On May 19, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Almirall S.A. (ALM), a global biopharmaceutical company focused on skin health, reported a multi-target alliance in Medical Dermatology (Press release, Evotec, MAY 19 , 2022, View Source [SID1234614843]). The companies aim to discover and develop novel therapeutics for severe skin diseases, including immune-mediated inflammatory conditions such as atopic dermatitis and non-melanoma skin cancer such as basal cell carcinoma.

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The alliance will leverage Evotec’s fully integrated multimodality platform and combine it with Almirall’s leading expertise in Medical Dermatology. Both partners will contribute drug targets in the research process. Leveraging the Company’s end-to-end integrated, AI/ML-driven EVOiR&D platform, Evotec will be responsible for drug discovery and pre-clinical development. Almirall will lead the clinical development and marketing.

Under the agreement, Evotec receives an undisclosed upfront payment, research payments, as well as success-based milestones of potentially up to € 230 m per programme and royalties on net sales in the high single-digit percentage range.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "We are very happy to enter this collaboration with Almirall, one of the leaders in the field of Medical Dermatology. The collaboration has the potential to deliver superior first-in-class therapeutic options for many patients suffering from severe skin diseases such as atopic dermatitis or basal cell carcinoma. We are looking forward to leveraging the complementary expertise of Evotec and Almirall in order to develop promising new drug candidates."

Dr Karl Ziegelbauer, Chief Scientific Officer of Almirall, stated: "We are very excited about the strategic alliance with Evotec and believe that combining Almirall’s experience and know-how in Medical Dermatology with Evotec’s integrated drug discovery and preclinical development small molecule platform will enable us to deliver novel solutions for patients suffering from auto-immune skin diseases or common forms of skin cancer."

On May 18, 2022 METiS reported officially joining the Roche Accelerator with the goal to tap into Roche’s global scientific expertise, laboratory facilities and foster collaboration discussions on formulation development and optimization with Roche Innovation Center Shanghai (Press release, METiS Therapeutics, MAY 18, 2022, View Source [SID1234648429]).

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"We are excited to become a member of the Roche Accelerator and to establish a closer connection with a global leader in healthcare like Roche," said Chris Lai, co-founder and CEO of METiS. "We look forward to testing METiS’ proprietary AiTEM platform together and exploring deeper collaboration opportunities to bring optimized therapeutics to patients around the world."

Traditionally, new drug molecules face many obstacles in drug development, including inadequate pharmacokinetic properties due to poor permeability and / or low solubility, which significantly affect their druggability. Tissue-specific delivery of nucleic acid-based medicines can be even more challenging, and it is critical to understand how drug molecular structures interact with excipients and nanomaterials, and the impact of physiological microenvironments on the physical and chemical properties.

The METiS platform, AiTEM, combines cutting-edge AI data-driven algorithms, mechanism-driven quantum mechanics and molecular dynamics simulations, to calculate Active Pharmaceutical Ingredient (API) properties, elucidate APItarget and API-excipient interactions, and predict chemical, physical and pharmacokinetic properties of small molecule and nucleic acid therapeutics in specific microenvironments, and screen for optimal formulations from tens of thousands of data points. This enables rapid and efficient candidate selection and formulation design, programmable nucleic acid drug development and its delivery design.

Dr. Qiusong Tang, Head of Roche Accelerator, said: "We have been witnessing digitalization and AI along the entire pharma R&D value chain, and I’m very glad to welcome METiS as the first Roche Accelerator portfolio start-up focusing on AI."

On May 18th, 2022, Inzen Therapeutics merged with Cygnal Therapeutics to create Sonata Therapeutics (Press release, Inzen Therapeutics, MAY 18, 2022, View Source [SID1234635157]).

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Despite the recognized importance of the microenvironment to biology and disease, the networks of its inputs, constituents, and targets have never been fully characterized or understood. Sonata’s product-platform creates drugs based on a systematic, comprehensive characterization of the microenvironment in diseases with high unmet medical need.

