Overview
NovoNordisk Collaboration with Omega Therapeutics and Cellarity
Novartis and Voyager Collaboration to Develop Gene Therapies for Huntington's Disease and SMA
Novartis Plans to Acquire Morphosys
AstraZeneca to acquire Amolyt Pharma; aims to strengthen its rare disease portfolio
AstraZeneca to acquire Fusion Pharmaceuticals
Novo Nordisk to acquire Cardior Pharmaceuticals
AbbVie to acquire Landos Biopharma, aims to strengthen its immunology portfolio
January 04, 2023
Novo Nordisk Forges Innovative Collaborations with Omega Therapeutics and Cellarity for Advanced Cardiometabolic Disease Treatments
Novo Nordisk has initiated research collaborations with Omega Therapeutics and Cellarity to explore innovative treatment strategies for cardiometabolic diseases. The partnership with Omega aims to utilize its proprietary platform for developing an epigenomic controller to enhance metabolic activity, introducing a potential novel approach to managing obesity. Meanwhile, the collaboration with Cellarity focuses on unraveling new biological factors in metabolic dysfunction-associated steatohepatitis (MASH) and using Cellarity's platform to create a small molecule therapy for the disease.
These initiatives mark the initial two research programs under the existing collaboration framework between Novo Nordisk and Flagship Pioneering, utilizing Flagship's bioplatform companies to pioneer inventive treatments for cardiometabolic diseases. Novo Nordisk will cover the research and development costs, with each partnering company and Flagship's Pioneering Medicines eligible for upfront and milestone payments totaling up to 532 million US dollars, along with tiered royalties.
Globally, over 800 million adults grapple with obesity, prompting a need for effective interventions beyond appetite regulation. Omega's distinctive platform, tapping into the body's inherent mechanisms for controlling cellular identity and gene expression, holds promise for creating an epigenomic controller to boost thermogenesis and metabolic activity.
Metabolic dysfunction-associated steatohepatitis (MASH) presents a pressing health challenge, lacking an approved treatment. It is a chronic liver disease linked to an increased risk of type 2 diabetes and cardiovascular issues. Cellarity, with its unique capabilities bridging biology and chemistry through high-dimensional transcriptomic data, is poised to leverage its platform for developing a small molecule therapy against MASH. The collaboration expands on previous work initiated in September 2022 when Novo Nordisk engaged Cellarity to identify novel cellular behaviors associated with MASH disease progression.
In this endeavor to pioneer advanced treatments, Novo Nordisk is forging dynamic partnerships, capitalizing on cutting-edge technologies to address critical health concerns in the realm of cardiometabolic diseases.
Novartis and Voyager Therapeutics entered a collaboration to develop gene therapies for Huntington’s disease and spinal muscular atrophy
Voyager Therapeutics has entered into a strategic collaboration and capsid license agreement with Novartis, to advance gene therapies for Huntington’s disease (HD) and spinal muscular atrophy (SMA). This collaboration aims to explore new approaches for these diseases.
Novartis will be granted a target-exclusive license to access Voyager’s TRACER capsids and other intellectual property for HD and SMA. The companies will work together to progress a preclinical gene therapy candidate for HD. Novartis had previously exercised options to license novel capsids from Voyager’s TRACER capsid discovery platform for two undisclosed neurological disease targets.
As part of the collaboration's financial terms, Novartis will provide an upfront consideration of $100 million, including a $20 million purchase of newly issued equity in Voyager. Voyager stands to receive up to $1.2 billion in milestone payments related to preclinical, development, regulatory, and sales achievements, along with tiered royalties on global net sales of products incorporating Voyager’s TRACER capsids.
Novartis will have exclusive access to Voyager’s TRACER capsids for SMA throughout the agreement, taking responsibility for development and commercialization.
Additionally, Novartis will gain worldwide rights to Voyager’s AAV gene therapy for HD, utilizing Voyager’s TRACER capsids and proprietary payloads. Voyager will oversee preclinical advancement, while Novartis will handle all clinical development and commercialization for the HD program.
Voyager’s TRACER Capsid Discovery Platform is an RNA-based screening platform that facilitates the swift discovery of AAV capsids with robust blood-brain barrier penetration and enhanced central nervous system tropism. TRACER capsids, generated in preclinical studies, have shown widespread gene expression in the CNS compared to conventional AAV capsids. They also exhibit cell- and tissue-specific transduction, reaching challenging areas of the brain while avoiding the liver and dorsal root ganglia.
