Bicycle and Genentech Forge Immuno-Oncology Collaboration Worth up to $1.7 Billion

BioSpace | February 25, 2020

Shares of U.K.-based Bicycle Therapeutics are climbing this morning after the company announced it entered into a strategic immuno-oncology collaboration with Genentech to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. The collaboration has a value of up to $1.7 billion if all milestones are hit. Under terms of the agreement, Bicycle will receive an upfront payment of $30 million to focus its proprietary bicyclic peptides platform on a wide range of immuno-oncology targets. The U.K. company’s proprietary discovery platform allows for rapid screening of novel targets to identify Bicycles and the ability to readily conjugate these together to create novel molecules that may overcome the potential limitations of other modalities. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, which makes Bicycles attractive candidates for drug development, the company said.

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CELL AND GENE THERAPY

Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine

HDT Bio Corp. | January 17, 2022

HDT Bio Corp., a U.S. developer of immunotherapies for oncology and infectious diseases and SENAI CIMATEC, an important Brazilian education, research, and innovation institute, have dosed the first healthy volunteers in Brazil in a Phase 1 trial of HDT Bio’s RNA COVID-19 vaccine, HDT-301. SENAI CIMATEC will conduct the clinical trial under the name Vaccine RNA MCTI-CIMATEC-HDT. The vaccine uses HDT Bio’s proprietary lipid nanoparticle RNA-delivery technology. “This clinical trial in Brazil is the second international study to get under way in our efforts to help partners in historically underserved nations fight this pandemic by transferring our unique technology to provide them local control over development, manufacturing and distribution of a COVID-19 RNA vaccine. The first was in India with our partner Gennova Biopharmaceuticals which has moved the vaccine into Phase 2 and Phase 3 trials.” HDT Bio CEO Steve Reed HDT Bio has other partnerships for its RNA COVID-19 vaccine, including in South Korea and China. “These partnerships are part of our company’s mission and business strategy aimed at bringing our advanced immunotherapies to underserved nations to help address global health inequities,” Reed explained. "Through the partnership with HDT Bio Corp., SENAI CIMATEC is incorporating in Brazil the development and qualification for a state-of-the-art technology in an exclusive way, as well as the first clinical study involving an RNA self-amplifying vaccine. This moment can be considered as an important demonstration of the potential of Brazilian science, represented in this study by SENAI CIMATEC,” said President of Federation of Industries of the State of Bahia Ricardo Alban “We also highlight the important funding received through the Ministry of Science, Technology and Innovations which has supported the execution of the initial clinical phases, “Alban added. “From the clinical studies of the Vaccine RNA MCTI CIMATEC HDT we expect to obtain sufficient data to demonstrate the efficacy and safety of this product to the population. In this way, the development of the Vaccine RNA MCTI CIMATEC HDT represents a crucial milestone for the modernization of the national health system, since it can later be produced in the country itself,” said infectious disease doctor and Principal Investigator of the clinical studies in Brazil Roberto Badaró. SENAI CIMATEC’s double-blind, placebo-controlled, dose-ranging Phase 1 clinical trial will enroll 90 healthy adult volunteers. The trial will assess the safety, tolerability, and immunogenicity of the vaccine at three dose levels, 1 µg, 5 µg and 25 µg. Safety and tolerability will be the primary endpoints assessed by incidence of adverse events for each dose through 12 months after the vaccination. Scheduled interim evaluations to measure immunogenicity also will be conducted. HDT Bio’s innovative vaccine, which also will undergo a Phase 1 trial in the U.S., uses its proprietary lipid nanoparticle carrier system for delivery of RNA. The vaccine is significantly different from existing commercially available RNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine activates the immune system at a much lower dose than commercially available vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the nanoparticle delivery system rather than being encapsulated within it, providing for enhanced stability. ABOUT HDT BIO CORP. HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas. The company seeks to harness the body’s immune system to deliver therapies that narrowly target the specific areas of the body where they are needed. HDT Bio’s work focuses on oncological and infectious disease applications. HDT Bio’s founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants. One of the company’s core technologies, RNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. ABOUT SENAI CIMATEC SENAI CIMATEC focuses on higher education, research and innovation for the development of industry. Its manufacturing and technology integrated campus is one of the most advanced centers for education specialized services, applied research and innovation projects in Brazil. CIMATEC operates in more than 40 different areas of competence, with emphasis on computer technology, engineering, health and biotechnology, with the main objective to support industries, including the Brazilian Industrial Health Complex.

