On November 23, 2021 Nykode Therapeutics (formerly Vaccibody*)) (Euronext Growth (Oslo): VACC), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that it has entered into a license and collaboration agreement with Regeneron for the discovery, development and commercialization of potential new vaccines for cancer and infectious diseases (Press release, Vaccibody, NOV 23, 2021, View Source [SID1234595932]).

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The agreement includes five distinct programs, three within cancer and two within infectious diseases. Each of these may include several vaccine candidates, all of which being eligible for milestone and royalty payments. The vaccines will combine Regeneron’s unique antigen selection expertise and innovative VelociSuite in vivo models with Nykode Therapeutics’ modular vaccine platform and expertise in vaccine design. Nykode Therapeutics will be responsible for vaccine generation and characterization, as well as product supply through the end of Phase 1 trials. Regeneron will be responsible for antigen identification, preclinical and clinical development, manufacturing (from the end of Phase 1 trials) and commercialization.

Under the terms of the agreement, Nykode Therapeutics will receive a USD 30 million upfront payment and a USD 20 million equity investment at a premium of 20% on a 30-day volume weighted average price of the Nykode Therapeutics share for the last 30 trading days before the effective date of the agreement. Additionally, Nykode Therapeutics will potentially be eligible to receive more than USD 875 million in milestone payments, plus high single-digit to low double-digit tiered royalties on sales of commercialized products arising from the collaboration, bringing the total potential value of the agreement to more than USD 925 million, plus royalties. Regeneron will cover costs for research, as well as potential clinical, regulatory, manufacturing and commercialization activities.

Michael Engsig, CEO of Nykode Therapeutics, said: "We are very pleased to have entered into this groundbreaking agreement with Regeneron that may accelerate the expansion of our pipeline and fully leverage our unique and modular vaccine technology platform within multiple, large and commercially significant disease areas, in line with our corporate strategy. The agreement further validates Nykode Therapeutics’ position as a leading next-generation immunotherapy platform company. We are thrilled about the choice of programs and their therapeutic potential within cancer, and prophylactic and therapeutic potential within infectious diseases."

Agnete B. Fredriksen, Chief Innovation & Strategy Officer of Nykode Therapeutics, continued: "Regeneron has generated unique know how in selecting and validating immunogenic antigens from extensive analysis of patient material. These can now be incorporated into our vaccine platform to deliver the antigens directly to antigen presenting cells and optimize the likelihood of inducing strong and broad clinically relevant immune responses. Regeneron has also developed a unique suite of proprietary VelociSuite technologies and in vivo models that can accelerate and improve the traditional drug development process, and they will use their deep clinical expertise to guide development of these novel vaccines. Therefore, Regeneron will be a tremendous partner as we work to bring multiple additional vaccines based on our technology platform to patients in the fastest and broadest manner and complement the expansion and acceleration of internal programs."

Mikkel W. Pedersen, Chief Scientific Officer of Nykode Therapeutics, added: "We are excited about the opportunity to work with the Regeneron team. The extensive disease biology expertise of Regeneron coupled with Nykode Therapeutics’ modular and targeted vaccine platform will enable us to design and potentially bring into the clinic new unique therapeutic vaccine concepts within both oncology and infectious diseases."

Gavin Thurston, Ph.D., Senior Vice President, Oncology Research, at Regeneron said: "Collaborating with Nykode Therapeutics will bring another dimension to Regeneron’s already robust research and development programs for oncology and infectious disease and, in particular, provides new opportunities to help people with challenging tumor types or infectious diseases with high unmet need. Nykode Therapeutics’ platform efficiently delivers vaccine payloads to antigen presenting cells and allows for vaccine candidates that can be easily manufactured. It has already shown robust CD8+ antigen-specific T cell responses in animal models and in patients with cancer. Combining their platform with our industry-leading VelociSuite technologies and expertise may help to accelerate this emerging and promising therapeutic approach."

Webcast

CEO Michael Engsig and other members of management will host a webcast on November 23, 2021 at 4 p.m. CET / 10 a.m. EST to present the license and collaboration agreement with Regeneron. The slides will be made available before the webcast. The webcast may be viewed here:
https://channel.royalcast.com/landingpage/hegnarmedia/20211118_4/

*) Vaccibody AS, which is changing its company name to Nykode Therapeutics AS, has called for an EGM on November 30, 2021, to vote for the approval of the change of its company name from Vaccibody AS to Nykode Therapeutics AS.

On November 23, 2021 Isofol Medical AB (View Source) (publ) (Nasdaq Stockholm: ISOFOL), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the development of the Company’s lead drug candidate arfolitixorin, the stabilized and biologically active pure form of folate ([6R]-MTHF), for treatment of patients with metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, NOV 23, 2021, View Source [SID1234595971]). The FDA’s decision is based on the potential for arfolitixorin to address a large unmet medical need for new and more effective treatments of mCRC, the second deadliest and third most common form of cancer. Fast Track Designation facilitates frequent communication with the FDA and can result in expedited review timelines and a potential earlier market authorization and approval to ensure that new treatments can be made available quicker for patients with serious diseases.

