GenScript Launches Neoantigen Specific Peptide Synthesis Service for Precision Immuno-oncology Therapeutic Development

On April 1, 2020 GenScript, a world leading biotechnology company, reported the commercial launch of its neoantigen peptide synthesis service for biotech and pharma companies developing personalized cancer therapeutics (Press release, GenScript, APR 1, 2020, View Source [SID1234556082]). The service builds on GenScript’s work over the past year producing 2,500 highly difficult neoantigen peptides for more than 50 of the world’s leading immuno-oncology companies.

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Unlike traditional targets such as tumor-associated antigens, neoantigens are novel peptides only present within tumor cells and not in healthy tissue. Because of this, neoantigen-based immunotherapy stimulates stronger anti-tumor immune responses with fewer negative and off target effects than other immunotherapies. When generating personalized cancer vaccines or T-cell therapies, neoantigen peptides are critical for in-vitro functionality screening, pre-clinical safety analysis, and post-clinical efficacy screening; however, manufacturing these peptides is very challenging due to extreme hydrophobicity and other physiochemical properties.

GenScript partnered with several T-cell therapy and personalized cancer vaccine companies to develop the infrastructure to reliably manufacture difficult peptides for its neoantigen peptide synthesis platform. This effort resulted in several successful projects, most recently Avidea Technologies’ SNAP vaccine platform, as reported in Nature Biotechnology, as well as a collaboration involving 3T Biosciences’ proprietary T-cell therapy screening platform.

"3T Biosciences has been working with GenScript since 2017 to generate thousands of peptides to understand how T-cell receptors recognize their targets. With that information we can better understand how to identify novel targets in solid tumors and generate safe and effective T-cell receptors," said Marvin Gee, Ph.D., 3T Biosciences’ co-Founder and Head of Target Discovery. "The 3T technology is multi-faceted due to the ability to uncover specificities in any T-cell- mediated disease, covering not only oncology but also allergy, inflammation, autoimmune disease, and infection, which is pertinent for the ongoing situation with COVID-19."

GenScript has been synthesizing peptides for more than 15 years, successfully delivering over 600,000 high-quality peptides – a 98 percent delivery rate – to more than 10,000 scientists worldwide. The company has developed multiple innovative synthesis technologies, including its patented NeoPreTM neoantigen synthesis prediction algorithm. The algorithm is applied during neoantigen peptide synthesis to analyze a peptide’s physiochemical properties (hydrophobicity, charge, aggregation potential, etc.) in order to determine which of GenScript’s technologies provides the highest chance of successful synthesis. From there, highly skilled GenScript scientists synthesize each peptide through the recommended methodology, ranging from automated microwave technology for fast turn-around time to manual liquid phase technology for difficult to purify peptides with high yields.

"GenScript is committed to developing innovative new synthesis platforms and bioinformatics tools to help our customers bring safe and effective life-saving treatments to patients more quickly and efficiently," said Xin Zhang, GenScript Biotech’s associate director of peptide services. "Neoantigen peptide synthesis is significantly challenging, but by leveraging our microwave, solid, and liquid phase synthesis platforms along with our new NeoPreTM production algorithm, we are able to consistently produce difficult peptides for cancer research and drug development."

Peptide production is guided by the diverse needs of each project, including number of peptides, yields, turnaround time, specialized quality control requirements, and pooling. GenScript’s flexible approach allows for customization in ways that traditional GMP providers find difficult. For example, groups developing personalized cancer vaccines will often initially require large libraries of micro-scale peptides for functional validation of neoantigen candidates. Once identified, these neoantigen peptides will then need to be produced at large yields with extremely high purity in order to generate vaccine prototypes for animal studies.