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CELL AND GENE THERAPY

Enzychem Lifesciences Announces Formation of Corporate Advisory Committee

Enzychem Lifesciences | March 03, 2022

Enzychem Lifesciences a clinical-stage biotechnology company, announced today the formation of its Corporate Advisory Committee. Composed of four eminent physicians, its mission is to support and guide corporate activities including technology transfer for its lead compound, EC-18, seeking strategic partnerships, and preparing U.S. phase 3 clinical trials to successfully commercialize EC-18. After the completion of its phase 2 U.S. clinical trial with EC-18 in Chemoradiation–induced Oral Mucositis (CRIOM), Enzychem is actively negotiating licensing deals with several partnering candidates while also preparing a phase 3 trial under a US FDA IND. To reinforce such corporate initiatives, and to start supporting the company’s next stage activities, Enzychem has formed the Corporate Advisory Committee. Enzychem Lifesciences recognizes the need for engagement of key opinion leaders at an earlier stage in the process of developing new therapeutics for a large population with high unmet needs such as Chemoradiation-induced Oral Mucositis (CRIOM). Enzychem is proactively bringing more experts to the company to strengthen its new drug development capabilities. The newly appointed corporate advisors will actively influence the development of strong business strategies to successfully meet corporate objectives. The four physicians appointed are Dr. Alexander Fleming, a former FDA reviewer and supervisory medical officer, as head of the metabolic group, Dr. Frank Castellana, a market value assessment expert, Dr. Joe McMenamin, a health lawyer, and Dr. Richard Hamrick, a former healthcare provider executive. Based on their extensive experience, the corporate advisors will assist Enzychem in accomplishing its business milestones. For two years, until 2018, Dr. Fleming served as Enzychem’s Chief Technology Officer (CTO). During his term, Dr. Fleming had recommended CRIOM as the lead indication for EC-18 and introduced Dr. Steve Sonis of Harvard School of Dental Medicine as Enzychem’s key advisor for the U.S. phase 2 CRIOM Study. Enzychem Lifesciences is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for patients with unmet medical needs in oncology, metabolic, and inflammatory diseases. Founded in 1999, the company’s lead compound, EC-18, acts as an immunomodulator, facilitating the resolution of inflammation and the early return to immune homeostasis. Enzychem is headquartered in South Korea, with an office in the United States.

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INDUSTRIAL IMPACT

Amnio Technology Launches Two New Dual-Layer Allografts, FDA Recognizes Products as Minimally Manipulated, Homologous Use HCT/Ps

