Selecta Biosciences and Cyrus Biotechnology Enter Collaboration to Create Novel Engineered Therapeutic Proteins

On September 08, 2021 Selecta Biosciences, Inc., a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, and Cyrus Biotechnology, Inc. a leading protein design company, reported a protein engineering collaboration combining Selecta’s ImmTOR platform with Cyrus’ ability to radically redesign protein therapeutics (Press release, Selecta Biosciences, SEP 8, 2021, View Source [SID1234587493]). The lead program in the collaboration is a proprietary interleukin-2 (IL-2) protein agonist designed to selectively promote expansion of regulatory T cells (Treg) for the treatment of patients with autoimmune diseases and other deleterious immune conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Novel IL-2 approaches and technologies are driving innovation in the therapeutic development space. The IL-2 pathway influences critical aspects of both immune stimulation and immune regulation, through the development and expansion of regulatory T cells (Treg). These Treg cells are a specialized subpopulation of T cells involved in suppressing certain immune responses and maintaining the body’s self-tolerance. Reductions in the number of Treg cells have been shown to drive a spectrum of autoimmune diseases and conversely, increasing Treg expansion may have clinical utility in reducing inflammation and improving disease outcomes. Early preclinical data investigating the effects of ImmTOR in combination with a Treg-selective IL-2 mutant protein (IL-2 "mutein") demonstrate substantial synergistic activity in increasing the percentage and durability of Treg expansion in the spleen (Figure below). This supports the potential of ImmTOR in combination with IL-2 proteins to restore immunotolerance to autoantigens and forms the basis for this partnership. Although IL-2 has been an attractive target for autoimmune indications, overcoming its immunostimulatory activities, short half-life and anti-IL-2 antibody formation has been challenging. Building on recent advancements in the field, our strong preliminary data suggest that ImmTOR in combination with Cyrus’ novel IL-2 protein agonist has the potential to unlock the value of this target and drive the development of a next generation, best-in-class asset.

A figure accompanying this announcement is available at View Source

"We are excited to collaborate with Cyrus, and we see this strategic protein engineering partnership as an important step in advancing our ImmTOR platform for the treatment of autoimmune diseases," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "We are encouraged by the preclinical data generated to date and the growing literature that supports the potential of IL-2 therapeutics in treating immunological diseases."

Dr. Brunn added, "We look forward to leveraging Cyrus’ ability to both reengineer immune epitopes and rationally design novel proteins using non-traditional starting sequences, including non-human, non-natural and ancestral versions. For our first program, this combination will allow us to potentially mitigate unwanted immune responses by reducing the inherent immunogenicity of the protein while also promoting immune tolerance. We are fortunate to have this opportunity to optimize and advance our portfolio through the design and generation of innovative protein therapeutics. Beyond leading a paradigm shift in the way biologics are made, ultimately this collaboration has the potential to unlock new treatment options and improve the lives of patients who suffer from serious and debilitating diseases."

Lucas Nivon, Ph.D., Chief Executive Officer of Cyrus, commented, "We welcome Selecta as a deeply experienced partner. This collaboration is in perfect alignment with our protein design expertise and represents an important endorsement of our platform, which has the potential to further enhance the potency of ImmTOR’s tolerizing power. With our current partners, we have demonstrated our ability to redesign existing protein biologics or build them from the ground-up — expanding the potential for therapeutics and intellectual property. We look forward to executing on our shared vision."

Under the terms of the collaboration, Selecta has provided an upfront payment, and Cyrus is eligible to earn discovery, development and sales based milestones. Novel engineered protein therapeutic candidates from the partnership will be used to expand Selecta’s proprietary pipeline and further bolster Selecta’s clinically validated ImmTOR platform.

ESMO Congress – 2021

On September 8, 2021 NETRIS Pharma reported that a "trial in progress" abstract has been accepted to the ESMO (Free ESMO Whitepaper) congress (European Society for Medical Oncology) taking place September 16th-20th (Press release, Netris Pharma, SEP 8, 2021, View Source [SID1234587455]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The corresponding e-Poster "GYNET – Safety & efficacy of NP137 in combination with chemotherapy and/or Pembrolizumab in patients with pretreated locally advanced/metastatic endometrial carcinoma or cervix carcinoma: an adaptative multi-arms randomized Phase I/II" will be presented by Prof. Isabelle Ray-Coquard as Principal Investigator.

