MEDICAL

Pfizer Invests $120 Million in Four Clinical-stage Biotech Companies Through the Pfizer Breakthrough Growth Initiative

Pfizer | January 15, 2021

Pfizer Inc. declared that, during the second 50% of 2020, it put a sum of $120 million of every four clinical-stage biotech organizations as a feature of the Pfizer Breakthrough Growth Initiative (PBGI). Through PBGI, Pfizer is putting up to $500 million in biotechnology organizations, giving subsidizing and admittance to Pfizer's logical skill to help guarantee the coherence of promising clinical improvement projects of likely future vital interest to Pfizer.

Pfizer's initial PBGI investments include:

$10 million in Vancouver, BC-based ESSA Pharma, a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer.

$25 million in Cambridge, Mass.-based Trillium Therapeutics, a clinical-stage immuno-oncology company focused on developing innovative therapies for the treatment of cancer. In addition, Jeff Settleman, Senior Vice President and Chief Scientific Officer of Pfizer’s Oncology Research & Development Group, was named to Trillium’s Scientific Advisory Board.

Spotlight

"Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Speed and revenue are also intertwined at Large Pharma as they struggle with R&D productivity and the pressure to fill pipelines with promising options. Speed to market takes on even greater urgency when you consider how critical it is to get these new treatments to the patients who need them. Read how CDMOs are responding to the mounting pressure.

Spotlight

"Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Speed and revenue are also intertwined at Large Pharma as they struggle with R&D productivity and the pressure to fill pipelines with promising options. Speed to market takes on even greater urgency when you consider how critical it is to get these new treatments to the patients who need them. Read how CDMOs are responding to the mounting pressure.

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INDUSTRIAL IMPACT

Gilead Sciences to Acquire MiroBio

Gilead Sciences, Inc. | August 05, 2022

Gilead Sciences, Inc. and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments. The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response. MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years. “The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.” “We are excited to be joining Gilead. MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.” Eliot Charles, Chairman of MiroBio Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. About MiroBio MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California

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MEDICAL

Be Bio and Resilience Announce Strategic Collaboration to Manufacture Engineered B Cells, a New Class of Cellular Medicines

Be Bio | May 20, 2022

Be Biopharma, Inc. (“Be Bio”) and National Resilience, Inc. (Resilience) today announced a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning. The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties. Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner, Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs.” Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio. Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work. This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies, By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. About B Cells – A New Class of Cellular Medicines Imagine what could “Be?” In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas. About Be Biopharma Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. About Resilience Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.

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INDUSTRIAL IMPACT

Ginkgo Bioworks and the Rwanda Development Board Announce Plans to Develop and Implement New Biosecurity Capabilities in Rwanda

Ginkgo Bioworks | August 12, 2022

Ginkgo Bioworks the leading horizontal platform for cell programming, and the Rwanda Development Board representing the government of the Republic of Rwanda, today announced that they have entered into a Memorandum of Understanding with the intent of developing and implementing new biosecurity capabilities in Rwanda. The initial goal of the planned partnership is to support Rwanda's public health institutions as they work to address biosecurity challenges in the region. Ginkgo, through its biosecurity and public health initiative, Concentric by Ginkgo, plans to collaborate on the ground with RDB to equip these institutions with biosecurity tools and training as well as the secure data infrastructure they need to leverage automation, data analysis, bioinformatics capabilities, and other critical genomic sequencing technologies. Concentric leverages a nationwide laboratory network to provide pathogen monitoring capabilities across thousands of sites in the U.S., including schools, airports, and other congregate settings. Concentric aims to build sustainable global biosecurity infrastructure to prepare for the next new variant or novel pathogen, and this planned partnership with RDB is a significant milestone in its international expansion as it continues to scale its biosecurity offering. RDB, a Rwandan government institution, was established in 2008 to accelerate Rwanda's economic development by enabling private sector growth. Ginkgo will build relationships with Rwandan public health institutions and private sector-led biotechnology initiatives in Rwanda; the RDB will contribute expertise in skills development and on-the-ground support for the partnership. Concentric and RDB recognize the importance of international collaboration and cooperation to promote global health security as biological threats emerge. Effective pathogen monitoring and data sharing capabilities can empower government officials, community leaders, and other stakeholders to make informed public health decisions. In the long-term, these capabilities can also be leveraged to form the foundation for a sustainable regional bioeconomy. For example, in the context of this MOU, Ginkgo and RDB plan to collaborate to inform workforce development priorities in the areas of biotechnology, biomanufacturing, and bioengineering, and to explore potential opportunities for Rwanda to leverage its biodiversity as a foundation for innovation within its bioeconomy. "The future of biosecurity is global—COVID-19 has shown us all that pathogens don't recognize national borders. To prepare for the next biological threat, we need the infrastructure in place to build a global weather map tracking the spread and evolution of infectious diseases. We deeply appreciate Rwanda's leadership working to define a new era of biosecurity, and we are incredibly excited to use our platform to support Rwanda's public health institutions with critical capabilities that we believe will help them face challenges ranging from this pandemic to agricultural and travel biosecurity." Matt McKnight, General Manager, Biosecurity at Ginkgo Bioworks Clare Akamanzi, Chief Executive Officer of the Rwanda Development Board, noted, "The COVID-19 pandemic has exposed the need for robust public health and biotechnology infrastructure in Rwanda and around the world. We are excited about our plans to partner with Ginkgo to bring cutting-edge biosecurity capabilities to Rwanda across various sectors including health and agriculture. We believe this will stimulate our growing bioeconomy and help us learn more about our biodiversity." About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. About the Rwanda Development Board The Rwanda Development Board is a government agency responsible for leading the country's transformation into a dynamic global hub for business, investment, tourism and innovation. Its mission is to fast-track economic development in Rwanda by enabling private sector growth.

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