GenScript’s service also includes stage-specific tools and a library design program, which assists customers in creating their own peptide libraries. Currently, GenScript offers seven different types of libraries, including alanine scanning, overlapping, and T-cell truncation to help customers optimize the safety and efficacy of their neoantigen therapeutics.

iTeos Therapeutics Closes $125 Million Series B2 Financing

On April 1, 2020 iTeos Therapeutics Inc., a privately-held clinical-stage biotechnology company developing innovative cancer immunotherapies, reported the closing of an oversubscribed Series B2 financing, which raised a total of $125 million (Press release, iTeos Therapeutics, APR 1, 2020, View Source [SID1234556067])

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The Series B2 financing round was co-led by RA Capital Management and Boxer Capital, and included new investors Janus Henderson Investors, RTW Investments and Invus along with existing investors MPM Capital, HBM Partners, 6 Dimensions Capital, Curative Ventures, Fund+, VIVES Louvain Technology Fund, SRIW, and SFPI.

Proceeds from the financing will support the Company’s continued growth and advance the clinical development of its two lead product candidates, EOS-850, a best-in-class adenosine A2A receptor antagonist and EOS-448, an ADCC-enabled anti-TIGIT antibody. EOS-850 is currently being evaluated in a Phase 1/2 clinical trial both as a single agent and in combination in several solid tumor indications. The Company plans to initiate dosing for the combination cohorts for this trial in the second quarter of 2020. The Company also recently initiated the Phase 1 portion of a Phase 1/2 clinical study of EOS-448, currently being evaluated in patients with solid tumors and hematological malignancies. Proceeds from this financing will also support the advancement of additional first-in-class preclinical programs targeting the adenosine pathway and Tregs.

"We are very pleased to have the strong support of this leading class of investors who share our excitement for the highly innovative oncology therapies we have developed at iTeos," said Michel Detheux, PhD, President and Chief Executive Officer at iTeos. "We look forward to accelerating and expanding our clinical development efforts to identify the most promising indications and combinations for people suffering with cancer. This financing maximizes our ability to execute our development plans alone or in partnership."

"iTeos’ pipeline of best-in-class agents has the potential to usher in a new wave of immuno-oncology therapeutics and the Company is well-positioned to make a significant, positive impact in the treatment of patients with a wide variety of cancer types," commented Derek DiRocco, Principal, RA Capital Management. "We are thrilled to collaborate with this experienced group of high-quality investors and partner with the iTeos management team as they continue to innovate and progress these exciting programs through clinical development."

"The iTeos team has done a remarkable job developing a pipeline of differentiated, potentially best-in-class cancer therapies," said Aaron Davis, Co-Founder and Chief Executive Officer, Boxer Capital of the Tavistock Group. "We are pleased to be joining them as they continue to execute and implement their vision for transforming the cancer treatment landscape."

Derek DiRocco and Aaron Davis will join the iTeos Board as Non-Executive Directors.

Stamford Pharmaceuticals Inc Announces Clinical Collaboration with Roche

On April 1, 2020 Stamford pharmaceuticals a clinical stage immunology and inflammation focused company developing novel combination therapies for cancers, reported a clinical collaboration with Roche (SIX:RO, ROG) to explore SP-002 (formerly ASN-002/TG1042), Stamford’s adenoviral vector immunotherapy, in combination with Roche’s vismodegib (Erivedge), a Hedgehog Pathway inhibitor approved for the treatment of adult patients presenting with locally advanced and metastatic basal cell carcinoma (Press release, Ascend Biopharmaceuticals, APR 1, 2020, View Source [SID1234556083]). The combination study will be conducted in patients with multiple basal cell carcinomas (BCCs).

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"This collaboration is an opportunity to create a new treatment paradigm for patients with multiple BCCs." said Clement Leong, PhD., Stamford Pharmaceutical’s Chief Executive Officer. "We believe that SP-002 when combined with vismodegib has potential to enhance the response rate1 of BCC lesions directly injected with SP-002 but can also confer responses in distant non-injected BCCs. This would represent a major advancement for the management of patients with multiple BCCs who currently have to endure the morbidity that arises from many surgical procedures."

