RESEARCH

Prellis Biologics Announces Collaboration and License Agreement with Bristol Myers Squibb

Prellis Biologics, Inc. | January 14, 2022

Prellis Biologics, Inc. (Prellis), a Bay Area biotechnology company, announced that it has entered into a multi-target drug discovery collaboration and licensing agreement with Bristol Myers Squibb utilizing Prellis Biologics’ first-in-class externalized human immune system based on human lymph node organoids. The collaboration leverages Prellis’ EXIS platform that can break tolerance mechanisms in vitro to create high affinity human antibodies targeting human proteins.

Under the terms of the agreement, Prellis and Bristol Myers Squibb will collaborate on the generation of human antibody libraries for select targets. Prellis will receive from Bristol Myers Squibb an undisclosed up-front payment, funding for research activities, development, sales milestones and royalties for licensed antibodies.

"With industry leading speed, the EXIS platform provides high affinity antibodies, derived from lymph node organoids printed with Prellis’ foundational technology, using human PBMCs. We are looking forward to working with Bristol Myers Squibb to demonstrate advantages of in vitro human antibody discovery with the EXIS platform."

Melanie P. Matheu, PhD, Founder and CEO of Prellis Biologics

Kevin Chapman, PhD, CSO of Prellis, added, "The EXIS platform effectively breaks tolerance enabling direct discovery of human antibodies to challenging human antigens in less than two weeks."

About Prellis
Prellis Biologics, Inc. is the first company to develop a fully synthetic, animal-free, functional human immune system, EXIS™.  The EXIS platform allows Prellis to harness fully human immune responses for the development of antibody therapeutics, disease models, and target discovery. With industry-leading speed and resolution, Prellis’ proprietary holographic printing technology is able to accurately match and rapidly replicate human organ and tissue structures. Prellis is dedicated to improving patient lives by discovering novel therapeutics, utilizing its unique capabilities in antibody discovery and in vitro human disease models. Prellis Biologics, Inc. was founded in 2016 and is a privately held company based in the San Francisco Bay Area. 

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INDUSTRIAL IMPACT

EyeBio Raises $65M in Series A Funding to Develop New Generation of Eye Disease Therapies

Eyebiotech Limited | February 23, 2022

Eyebiotech Limited a privately held ophthalmology biotechnology company working to deliver a new generation of therapies for eye diseases, today announced the completion of a successful $65 million Series A funding round. SV Health Investors led the round, alongside Samsara BioCapital and Jeito Capital, with additional financial backing from MRL Ventures. The Series A brings together an international team of executives and investors with an extensive track record for developing ground-breaking ophthalmology therapies. EyeBio launches with a specific mission: to protect, restore, and improve vision for people who are underserved by available eye disease therapies. The company will use proceeds from the Series A to assemble and develop a diversified pipeline of product candidates that combines scientifically compelling targets with innovative translational approaches. The company has established a footprint in the United Kingdom to take advantage of the innovation-friendly environment for its clinical trial development. EyeBio welcomes inquiries regarding in-licensing and acquisition of assets into its portfolio. “Advances in research are revealing new opportunities to translate science into solutions that serve patients with eye diseases who have urgent and unaddressed medical needs. Patients and physicians deserve new and better solutions, which is why this team of serial disruptors has banded together to form EyeBio. We are launching at an exciting time, and we are equipped with the resources to make a significant impact.” Dr. Guyer, Co-Founder, President, and Chief Executive Officer of EyeBio “EyeBio is well positioned to improve outcomes for patients by addressing a segment of ophthalmology that needs further innovation,” said Dr. Adamis, Co-Founder, Director, and Chair of the Advisory Board of EyeBio. “Success requires an ability to execute and deliver new therapies with speed and quality. EyeBio has the talent, skillset, and willingness to introduce new solutions to address familiar problems.” Prior to co-founding EyeBio, Dr. Guyer served as executive chairman and CEO of Iveric Bio, a biopharmaceutical company developing novel treatments for retinal diseases. Dr. Adamis previously served as Senior Vice President of Development Innovation at Genentech, a member of The Roche Group. Over his career, he led development programs in multiple therapeutic areas and oversaw 25 U.S. Food and Drug Administration (FDA) approvals. About EyeBio Eyebiotech Limited is a privately held ophthalmology biotechnology company dedicated to developing and delivering a new generation of therapies to protect, restore, and improve vision in patients with sight-threatening eye diseases. Founded in August 2021 by David Guyer, M.D., and Anthony P. Adamis, M.D., EyeBio has a leadership team composed of serial disruptors in ophthalmology drug development. With operations in the United States and the United Kingdom, EyeBio is building and advancing a pipeline of ocular therapies that combine scientifically robust targets with innovative translational approaches. About SV Health Investors SV Health Investors is a leading healthcare fund manager committed to investing in tomorrow’s healthcare breakthroughs. The SV family of funds invests across stages, geographic regions, and sectors, with expertise spanning biotechnology, dementia, healthcare growth, healthcare technology and public equities. With approximately $2.7 billion in assets under management and a truly transatlantic presence with offices in Boston and London, SV has built an extensive network of talented investment professionals and experienced industry veterans. Since its founding in 1993, SV has invested in more than 200 companies with more than 90 of these having achieved successful acquisitions or IPOs. About Samsara BioCapital Samsara BioCapital is a new breed of biotech investment fund focused on translating cutting-edge biology into new therapies to treat patients with unmet medical needs. Founded in 2016 by Srinivas Akkaraju, M.D., Ph.D., our team of scientists, investors, and entrepreneurs takes a long-term view to value creation across all stages of public and private life science companies. We believe in a collaborative, hands-on approach, working closely with entrepreneurs to harness exciting scientific advances and build leading companies. Samsara actively manages over US $1 billion in assets on behalf of endowments, foundations, and family offices. About Jeito Capital Jeito Capital is a global leading investment company with a patient benefit-driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports entrepreneurs through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access in Europe and the United States. Jeito Capital has €534 million under management. Jeito Capital is based in Paris with a presence in Europe and the United States. About MRL Ventures MRL Ventures Fund (MRLV) is the therapeutics-focused corporate venture fund of Merck & Co., Inc., with headquarters in Kenilworth, N.J., USA. From its headquarters in Cambridge, Mass., USA, the MRLV team invests globally in early-stage innovative therapeutics companies that are developing transformative medicines in any therapeutic area using any modality. The MRLV team of experienced life-sciences venture capital professionals is committed to supporting great entrepreneurs in their quest to create value through building companies that have a meaningful impact on health and disease.

