On September 19, 2022 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT8009, a Nectin-4 targeting Bicycle Toxin Conjugate, was published in Molecular Cancer Therapeutics (Press release, Bicycle Therapeutics, SEP 19, 2022, View Source [SID1234619649]). The article, titled "BT8009: a Nectin-4 targeting Bicycle Toxin Conjugate for treatment of solid tumors" is available online via this link.

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"Having already announced interim, positive results from our ongoing Phase I trial of BT8009, we are pleased to describe the work leading to its identification and the preclinical studies that support its potential to rapidly diffuse into, and to kill, solid tumor cells." said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "The data published in Molecular Cancer Therapeutics describe BT8009’s pre-clinical efficacy in a wide range of cell-derived xenograft and patient-derived xenograft tumor models, with full tumor regression frequently seen in large and small tumors. We look forward to providing additional clinical data on BT8009 later this year."

On September 19, 2022 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech" or "AXIM"), an international healthcare solutions company targeting ocular surface diseases, reported that it has signed an exclusive global commercial partnership agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. ("Verséa"), one of the fastest growing U.S. healthcare companies, specialized in the sale and distribution of ocular diagnostic and therapeutic solutions (Press release, AXIM Biotechnologies, SEP 19, 2022, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-signs-exclusive-global-commercialization-agreement-with-versea-ophthalmics-for-distribution-and-sales-of-novel-ophthalmic-diagnostics-solutions [SID1234619648]).

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The agreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. The three AXIM’s key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 0.5 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.

Verséa plans to launch IgE and Lactoferrin tests at the upcoming 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in the next 18-24 months.

In recent months, AXIM has been preparing for the scaling of production of its tests in anticipation of an agreement such as the one reached with Verséa and is now prepared to support new orders associated with the agreement and subsequent launch.

"This is an exciting day for AXIM, one that has been years in the making – this is the moment where we move from a development-stage biotech company to a revenue generating healthcare organization," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "Since the development of our novel ocular diagnostic tests and subsequent success in proving their effectiveness, rather than building an internal team to commercialize the tests, we have been searching for a partner with a solid commercial infrastructure and a firm commitment to eye care, capable of bringing our tests to clinical offices on a global scale. I am more than confident that we have found that partner in Verséa. With existing sales channels to support their human amniotic membrane therapeutics, Verséa has expressed strong support for our business and a true excitement for adding our technology to their expanding portfolio of healthcare solutions. I personally believe that together, we will be able to change the landscape of dry eye disease diagnosis."

The agreement is an illustration of Verséa’s recent commitment to the eye care space following its appointment of Dr. Rob Sambursky, MD, as their President of Corporate and of Verséa Ophthalmics, a new business division set to provide innovative solutions for the diagnosis, treatment and management of ocular surface diseases.

"We are delighted to be selected by AXIM as their exclusive partner for the commercialization of their innovative suite of diagnostic solutions," said Sean Fetcho, CEO and co-founder of Verséa. "With exclusive global licensing rights to AXIM’s Eye Diagnostics portfolio, Verséa will be introducing a new innovative, rapid, tear-based, POC lab-testing platform designed specifically to assist eye-care clinicians in detecting and quantifying a variety of biomarkers associated with external ocular disorders."

The President of Verséa Ophthalmics, Dr. Sambursky, MD, explained the significance of the new diagnostic technology: "Mild allergic conjunctivitis is frequently confused with dry eye, while more severe allergic disease is frequently misdiagnosed as viral conjunctivitis; yet the appropriate clinical management and treatments are different. The AXIM diagnostic technology will allow eye doctors to not only identify and differentiate clinically overlapping conditions but also drive more targeted therapeutic interventions. Having access to real-time quantitative results (a specific number) at the office visit will significantly help to confirm therapeutic impact, leading to overall improved personalized patient care."

Lactoferrin is a protein contained in tears that protects the ocular surface with its antimicrobial and anti-inflammatory properties. Lower concentrations of lactoferrin have been demonstrated in patients with dry eye, which is associated with decreased aqueous tear production. Ocular Immunoglobulin E (IgE) is a biomarker for allergies and a key biomarker primarily associated with allergic conjunctivitis. Both tests are FDA-cleared and have dedicated Medicare CPT codes.

