Introducing Bioneer’s new R&D programs for 2021-2024

On June 29, 2021 Bioneer reported that has initiated two very exciting and ambitious R&D programs that during the next four years will strengthen our capabilities and service solutions that we offer to life science companies (Press release, Bioneer, JUN 29, 2021, View Source [SID1234584838]). We look forward to seeing our R&D organization move these programs forward and be able to assist a broad range of companies with the best services that can contribute to new therapies and medicines.
The first program within "In Vitro Modelling" aims at developing a new generation of in vitro models within CNS, immunology, cancer and the gastro-intestinal system. Our ambition is to develop the best-in-class in vitro models matching the industry needs where especially the CNS track will take us into the area of screening and automation. We are also excited to enter the fast-moving field of Artificial Intelligence that we will couple to our new generation of in vitro models.

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The other R&D program within "Early Stage Development of Drug Candidates" will further strengthen our ambition to assist companies from "gene to protein" and with peptide and small molecule development. This ambitious program will move our capabilities in the field of recombinant protein manufacturing to a new level both in terms of production efficiency and the ability to complete CMO transfers. We also look into the exciting world of peptides, where we will use our strong formulation competences to strengthen the service offering.

Bioneer encourages companies, universities and hospitals to contact us. If you would like to know more about the R&D programs, learn how you could benefit from the development activities, or would like to collaborate on one of the topics, feel free to contact CSO Christian Clausen (e-mail).

Vivoryon Therapeutics and Simcere Announce Strategic Regional Licensing Partnership to Develop and Commercialize N3pE Amyloid-targeting Medicines to Treat Alzheimer’s Disease in Greater China

On June 29, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines and Simcere Pharmaceutical Group Ltd (HKEX: 2096) (Simcere) reported that they have entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer’s disease (AD) in Greater China (Press release, Vivoryon Therapeutics, JUN 29, 2021, View Source [SID1234584410]).

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The agreement grants Simcere a regional license to develop and commercialize varoglutamstat (PQ912), Vivoryon’s Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company’s preclinical monoclonal N3pE-antibody PBD-C06 in the Greater China region.

QPCT is an enzyme responsible for the formation of N3pE amyloid, a neurotoxic molecule that is not found in healthy individuals and has been identified as a driver of AD pathology. N3pE amyloid is not only implicated in Abeta peptides aggregating into plaques which are widely observed in AD patients, but also has a negative impact on other pathologies that underly the disease, including tau pathology, neuroinflammation, and impairment of synaptic function. By inhibiting QPCT and thus preventing the formation of toxic N3pE amyloid, varoglutamstat acts very early in disease pathogenesis and thereby has the potential to prevent neuronal damage.

Vivoryon’s monoclonal N3pE-antibody PBD-C06 is specifically designed to bind to and remove neurotoxic N3pE amyloid from the brain and has been optimized with respect to low immunogenicity and low potency to induce amyloid-related imaging abnormalities (ARIAs), a major side effect in antibody-based AD therapies.

Under the terms of the agreement, Vivoryon will receive an undisclosed upfront payment and will also be eligible for payments upon achievement of certain development and sales milestones, with all components amounting to a total of over US$565 M. In addition, Vivoryon will receive double-digit royalties on sales. Further financial details were not disclosed.

Pursuant to the agreement, Simcere will be responsible for clinical development of varoglutamstat in patients with early AD in China. The clinical development program in Greater China is intended to be complementary to Vivoryon’s efforts in Europe and the US including Vivoryon’s ongoing European VIVIAD Phase 2b trial as well as the Company’s planned Phase 2a/b study in the US, which is anticipated to start in the second half of this year. Simcere has also acquired an option to advance PBD-C06, an antibody that specifically targets N3pE amyloid, towards clinical development.

