On January 13, 2021 IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win technology, reported that it has raised EUR 127 million in Series B financing (Press release, IO Biotech, JAN 13, 2021, View Source [SID1234573924]). The financing round was led by HBM Healthcare Investments, and other new investors joining the round included Vivo Capital, Kurma Partners, Avoro Capital, RA Capital Management, Samsara Biocapital, Idinvest Partners1, PFM Health Sciences, Soleus Capital, Eir Ventures and Serrado Capital, with the participation of existing investors Novo Seeds, Lundbeckfonden Emerge and Sunstone Life Science Ventures. Additionally, Dr. Priyanka Belawat of HBM Partners, Jack B. Nielsen of Vivo Capital and Vanessa Malier of Kurma Partners will join IO Biotech’s board of directors as part of the closing of the financing.

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On December 15, 2020, the U.S. Food and Drug Administration (FDA) granted IO Biotech breakthrough therapy designation for a combination of the potential therapies IO102 and IO103 with anti-PD-1 monoclonal antibodies for patients with unresectable or metastatic melanoma. IO Biotech intends to use the net proceeds of the transaction towards the funding of clinical trials for its early and late-stage immuno-oncology programs, including a large randomized trial for IO102 and IO103 with anti-PD-1 monoclonal antibodies in metastatic melanoma.

"We are excited to have such a strong group of investors backing our company at this stage, and I am proud that this financing round had such high interest and can close oversubscribed," said Mai-Britt Zocca, PhD, Chief Executive Officer, and founder of IO Biotech. "The funding will enable us to execute on our breakthrough therapy designation grant and advance our lead programs in late-stage clinical development, as we are committed to bringing our treatment to patients as soon as possible."

"HBM is excited to be joining IO Biotech as a shareholder. IO Biotech offers a unique treatment modality in oncology, harnessing novel immunomodulatory mechanisms through proprietary vaccine candidates. The financing will help the company bring forward its promising clinical and pre-clinical pipeline closer to the patients in medical need," said Dr. Priyanka Belawat, Investment Advisor at HBM Partners.

"IO Biotech is building a significant immunotherapy pipeline based on compelling scientific and clinical validation. On behalf of existing investors, I warmly welcome the new investors to the company," said Christian Elling, Managing Partner at Lundbeckfonden Emerge. "Together we can accelerate the development of the company’s unique breakthrough cancer medicines to the benefit of patients and physicians."

About IO102 and IO103
IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy designation was based on data from the MM1636 Phase 1/2 clinical trial of 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1 monoclonal antibodies. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.

On January 13, 2021 Taiho Pharmaceutical Co, Ltd., (hereinafter Taiho) reported that it and Astex Pharmaceuticals (UK), (hereinafter Astex), both Otsuka group companies, have granted an exclusive license under their joint, small-molecule drug discovery program targeting SHP2 to Merck & Co., Inc., Kenilworth, NJ, USA, known as MSD outside the United States and Canada (hereinafter MSD) through a subsidiary (Press release, Taiho, JAN 13, 2021, View Source [SID1234573914]).

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An option for MSD to acquire the exclusive license to the Astex-Taiho SHP2 program was included as part of the strategic oncology collaboration between MSD, Astex and Taiho, announced in January 2020. The collaboration focuses on the discovery and development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.

SHP2, a dephosphorylating enzyme, is a signaling molecule which regulates various cellular processes including cell proliferation and differentiation, and acts as a regulator in the activation of the RAS signaling pathway such as KRAS.*1

"We are delighted to have extended the breadth of our strategic oncology collaboration with MSD to encompass assets from the joint Astex-Taiho SHP2 program", said Teruhiro Utsugi, Ph.D., managing director at Taiho. "This will allow for a number of important drug-drug combinations to be explored as potential new treatment modalities for patients."

In exchange for providing MSD with an exclusive global license to their small molecule SHP2 inhibitor candidates, Taiho and Astex will receive an option-exercise fee payment and will be eligible to receive further undisclosed payments contingent upon the achievement of clinical, regulatory and sales milestones for SHP2 products, as well as tiered royalties on sales. MSD will be solely responsible for funding all further research and development and will be responsible for commercialization of SHP2 products globally. Taiho has retained co-commercialization rights in Japan and an option to promote SHP2 products in specific areas of Southeast Asia.

"We are pleased with the discovery research progress and collaboration with Taiho and Astex as we seek to develop new small molecule candidates for the treatment of cancer," said Nick Haining, vice president, Discovery Oncology and Immunology, MSD Research Laboratories. "We look forward to working more extensively with Taiho and Astex on the SHP2 pathway and accelerating this promising research which has the potential to impact a number of cancer types."

Harren Jhoti, Ph.D., president and CEO of Astex Pharmaceuticals (UK), commented,

"Together with our Taiho colleagues, we are delighted to extend our strategic alliance with MSD to include assets from our joint SHP2 program that have been generated using our leading fragment-based drug discovery approach."

On January 13, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported that it has entered into a research collaboration for molecular targeted radiotherapies with Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM, Chief Executive Officer and Chairman of the Board: Sandesh Seth, "Actinium") (Press release, Astellas, JAN 13, 2021, View Source [SID1234573913]). This collaboration is a component of Astellas’ initiative to develop "theranostics" as part of its Rx+ business1.

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Theranostics is a combined term of "therapeutics" and "diagnostics", defined as a treatment protocol or concept in which healthcare professionals assess lesion sites and simultaneously determine the appropriate treatment for each patient2. Through utilization of a diagnostic agent developed in parallel with a therapeutic agent that shares the same target, it may be possible to identify patients in advance who would benefit from the treatment. This approach may help healthcare professionals provide more efficient and effective treatment.

