MEDICAL

Merck Enters into Supply Agreement with U.S. Government to Manufacture and Initial Distribution of Investigational Biological Therapeutic

Merck | December 28, 2020

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today declared it has gone into a agreement with the United States Government to help the turn of events, assembling and introductory dispersion of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon endorsement or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the securing of OncoImmune, a privately held, clinical-stage biopharmaceutical organization.

“Building upon the promising clinical findings to date for MK-7110, Merck is pleased to be collaborating with the U.S. Government to advance the manufacture and distribution of this candidate for patients with serious COVID-19 disease,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.

Under the arrangement, Merck will get up to around $356 million for assembling and supply of roughly 60,000-100,000 dosages of MK-7110 to the U.S. Government through June 30, 2021 to meet the public authority's Operation Warp Speed objectives. This methodology is proposed to assist conveyance of MK-7110 to the American individuals as fast as could be expected under the circumstances, following potential EUA or FDA endorsement. Merck is manufacturing contributing to extend its assembling ability to expand supply of MK-7110.

Spotlight

The International Service for the Acquisition of Agri-biotech Applications (ISAAA) released its annual report showcasing the 110-fold increase in the adoption rate of biotech crops globally in just 21 years of commercialization – growing from 1.7 million hectares in 1996 to 185.1 million hectares in 2016. ISAAA’s report, “Global Status of Commercialized Biotech/GM Crops: 2016,” continues to demonstrate the long-standing benefits of biotech crops for farmers in developing and industrialized countries, as well as consumer benefits of recently approved and commercialized varieties.

Spotlight

The International Service for the Acquisition of Agri-biotech Applications (ISAAA) released its annual report showcasing the 110-fold increase in the adoption rate of biotech crops globally in just 21 years of commercialization – growing from 1.7 million hectares in 1996 to 185.1 million hectares in 2016. ISAAA’s report, “Global Status of Commercialized Biotech/GM Crops: 2016,” continues to demonstrate the long-standing benefits of biotech crops for farmers in developing and industrialized countries, as well as consumer benefits of recently approved and commercialized varieties.

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INDUSTRIAL IMPACT

eTheRNA Announces Research Agreement with Merck KGaA, Darmstadt, Germany to access mRNA technologies

eTheRNA | February 04, 2022

eTheRNA immunotherapies NV ("eTheRNA") is pleased to announce the start of a strategic partnership with Merck KGaA, Darmstadt, Germany with the signing of a Research Agreement. The partnership will investigate the application of eTheRNA's proprietary mRNA design expertise and LNP-delivery platforms to disease areas selected by Merck KGaA, Darmstadt, Germany. The ongoing pandemic has underlined the capability for mRNA vaccines as a new therapeutic modality. eTheRNA and Merck KGaA, Darmstadt, Germany both recognise the potential for using targeted mRNA therapeutics in an expanded range of diseases. With this collaboration, eTheRNA and Merck KGaA, Darmstadt, Germany will assess the feasibility of using eTheRNA's mRNA and LNP technologies to develop therapeutic vaccination approaches in models of disease. If successful, mRNAs encoding antigens nominated by Merck KGaA, Darmstadt, Germany and directly relevant for human diseases will then be designed and evaluated preclinically. "We are extremely pleased to sign this partnership agreement with Merck KGaA, Darmstadt, Germany, a leading German science and technology company. As two companies committed to innovation and creating patient focused solutions, we are excited about the many advantages such a partnership can offer to improve patient care and address a significant market need". Steven Powell, eTheRNA CEO About eTheRNA immunotherapies eTheRNA immunotherapies NV is developing immunotherapy and vaccine products for the treatment of cancer and infectious disease from its mRNA chemistry, antigen identification, lipid chemistry and delivery and process engineering platforms. The company is headquartered in Belgium and was established in 2013. Its founding shareholders include Progress Pharma and VUB. eTheRNA is supported by an international group of specialised investors; BNP Fortis Private Equity, Boehringer Ingelheim Venture Funds, Everjoy Fortune PTE. LTD, Grand Decade Development Limited, Fund+, LSP, Novalis Lifesciences, Omega Funds, PMV and Ying Zhou Enterprise Management Company Limited who share the Company's ambition to build a world-leading company in the RNA field. To date, the Company has raised €63 million of venture funding.

