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Change in the number of shares and votes in BioInvent International AB

On February 26, 2021 BioInvent International AB (publ) (Nasdaq Stockholm: BINV) reported that the company’s total number of shares as per February 26, 2021 amounts to 42,210,495 shares, corresponding to an equal number of votes (Press release, BioInvent, FEB 26, 2021, View Source,c3296287 [SID1234575729]). The increase in the number of shares and votes results from the directed issue of MSEK 143 to Swedish and international institutional investors by issuance of 2,834,399 shares, announced on February 23, 2021.

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Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)

On February 26, 2021 Incyte (Nasdaq:INCY) reported the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy (Press release, Incyte, FEB 26, 2021, View Source [SID1234575694]). The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

"The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us closer to providing a new option for patients in Europe with this rarely studied tumor."

"While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us closer to providing a new option for patients in Europe with this rarely studied tumor."

The MAA is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy which were presented at the 2020 virtual ESMO (Free ESMO Whitepaper) Congress.

SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 In Europe, each year approximately 12,000 patients receive SCAC diagnosis.2 Patients with metastatic SCAC have a poor 5-year survival and there are no approved treatments for patients who progress on platinum therapy.3

About POD1UM-202

POD1UM-202 (NCT03597295) is a global, open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

For more information about the study, please visit View Source

About POD1UM

The POD1UM (PD1 Inhibitor Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 in SCAC along with and benchmarking studies in endometrial cancer, Merkel cell carcinoma and other solid tumors. A Phase 3 trial in NSCLC (POD1UM-304) is also enrolling, as are studies in combination with epacadostat, pemigatinib, and other development compounds in the Incyte portfolio.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell anal carcinoma (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of anal cancer, and the Biologics License Application for retifanlimab has been accepted for Priority Review.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

Scorpion Therapeutics Announces Leadership Change

On February 26, 2021 Scorpion Therapeutics reported that Dr. Adam Friedman, M.D., Ph.D., has been appointed Chief Executive Officer on an interim basis (Press release, Scorpion Therapeutics, FEB 26, 2021, View Source;utm_medium=rss&utm_campaign=scorpion-therapeutics-announces-leadership-change [SID1234575678]). The Board of Directors is currently evaluating candidates to lead the Company’s next phase of growth.

"I am humbled by the trust the Board has placed in me and honored to have an opportunity to lead this organization until a permanent CEO is identified," said Dr. Friedman. "Scorpion Therapeutics has strong momentum with its lead precision oncology programs, multiple discovery platforms, and proven leadership from its veteran R&D team."

Dr. Friedman was previously a Founder and Director at Raze Therapeutics and, together with Scorpion’s co-founder Keith Flaherty, founder of the oncology platform discovery company Vivid Biosciences, where he served as President and Chief Executive Officer.

Scorpion Therapeutics has secured $270 million in financing since it was founded in the first quarter of 2020, and will continue development of Scorpion’s drug hunting engine, which integrates state-of-the-art capabilities across multiple fields of translational medicine, chemical biology, medicinal chemistry, and data science, as well as the advancement of Scorpion’s growing portfolio, which includes several therapeutic candidates across a range of biological approaches for tumor targeting.

Kuano raises pre-seed funding

On February 25, 2021 Kuano reported that the o2h human health EIS Fund is leading a consortium of investors participating in a pre-seed round in order to establish proof of concept of our unique quantum modelling and AI-inspired drug discovery technology (Press release, Kuano, FEB 25, 2021, View Source [SID1234639047]). Our platform, which focuses on modelling the quantum transition state of the catalytic site of enzymes, brings a new perspective to designing better enzyme inhibitors. This approach overcomes key limitations of existing discovery technologies and enables us to develop drugs with improved potency and selectivity while minimizing susceptibility to resistance caused by mutations.

Kuano is establishing an early stage pipeline of inhibitors of attractive drug targets in areas such as protein degradation and immunometabolism. Simultaneously we are seeking collaborative deals with pharma and biotech to leverage our technology platform to develop novel inhibitors to challenging high value enzymes.

o2h Ventures has a track record of nurturing and investing in some of the most innovative early stage biotech companies in the UK. Joining o2h Ventures in this investment round is Meltwind, Syndicate Room and Cambridge Angels.

Dr. Vid Stojevic, Co-Founder CEO of Kuano, said:

o2h Ventures have been supportive over the last six months to develop our business model and also to identify high value drug targets. I am very excited to work with a fund with the deep expertise and network that o2h Ventures can bring in the biotech space.

Sunil Shah, CEO at o2h Ventures said:

We are very pleased to back Kuano in this venture. Being able to more accurately understand and predict subtle changes around enzyme’s active sites could unlock faster opportunities to push inhibitors for difficult drug targets through discovery and development. Vid and Dave using their knowledge of quantum physics and Parminder and Jarryl with their previous big pharma and biotech drug discovery experience make a great team to both develop the platform and advance the drug assets from this. I am very much looking forward to joining the board and supporting this venture.

ZENTALIS PHARMACEUTICALS AND TEMPUS ANNOUNCE STRATEGIC COLLABORATION TO ADVANCE RESEARCH AND DEVELOPMENT CAPABILITIES

On February 25, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) reported a strategic collaboration with Tempus to leverage the company’s patient-derived organoid biological modeling platform to strengthen Zentalis’ discovery and research capabilities (Press release, Zentalis Pharmaceuticals, FEB 25, 2021, View Source [SID1234598457]).

Zentalis CEO Anthony Sun commented, "We are thrilled to be entering into this collaboration with Tempus and its unique platform to help us discover and develop novel therapies aimed at a variety of cancers. This partnership provides Zentalis with access to Tempus’ one-of-a-kind resource to help validate our mechanistic discoveries, beginning with our WEE1 inhibitor, and ultimately to expand our growing product pipeline."

Tempus’ proprietary platform has the ability to grow and recapitulate tumors both genetically and functionally, some of which can be used for DNA repair profiling and research on potential therapeutic sensitivity. In harnessing Tempus’ cutting-edge approach, the collaboration will initially aim to validate Zentalis’ WEE1 inhibitor, ZN-c3, and its DNA damage response pathway in genetically distinct patient populations. The platform will also be used to investigate additional novel targets of cancer pathways that may be identified by Zentalis, as well as support the study of Zentalis’ current product candidates across various indications.

"We believe that our library of patient-derived organoids is well positioned to better identify patient populations that could benefit from Zentalis’ WEE1 inhibitor, ZN-c3," said Marc Yoskowitz, Chief Strategy Officer of Tempus. "We look forward to applying the full potential of our platform to address the ever-increasing unmet needs of cancer patients."

Zentalis retains full ownership of its therapeutic candidates.

About ZN-c3

ZN-c3 is an oral inhibitor of WEE1 in development for the treatment of advanced solid tumors. The inhibition of WEE1, a DNA damage response protein, aims to generate sufficient DNA damage in cancer cells, causing cell death, thereby preventing tumor growth and potentially causing tumor regression. Zentalis is currently conducting a Phase 1/2 clinical trial in patients with advanced solid tumors and expects to report data from the Phase 1 portion at the AACR (Free AACR Whitepaper) Annual Meeting 2021. In addition, the Company is also conducting a Phase 1b trial evaluating ZN-c3 in combination with chemotherapy in patients with advanced ovarian cancer, with plans to initiate a Phase 2 trial investigating ZN-c3 as a monotherapy in patients with uterine serous carcinoma in 2021.