On July 5, 2022 Nordic Nanovector ASA (OSE: NANOV) reported an update on PARADIGME, its Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed and anti-CD20 refractory follicular lymphoma (3L R and R FL) (Press release, Nordic Nanovector, JUL 5, 2022, View Source [SID1234616506]). Following a comprehensive review and independent data evaluation of PARADIGME and a subsequent request for regulatory agency interaction, the Board of Directors (Board) has taken the difficult decision to discontinue the study. No further patients will be enrolled into PARADIGME.

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The PARADIGME trial enrolled a total of 109 patients. The Company will now ensure a wind-down of PARADIGME in a structured manner ensuring patients receive the best possible care during this period.

While Betalutin, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab (40/15), has continued to display an attractive safety profile and positive signs of efficacy in some patients, the Board considers that the observed profile does not fully meet the objectives set out for the PARADIGME study. Only one out of three patients responded to the treatment with the average duration of the response of approximately six months. As a result, the Board is of the opinion that the demonstrated profile is no longer sufficiently competitive to bring Betalutin to the market in the third line relapsed and refractory FL indication, within a timeframe that makes financial and commercial sense for the Company.

The Company still believes there could be a market for Betalutin in light of its safety profile, promising efficacy in earlier lines of therapy and unique feature of being delivered as a one-time dose. However, a potential new development programme would need to be conducted in a different patient population and line of treatment. The Company will therefore explore potential partnerships and will also seek advice from the US Food and Drug Administration (FDA) to discuss if there could be a possible way forward for Betalutin in an alternative setting.

The Company will now focus its efforts and resources on developing its pipeline of proprietary CD37-targeting products from which Nordic Nanovector believes it can create value for shareholders over the longer term. These pipeline opportunities include:

Humalutin, a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta-emitting radionuclide lutetium-177 for non-Hodgkin lymphoma (NHL).
Alpha37, an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212, currently being explored with partner OranoMed for relapsed/refractory chronic lymphocytic leukaemia.
A portfolio of fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases.
A CD37 DOTA CAR-T cell opportunity in haematological cancers, which is the subject of a research collaboration with the University of Pennsylvania.
Following the decision to discontinue PARADIGME, the Board has also decided to implement a restructuring of the Company with immediate effect with the purpose of reducing costs where necessary to enable support of essential activities associated with development of the pipeline.

The Company’s cash position at the end of Q2 2022 was approximately NOK 280m (end of Q1 NOK 356.3m). Full Q2 results will now be reported on 31 August.

Chairman, Jan H. Egberts commented: "The decision to discontinue PARADIGME is extremely disappointing not only for the Nordic Nanovector team, but also for patients, healthcare providers and our shareholders as there continues to be an unmet medical need in frail and elderly patients with Follicular Lymphoma. The new independently reviewed data from PARADIGME, in an increasingly competitive market and with the slow speed of recruitment makes progressing PARADIGME further very difficult. Consequently, the Board no longer sees a viable path to commercialisation in the current indication that would make sense for the Company and its shareholders. We are extremely grateful to all the clinical investigators and patients who have participated in PARADIGME.

CEO, Erik Skullerud commented: Our focus will now shift to our pipeline of other CD37-targeting assets, which give us multiple shots on goal, including Humalutin, Alpha37, a portfolio of fully humanized anti-CD37 antibodies and the CD37 CAR-T. We look forward to communicating our development plans for these assets in more detail in the coming months."

Nordic Nanovector will host a webcast at 08.30 CEST on Wednesday 6 July, elaborating on the strategic decision to stop PARADIGME and including a Q&A session. To join the webcast please sign up via our website www.nordicnanovector.com.

On July 5, 2022 Bio-Techne Corporation (NASDAQ:TECH), reported it has completed the acquisition of Namocell, Inc (Press release, Bio-Techne, JUL 5, 2022, View Source [SID1234616470]). The Namocell acquisition adds easy-to-use single cell sorting and dispensing platforms that are gentle to cells and preserve cell viability and integrity. Namocell’s instruments and consumables are critical technologies in various workflows in both biotherapeutics and diagnostics, including cell and gene therapy development and commercialization, cell engineering, cell line development, single cell genomics, antibody discovery, synthetic biology, and rare cell isolation.

