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Clinical Study Collaborator HCL Sends First Surgically Excised Ovarian Cancer Tumors to BioVaxys for BVX-0918 Vaccine Process Development

On June 15, 2022 BioVaxys Technology Corp. (CSE: BIOV; FRA: 5LB; OTCQB: BVAXF) ("BioVaxys" or "Company"), reported that its clinical study collaborator Hospices Civils de Lyon in France ("HCL") has surgically excised the first ovarian cancer tumors from cancer patients to be used by BioVaxys for process development and manufacturing "dry runs" of BVX-0918, a major step leading to the completion of Good Manufacturing Process ("GMP") production of the Company’s ovarian cancer vaccine (Press release, BioVaxys Technology, JUN 15, 2022, View Source [SID1234615997]).

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BioVaxys recently entered collaborations with HCL and Deaconess Research Institute in the United States to provide the Company with surgically debulked tumors from Stage III/Stage IV ovarian cancer patients. Tumor samples from both hospitals are being used by BioVaxys’ Lyon-based manufacturing partner, BioElpida ("BioElpida"), to validate the tumor collection protocol, cryopackaging, cryopreservation, and supply chain logistics for BVX-0918 bioproduction for prospective patients in the US and EU.

Donors of ovarian cancer tumors are required to sign a patient consent form, with the tumor extraction, storage, and shipping logistics following a strict protocol developed by Biovaxys, and subjected to institutional and regulatory approval.

BVX-0918 produced from the surgically removed tumor cells from HCL will be screened using the identity assays derived from the OVCAR-3 cell line recently completed by BioElpida. The identity assay will be performed on every batch of autologous ovarian cancer vaccine, and is mandatory for regulatory bodies in the EU and United States.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated that "The production of BVX-0918 is a process that built on the prior successful execution of sequential steps, such as the bioproduction technology transfer to BioElpida, development of validation procedures needed to support GMP manufacturing, sterility testing for transport, hapten fixation, cryopreservation methods, antibody generation, bioburden screening, endotoxin assays, and most recently, the development of the identity assays from the OVCAR-3 cell line. With the surgically excised tumors we can now begin the final stages of the vaccine production protocol and GMP validation."

BioVaxys’ vaccine platform is based on the established immunological concept that modifying surface proteins—whether they are viral or tumor—with haptens makes them more visible to the immune system. This process of haptenization "teaches" a patient’s immune system to recognize and make target proteins more "visible" as foreign, thereby stimulating a T-cell mediated immune response. BioVaxys’ cancer vaccines are created by extracting a patient’s own (autologous) cancer cells, chemically linking with a hapten, and re-injecting them into the patient to induce an immune response to proteins which are otherwise not immunogenic. Haptenization is a well-known and well-studied immunotherapeutic approach to cancer immunotherapy and has been clinically evaluated in both regional and disseminated metastatic tumors.

A first generation single-hapten vaccine invented by BioVaxys Co-Founder and Chief Medical Officer David Berd, MD, achieved positive immunological and clinical results in Phase I and Phase II human trials in over 600 patients with different tumor types, as well as having no observed toxicity in years of clinical study. These studies were conducted under an FDA-reviewed IND. A first generation autologous, haptenized vaccine was also tested by Dr. Berd in women with advanced ovarian cancer who had ceased to respond to conventional chemotherapy. The results were encouraging: In 24 patients, the median overall survival was 25.4 months with a range of 4.5-57.4 months; 8 patients survived for more than 2 years. BioVaxys has enhanced the first-generation approach by utilizing two haptens ("bi-haptenization"), which the Company believes will yield superior results.

Kintara Therapeutics Granted Fast Track Designation from the FDA for VAL-083 for Newly-Diagnosed Glioblastoma

On June 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s VAL-083 for the treatment of patients with newly-diagnosed unmethylated glioblastoma (GBM) (Press release, Kintara Therapeutics, JUN 15, 2022, View Source [SID1234615995]).

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Some of the significant benefits of FTD include:

Enhanced access to the FDA, including opportunities for more frequent meetings and written consultation throughout the remaining development of VAL-083.
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
FTD also allows for ‘rolling review’, whereby Kintara may submit completed sections of the VAL-083 NDA as they become available, rather than at the end of development.
"We believe Fast Track Designation is indicative of VAL-083’s potential to improve outcomes for patients with GBM, the most aggressive form of brain cancer," stated Robert E. Hoffman, President and CEO of Kintara. "We look forward to announcing top-line data from the international registrational phase 2/3 GBM AGILE Study around the end of calendar year 2023. Fast Track Designation allows us to work closely with the FDA and may expedite our commercial launch of VAL-083, if approved."