The third test, a quantitative tear Matrix Metalloproteinase 9 (MMP-9) test, is a significant advancement in the measurement of the intensity of inflammation affecting dry eye patients. Being a quantitative test for MMP-9, this test allows for a more objective classification and management of dry eye disease as well as subsequent pre-surgical and post-surgical therapeutic guidance. Post-surgical complications, such as worsening symptoms of dry eye and refractive error, may be mitigated by identifying and treating dry eye prior to cataract and refractive surgery corneal measurements.

On September 19, 2022 Astellas Venture Management LLC (President: William Watt, Ph.D., "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), and Mission Bay Capital BioLabs ("MBC BioLabs"), a life-science incubator, reported their collaboration on the "Astellas Future Innovator Prize" formerly known as the Astellas Golden Ticket competition (Press release, Astellas, SEP 19, 2022, View Source [SID1234619647]). Building on over three successful years, the competition offers entrepreneurial scientists or emerging biotechnology start-ups one year’s priority usage of MBC BioLabs’ state-of-the-art lab facility and access to Astellas’ research and development (R&D) capabilities and business leaders.

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With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, AVM and MBC BioLabs are continuing their partnership to support scientists and early-stage companies to accelerate their novel therapeutic programs, modalities or platforms. The 2022 competition will prioritize innovative research that compliment Astellas’ Focus Area Approach and pipeline.

"We are truly thrilled to host the Astellas Future Innovator Prize again this year," said William Watt, President, AVM. "Through our long-term collaboration with MBC BioLabs, we aim to create an environment that encourages innovation to thrive. The Astellas Future Innovator Prize enables us to provide biotech companies with expertise and capabilities to turn an innovative idea into a real solution, which could transform the lives of patients in need around the world."

"We are pleased to continue our partnership with Astellas to uncover the innovators of tomorrow," said Douglas Crawford, MBC BioLabs General Manager. "The past winners of the Astellas Future Innovator Prize show what can be achieved by combining Astellas’ support, advice and expertise with our laboratory incubator, and we are excited to see the result of our ongoing collaboration."

Entrepreneurial scientists, emerging life-science and biotechnology start-ups have until November 4, 2022 to enter the Astellas Future Innovator Prize.

About the Astellas Future Innovator Prize at MBC BioLabs
Astellas is offering up to two prizes for pioneering scientists with innovative research that complements Astellas’ areas of interest in alignment with its Focus Area Approach and pipeline, including Blindness & Regeneration, Mitochondria, Genetic Regulation, Immuno-Oncology, Cell Therapy, and other areas.

Companies awarded an Astellas Future Innovator Prize will gain one year’s priority admission or renewal to MBC BioLabs’ state-of-the-art laboratory and access to Astellas’ R&D scientists and business leaders. The competition is open from September 19 to November 4, 2022. Entrepreneurial scientists, emerging life-science or biotechnology start-ups should submit their non-confidential company presentation, including a one-page executive summary, to View Source to be considered. The decision to award any Astellas Future Innovator Prize and the assessments underlying such decision, are solely within the judgment of Astellas and are not subject to any objection or appeal.

The 2021 Astellas Future Innovator Prize winners were Vcreate and Weatherwax Biotechnologies, chosen for the potential of their innovations to deliver therapeutic advances for unmet medical needs and their potential synergy with Astellas’ Focus Area Approach.

On September 19, 2022 Alligator Bioscience AB ("Alligator") and Aptevo Therapeutics ("Aptevo") reported that the US Food and Drug Administration (FDA) has issued a "may proceed" notification for the ALG (Press release, Alligator Bioscience, SEP 19, 2022, View Source [SID1234619646]).APV-527 investigational new drug application (IND), allowing the companies to initiate clinical trials evaluating the compound for the treatment of 5T4-expressing tumor antigens in multiple solid tumor types. The companies are moving rapidly to initiate a multi-center Phase 1 trial in the US.

"We are very happy to see ALG.APV-527 make significant progress towards the clinic this year, an important milestone achievement for the Alligator and Aptevo teams. It’s exciting to know that this compound will soon join APVO436, currently in a phase 1b clinical trial for the treatment of AML, in clinical studies here in the US. I would like to thank our partners at Alligator for their close collaboration and expertise. Advancing ALG.APV-527 has been a true team effort and we value our partnership," said Marvin White, President, and CEO of Aptevo. "ALG.APV-527 is specifically designed to trigger 4-1BB-mediated antitumor activity in 5T4-expressing tumor indications, meaning it has potential across a range of solid tumors with high unmet medical need. The addition of a new clinical candidate in active development serves as further validation of Aptevo’s proprietary ADAPTIRÒ platform."