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INDUSTRIAL IMPACT

Cyclica launches Perturba Therapeutics, a spin out from the University of Toronto, creating the next-generation oncology biotech

Cyclica Inc. | February 10, 2022

Cyclica Inc. a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, launches Perturba Therapeutics Inc. a spin out from the Stagljar Lab at the University of Toronto, Donnelly Centre for Cellular and Biomolecular Research. Perturba is advancing a rich pipeline of assets from undrugged protein-protein interactions (PPIs). Only a small subset of biologically important drug targets are currently being explored within the pharma industry. Perturba is taking this challenge on by integrating Cyclica’s comprehensive AI-augmented proteome-wide drug design technology with two first-in-class live cell-based assays from the Stagljar Lab. With this integrated AI-augmented drug design and empirical phenotypic approach, Perturba is developing precision therapies that modulate PPIs and PPI-mediated biological processes with a focus on difficult-to-treat cancers. Perturba will initially focus on advancing two EGFR triple mutant inhibitors for non-small cell lung cancer, and four programs targeting small GTPases for various intractable cancers. Naheed Kurji, Co-Founder, CEO and President of Cyclica indicates that “More than half of all human disease-related proteins are considered undruggable using conventional approaches. As a result, patients suffering from life threatening diseases are left waiting for treatment. What others view as “undruggable”, we see as potential. Perturba represents an important franchise in the pursuit of our cancer strategy. We’re so excited to partner with Professor Stagljar and the world class Stagljar Lab in driving forward our shared vision.” "over the past two years, my lab has developed two high impact, live cell-based technologies for studying protein-protein interactions and identifying novel drug molecules – MaMTH-DS and SIMPL. Combining these two technologies with Cyclica’s world-class AI-drug design approach will usher in a new way to conduct drug discovery for highly intractable targets in an unprecedented way at scale. I’ve known Naheed and the team at Cyclica for years and jointly have shown multiple proof points using our platforms with a program targeting an osimertinib resistant EGFR triple mutant that we will be progressing in Perturba, and a program targeting an oncogenic KRAS in a separate collaboration that gave us confidence to target other small GTPases in Perturba.” Dr. Igor Stagljar, Professor at University of Toronto’s Temerty Faculty of Medicine and Principal Investigator at the Donnelly Centre Seasoned drug developer Rick Panicucci, PhD, SVP at BridgeBio Pharma and a long time advisor at Cyclica has been appointed as non-executive Chairman of Perturba to help oversee the company's strategy. Su Dharmawardhane Flanagan, PhD, Tony Hunter, PhD and Ming Tsao, MD, have been appointed to Perturba’s Scientific Advisory Board. Cyclica will provide initial funding for Perturba and will seek external funding from strategic partners as required. “I’ve been involved in drug discovery & development for over 25 years. What I can say with certainty is that the way things will be done going forward is going to be very different from how it was done before. I’ve been an advisor at Cyclica for 6 years and have witnessed first hand the power of AI and data-first approaches to drive drug discovery fast and with quality. Now, with Perturba and integrating AI drug design and phenotypic assays opens a whole new way of design-make-test-analyze at scale for target classes that have been ignored for too long,” shares Panicucci. About Perturba An integrated oncology focused biotech company for unaddressable and undrugged targets. Founded in 2021 as a venture between Cyclica and the Stagljar Lab at the University of Toronto, Perturba integrates Cyclica’s AI-augmented drug discovery platform with sensitive, live-cell drug screening assays, MaMTH-DS and SIMPL from the Stagljar lab. Perturba is developing precision therapies at scale that modulate PPIs and PPI-mediated biological processes. About Cyclica Cyclica advances molecules that embrace the complexity of disease. A neo-biotech whose work spans dozens of collaborations with large pharma, biotech and several joint ventures. We are a passionate team of biotech and pharma professionals, biologists, chemists, and computer scientists who live and labour at the intersection of our collective expertise. About the Stagljar Lab and the Donnelly Centre The Stagljar lab at the University of Toronto is one of the world leading labs in the field of proteomics/chemical genomics, developing high-throughput technologies to facilitate the study of the protein-protein interactions (PPIs) of various human membrane proteins involved in cancer and rare genetic diseases such as cystic fibrosis. The Stagljar lab is currently directing major proteomics/chemical genomics projects to map how integral membrane proteins interact to produce either healthy or diseased cells, to identify novel therapeutic targets, and to screen for novel drugs using artificial intelligence platforms, in particular to target lung, colon, breast and pancreatic cancer. In close collaboration with medicinal chemists and clinical investigators, the Stagljar lab investigates the molecular mechanisms behind challenging, unexplained observations on drugs and on pathological events.

