On June 29, 2021 IONTAS Limited (IONTAS), a leader in the discovery and optimization of fully human antibodies, reported that F-star Therapeutics, Inc. (NASDAQ: FSTX), has dosed the first patients in a Phase 1 clinical trial, with FS222, a CD137/PD-L1 bispecific antibody.

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IONTAS applied its proprietary technology to generate a component utilized within FS222, which was subsequently licenced to F-star. The initiation of this trial adds to the growing portfolio of antibodies generated by IONTAS that are entering clinical trials.

António Parada, CEO at IONTAS, commented: "We are delighted with the progress of this molecule, the platform offered by F-star taps into the growing number of bispecific antibodies entering the clinic and we are proud to be part of this movement. We wish F-star every success with the clinical trial and hope this can be the foundation of an effective cancer treatment."

On June 29, 2021 European Organisation for Research and Treatment of Cancer (EORTC) and Pierre Fabre reported a strategic partnership in support of patients with resected Stage 2 BRAF-mutant melanoma (Press release, EORTC, JUN 29, 2021, View Source [SID1234584439]). The partnership includes the planning, design and execution of a large Phase 3 study investigating the use of BRAF and MEK targeted therapies to reduce the risk of relapse in this patient population, currently under approval with authorities.

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"Sadly, still today too many patients with Stage 2 melanoma have their cancer come back, even after their tumour is removed. Further understanding how effective treatments can have an impact on recurrence is essential," said Dr Denis Lacombe, CEO of EORTC. "We are pleased to collaborate with Pierre Fabre who bring strong heritage and expertise in this therapeutic area, to make a true difference to people living with Stage 2 melanoma."

"Collaboration between Pierre Fabre and EORTC is the perfect match between our medical and clinical capabilities and a leading global network in oncology research. Our strong complementary expertise have potential to transform patient care in melanoma", said Dr Deborah Szafir, EVP, Head of Medical and Patient Centricity Division at Pierre Fabre. "Our strategic partnership on a pioneering Phase 3 study confirms Pierre Fabre’s R&D commitment to oncology and particularly in skin cancers. Through our growing expertise in BRAF and MEK inhibitors, we aim to strengthen our support for patients with skin cancers."

Pierre Fabre has a long-standing commitment to the melanoma community and takes a unique holistic approach to skin health through combined expertise in oncology, dermatology, and dermo-cosmetics. EORTC, a network uniting 2,800 clinical cancer research experts across the globe, shares Pierre Fabre’s commitment to improving the standard of cancer treatment for patients.

About Melanoma

Melanoma develops when unrepaired DNA damage to skin cells triggers mutations that may lead them to multiply and form malignant tumours.1 There are about 324,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma.2,3,4 By 2025, cases are expected to increase to over 340,000.5

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.

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.

On June 29, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology that enables antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the signing of a non-exclusive, target-specific license agreement with Innovent Biologics Inc., a leading biopharmaceutical company developing innovative medicines for the treatment of major diseases (Press release, Synaffix, JUN 29, 2021, View Source [SID1234584408]).

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Under the terms of the agreement, Synaffix will provide all the necessary proprietary ADC technologies including GlycoConnect, HydraSpace and one of its toxSYN linker-payloads, to enable Innovent to rapidly progress one of its antibodies as a best-in-class ADC candidate. The deal is the culmination of a successful initial proof-of-concept research period between the companies.

Upon signature, Innovent is granted the rights to deploy the above ADC technologies for one therapeutic molecule. Innovent will be responsible for the research, development, manufacturing and commercialization of the ADC product. Synaffix will closely support Innovent’s research activities and will be responsible for manufacturing components that are specifically related to its proprietary technologies.

Synaffix is eligible to receive an upfront payment, milestone payments related to certain development and sales performance achievements, as well as royalties on potential future commercial sales of the ADC product­­.

Dr. Yongjun Liu, President of Innovent said:

"We are excited to collaborate with Synaffix as Innovent is expanding its pipeline into the ADC space. Our collaboration with Synaffix adds a promising new ADC candidate to our preclinical pipeline through leveraging Synaffix’s validated, differentiated and innovative ADC technology platform and Innovent’s strong antibody capabilities. Based on Synaffix’s seamless partnering model, we could rapidly combine Synaffix’s ADC technologies with Innovent’s antibody, generate compelling research data and keep moving the project ahead swiftly."

Peter van de Sande, CEO of Synaffix said:

"This is the fourth commercial licensing deal that illustrates the potential of the Synaffix platform to increase the competitive position of our partners within the ADC space. Innovent is an ideal partner for Synaffix due to its strategic focus on innovative medicines and strong R&D capability for high quality biologic drugs. We look forward to working closely together on this exciting development program."

"Central to enhancing our value proposition has been the addition of multiple new proprietary linker-payloads to our ADC technology portfolio. In addition to our well-understood, clinical-stage technologies, GlycoConnect and HydraSpace, our proprietary toxSYN linker-payload platform facilitates any company with an antibody to develop its own highly-competitive ADC."