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MEDTECH

Pfizer to Acquire Trillium Therapeutics Inc.

Pfizer Inc | August 24, 2021

Pfizer Inc. and Trillium Therapeutics Inc. today announced that the companies have entered into a definitive agreement under which Pfizer will acquire Trillium, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash. This represents a 118% premium to the 60-day weighted average price for Trillium. Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies. TTI-622 and TTI-621 are novel, potentially best-in-class SIRPα-Fc fusion proteins that are currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies. “Today’s announcement reinforces our commitment to pursue scientific breakthroughs with the addition of potentially best-in-class molecules to our innovative pipeline,” said Andy Schmeltz, Global President & General Manager, Pfizer Oncology. “The proposed acquisition of Trillium builds on our strong track record of leadership in Oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our deep experience in understanding the science of blood cancers, along with the diverse knowledge base we have developed across our growing hematology portfolio of eight approved and investigational therapies, provide us with a foundation to advance these important potential medicines to patients who need them.” Hematological malignancies are cancers that affect the blood, bone marrow, and lymph nodes. This classification includes various types of leukemia, multiple myeloma, and lymphoma. More than 1 million people worldwide were diagnosed with a blood cancer in 2020, representing almost 6% of all cancer diagnoses globally. In 2020, more than 700,000 people worldwide died from a form of blood cancer. “We’re delighted to announce Pfizer’s proposed acquisition of Trillium. Today’s announcement reflects Trillium’s potentially best in class SIRPα–CD47 status and contribution to immuno-oncology,” said Dr. Jan Skvarka, Chief Executive Officer of Trillium. “Trillium has the only known SIRPα–CD47 targeting molecules with clinically meaningful monotherapy responses as well as a strong basis for combination therapies, which is supported by preclinical evidence with a diverse set of therapeutic agents. With Pfizer’s global reach and deep capabilities, we believe our programs will advance more quickly to the patients we’ve always aspired to serve. We believe this is a good outcome for patients and our shareholders.” In clinical studies to-date, TTI-622 and TTI-621 have demonstrated activity as monotherapy in relapsed or refractory lymphoid malignancies, including Diffuse Large B-cell Lymphoma (DLBCL), Peripheral T-cell lymphoma (PTCL), Follicular Lymphoma (FL), and other lymphoid malignancies. As of July 26, 2021, Phase 1 data for TTI-622 in 30 response-evaluable patients have shown deep and durable responses in heavily pretreated patients, including two complete responses (CRs), one lasting over 114 weeks, with responses ongoing. TTI-622 and TTI-621 are currently the only known CD47-targeted molecules that have demonstrated meaningful single agent activity and CRs in multiple hematological malignancies. Thus far, adverse events (AEs) reported with TTI-622 and TTI-621 have been manageable. Related Grade 3 and 4 AEs with TTI-622 were rare and limited to transient cytopenias. In particular, the molecules demonstrate minimal red blood cell binding and few reported cases of anemia, an observed risk with other CD47-targeted approaches. Further data are expected to be shared at a forthcoming medical conference. “We are encouraged by the early clinical data for TTI-622 and TTI-621 monotherapy for patients with heavily pretreated lymphoid malignancies and early encouraging activity for TTI-622 in patients with multiple myeloma. Just as PD-1 and PD-L1 blockers have proven to be effective immuno-therapeutics for many solid tumors, the SIRPα-CD47 interaction defines a second key immune checkpoint for which disrupting agents are expected to become another important backbone immunotherapy for multiple types of cancer, especially hematological cancers,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology, Pfizer Global Product Development. “Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of SIRPα fusion proteins as a potential new scientific breakthrough and explore combinations within our own portfolio and with innovative next-generation medicines for hematological malignancies.” In September 2020, as part of the Pfizer Breakthrough Growth Initiative (PBGI), Pfizer invested $25 million in Trillium and Jeff Settleman, Senior Vice President and Chief Scientific Officer of Pfizer’s Oncology Research & Development Group, was named to Trillium’s Scientific Advisory Board. Established in June 2020, PBGI’s goal is to provide funding for scientific research as well as access to Pfizer’s experts to ensure the continuity of clinical programs that could be of potential strategic interest for Pfizer. Pfizer has committed to providing up to $500 million in total funding to the PBGI. Additional Transaction Details The proposed acquisition of Trillium is to be completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) and subject to customary closing conditions, including approval of 66⅔% of the votes cast by Trillium shareholders, voting together as one class, at a special meeting of Trillium and approval of 66⅔% of the votes cast by Trillium shareholders and warrant holders, voting together as one class, at a special meeting of Trillium. Completion of the acquisition is also subject to court and regulatory approval, as well as certain other closing conditions customary for transactions of this nature. Pfizer’s financial advisors for the transaction are BofA Securities, Inc., with Ropes & Gray LLP and Norton Rose Fulbright Canada LLP acting as its legal advisors. Centerview Partners LLC served as Trillium’s financial advisor, while Goodwin Procter LLP and Baker McKenzie LLP (Canada) served as its legal advisors. About SIRPα/CD47 Accumulating data suggest that the SIRPα–CD47 axis is a key immune checkpoint in hematologic malignancies, similar to the PD-L1 / PD-1 checkpoint for solid tumors. CD47 is a protein that is overexpressed in numerous cancer cells, and in general, high CD47 expression correlates with more aggressive disease and poorer clinical outcomes. SIRPα is an inhibitory receptor expressed on myeloid cells that binds to CD47, preventing the immune system from destroying cancer cells. Disruption of the CD47-SIRPα interaction has been proven to elicit tumor destruction through triggering of an innate immune response. About Pfizer Oncology At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of people living with cancer. Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma. About Pfizer: At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. About Trillium Therapeutics Trillium is an immuno-oncology company developing innovative therapies for the treatment of cancer. The company’s two clinical programs, TTI-622 and TTI-621, target CD47, a “don’t eat me” signal that cancer cells frequently use to evade the immune system.