"This IND clearance marks an important step in the development of ALG.APV-527 and is a testament to the strength of our partnership with Aptevo. This new IND also demonstrates our ability to bring innovative antibodies to the clinic" said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "This compound will now become Alligator’s third asset in clinical development. We are looking forward to initiating this Phase 1 first in human study in multiple solid tumors and further investigating the indications where it is most effective."

ALG.APV-527 is an antibody with dual function: tumor-binding and 4-1BB immunomodulatory agonist effects. This has the potential to be clinically important because 4-1BB has the ability to stimulate the immune cells (antitumor-specific T cells) involved in tumor control, making immune cell stimulation through 4-1BB a particularly compelling target for cancer immunotherapy. Preclinical results, presented at the Society of Immunotherapy Cancer’s 2021 Annual Meeting, highlighted the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in in vitro models.

The tumor-binding function of ALG.APV-527 targets the 5T4 tumor-associated antigen. 5T4 is a protein expression in multiple solid tumor types and limited expression in normal tissues, making 5T4 a compelling target molecule for cancer therapy.

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On September 19, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported the succession of its President and Chief Executive Officer, Ivor Royston, M.D. to Mark Rothera, who was appointed as President and CEO and member of the Board of Directors, effective today (Press release, Viracta Therapeutics, SEP 19, 2022, View Source [SID1234619644]). Dr. Royston will support the leadership transition and continue to serve as a member of the Board of Directors.

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"We are pleased to welcome Mark as Viracta’s new President and Chief Executive Officer, given his demonstrated strategic execution, deep commercialization experience and proven global leadership skills, as the Company advances Nana-val towards later-stage clinical development, marketing approval and important global strategic positioning," said Roger J. Pomerantz, M.D., F.A.C.P, Chairman of the Board of Directors at Viracta. "On behalf of the Viracta Board of Directors, we would like to thank Ivor for his visionary leadership in advancing a new and potentially disruptive modality in the treatment of Epstein-Barr virus-associated cancers, and look forward to his continued service on the Board."

"I am thrilled to be joining Viracta at this exciting time, as the company progresses Nana-val across multiple indications with the ambition of representing a tumor-agnostic approach to Epstein-Barr virus-associated cancers," said Mr. Rothera. "I appreciate the solid foundation Ivor has established at Viracta, the strong team that he has assembled and the opportunity to expand on the promising clinical data in EBV-positive lymphoma. I view this transition as a passing of the baton and look forward to leveraging my strategic and global commercial experience to optimally position Nana-val to help patients suffering from some of the most aggressive forms of cancer, whilst maintaining a clear focus on driving shareholder value."

Mr. Rothera brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of commercial and global leadership, including driving the successful build of multiple biotech companies, predominantly in the field of rare or specialty diseases. Prior to joining Viracta, Mr. Rothera served as President and CEO of Silence Therapeutics, a clinical-stage organization focused on developing RNA therapies for hematology, cardiovascular and rare diseases. He previously served as CEO of Orchard Therapeutics, where he oversaw its transformation from a small U.K.-based, privately held company with two clinical-stage programs into a leading gene therapy company with seven clinical-stage programs and fully integrated capabilities. During his tenure, Orchard Therapeutics secured more than $600 million in financing and grew from a market capitalization of $250 million to more than $1.7 billion at its peak. Prior to Orchard, Mr. Rothera served as Chief Commercial Officer of PTC Therapeutics, where he helped it evolve into a commercial company with a global footprint, including the successful launch of two rare disease therapies. Previously, he served as Global President of Aegerion Pharmaceuticals Inc. and Vice President and General Manager of commercial operations at Shire Human Genetic Therapies for Europe, Middle East and Africa. Mr. Rothera received an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

"As the Company progresses in its transition from development stage towards commercialization, Viracta will benefit from Mark’s over 30 years of global leadership experience in the biopharmaceutical industry, having driven the strategic advancement of multiple biotechnology companies from development stage to commercialization," stated Dr. Royston. "I am fortunate to have been involved in building a superb management team that will continue our vision of creating new therapies for virus-associated cancers. With this transition, I look forward to supporting the advancement of the Company as a Viracta board member and I am confident and excited about Viracta’s future under Mark’s leadership."

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma and gastric cancer.