On June 7, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the company has entered into a clinical trial collaboration agreement with Seagen Inc. to evaluate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with SEA-BCMA, Seagen’s investigational monoclonal antibody targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma (Press release, SpringWorks Therapeutics, JUN 7, 2021, View Source [SID1234583795]).

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase levels of membrane-bound BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.

"We continue to make significant progress advancing nirogacestat as a potential best-in-class cornerstone of BCMA combination therapy for patients with multiple myeloma and are delighted to work with Seagen to study nirogacestat in combination with SEA-BCMA, our first collaboration with a monoclonal antibody targeting BCMA," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our goal is to meaningfully improve clinical outcomes for patients with multiple myeloma and we look forward to generating clinical data using nirogacestat in combination with BCMA-directed therapies across modalities."

Under the terms of the agreement, Seagen will sponsor and conduct the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. Seagen and SpringWorks will also form a joint development committee to manage the clinical study, which is expected to commence in the second half of 2021.

In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat as a monotherapy in adults with progressing desmoid tumors.

About Nirogacestat
Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. In addition, SpringWorks and Fred Hutchinson Cancer Research Center have entered into a sponsored research agreement to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA directed therapies using a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

On June 7, 2021 Thermo Fisher Scientific, the world leader in serving science, and Newomics, a commercial-stage biotechnology company, reported that they are collaborating to develop a novel native liquid chromatography-mass spectrometry (LC−MS) platform to support various LC−MS applications (Press release, Lifescience Newswire, JUN 7, 2021, View Source [SID1234583793]). This agreement utilizes Newomics’ experience in creating innovative and integrative platforms and solutions for precision medicine and Thermo Fisher’s cutting-edge LC-MS systems to improve the throughput and robustness of microflow LC-MS in proteomics and biopharmaceutical applications.

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The agreement will bring together Thermo Fisher’s new-generation LC-MS systems, providing high-performance, innovative technology, and the Newomics Microflow-nanospray Electrospray Ionization (MnESI) source, to achieve high-sensitivity and high-throughput LC-MS analysis of bioorganic complexes, while maintaining their native state. The platform can tolerate a wide range of LC flow rates and high salt concentrations, which are critical for accommodating different native LC methods. The MnESI-MS platform provides a highly sensitive and reproducible analysis of nanospray applications, such as targeted peptide quantitation, and intact native and denatured protein analysis.

"Native MS is a powerful technique for studying the structure of intact proteins, large protein complexes, and protein-protein, protein-ligand interactions; however, the analysis of large native protein complexes and their mixtures in a high-throughput manner is challenging," said Andreas Huhmer, senior director of omics marketing, Thermo Fisher Scientific. "Our workflow with Newomics provides a hands-free approach to improve throughput for native MS analysis of large bioorganic complexes, providing the sensitivity of nanospray and the ability to maintain the native state of protein complexes during the MS analysis."

Dr. Daojing Wang, founder and CEO of Newomics, said, "Newomics is very excited to be launching our second co-marketing agreement with Thermo Fisher Scientific. When coupled with Thermo Fisher’s industry-leading mass spectrometers, Newomics’ new MnESI source offers an unmatched balance of sensitivity, robustness and reproducibility for small-volume, high-throughput analysis of biomolecules, such as therapeutic antibodies and RNAs for drug discovery and clinical research. The plug-and-play MnESI source works by rapidly delivering small amounts of samples to the award-winning Newomics M3 multinozzle emitters. The M3 emitter was the focus of Newomics’ first co-marketing agreement with Thermo Fisher in 2019, and once again, we’ll be working closely with their team to fulfill customer needs and address any challenges in mass spectrometry workflows."

To find out more about Thermo Fisher Scientific’s next-generation LC-MS systems, please browse our complete portfolio here.

Thermo Fisher Scientific will showcase its newest products, software solutions and collaborations in a company-hosted virtual event, "Innovation Summit: Shaping the Future of LC-MS in Life Science Together," from June 8-10, 2021. Register here to learn more.

On June 7, 2021 Elevation Oncology reported that it has filed to raise $100 million in an IPO (Press release, Elevation Oncology, JUN 7, 2021, View Source [SID1234583792]). The money will support development of an anti-HER3 antibody that failed multiple trials at Merrimack Pharmaceuticals before being picked up by Elevation and repositioned as a treatment for solid tumors harboring an NRG1 fusion.

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The antibody, seribantumab, failed multiple midphase trials, causing Sanofi to return the rights to the drug and ultimately leading to Merrimack offloading it to Elevation in 2019. Elevation picked up the molecule after identifying HER3 inhibition as an approach for tumors driven by an NRG1 fusion. In preclinical tests, HER3 inhibition led to reductions of growth for NRG1 fusion-driven tumors.

