which could be sold or transferred.

About WP1066

WP1066 is an immune/transcription modulator capable of directly inhibiting certain key oncogenic transcription factors, including the activated form of a protein known as STAT3. The activated form of STAT3 referred to as p-STAT3, is considered a master regulator of tumor activity. In addition to inhibiting p-STAT3 and several other signaling proteins linked to tumor development, WP1066 has also been shown in animal models to stimulate a natural immune response and immune memory to fight tumor progression.

Bio-Techne Announces Licensing of Proprietary Antibody to Xencor for Therapeutic Development

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."

PsiOxus and bluebird bio Present Novel Data Combining PsiOxus T-SIGn Platform with CAR-T Therapy to Clear Primary Tumors and Metastases

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.

NantHealth Announces $137.5 Million New Financing With Highbridge Capital Management and Nant Capital

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.