Coherus BioSciences Announces Upcoming Medical Conference Presentations

On September 8, 2021 Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported upcoming medical conference presentations. Toripalimab clinical data will be presented September 13 at the IASLC 2021 World Conference on Lung Cancer and September 17 at the European Society for Medical Oncology Congress 2021 (Press release, Coherus Biosciences, SEP 8, 2021, View Source [SID1234587453]). A real-world study comparing same-day and next-day administration of pegfilgrastim will be the topic of a poster presentation at the ASCO (Free ASCO Whitepaper) Quality Care Symposium on September 25. In addition, an oral presentation at the 54th Annual Scientific Meeting of the Retina Society on October 1 will highlight clinical data from the CHS-201 (also known as FYB201) program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IASLC 2021 World Conference on Lung Cancer (WCLC)

Mini-oral presentation: "CHOICE-01: A Phase 3 Study of Toripalimab versus Placebo in Combination with First-Line Chemotherapy for Advanced NSCLC" (Session #MA13)
Professor Jie Wang, MD, PhD, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, will present the interim results of the CHOICE-01 study detailed in the abstract published by WCLC on August 18, 2021.
Presentation time: September 13 at 8:10 p.m. Eastern Time
European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021

Mini-oral presentation: "JUPITER-06: A Randomized, Double-blind, Phase 3 Study of Toripalimab versus Placebo in Combination with First-Line Chemotherapy for Treatment Naive Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)" (Abstract #1373MO)
Dr. Ruihua Xu, President and Professor, Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou, will present interim results of the JUPITER-06 trial. ESMO (Free ESMO Whitepaper) will release the JUPITER-06 abstract at 6:05 p.m. Eastern Time on September 16.
Presentation time: September 17 at 12:05 p.m. Eastern Time
ASCO Quality Care Symposium

Poster presentation: "Real-world comparison of febrile neutropenia rates with same-day versus next-day administration of pegfilgrastim" (Abstract #299)
Kyle Kitchen, PharmD, Director of Pharmacy Services, Utah Cancer Specialists
Poster Session B: September 25 at 7 a.m. Eastern Time
The 54th Annual Scientific Meeting of the Retina Society

Oral presentation: "Columbus-AMD: Efficacy and Safety of FYB201, a Proposed Biosimilar to Ranibizumab, in Neovascular AMD (nAMD)"
Dr. Peter Kaiser, Professor of Ophthalmology, Cole Eye Institute of the Cleveland Clinic
Presentation Time: October 1 at 3:32 p.m. Eastern Time

Applied DNA Enters into Master Services Agreement with Flora Growth for Cannabis Validation and Authentication, Secures First Statement of Work Contract

On September 8, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported that it has entered into a Master Services Agreement (the "MSA") with Flora Growth (NASDAQ: FLGC) (Flora) to deploy the Company’s CertainT platform as part of Flora’s global cannabis product validation and authentication platform for consumers, distributors, and government regulators (Press release, Applied DNA Sciences, SEP 8, 2021, View Source [SID1234587450]). Concurrently, the Company received a Statement of Work (SOW) under the MSA from Flora to implement its CertainT platform and supply related equipment and services for three locations (1 in Florida; 2 in the Republic of Colombia), where the Company’s molecular tags will be applied to quantities of Flora’s cannabis flower and derivatives, as well as select products in their portfolio. Financial terms of the SOW were not disclosed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The MSA is the result of the Company’s strategic alliance, referral, and technology integration agreement with TruTrace Technologies, Inc. (CSE: TTT; OTCQB: TTTSF) (TruTrace) under which TruTrace’s blockchain-based StrainSecure platform was integrated with CertainT to deliver a complete, end-to-end supply chain security solution to cannabis companies. Flora will employ the integrated CertainT-StrainSecure solution to support its product validation and authentication platform to be utilized to deliver on Flora’s previously announced commercial agreements to export cannabis products internationally to open markets like Australia.

Flora, a manufacturer and wholesaler of cannabis and cannabis derivative products and operator of one of the largest outdoor cannabis cultivation facilities, is differentiated by its use of natural ingredients and value-chain sustainability. Flora’s cannabis derivative products are used in premium cosmetics, hemp textiles, and food and beverage applications.