"This regional partnership represents an important milestone on our journey to bringing novel therapeutic options to as many patients suffering from Alzheimer’s disease as possible," commented Michael Schaeffer, PhD, Vivoryon’s Chief Business Officer. "With prevalence rising in China, AD is already a heavy burden on patients, families and the country’s healthcare system. In partnering with Simcere, who is continuously recognized as one of the top innovative pharmaceutical and manufacturing enterprises in China, we hope to be able to make an impact beyond our own focus of developing varoglutamstat towards the markets in Europe and the US."

"We are extremely pleased to have entered into this agreement with Vivoryon to leverage the potential of innovative N3pE amyloid-targeting agents to treat Alzheimer’s disease in Greater China," added Kevin Oliver, PhD, Senior Vice President and Head of Global Business Development at Simcere. "Both partners are clearly committed to delivering meaningful therapies to AD patients in need, in line with Simcere’s mission of providing today’s patients with medicines of the future."

About varoglutamstat (PQ912)

Varoglutamstat is an orally administered small molecule inhibitor of glutaminyl cyclase (QPCT), an enzyme which catalyzes the formation of N3pE amyloid, a particularly neurotoxic molecule not found in healthy individuals that has been identified as a driver of Alzheimer’s disease (AD). N3pE amyloid triggers a number of pathological processes in AD, including the formation of toxic soluble Abeta oligomers, tau pathology, neuroinflammation, and impairment of synaptic function. By preventing formation of this toxic molecule, varoglutamstat acts very early in disease pathogenesis and thus has the potential to prevent neuronal damage. Varoglutamstat is currently in Phase 2 clinical development.

About PBD-C06

PBD-C06 is a preclinical stage humanized and de-immunized IgG1 antibody specifically designed to bind to and remove neurotoxic N3pE amyloid from the brain. The antibody is optimized with respect to low immunogenicity and low potency to induce amyloid-related imaging abnormalities (ARIAs), which represent the major severe side effects of antibody-based AD therapies.

Oncoinvent Secures NOK 250 M in an oversubscribed Pre-IPO Funding Round

On June 29, 2021 Norway Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that the company has raised NOK 250 million in an oversubscribed pre-IPO financing round syndicated by existing investors Hadean Ventures, Geveran, RADFORSK Investeringsstiftelse, Sundt, Must Invest, Canica, MP Pensjon and Watrium. The net proceeds from the Private Placement are expected to ensure financing past end of 2023 for its lead product candidate Radspherin, including financing of two clinical phase 2A studies (in ovarian cancer and colorectal cancer) as well as the advancement of the company’s proprietary targeted radiotherapy candidates. Oncoinvent has raised a total of NOK 535 million to date. The closing marks the last round of planned funding before Oncoinvent goes to its contemplated initial public offering (IPO) which the intends to carry out in the coming twelve months.

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"We are pleased by the response to our private placement offering from both new investors and those who had previously invested in the company," said Jan A. Alfheim, Oncoinvent CEO. "The demand was such that we increased the placement from NOK 200 million to NOK 250 million. The additional funding will allow the company to initiate preclinical development of our proprietary antibodies OI-1 and OI-3 in order to develop our pipeline of targeted radiotherapeutics one year earlier than planned."

Roy H. Larsen, Board Chair stated, "We are pleased to secure financing for developing Oncoinvent further and we thank our existing shareholders and new investors for their strong support."

Ingrid Teigland Akay, Managing Partner of Hadean Ventures and board member of Oncoinvent commented: "The strong demand from investors reflects both the growing interest we see in the radiopharmaceutical space, as well as the conviction in the Oncoinvent management, which has demonstrated the ability to execute on their strategy. We are pleased with the outcome of this financing round, enabling the next stage of the lead asset and an accelerated plan for the pipeline."

The Company intends to carry out a repair offering of up to 961,538 new shares at the same subscription price towards shareholders in the Company as of the 25th June 2021 (as registered in VPS on the 29th June 2021), who were not allocated shares in the Private Placement.