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On July 5, 2022 Brand Institute reported its work with Solasia Pharma K.K. ("Solasia") in developing the brand name DARVIAS (Press release, Brand Institute, JUL 5, 2022, View Source [SID1234616487]).

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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. DARVIAS provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. DARVIAS is expected to exert an anticancer effect by inducing cell cycle arrest and apoptosis.

DARVIAS has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan’s Ministry of Health, Labour and Welfare (MHLW). Japan is the first country in the world where DARVIAS has been approved. DARVIAS has been granted orphan drug designation in the US and EU.

"The entire Brand Institute and Drug Safety Institute team congratulates Solasia on the MHLW approval of the DARVIAS injection," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

On July 5, 2022 BioVaxys Technology Corp. (CSE: BIOV, FRA: 5LB,OTCQB: BVAXF) ("BioVaxys" or the "Company") reported that is proposing to settle an aggregate of approximately $497,000 in debt through the issuance of common shares to be issued at a deemed price of $0.10 per common share (Press release, BioVaxys Technology, JUL 5, 2022, View Source [SID1234616471]). Completion of the debt settlement remains subject to the finalization of definitive documentation and the approval of the Canadian Securities Exchange.

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On July 5, 2022 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo platform to enable precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, reported that Richard Nieman, MD, has been appointed Chief Medical Officer, effective July 11, 2022 (Press release, Lyra Therapeutics, JUL 5, 2022, View Source [SID1234616488]). Dr. Nieman brings more than 25 years of experience in drug development and medical affairs, with a proven track record in developing medicines through commercialization and beyond.

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"We’re pleased to welcome Dr. Nieman as our Chief Medical Officer," said Maria Palasis, PhD, CEO of Lyra Therapeutics. "Dr. Nieman joins the Lyra team at a critical time with our lead candidate LYR-210 in pivotal Phase 3 trials. Having successfully developed and launched numerous innovative medicines for patients and their families during the course of his career, his experience building and leading medical organizations will be invaluable as we work to bring new treatments to patients with chronic rhinosinusitis (CRS)."

"I’m thrilled to be taking on this role during such an exciting time in Lyra’s growth and evolution with late-stage clinical programs," said Dr. Nieman. "There is a significant need for effective treatments for patients suffering with CRS, and I look forward to working with the Lyra team to build on the compelling data to date and contributing my abilities and experience as the company drives towards commercialization."

Dr. Nieman, a respiratory physician (pulmonologist) with deep pharmaceutical medicine experience, has had prior leadership roles as SVP & Worldwide Medical Head of Immunology at Bristol Myers Squibb (BMS), Head of R&D China at BMS, Global Medical Officer & Head of Medical at Teva, and Head of Asia Pacific Medical at Bayer. At Teva, he led the company’s medical and heath economic and outcome research (HEOR) function of 550 professionals and was a member of the Specialty Executive Team. In addition to his U.S. experience and credentials, Richard has also spent significant time working in China, throughout Asia and in Europe. He has been involved in bringing numerous important medicines to the market in the U.S. and Europe, including Cinquair in asthma, Copaxone 40 mg 3x/week in multiple sclerosis, Austedo in movement disorders, Ajovy in migraine and Xarelto in thrombosis and stroke prevention. Richard is a Fellow of the UK Royal College of Physicians, a Visiting Senior Lecturer at the School of Cancer and Pharmaceutical Sciences, Kings College, London, and was a Visiting Professor at Fudan University School of Public Health in Shanghai, China. He has published extensively and trained and practiced medicine in the UK. Dr. Nieman assumes the role of Chief Medical Officer previously held by Dr. Robert Kern, who will continue to work closely with the Company in the role of Chief Clinical Advisor.

Lyra has approved the issuance of an equity-based award pursuant to its 2022 Inducement Award Plan to Dr. Nieman upon the commencement of his employment. The inducement grant was approved by a majority of the Company’s independent directors and was made as a material inducement to Dr. Nieman’s acceptance of employment with Lyra in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation. The inducement grant consists of a non-qualified stock option to purchase an aggregate of 230,000 shares of the Company’s common stock. The inducement grant is subject to the terms and conditions of the award agreement covering the performance stock option grant and the Company’s 2022 Inducement Award Plan.