Amnio Technology | February 15, 2022

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane products, PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane. The new allografts, like the entire family of PalinGen® membrane products, are minimally manipulated, homologous use and chorion-free. The dual-layered nature of the allografts allow for unidirectional application with two outward facing epithelial sides. The proprietary Advantek® process used to manufacture PalinGen® membranes preserves the extracellular matrix components and regulatory proteins present in amniotic tissues. Preserving the characteristics of the natural tissue aids in wound management. PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are indicated for patients suffering from non-healing acute and chronic wounds as well as complex and/or open surgical wounds and burns. Senior Director of New Product Development, Robert Diller, PhD, shared his insight into the motivation for developing a multilayered amniotic product, "The PalinGen® Dual layer membranes have increased durability and slower resorption, which makes them ideal for use in robotic and other surgical applications" "With the application of single-layer PalinGen® membrane products, patients already experience improved clinical outcomes compared to treatment with standard of care. Cytokines, growth factors, and extracellular matrix proteins have been identified in amnion membranes and contribute to the complex wound healing process. Compared to single layer allografts, PalinGen® Dual Layer membranes deliver twice as many of these components to the wound area," lead Research Scientist on the development project, Sarah West The FDA recognized PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane as being minimally manipulated, homologous use human cell, tissue, and cellular and tissue-based products or HCT/Ps. In letters received from the Tissue Reference Group (TRG) within the Office of Tissues and Advanced Therapies (OTAT) on September 30, 2021, and February 8, 2022, respectively, FDA confirmed that PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane would be regulated solely under section 361 of the PHS Act and the regulations in 21 CFR 1271. Amnio Technology has a long history of Good Tissue Practices (GTP) experience and compliance. In recent years, the FDA has issued final guidance on its Framework for the Regulation of Regenerative Medicine Products, making the confirmation of the regulatory status of amniotic products critical for business continuity in the amniotic tissue space. William Brown, Managing Director of Operations at Amnio Technology, recognized the efforts of the entire Amnio Technology Team, "We continue to be successful in the development and launch of new Products in our pipeline, which meet the Regulatory framework of the FDA and other Agencies. With a Team dedicated to compliance from the first step, we continue to expedite new product availability to clinicians for implementation into their practice and, ultimately, the ability to improve quality of life for the patient." Both PalinGen® Dual-Layer Membrane and Dual Layer PalinGen® X-Membrane are available in a variety of sizes suited for the patient's needs. About Amnio Technology Amnio Technology is a clinical stage biotechnology company dedicated to advancing the science of regenerative medicine. Established in 2013, Amnio Technology has developed core competencies in Good Tissue Practice and HCT/P Safety becoming a global leader in the development and distribution of amniotic tissue allografts. The Company has a robust pipeline of products and its liquid allograft for the treatment of chronic ulcers, PalinGen® Flow, is currently in a Phase 2 clinical trial.

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INDUSTRIAL IMPACT

Chimeron Bio Expands Footprint in Philadelphia by Joining BioLabs at The Curtis

Chimeron Bio | January 25, 2022

Chimeron Bio, a biotechnology company pioneering a novel class of self-amplifying RNA-vaccines and therapeutics announced its plan to expand operations in the Philadelphia area and move to The Curtis, a landmark site in Center City Philadelphia under BioLabs, the leading developer and operator of life science co-working spaces in the U.S. and internationally. The move stems from Chimeron’s need for an expanded footprint to accommodate its growing R&D team and operations. The Curtis, a historical landmark has been reimagined to host first-class wet labs and is quickly becoming a hub for top-tier life science organizations in the Philadelphia area. Chimeron Bio’s move to The Curtis will solidify their position as emerging leaders in biotechnology as the company works to advance its pipeline to the clinic. “We are pleased to be joining BioLabs Philadelphia, a facility that offers unwavering support for success and growth. We expect this new facility to drive our next phase of growth by enabling our growing team to conduct cutting-edge research as we work to bring high-impact accessible RNA medicines to patients. At this new site, we look forward to continuing our trajectory of attracting premier talent and becoming a major player in Philly’s growing life science ecosystem,” Dr. Jolly Mazumdar, PhD, MBA, co-founder and CEO of Chimeron Bio About Chimeron Bio Chimeron Bio is a biotechnology company focused developing a pipeline of self-amplifying RNA medicines, both therapeutics and vaccines, designed on its proprietary ChaESAR™ delivery technology platform.

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Spotlight

Qubit™ instruments and assays have a proven track record, with over 3,000 citations and hundreds of testimonials. With high sensitivity for DNA, high specificity for RNA, and a broad range of available assays, the Qubit Fluorometer is the instrument of choice when accuracy matters most.

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