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eTheRNA raises EUR 34 million in Series B financing to accelerate multiple mRNA therapeutic development programs through to clinical proof of concept

On June 16, 2020 eTheRNA immunotherapies NV (‘eTheRNA’ or ‘The Company’), a clinical-stage company developing immunotherapies from its proprietary mRNA TriMix platform for the treatment of cancer and infectious diseases, reported that it has successfully raised Euro 34 million in a Series B equity financing round (Press release, eTheRNA, JUN 16, 2020, View Source [SID1234561140]). All existing investors – LSP (the Netherlands), PMV (Belgium), Boehringer Ingelheim Venture Fund (Germany), Fund+ (Belgium) and Omega Funds (USA) – are participating in the round. They are joined by Grand Decade, a BVI subsidiary owned by China Grand Pharmaceutical and Healthcare Holdings Ltd (‘GP(HK)’; HKSE Stock code 00512), BNP Paribas Fortis Private Equity (Belgium), Yijing Capital (China) and Novalis LifeSciences LLC (USA). GP(HK) and eTheRNA have also agreed outline terms for a possible exclusive strategic partnership for mRNA manufacturing, independent research and development, production and commercialization in Greater China.

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Proceeds of the financing will fund continued development and commercialization of proprietary mRNA technologies and a range of therapeutic products. eTheRNA’s TriMix platform is a core differentiating component in the Company’s product programs and comprises three mRNAs encoding proteins that act together to significantly increase immune responses. TriMix has demonstrated broad application across major cancer types, both preclinically and clinically, offering the prospect of therapeutic vaccines and localised tumor treatments acting synergistically with standard of care treatments. To facilitate its product development activities eTheRNA has developed a proprietary lipid nanoparticle (LNP) platform to enable intravenous delivery of various (neo)antigens, which in combination with TriMix results in unprecedented immune responses. Not only will eTheRNA start clinical development of its internal programs for intravenous mRNA delivery, the Company will also explore partnering opportunities. In infectious diseases, eTheRNA’s technologies are being deployed in an eTheRNA-led international consortium which is developing a cross-strain protective SARS-CoV-2 mRNA vaccine for high risk populations.

Dr Russell Greig, Chairman eTheRNA, commented: "The growing evidence of TriMix’s robustness and versatility as a differentiating immune stimulatory platform in a number of clinical indications was a key factor in the successful conclusion of this new funding round. We are excited that the current Series B financing provides eTheRNA with the opportunity to advance its oncology and infectious diseases pipeline further into the clinic, with the primary objective being to demonstrate clinical proof-of-concept in the near term, including for its proprietary LNP platform enabling intravenous delivery of (neo)antigens. We are delighted with the response from both existing and new investors. In addition, the strategic partnership with China Grand Pharma opens a wealth of opportunities in this potentially vast market and we are looking forward to concluding this partnership."

Exicure Announces First Patient Dosed in Phase 2 Merkel Cell Carcinoma Trial of Cavrotolimod (AST-008)

On June 16, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported the dosing of the first patient enrolled in the Phase 2 dose expansion stage of the cavrotolimod (AST-008) Phase 1b/2 clinical trial (ClinicalTrials.gov identifier: NCT03684785) (Press release, Exicure, JUN 16, 2020, View Source [SID1234561139]).

"We believe this milestone marks an important step toward fulfilling an unmet treatment need for Merkel cell carcinoma patients who have been resistant to checkpoint inhibitor antibody therapy," said Dr. Douglas Feltner, Chief Medical Officer of Exicure.