In this collaboration, the potential therapeutic effect will be assessed by combining certain targeted oncology drugs that were discovered by Astellas based on its drug discovery capabilities cultivated thus far with Actinium’s nuclear medicine technology which utilizes an alpha particle-emitting radioisotope3 (Actinium-225). Astellas is already conducting pre-clinical trials of the diagnostic agents on the target　molecule．When a promising therapeutic drug candidate is identified in the course of this collaboration, clinical trials for the theranostics may be initiated.

Through its Rx+ business, Astellas aims to realize a society where people can live in their own way, both physically and mentally through scientifically based on scientific evidence. Astellas aims to optimize therapeutic approach by improving diagnostic and surgical accuracy and maximize patient outcomes. The development of theranostics that integrates diagnostics and therapeutics is part of this effort.

Astellas has already reflected the impact from this collaboration in its financial forecast of the current fiscal year ending March 31, 2021.

On January 12, 2021 PharmEnable reported that the company has entered a new partnership with Sosei Heptares (Press release, PharmEnable, JAN 12, 2021, View Source [SID1234641050]). This collaboration will drive a novel drug discovery programme against a challenging G protein-coupled receptor (GPCR) target, which is associated with neurological disease.

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Sosei Heptares is an international biopharmaceutical group, focused on the discovery and early development of new medicines originating from their world-leading GPCR-targeted StaR technology and structure-based drug design platform capabilities.

Miles Congreve, Chief Scientific Officer of Sosei Heptares, said: "We have been very impressed with PharmEnable’s technology and approach, which we believe to be highly complementary to our own, offering important synergies for drug discovery on challenging GPCR targets. We are excited to apply these technologies on a peptidergic GPCR target that has proved particularly difficult to drug. We have so far assembled a wealth of structural and ligand-binding information on the target and created several promising molecules but have yet to identify compounds with sufficiently desirable neurological drug-like properties to advance into preclinical studies. Combining our respective technologies and expertise may be the key that unlocks this target and enables the identification of higher quality molecules to progress into preclinical development."

Dr Hannah Sore, Founder and CEO of PharmEnable, commented: "We are excited to partner with Sosei Heptares on this challenging and complex GPCR target. We have proven the strength of our platform in tapping unexplored parts of the chemical universe to find novel and specific hits for currently undruggable targets. Combining our platform with the technology and structural insights developed by Sosei Heptares should enable us to generate several potential hits, and to establish our pipeline of candidate molecules for the treatment of challenging diseases.".

The collaboration will enhance innovation and development of the next generation of small molecule drugs against the particularly difficult GPCR target. PharmEnable is excited to begin this collaborative project and look forward to working closely with Sosei Heptares.

On January 12, 2021 Almac Sciences, a member of the Almac Group, reported that it has secured £2million of support from Invest Northern Ireland (INI) to accelerate a programme of enzyme research (Press release, Almac, JAN 12, 2021, View Source [SID1234575424]).

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Almac Sciences had previously established a cutting-edge biotechnology platform for enzyme chemistry and biology through two successfully completed rounds of R&D investment supported by Invest NI. This investment in R&D, awarded by INI and supported by the European Regional Development Fund, will further develop the program to establish IN Silico Informed metaGenomic Harvesting Technology (INSIGHT), a platform built from multi-disciplinary research bringing together computational, metagenomics, biology and chemistry methodologies.

Routes of synthesis for most drugs are amenable to biocatalytic intervention. The INSIGHT project aims to improve the enzyme discovery process to allow more robust enzymes to supersede multi-step chemical routes currently used to produce pharmaceutical intermediates and products.

The unique project involves the development of an enzyme identification platform based around the exploitation of Almac’s existing metagenomic data mining using enzyme modelling / engineered lead diversity screening married with the company’s strength on industrial focus. This combination approach has never been developed to accelerate enzyme discovery and their subsequent application in the past and is a significant research and development programme.

This new technology will bring significant benefit to, not only Almac, but also to the wider pharmaceutical industry as it will offer simpler, lower cost and less polluting enzymatic processes. Specifically, INSIGHT will deliver new, best-in-class metagenomics, computational and engineering platforms for the pharmaceutical, biotechnology, life sciences and fine chemicals sectors.

Dr Stefan Mix, Almac Sciences’ Head of Biocatalysis, will lead a team of experts to complete the project and deliver the foundations for future commercialisation. The INSIGHT project will span six work packages which will run over 36 months once recruitment has been secured.

Professor Tom Moody, VP Technology Development and Commercialisation, Almac Sciences and Arran Chemical Company commented: "This project, and the related INI support, will be vital to ensure we can achieve our aspiration of becoming a global leader in biotechnology. The ambitious project will bring together each of the critical elements to accelerate enzyme identification and discovery and will de-risk the enzyme development pipelines for Almac. As a result of this unique project there will be both major academic and commercial benefits, providing significant growth opportunity for the NI Bio-economy and the wider economy."

Welcoming the investment, Kevin Holland, CEO of Invest NI said: "Almac has long been one of Northern Ireland’s most successful companies within our thriving life & health sciences sector and has worked hard to build an impressive global reputation for ground-breaking work in the global pharmaceutical industry. It recognises the benefits of investing in cutting edge R&D and is making this new investment to build upon the foundations from previous R&D and capital investment over the last number of years.

"Invest NI has developed a strong collaborative partnership with Almac over the years, offering support for job creation and highly successful R&D projects. Our £2million ERDF funded offer of support for this new investment will further cement the company’s world-renowned reputation and enable it to expand its biocatalysis capability creating a new, greener and more cost-effective solution to industry. The development of this new technology enhances Northern Ireland’s global reputation in the field."

Invest NI’s R&D support is part financed by the European Regional Development Fund under the EU investment for Growth and Jobs Programme 2014-2020.