Portage Biotech Added to Russell 2000® Index

On June 29, 2021 Portage Biotech Inc., (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies targeting cancer treatment resistance, reported that the Company has been added to the Russell 2000 Index at the conclusion of the 2021 Russell Indexes annual reconstitution, effective after the U.S. market opened on June 28 (Press release, Portage Biotech, JUN 29, 2021, View Source [SID1234584460]).

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"Inclusion in the Russell 2000 index marks another key milestone for Portage, recognizing the significant steps we’ve taken over the past year to transform the company and position it to create value for shareholders," said Dr. Ian Walters, chief executive officer of Portage Biotech. "In conjunction with the recent public offering in late June 2021, inclusion in the Russell 2000 brings added visibility to our robust pipeline and the multiple data readouts we expect over the next 12-24 months. This increased visibility has enabled us to gain the confidence of fundamental biotech investors in our unique forward-looking business model and secure capital runway to advance first-in-class immuno-oncology therapies such as our invariant natural killer T cells ("iNKTs") through Phase 1/2 clinical trials. We look forward to further engaging with a growing investor base about the compelling opportunities we are developing."

Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider.

FTSE Russell determines membership for its Russell Indexes primarily by objective, marketcapitalization rankings and style attributes. Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, ranking them by total market capitalization.

For more information on the Russell 2000 Index and the Russell indexes reconstitution, visit the "Russell Reconstitution" section on the FTSE Russell website.

Boston Children’s Hospital and ElevateBio Announce Five-Year Cell and Gene Therapy Collaboration

On June 29, 2021 Boston Children’s Hospital, which has the largest National Institutes of Health-funded pediatric research enterprise in the United States, and ElevateBio, a cell and gene therapy technology company focused on powering transformative cell and gene therapies, reported that they have entered into a five-year collaborative agreement to advance cell and gene therapy programs originating out of Boston Children’s Hospital with an introduction to Boston Children’s translational research capabilities.

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The agreement enables Boston Children’s and ElevateBio to form multiple cell and gene therapy companies together; provides Boston Children’s researchers access to ElevateBio’s core-enabling technologies, manufacturing, and leading expertise to advance their programs; and will guarantee Boston Children’s researchers dedicated viral-vector manufacturing space at ElevateBio BaseCamp, ElevateBio’s centralized world-class research and development manufacturing center. In addition, under this agreement, ElevateBio will commit to sponsored research agreements with Boston Children’s investigators as part of the company formation process.

"At Boston Children’s Hospital, we are proud of the foundation we’ve established as a leading innovator in cell and gene therapy, so collaborating with ElevateBio – a company so well-positioned to change the face of cell and gene therapy forever – is a natural fit into our overall vision," said David Williams, M.D., formerly Senior Vice President for Research and Chief Scientific Officer, currently Chief of Hematology / Oncology, Boston Children’s Hospital. "Using ElevateBio’s world-class enabling technologies, this alliance will help catalyze the science being conducted in the labs across Boston Children’s, moving potential treatments into the clinic and accelerating the development of multiple cell and gene therapy platforms."

"Boston Children’s Hospital is committed to accelerating the translation of our research into treatments that will improve patients’ lives," said Irene Abrams, Vice President of Technology Development and New Ventures, Boston Children’s Hospital. "and this relationship with ElevateBio is a key part of that effort."

"At ElevateBio, we have built unique end-to-end capabilities that leverage our suite of enabling technologies, technologic know-how, and world-class expertise to advance our own innovative cell and gene therapies as well as accelerate those of industry and academic collaborators," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "Boston Children’s Hospital has a strong history of innovation in the cell and gene therapy sector through ground-breaking science and spinning out companies to deliver medicines to patients. Through this collaboration, we’re excited to work with the team at Boston Children’s to form new companies, the first of which we’ve identified and will announce later this year, and also enable access to our cutting-edge viral vector manufacturing facilities that will help Boston Children’s researchers move their therapies through development more efficiently."