The Phase 2 dose expansion stage includes two cohorts of patients with advanced or metastatic cancer: patients with Merkel cell carcinoma (MCC) and patients with cutaneous squamous cell carcinoma (CSCC). MCC is a rare, aggressive skin cancer considered more deadly than melanoma. Risk factors for MCC include sun exposure and a weakened immune system. Advanced or metastatic CSCC is an uncommon form of skin cancer associated with significant morbidity and mortality.
The dose expansion stage is designed to assess the anti-tumor response rate of cavrotolimod plus checkpoint inhibitor treatment, the safety and tolerability of the combination, and drug pharmacodynamics and pharmacokinetics. Patients enrolled in the dose expansion cohorts must have recently documented tumor progression despite anti-PD-1 or anti-PD-L1 antibody monotherapy.

About Cavrotolimod (AST-008)
Cavrotolimod (AST-008) is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications. In December 2019, Exicure announced preliminary results from the Phase 1b stage of the clinical trial including potential signs of anti-tumor activity with cavrotolimod in combination with pembrolizumab in patients with MCC. To date, 20 patients in the Phase 1b stage of the clinical trial have been dosed, and no cavrotolimod-related serious adverse event or dose-limiting toxicity has been reported. The most commonly reported adverse events were injection site reactions and flu-like

symptoms. In the second quarter of 2020, Exicure initiated Phase 2 dose expansion cohorts of intratumoral cavrotolimod in combination with approved checkpoint inhibitors to treat two cohorts of patients with advanced or metastatic MCC or CSCC. Each cohort is expected to enroll up to 29 patients whose tumors have progressed on anti-PD-1/PD-L1, or programmed cell death protein 1/programmed death-ligand 1, antibody monotherapy.

PORTAGE RAISES MORE THAN US$6.7 MILLION THROUGH NON-BROKERED PRIVATE PLACEMENT; TEMPORARY SYMBOL CHANGE ON OTC MARKETS

On June 16, 2020 Portage Biotech Inc. (CSE: PBT.U, OTC Markets: PTGEF) ("Portage" or the "Company") reported that, further to its news release dated May 25, 2020, it has closed a non-brokered private placement (the "Offering") for gross proceeds of US$6,788,600 through the issuance of 678,860 common shares (the "Common Shares") at a price of US$10.00 per Common Share (Press release, Portage Biotech, JUN 16, 2020, View Source [SID1234561138]).

Two of the Company’s directors, Dr. Gregory Bailey and Mr. James Mellon, provided standby commitments in respect of the Offering by subscribing for an aggregate of 200,000 Common Shares (US$2,000,000). The issuance of the Common Shares to Messrs. Bailey and Mellon are considered related party transactions within the meaning of Multilateral Instrument 61-101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The Company is relying on appropriate exemptions from the formal valuation and minority shareholder approval requirements of MI 61-101 in respect of their purchases.

Dr. Walters, CEO of Portage commented, "the Company’s pipeline is progressing nicely and we are on target to have 3 products in clinical testing by the end of this year despite COVID interruptions. In addition, our early pipeline companies continue to achieve their development milestones, and this financing will allow us to accelerate our programs, as well as to be able to take advantage of new value creating opportunities."

In connection with the Offering, the Company has paid cash finder’s fees on the non-insider portion of the Offering of approximately US$193,000.

All Common Shares issued in connection with the Offering are subject to a minimum statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities legislation. The Common Shares issued in connection with the Offering have not been registered under the U.S. Securities Act of 1933, as amended (the "Act"), and may not be offered or sold in the United States unless registered under the Act or unless an exemption from registration is available.

Portage will also like to advise that OTC Markets in the United States has assigned a temporary trading symbol, "PTGED", to the Company’s shares to reflect a recently completed share consolidation (reverse split) (see the Company’s news release dated June 3, 2020) and will automatically revert back to "PTGEF" after 20 trading days. Trading in Canada on CSE remains unchanged under the symbol "PBT.U".

Xenetic Biosciences, Inc. Announces Collaboration with Pharmsynthez and Multiple Academic Institutions in Russia and Belarus to Advance Development of XCART(TM) Platform

On June 16, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported it has entered into a master services agreement ("MSA") with PJSC Pharmsynthez to advance the development of the XCART technology for B-cell malignancies (Press release, Xenetic Biosciences, JUN 16, 2020, View Source [SID1234561137]). Under the terms of the MSA, Pharmsynthez will act as the primary contract research organization ("CRO") to assist in managing the collaboration with multiple academic institutions in Russia and Belarus.