Boston Scientific Announces Agreement to Purchase Majority Stake of M.I.Tech Co., Ltd from Synergy Innovation Co., Ltd

On June 15, 2022 Boston Scientific Corporation (NYSE: BSX) reported that it has entered into a definitive agreement with Synergy Innovation Co., Ltd, to purchase its majority stake (approximately 64 percent) of M.I.Tech Co., Ltd, ("M.I.Tech") a publicly traded Korean manufacturer and distributor of medical devices for endoscopic and urologic procedures. M.I.Tech is the creator of the HANAROSTENT technology, a family of conformable, non-vascular, self-expanding metal stents, which have been distributed by Boston Scientific in Japan since 2015 (Press release, Boston Scientific, JUN 15, 2022, View Source,-Ltd-from-Synergy-Innovation-Co-,-Ltd [SID1234615994]). The agreement consists of a purchase price of KRW 14,500 per share, which represents a total of KRW 291.2 billion or approximately $230 million at current exchange rates, subject to closing adjustments.

Non-vascular gastrointestinal and airway stents are used to help clear occlusions or strictures in various areas of a patient’s anatomy, including the biliary tree, pancreatic duct, esophagus, colon and duodenum. In many cases, stent placement is minimally invasive and may aid faster patient recovery compared to surgery.1,2 The HANAROSTENT technology features a unique hook-cross nitinol design intended to provide a natural and flexible fit within a patient’s anatomy, as well as flared ends to help prevent stent migration.

"M.I.Tech is an innovator in non-vascular stent development, with product offerings that complement our existing stent portfolio, including the differentiated AXIOS Stent and Electrocautery Enhanced Delivery System and the flexible and conformable Agile Esophageal Stent System," said Art Butcher, executive vice president and group president, MedSurg and Asia Pacific, Boston Scientific. "We are committed to investing in technologies that advance care for patients around the world and are eager to work more closely with M.I.Tech to expand their international footprint."

The company expects to complete the transaction in the second half of 2022, subject to customary closing conditions. The impact to GAAP and adjusted earnings per share is expected to be immaterial in 2022.

Scandion Oncology publishes prospectus in connection with the rights issue of up to approximately SEK 93.7 million

On June 15, 2022 Scandion Oncology (Scandion or "The Company"), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported a prospectus in connection with the rights issue of shares (the "Rights Issue") announced on June 1, 2022, for which the subscription period commences on June 16, 2022 (Press release, Scandion Oncology, JUN 15, 2022, View Source,c3585777 [SID1234615991]). The prospectus has today been approved and registered by the Danish Financial Supervisory Authority (Finanstilsynet).

Summary of the Rights Issue

For one (1) existing share on the record date of June 13 2022, shareholders will receive one (1) subscription right, three (3) subscription rights entitle to subscription of one (1) share.
The subscription price is SEK 8.75 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 93.7 million before deduction of transaction costs.
Subscription and guarantee commitments have been received from principal owners and new investors amounting to approximately SEK 75 million, corresponding to approximately 80% of the issue proceeds.
For complete information on the Rights Issue, please see the published prospectus.

Prospectus

The prospectus has been prepared in connection with the forthcoming Rights Issue and has today, on June 15 2022, been approved and registered by the Danish Financial Supervisory Authority. The prospectus, including full terms and conditions, is available on the Company’s, Hagberg & Aneborn Fondkommission AB’s and Redeye’s respective websites (www.scandiononcology.com, www.hagberganeborn.se, www.redeye.se). The Swedish Financial Supervisory Authority (Finansinspektionen) will issue a certificate of European passport today, on June 15 2022. A summary of the prospectus in Swedish will be available on the above websites when the certificate is issued. Application forms for subscription without preferential rights will be available on the above websites as the subscription period commences.

Timetable for the Rights Issue

The record date for participating in the Rights Issue was June 13 2022. The last day of trading including the right to subscribe for shares was June 9. The first day of trading excluding the right to subscribe for shares was June 10 2022.