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– We are thrilled that the FDA has granted Fast Track Designation to our lead candidate arfolitixorin. This serves as a strong external validation of arfolitixorin’s potential to benefit patients with this devastating disease. Our next clinical milestone is reaching 300 progression-free survival events in the Phase III AGENT study which means that data can be deblinded so that we can analyze and present top-line results in the first half of 2022. The Fast Track Designation will enable us to engage more frequently with the FDA to optimally plan for the continued development of arfolitixorin and potentially make it the first novel drug to improve the standard of care in mCRC in over 40 years, said Ulf Jungnelius, CEO of Isofol.

As defined by the FDA, Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, thereby meeting an unmet medical need. The designation allows for such options as eligibility for priority review, if relevant criteria are met, more frequent meetings with FDA, and rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. The NDA review otherwise usually does not begin until the drug company has submitted the entire application to the FDA. More information about the Fast Track Designation can be found here.

As the first and only pure form of the folate ([6R]-MTHF) that increases 5FU-cytotoxicity, arfolitixorin is currently being evaluated in the global pivotal Phase III AGENT study. The AGENT study is fully recruited and approximately 90 clinics in the United States, Canada, Europe, Australia and Japan have been involved in the study. Isofol’s ambition is to conclude the AGENT study in 2022 and thereafter apply for market approval with the FDA and EMA, which could result in a potential commercialization of arfolitixorin as early as 2023.

This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18:45 CET on November 23, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

About the AGENT study
The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin.

The study has involved approximately 90 clinics in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients were recruited, which is the basis in the statistical analysis plan. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment with either leucovorin or arfolitixorin for metastatic colorectal cancer (mCRC). The company expects that top-line results of the AGENT study will be available during H1 2022. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id:NCT03750786.

On November 23, 2021 Exscientia (Nasdaq: EXAI) reported that Andrew Hopkins, DPhil., Exscientia’s founder and CEO, Ben Taylor, CFO & Chief Strategy Officer, and Garry Pairaudeau, Chief Technology Officer, will participate in a fireside chat at the Evercore ISI 4th Annual HealthCONx Virtual Conference on Thursday, December 2, 2021 at 10:30 a.m. ET (3:30 p.m. GMT) (Press release, Exscientia, NOV 23, 2021, View Source [SID1234595989]).

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A live webcast of the fireside chat will be available on the Company’s website, under the "Investors & Media" section at investors.exscientia.ai. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On November 23, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported that Daniel Vitt, Ph.D., Chief Executive Officer and President, will participate in a fireside chat at the Piper Sandler & Co. 33rd Annual Virtual Healthcare Conference, taking place November 29-December 2, 2021 (Press release, Immunic, NOV 23, 2021, View Source;co-33rd-annual-virtual-healthcare-conference-301430529.html [SID1234596006]).

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The pre-recorded presentation is available for registered attendees via the Piper Sandler conference site from Monday, November 22 to Thursday, December 2 and on the "Events and Presentations" section of Immunic’s website at: View Source An archived replay will be available on the company’s website for a period of 90 days after the conference.

On November 23, 2021 CureLab Oncology reported that it has been granted a patent protection in India for anti-cancer application of our lead product, Elenagen (Press release, CureLab Oncology, NOV 23, 2021, View Source [SID1234596166]). This brings the total number of countries in which CureLab Oncology has patent protection to over 20 — you can see the complete list here.

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Because of its huge population and established biotech expertise, we see enormous potential in the Indian market for CureLab’s therapies. According to INVEST INDIA, India is among the top 12 destinations for biotechnology in the world, with an approximately 3% share of the global biotechnology industry. In aggregate, the biotech sector is a key contributor to India’s vision of reaching a $5 trillion economy by 2024.

The rising incidence of cancer in India is expected to boost the immuno-oncology drugs market expansion across the country. According to the Indian Council of Medical Research (ICMR) – National Institute of Cancer Prevention and Research (NICPR), incidence of breast cancer is 25.8 per 100,000 women in 2018 and is expected to reach 35 per 100,000 women in 2026.

The India immuno-oncology drugs market was valued at $172.8 million in 2018 and is expected to experience a CAGR of 13.1% from 2018 through 2026.
Like any promising biotech company, we view a comprehensive, global approach to IP protection as immensely important to our strategic business plan. One reason is that annual industrial biopharmaceutical R&D spending has declined over the past decade, with large pharmaceuticals instead focusing on partnership and acquisition strategies with biotech startups whose technology shows great promise.

As we expand our patent portfolio and geographic operations, we will adapt our IP strategy to maximize the value of the company.