"Business imperatives centered on branding and supply chain mastery will be the defining characteristics of cannabis companies positioning to compete globally. To that end, CertainT’s value proposition delivers brand and product differentiation, IP protection, and supply chain security from inception to consumption that, we believe, will further catalyze interest and adoption of our platform," stated Dr. James A. Hayward, president and CEO of Applied DNA. "CertainT offers customers like Flora unmatched levels of transparency, traceability, and trust across their supply chains that are further improved through our integration with TruTrace. We are very pleased to undertake our first international commercial cannabis venture alongside Flora and, given its growing and diverse portfolio of cannabis and cannabis derivative products, we believe we are in the early stages of a mutually beneficial commercial relationship with Flora."

Robert Galarza, CEO of TruTrace, stated, "The first fruits of our partnership with Applied DNA have been realized and at a time when the cannabis industry’s globalization has accelerated the need for solutions to verify supply chains in defense of a brand’s intellectual property and brand equity. Companies like Flora, who recognize and address this need, will hold a competitive advantage in the market and offer compelling value to end-customers. The integration of our platform with CertainT is designed specifically to meet that need."

About the CertainT Platform

The CertainT platform has three technology pillars (Tag, Test, Track), which allows raw materials and products to be tagged with a unique molecular identifier. This identifier can then be tested for its presence as it travels throughout a global supply chain. All the data points associated to tagging and testing are tracked by uploading to a secure cloud database. The CertainT platform can be used across industries such as textiles, cannabis, military, leather, fertilizer, pharmaceuticals, personal care.

Science 37® and Foundation Medicine Partner to Enable Interventional Home-Based Clinical Trials in Oncology

On September 8, 2021 Science 37 and Foundation Medicine reported a collaboration to enable decentralized clinical research in oncology that will optimize recruitment and enrollment, improve patient retention, and expand access to precision cancer care (Press release, Foundation Medicine, SEP 8, 2021, View Source [SID1234587449]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

It is estimated that less than 1 in 20 patients with cancer participate in clinical trials.1 Further, more than 80 percent of clinical studies globally fail to enroll patients within the sponsor’s desired timeline.2 Lack of participation in clinical research may hinder a patient’s ability to access the latest therapeutic options and slow the pace of treatment discovery.

As part of this novel offering, Foundation Medicine’s FoundationSmartTrials patient identification solution will be used to identify patients who may be eligible for a trial based on results from its tissue and blood-based comprehensive genomic profiling (CGP) tests. Science 37 will then enroll the appropriate patients and provide ongoing support via its operating system—underpinned by its technology platform and specialized networks of mobile nurses, telemedicine investigators, remote coordinators and connected devices.

"Many advanced cancer patients are unable to travel to or visit in-person clinical trials sites, so it’s critical that we work across the ecosystem towards new and innovative solutions to improve access to clinical trials regardless of a patient’s location," said Jonathan Cotliar, M.D., Chief Medical Officer at Science 37. "Combining our operating system with Foundation Medicine’s precision oncology expertise sets us on an exciting path with the goal of accelerating treatment discovery while bringing the research directly to patients."

This partnership builds on a collaboration between Foundation Medicine and Science 37 to provide decentralized trial services for Roche’s ALPHA-T trial. The ALPHA-T trial seeks to assess the efficacy and safety of alectinib for patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic solid tumors excluding lung cancer. This type of tumor-agnostic approach represents a ground-breaking advance in cancer treatment and demonstrates further progress towards achieving personalized healthcare for patients with these types of cancers.

"Beyond providing high quality genomic profiling to support informed decision making, we’re committed to empowering practitioners to act on those decisions by identifying personalized treatment options, including clinical trials. Through this partnership with Science 37, leveraging our combined assets and expertise, our goal is to improve access to clinical trials for patients who aren’t frequently able to participate," said Brian Alexander, M.D., M.P.H., Chief Executive Officer at Foundation Medicine. "As we explore this decentralized approach to research, we hope to continue innovating on this model for other clinical programs in the future. Ideally, we’ll create a learning system where physicians and patients have more options, and their experiences help inform treatment for patients in the future."