SP-002 is an adenoviral-5 vector-based immunotherapy encoding the gene for human Interferon-. It will be evaluated in combination with a reduced duration of vismodegib treatment. It is expected that the combination will alter the tumor microenvironment to support more potent and durable anti-tumor responses, while using a shorter duration of vismodegib treatment to optimize tolerability. Stamford 1

Based on a composite endpoint of Complete Response (clinical assessment) and Histological Clearance W: www.stamfordpharmaceuticals.com E: info@ stamfordpharmaceuticals.com US Connecticut Office Melbourne Office Level 2, 330 Railroad Ave, 1/159 Dorcas Street Greenwich, CT 0683 South Melbourne, VIC 3205 USA Australia Pharmaceuticals plans to initiate an open-label, multicenter Phase 2a clinical trial of SP-002 administered as an intra-lesional injection to patients who have multiple basal cell carcinomas in both the basal cell nevus and sporadic BCC populations. The primary objective of the study is to evaluate the efficacy, safety and tolerability of SP-002 in combination with vismodegib in both target (lesions injected with SP-002) and non-target (non-injected) lesions. Stamford Pharmaceuticals will be the sponsor of the study and Roche will provide vismodegib and clinical and scientific support for the study.

Forbius to Present at the Upcoming 2020 Solebury Trout Virtual Investor Conference

On April 1, 2020 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat cancer and fibrosis, reported that Ilia Tikhomirov, CEO of Forbius, will present a corporate update at the upcoming Solebury Trout Virtual Investor Conference (Press release, Forbius, APR 1, 2020, View Source [SID1234556068]).

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The 25 minute presentation includes an interactive Q&A with participants prompted to submit questions electronically. Details are as follows:

Date/Time:

Thursday, April 2, 2020, at 2:30p.m. EDT

Access: https://78449.themediaframe.com/dataconf/productusers/solebury/mediaframe/36519/indexl.html

Evotec expands its iPSC-based cell therapy platform EVOcells through licensing agreement with panCELLa

On April 1, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) and the innovative biotechnology company panCELLa Inc. reported that the companies have entered into a licensing and investment agreement (Press release, Evotec, APR 1, 2020, View Source;announcements/press-releases/p/evotec-expands-its-ipsc-based-cell-therapy-platform-evocells-through-licensing-agreement-with-pancella-5921 [SID1234556085]).

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Under the terms of the agreement, Evotec will receive a non-exclusive licence to access panCELLa’s proprietary iPS cell lines "iACT Stealth Cells", which are genetically modified to prevent immune rejection of derived cell therapy products ("cloaking"). Furthermore, Evotec will also have access to a new-generation cloaking technology known as hypoimmunogenic cells. In addition, the "FailSafe" mechanism effectively addresses a key challenge in iPSC-based cell therapy, potential tumour formation by residual undifferentiated cells.

Using the cell lines, Evotec will be able to develop iPSC-based, off-the-shelf cell therapies with long-lasting efficacy that can be safely administered to a broad population of patients without the use of medication to supress the patients’ immune system. With a growing portfolio of iPSC-based cell therapy projects at Evotec, access to research as well as GMP-grade iPSC lines modified with one or both of the panCELLa technologies significantly accelerates Evotec’s cell therapy discovery and development efforts. Modified iPSC lines will be available for the development of cell therapy approaches across a broad range of indications by Evotec and potential partners. Furthermore, Evotec has made an investment to take a minority stake in panCELLa and has nominated Dr Andreas Scheel to join panCELLa’s supervisory board.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Cell therapies hold enormous potential as truly regenerative or curative approaches for a broad range of different diseases with significant medical need. Integrating panCELLa’s technology and cell lines into our ongoing proprietary research and development efforts strengthens Evotec’s position in cell therapy. It is our goal to provide safe highly-effective cell therapy products to as many patients as possible. In addition to small molecules and biologics, cell therapy will become yet another major pillar of Evotec’s multimodality discovery and development platform."

Mahendra Rao, MD, PhD, CEO at panCELLa, added: "We welcome the partnership with Evotec. Evotec’s widely recognised expertise and existing portfolio of iPSC-related technology platforms will allow panCELLa to rapidly advance its own therapeutic interests in NK cell therapy, pancreatic islet production and iPSC-derived MSC platform, in addition to enabling panCELLa to make its platform technologies widely available. I believe that the investment by Evotec in our company is a strong validation of the leading role of panCELLa in the field of regenerative medicine and in the utility of its platform technologies. We welcome Dr Andreas Scheel to our Board."