"We believe that direct inhibition of the NRG1 activation of HER3 with a monoclonal antibody approach may drive improved responses for these patients given its direct role in sustaining proliferation and survival of tumors harboring an NRG1 fusion," Elevation wrote in its IPO paperwork.

Elevation raised almost $100 million across series A and B rounds from investors including Aisling Capital, venBio Partners and Cormorant Asset Management, giving it the means to start a phase 2 clinical trial. Now, the biotech is seeking public investment for further development of seribantumab.

If successful, Elevation believes the phase 2 may support a filing for FDA approval. The 55-subject pivotal cohort of the study is enrolling patients with a centrally confirmed NRG1 fusion who haven’t been previously treated with an EGFR-, HER2- or HER3-directed therapy. The primary endpoint is the overall response rate.

Elevation sees other ERBB or HER3 inhibitors in development at companies including Merus, Rain Therapeutics, Hummingbird Bioscience, GamaMabs Pharma and AVEO Oncology as the key rivals to seribantumab. Other companies such as Daiichi Sankyo, GlaxoSmithKline and Boehringer Ingelheim are working on similar drugs, but Elevation is unsure whether they are targeting NRG1 fusion tumors.

On June 7, 2021 Ambrx, a San Diego clinical-stage biotech with operations in Shanghai, reported that it has filed for a US IPO that is expected to raise $100 million (Press release, Ambrx, JUN 7, 2021, View Source [SID1234583791]). Founded in 2003, Ambrx develops antibody-drug conjugates and bispecifics for unmet oncology needs. It builds engineered precision biologics by incorporating synthetic amino acids (SAAs) into proteins within living cells, a technology that offers better efficacy and safety, according to the company. Its lead drug, an ADC candidate, is being tested in a China Phase II/III trial for HER2-positive metastatic breast cancer led by a China partner, NovoCodex Biopharma.

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On June 7, 2021 MSD Animal Health, a division of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE:MRK), reported its intention to acquire the assets of LIC Automation Ltd. ("LICA"), from New Zealand-based, farmer-owned cooperative Livestock Improvement Corporation Ltd. ("LIC") (Press release, Merck & Co, JUN 7, 2021, View Source [SID1234583738]). LICA is a leader in automation and technology for the dairy industry. Specific terms of the agreement were not disclosed.

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LICA, a privately held company in New Zealand, manufactures and supplies specialised, integrated herd management systems and milk-testing sensors for the dairy industry. Farm productivity has become increasingly important on the dairy farm. LICA’s automated offerings including Protrack technology solutions, enables dairy farmers to gather precise information on the health and milking habits of dairy cows, which supports their efforts in herd management, real-time milk analysis, animal evaluation and reproductive health and wellness. LICA products are available in New Zealand and in selected European markets.

"We are pleased to take this step forward with the acquisition of LICA technology, as we continue to broaden our portfolio with complementary products and technologies to advance animal well-being and outcomes for our customers," said Rick DeLuca, president, MSD Animal Health. "Our portfolio of enhanced dairy farm management and livestock intelligence solutions for the dairy industry help address the evolving customer needs of dairy farmers and strengthen our leadership in shaping the future of animal health."

"We are excited to add LICA’s products to our existing veterinary medicines, vaccines and health management solutions and services, as well as Allflex Livestock Intelligence’s digitally connected identification, traceability and monitoring products to benefit farmers and veterinarians," said Pauline Calvert, Livestock Business Unit lead, MSD Animal Health, New Zealand. "MSD Animal Health has a substantial footprint in New Zealand as a leading partner in the agricultural community. The solutions we offer build upon our strong presence in New Zealand, which includes manufacturing facilities at Palmerston North (Allflex Livestock Intelligence, a business unit within MSD Animal Health), Upper Hutt (animal health vaccines) and now Hamilton (LICA milking intelligence and automation). We are exceptionally proud of our continuous commitment and investment to advance animal health and well-being for our unique pastoral-based farming systems in Aotearoa (New Zealand), that supports the efforts of our farmers’ in their day-to-day operations today and into the future. We look forward to continuing to expand our world-class animal health solutions both locally and globally."

LICA’s product portfolio joins Allflex Livestock Intelligence, the leading New Zealand livestock intelligence business. Allflex Livestock Intelligence is a complementary business that specialises in identification and monitoring technology that delivers real-time, actionable data and insights to help improve livestock management.

"We are pleased that MSD Animal Health has chosen to acquire this technology," said Wayne McNee, LIC chief executive. "MSD Animal Health has a reputation for investing heavily in research and development for animal health and welfare. The company has extensive scientific and technological capabilities that can take this technology to the next phase and deliver more value to farmers."