Through its pioneering science, Sonata identifies new targets for therapeutics that induce the release of a programmed diversity of signals that drive curative microenvironments. Sonata uses a combination of proprietary pharmacologic and genetic perturbations, high-throughput and co-culture assays, phenotypic analyses, and machine learning, to enable target discovery.

Sonata is generating a growing pipeline of small molecule drugs and genetic therapeutics. Currently, the company’s pipeline includes six preclinical programs that address a broad range of oncologic indications, as well as exploratory efforts in fibrosis and autoimmune disorders.

"Sonata is taking an exciting and innovative approach to unlocking the enormous value potential of the cellular microenvironment," said Doug Cole, M.D., Managing Partner at Flagship and Chairman of Sonata’s Board of Directors. "It has the scale, technology, and team to translate the longstanding promise of the microenvironment into therapeutics that help patients with serious diseases."

Sonata Therapeutics was formed by combining two Flagship companies, Inzen Therapeutics and Cygnal Therapeutics, and builds on each company’s pioneering work characterizing different inputs into the cellular microenvironment and their roles in causing disease, and developing therapeutic strategies based on these insights.

Noubar Afeyan, Ph.D., Flagship Pioneering Founder and CEO, added, "Flagship’s focus on pioneering breakthroughs in human health, is embodied in the groundbreaking work of both Inzen and Cygnal. As the companies grew and their science advanced, their shared vision to reprogram the cellular microenvironment became clear. Sonata combines the expertise, resources, and vision of both companies to build a single stronger entity."

Former Inzen Chief Executive Officer, Volker Herrmann, M.D., has taken on the role of Sonata’s CEO. Former Cygnal CEO, Pearl Huang, Ph.D., recently announced her departure from the company to pursue new opportunities.

Volker Herrmann, M.D., Sonata CEO and Flagship Pioneering CEO-Partner added, "Remodeling the microenvironment requires the simultaneous control of a diversity of signals. Sonata Therapeutics’ unique approach harnesses these signals to develop curative treatments for serious diseases. I look forward to overseeing and accelerating Sonata’s growth and its transformative approach to medicine."

On May 18, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceuticals company primarily focussed on the development of novel immune-oncology vaccines and drug delivery technologies, is pleased to reported the development of novel dual-acting AccumTM-linked protein vaccine, AccuVAC-PTE7, dedicated to protect from cervical cancer (prophylactic vaccine) or to treat (therapeutic vaccine) patients with pre-established cervical tumors (Press release, Defence Therapeutics, MAY 18, 2022, View Source [SID1234626249]).

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The protection from cervical cancer can currently only be achieved with the use of Gardasil-9 or Cervarix, two vaccines directed against the L1 proteins of HPV. However, there is currently no cure for patients with established cervical cancer and the clinical trials conducted previously with other companies with both the E6 and E7 proteins were highly disappointing.

Since the AccumTM molecule was previously shown to significantly enhance the immunogenicity of various proteins, the Defence team engineered a novel protein-based vaccine targeting the oncogenic protein E7 normally used by HPV to transform healthy cells into an outgrowing tumor. Pre-clinical studies conducted on this new vaccine, AccuVAC-PTE7, not only provide a 100% protection from cervical cancer if delivered prophylactically (e.g. before tumor growth), but also show potent anti-tumoral effects against established tumors when combined with various immunecheckpoint blockers such as anti-PD-1, anti-CTLA4 or anti-CD47.

"The idea of having a dual-acting vaccine targeting cervical cancer capable of both protecting and treating patients from cervical cancer is a giant step in the field of cancer vaccines. In addition, this vaccine contains a single protein, the E7, which makes it easier to manufacture and use compared to a mix of 9 proteins as provided by the Gardasil-9 product", says Mr. Plouffe, the CEO of Defence Therapeutics.

According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Bn in 2019 & is projected to reach $12.69 Bn by 2027, with a CAGR of 16.3%

On May 18, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually (Press release, Outlook Therapeutics, MAY 18, 2022, View Source [SID1234616060]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Tuesday, May 24, 2022, at 7:00 AM ET for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.