Disarm Therapeutics brings on former Enzyvant boss Shih as CEO

Fiercebiotech | July 22, 2019

Disarm Therapeutics has a full-time CEO the neuro-focused biotech has signed on Alvin Shih, MD, the former Retrophin R and D chief who went on to helm Enzyvant until February this year. Shih joins Disarm as it moves its stable of SARM1 inhibitors through preclinical development. The company uncloaked in September 2017 with $30 million in series A cash to work on treatments targeting axonal degeneration in neurological diseases. The Cambridge, Massachusetts-based biotech’s mission is to “disarm” the SARM1 protein, which plays a key role in the degeneration of axons, the nerve fibers that carry signals between neurons. It has licensed exclusive rights to key SARM1 discoveries from Washington University in St. Louis. “Scientists and physicians have long sought to identify the underlying trigger or mechanism driving axonal degeneration because of its early and ongoing role in disability and disease progression. (Jeffrey Milbrandt and Aaron DiAntonio of Washington University) recently identified that SARM1 possesses intrinsic enzymatic activity that is itself the central driver of axonal degeneration, providing an important new target,” said Disarm co-founder and Atlas Venture partner Jason Rhodes at launch. He's been keeping the seat warm as acting CEO until now. The company is betting that targeting axonal degeneration could slow or even stop the progression of diseases of the central, ocular and peripheral nervous systems, including multiple sclerosis and amyotrophic lateral sclerosis.

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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CELL AND GENE THERAPY

Through Cutting-Edge mRNA and AI Technology Platforms, I-Mab Expands Its Emerging Portfolio of Next-Generation Novel Oncology Therapeutics

I-Mab | July 12, 2021

I-Mab, a clinical-stage biopharmaceutical business dedicated to discovering, developing, and commercialization of novel biologics, announced today the signing of two new partnerships with Chinese emerging biotech firms to enhance its next-generation innovation pipeline. Collaborations with Immorna, an mRNA biotech company, and neoX Biotech, an AI-enabled R&D biotech company, provide I-Mab access to revolutionary technologies to search for new cancer treatments. I-Mab will create new anti-cancer antibody therapies using Immorna's ground-breaking self-replicating mRNA technology. Furthermore, I-Mab will collaborate with neoX Biotech on up to ten new biologics programs that will use neoX's unique artificial intelligence algorithm under a strategic partnership agreement. Today's announcement adds to the Company's existing collaboration agreements with Complix for a cell-penetrating antibody platform and Affinity for a masking antibody platform in March 2021, allowing it to continue expanding its globally competitive pipeline of next-generation antibody assets enabled by transformative technologies. The cooperation agreements specify that both partner firms will earn secret upfront and milestone payments. About I-Mab I-Mab is a global biotech business focused on discovering, developing and ultimate commercialization of new and highly distinct biologics in the immuno-oncology therapeutic space. Through drug discovery, the Company's goal is to deliver transformational medicines to patients all around the globe. I-internationally, Mab's competitive pipeline of more than 15 clinical and preclinical stage therapeutic candidates is driven by its internal R&D capabilities and global licensing agreements based on the Company's exclusive Fast-to-Proof-of-Concept and Fast-to-Market pipeline development methods. The Company is quickly transitioning from clinical-stage biotech to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility, and commercialization capacity. I-Mab has a global presence in Shanghai, Beijing, Hangzhou, Hong Kong in China, and Maryland and San Diego in the United States. About Immorna Immorna, founded in 2019, is a rapidly expanding biotech company focused on creating self-replicating and traditional mRNA-based therapeutics and vaccines. Immorna has developed a strong CMC platform for mRNA synthesis, purification, and analytical testing since its inception, and it is ideally suited for commercial development. In addition, Immorna has developed an arsenal of mRNA delivery vehicles using cutting-edge screening tools, including polymers and lipid nanoparticles containing multiple proprietary cationic lipids suited for intramuscular, intravenous, or tissue-targeting delivery. Immorna's pipeline is diverse, including cancer immunotherapy, infectious diseases, rare genetic disorders, and cosmetology. Immorna's oncology and infectious disease projects are nearing the clinical stage. Immorna's global presence includes Hangzhou, Shanghai in China, and Wilmington, DE in the United States. About neoX Biotech neoX Biotech is a next-generation biotech firm that focuses on computational design for novel drug research and development. neoX focuses on studying and developing macromolecular medicines and multi-specific drugs by combining artificial intelligence (AI), biophysics, and high-throughput experiments. neoX has created a highly transferable and sophisticated platform for early drug discovery via in-depth protein-protein interaction analysis (PPI). NeoX has shown preclinical success in a number of novel drug pipelines derived from this platform. Founded in 2018 by two physicians from MIT and Caltech, neoX has received over $100 million in funding from renowned venture capital firms such as Sequoia Capital China, 5Y Capital, Vision Plus Capital, Vertex Ventures, LYFE Capital, ZhenFund, and others.

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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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Innatoss Laboratories Launches Neutralizing Antibody Testing Service Against SARS-CoV-2 using GenScript's cPass ™ Kit

Innatoss Laboratories | September 15, 2020

Innatoss Laboratories announced today the first neutralizing antibody testing service against SARS-CoV-2 for the public in Europe, using GenScript's cPass ™ SARS-CoV-2 Neutralization Antibody Detection Kit. The kit is the first in the world that enables rapid detection of neutralizing antibodies (NAbs), the specific antibodies present in the serum of COVID-19 patients that are responsible for clearing the viral infection. Innatoss is the first medical lab in Europe to provide a service of this kind for the public. "Our collaboration with GenScript is a crucial step toward offering high-quality, innovative products to combat the COVID-19 pandemic, which poses a global threat to public health," said Dr. Anja Garritsen, CEO of Innatoss. "cPass ™ uses a novel test method that is capable of detecting the presence of virus-specific neutralizing antibodies. The test would be useful in determining the longevity of potential immunity both in individuals and the broader population, and facilitating development of vaccines and monoclonal antibody therapy development. It will become the key test to monitor titers once vaccination has been implemented." Innatoss recently performed a study in Kessel, a city in the south of the Netherlands that was severely affected during the first wave of COVID-19, to determine the longevity of binding antibodies versus neutralizing antibodies in individuals. The people were initially tested 2-4 months post infection using a rapid test for IgG and IgM levels, and then were retested 2-3 months later. Afterwards, the patients' samples were tested for neutralizing antibodies using the GenScript cPass™ kit. In 90 percent of the cases the binding antibody levels dropped significantly over time while the level of functional antibodies (neutralizing antibodies) was stable in 70 percent of those tested.

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