June 16 – June 28, 2022 Trading in subscription rights
June 16 – July 1, 2022 Subscription period
June 16 – until registration with the Danish Business Authority Trading in paid subscription shares (Sw. "BTA")
July 5, 2022 Estimated announcement of outcome in the Rights Issue
Advisers

Redeye AB acts as financial adviser and Horten Advokatpartnerselskab (as to Danish law) and Advokatfirman Schjødt (as to Swedish law) acts as legal advisers in connection with the Rights Issue. Hagberg & Aneborn Fondkommission AB acts as the issuing agent in the Rights Issue.

Vivoryon Therapeutics N.V. Reports Q1 2022 Financial Results and Highlights Operational Progress

On June 15, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results and the corporate update for the first quarter of 2022, ending March 31, 2022 (Press release, Vivoryon Therapeutics, JUN 15, 2022, View Source [SID1234615990]). The report is available on the Company’s website at View Source

"In the first quarter of 2022, we continued to make meaningful progress, further advancing our unique QPCT/L inhibitor varoglutamstat to treat patients with Alzheimer’s disease through clinical development in Europe and the U.S., with both our European Phase 2b VIVIAD study and our U.S. Phase 2a/b study VIVA-MIND on track," said Dr. Ulrich Dauer, CEO of Vivoryon. "There still is an extremely high unmet medical need for safe, effective and widely available treatments against this devastating disease, and we at Vivoryon remain fully committed to playing an important role in making a real difference to patients and their families. We look forward to providing an update on varoglutamstat in the context of the VIVIAD interim safety analysis planned for mid-2022, where we anticipate to obtain important safety and tolerability data which will be key to our lead candidate’s further development."

Corporate Updates and Post-period Events

U.S. Phase 2a/b VIVA-MIND study (NCT03919162) for varoglutamstat in patients with early AD: actively enrolling patients, with currently eleven sites open and on track for an interim futility analysis planned for the first half of 2023.
European Phase 2b VIVIAD study (NCT04498650) for varoglutamstat in patients with mild cognitive impairment (MCI) and mild AD: actively enrolling patients, on track for an interim safety readout in mid-22, Vivoryon continues to anticipate final data in the second half of 2023.
Preparations for clinical development in Greater China, led by partner Simcere, ongoing with Clinical Trail Application for varoglutamstat approved by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA); preparations for Phase 1 and subsequent Phase 2 studies ongoing
Successful completion of a private placement in April 2022, raising gross proceeds of EUR 21 million, with net proceeds from the offering intended to be used to support the ongoing clinical development of lead candidate varoglutamstat, as well as for general corporate purposes; capital raise supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
Financial Results for Q1 of 2022

In the first quarter of 2022, research and development expenses amounted to EUR 5.8 million and increased compared to the first quarter of 2021 (EUR 4.3 million). This increase was mainly driven by costs associated with production cost for our compound varoglutamstat/PQ912 which is used in the VIVIAD trial as well as in the US trial VIVA-MIND which started in the fourth quarter of 2021.

General and administrative expenses decreased to EUR 0.8 million (Q1 2021: EUR 1.2 million). This decrease is largely attributable to consulting (Q1-2022: EUR 0.3 million, Q1-2021: EUR 0.6 million) and share based payment expense (Q1-2022: EUR 0.1 million, Q1-2021: EUR 0.2 million). The Company did not generate any licensing revenue in the reporting period.

Net loss of the period was EUR 6.4 million compared to EUR 5.4 million in the first quarter of 2021.

The Company held EUR 7.7 million in cash and cash equivalents as of March 31, 2022, respectively EUR 14.7 million as of December 31, 2021.

On April 1, 2022 the Company completed a private placement by way of accelerated book building. The gross proceeds of the offering amounted to approximately EUR 21.0 million.

All results are in line with management expectations.

Financial Guidance

Vivoryon updated its financial guidance following the capital raise completed in April 2022. According to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well as the general and administrative expenses and cash flows from investing and financing activities at least through end of May 2023. This guidance does not include potential milestone payments from development partnerships, potential payments from licensing agreements and/or additional financing measures, as far as such payments have not yet been recognized in revenues. The financial guidance takes into account all costs to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study.

Additional information regarding other relevant information is included in the financial statements as of December 31, 2021, which is included in the Company’s Annual Report 2021.