The initial stage of the collaboration will include an exploratory trial to evaluate and refine the XCART front-end process of target identification, screening and lead characterization, in a real-world clinical setting. This exploratory stage entails enrollment of NHL patients, obtaining tumor biopsies and then refining the XCART front-end methods. Subsequently the collaboration may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-cells. If successful, the Company has the potential to expand the clinical study component to dose a number of NHL patients in a Phase 1 dosing study.

"This agreement represents another significant milestone for the Company and provides access to a number of world-renowned academic institutions, researchers and clinical investigators in the area of oncology and hematology. Additionally, we are excited to again be working with the Shemyakin and Ovchinnikov Institute as they are intimately familiar with the XCART platform having been one of the primary inventors," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Coupled with our recently announced collaboration with Scripps Research, we believe we are well-positioned to execute on our strategic development plan as we work to advance this innovative technology, which we believe has the potential to address a significant unmet need in NHL."

Alexander Gabibov, academic, Head of the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS, commented, "The XCART platform was thoughtfully designed to target personalized, patient-specific tumor neoantigens and has demonstrated encouraging potential. Our team is uniquely positioned to carry out this important foundational work and, through this collaboration is able to leverage the additional expertise from the Belarus academic institutions. We are pleased to continue our collaboration with Xenetic through this agreement and look forward to helping to advance the XCART platform towards first-in-human dosing."

The XCART technology platform was designed to utilize an established screening technique to identify polypeptide domains that selectively bind to the unique B-cell receptor ("BCR") on the surface of an individual lymphoma patient’s malignant B-cell clones. This BCR-selective targeting domain is engineered into the antigen-binding domain of a chimeric antigen receptor ("CAR"), creating the possibility of a CAR T treatment that should only recognize a given patient’s malignant B-cell clones. An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

Genprex Expands Manufacturing Program with Aldevron to Advance Oncoprex™ Clinical Development

On June 16, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it has expanded its program for the manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for its lead drug candidate, Oncoprex immunogene therapy, by entering into a new agreement with manufacturing partner Aldevron, LLC, ("Aldevron") (Press release, Genprex, JUN 16, 2020, View Source [SID1234561135]). The new agreement provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. The Company’s manufacturing at this scale should also result in significantly lower costs per unit of product manufactured due to economies of scale.

Genprex’s upcoming clinical trials include a Phase I/II trial of Oncoprex combined with osimertinib (marketed by AstraZeneca as Tagrisso) for non-small cell lung cancer (NSCLC), which received Fast Track Designation in January 2020 and is expected to be initiated in early 2021. A clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck as Keytruda) in NSCLC is also planned.

"We are pleased with continued progress in the scale-up of our manufacturing processes. This new agreement with Aldevron increases our manufacturing capabilities in support of our clinical trials utilizing Oncoprex immunogene therapy in combination with targeted therapies and immunotherapies against lung cancer," said Rodney Varner, Chairman and Chief Executive Officer of Genprex.

"Our team is excited about the expansion of our manufacturing agreement and elevation of our long-standing relationship with Genprex," said Michelle Berg, President of GMP Nucleic Acids at Aldevron. "Aldevron’s GMP facility and campus buildout ensures we can meet the future manufacturing demands of companies experiencing significant growth such as Genprex; thereby enabling our ultimate goal of impacting the lives of patients."

Oncoprex consists of TUSC2 plasmid DNA encapsulated in a lipid nanoparticle. The TUSC2 gene is the active agent in Oncoprex. Data indicate that the resultant product when transfected into cancer cells both induces cell signaling that triggers programmed cell death and modulates the immune system so that the cancer cells are more susceptible to treatment.