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MEDTECH

Biotech Start-Up Aanika Biosciences Lands Initial $12M Funding for Cutting-Edge Food Tracing Technology

Aanika Biosciences | December 01, 2021

Biotech start-up Aanika Biosciences today announced the initial closing of its $12 million Series A round, led by Jon Cholak of Adit Ventures along with existing investors Draper Associates and SOSV. The investment will help scale the company’s food tracing technology platform, advance research and expand its Brooklyn food safety and manufacturing facility to approximately 30,000 square feet. Aanika's proprietary technology is designed to accelerate the speed and accuracy of how food safety issues are handled. The platform, which uses edible microbial ‘tags,’ has already been tested on leafy greens and has the potential to be applied to other foods and ingredients including oils, coffee, meats and grains. “Innovation in food safety is long overdue, and there couldn’t be a more important time to bring a technology like this to the market. The pandemic has truly exposed the fragility of our supply chain. Being able to expand and build out our capability will give farmers, insurers, food companies and consumers an added layer of transparency and security, as well as minimize the economic and environmental impact of food recalls.” Dr. Ellen Jorgensen, Chief Science Officer for Aanika The technology enables farmers to 'watermark' crops with edible, food-friendly microbes that can be detected at any point in the product’s journey through the supply chain, so that when there is a case of foodborne illness it can be traced directly to the source. “Foodborne illness impacts over 50 million people and costs the U.S. tens of billions of dollars a year. Our technology can help minimize the impact and we are developing solutions that may prevent it from happening in the first place,” said co-founder and CEO of Aanika, Vishaal Bhuyan. “Identifying the origin of food recalls is just the start of what this platform can do. We are excited to see how far we can push our microbial technology to add value in the form of combating contamination, increasing nutritional content and supporting crop health. We are also exploring how our technology can even revolutionize agricultural insurance underwriting. All of this is driven by the power of biology.” "We believe Aanika could transform the food system as their traceability technology can integrate with the blockchain and ensure high quality data from end-to-end,” said Tim Draper, Founder and Managing Partner of Draper Associates. About Aanika Biosciences Aanika Biosciences was co-founded in 2018 by Vishaal Bhuyan after he personally experienced the consequences of ordering fresh, ethically sourced seeds and receiving stale, contaminated products instead. He made it is his mission to create a safer food supply by finding a way to track, trace and authenticate products. Aanika’s customized microbial-based tags help companies gain valuable insights about their supply chains, help their customers make better consumption choices, and create a more sustainable world.

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