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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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MEDICAL

Kintor Pharma Provides Update on One of its Three Multi-Regional Phase 3 Trials of Proxalutamide for COVID-19

Kintor Pharma | December 29, 2021

Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, provided an update on its multi-regional study of proxalutamide for the treatment of COVID-19 infection. Statistical criteria were not met at an interim analysis of the phase III outpatient study, designed for testing efficacy and safety of proxalutamide for treating COVID-19 in non-hospitalized COVID-19 patients. At the interim analysis, 348 patients with mild-to-moderate COVID-19 symptoms were enrolled. Kintor Pharma will seek for Health Authorities including the U.S. Food & Drug Administration's consent to amend the protocol and continue to enroll higher risk COVID-19 patients only with multiple comorbidities and/or patients with no COVID-19 vaccination history. Based on the interim analysis, there were no safety concerns and no drug-related serious adverse events reported during the study. As of December 23, 2021, Kintor Pharma had completed the enrollment of this pivotal study according to the original protocol. More than 95 percent of the enrolled patients were from the U.S. For the interim analysis, all patients were from the U.S., where the hospitalization rate is very low. "The COVID-19 pandemic continues to evolve with the Omicron variant highlighting the need for therapeutics. It is important to investigate new modalities to treat those infected with the virus. We believe proxalutamide could become an important tool in the fight against COVID-19 infection and will continue to investigate its use. We will provide updates on the final data analysis from this outpatient clinical trial in due course." Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma The outpatient study is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of proxalutamide in outpatients with mild to moderate COVID-19 illness. For the interim analysis, the trial enrolled 348 male and female patients with one or more mild COVID-19-related symptoms within five days of symptoms onset. Participants were randomized to receive proxalutamide or placebo orally twice daily for 14 days. The enrolment covers the whole population including patients with a vaccination history, as well as without any risk factors. Both the treatment arm and placebo arm were given standard of care. The primary endpoint was the percentage of all-cause death and hospitalization for a period exceeding 24 hours by day 28. About Kintor's Multi-Regional Clinical Trials for Proxalutamide Kintor Pharma is conducting two registered Phase III multi-regional clinical trials of proxalutamide for the treatment of COVID-19 outpatients, and one Phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America, Asia and the European Union. The second outpatient study plans to enroll 724 patients, with the primary endpoint of percentage of subjects requiring oxygen by day 28. The inpatient study is a randomized, double-blind, placebo-controlled Phase III study. Male and non-pregnant female hospitalized adults are included. The primary endpoint is time to sustained recovery, and the key secondary endpoint is percentage of all-cause mortality. Kintor Pharma was granted an emergency use authorization for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay. About Proxalutamide Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which inhibits the overproduction of IL-6, proinflammatory cytokines, and chemokines. This mechanism of action reduces the intensity of the cytokine response, which may be of clinical benefit to patients with COVID-19 infection. About Kintor Pharmaceutical Limited Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne.

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