Novartis Aims to Bolster its Oncology Portfolio with MorphoSys Acquisition
Novartis intends to bolster its oncology portfolio through an agreement to purchase MorphoSys at EUR 68 per share, totalling EUR 2.7 billion in cash. This transaction encompasses pelabresib, a late-stage BET inhibitor targeting myelofibrosis (MF), and tulmimetostat, an early-phase dual inhibitor of EZH2 and EZH1 for solid tumours or lymphomas.
Recently, pelabresib achieved its primary goal of reducing spleen volume and exhibited promising trends in symptom alleviation with a well-tolerated safety profile in the Phase 3 MANIFEST-2 trial. Administered alongside ruxolitinib in JAK inhibitor-naive MF patients, this combination therapy holds potential as a groundbreaking first-line treatment for myelofibrosis, with a planned regulatory submission to the U.S. FDA in the second half of 2024.
This acquisition aligns with Novartis' strategic emphasis on oncology and reinforces its commitment to advancing next-generation cancer therapies. The all-cash offer of EUR 68 per share (or EUR 2.7 billion in total) has received unanimous approval from both Novartis and MorphoSys Boards and is expected to finalize in the first half of 2024, subject to customary closing prerequisites and regulatory clearances, including a minimum acceptance threshold of 65% of outstanding shares tendered in the takeover offer.
Upon completion, Novartis will gain ownership of pelabresib (CPI-0610), a novel therapy with the potential to revolutionize MF treatment when combined with ruxolitinib. Additionally, the acquisition includes tulmimetostat (CPI-0209), an early-phase dual inhibitor of EZH1 and EZH2 proteins under investigation for solid tumors or lymphomas.
February 12, 2024
Gilead to acquire CymaBay Therapeutics; aims to bring new therapy for PBC
Gilead Sciences has broadened its liver treatment offerings through the acquisition of CymaBay Therapeutics, adding Seladelpar to its portfolio. Seladelpar, a PPARδ agonist designed for treating Primary Biliary Cholangitis (PBC), is currently undergoing FDA priority review, with anticipated approval in the third quarter of 2024. Phase 3 data for Seladelpar demonstrates its efficacy as a second-line treatment for PBC, showcasing a best-in-disease profile.
The acquisition, valued at $4.3 billion, solidifies Gilead's commitment to providing innovative therapies to patients. PBC is a rare liver disease, particularly affecting middle-aged women, with symptoms including itching and fatigue. Left untreated, PBC can lead to severe liver complications and increased mortality risk.
Seladelpar functions as an oral, selective agonist of the peroxisome proliferator-activated receptor delta (PPARδ), targeting key metabolic and liver disease pathways. The FDA has prioritized its review, with an expected decision by August 14, 2024. Seladelpar has received Breakthrough Therapy Designation and Orphan Drug Designation, highlighting its potential in addressing unmet medical needs.
In the pivotal Phase 3 trial (RESPONSE), Seladelpar demonstrated significant improvement over placebo in key endpoints, including biochemical response and reduction of pruritus, providing hope for patients suffering from moderate to severe symptoms.
AstraZeneca to acquire Amolyt Pharma; aims to strengthen its rare disease portfolio
AstraZeneca is set to acquire Amolyt Pharma, marking a significant expansion in its late-stage pipeline for rare diseases. Amolyt Pharma, a clinical-stage biotech company, focuses on pioneering treatments for rare endocrine disorders.
This acquisition will strengthen AstraZeneca's Rare Disease portfolio, particularly its bone metabolism franchise, by incorporating eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide aimed at addressing the critical needs of patients with hypoparathyroidism. This strategic move builds upon AstraZeneca's success in bone metabolism and underscores its commitment to rare endocrinology.
Hypoparathyroidism, characterized by insufficient production of parathyroid hormone (PTH), leads to severe imbalances in calcium and phosphate levels, often resulting in debilitating symptoms and complications such as chronic kidney disease. This condition affects a substantial number of individuals globally, with around 115,000 cases in the United States and 107,000 cases in the European Union, predominantly affecting women.
Eneboparatide, acting as a PTH receptor 1 (PTHR1) agonist, offers a unique mechanism of action tailored to address the therapeutic needs of hypoparathyroidism. Phase II clinical data has demonstrated its ability to normalize serum calcium levels and potentially reduce the reliance on daily calcium and vitamin D supplements. Notably, in adults with chronic hypoparathyroidism and hypercalciuria, eneboparatide has shown efficacy in normalizing urinary calcium levels. Furthermore, it has exhibited the potential to preserve bone mineral density, a crucial benefit for patients susceptible to osteopenia or osteoporosis.
With this acquisition, AstraZeneca aims to advance its Rare Disease pipeline, addressing unmet medical needs and improving outcomes for patients with hypoparathyroidism and other rare endocrine disorders.
March 19. 2024
AstraZeneca to acquire Fusion Pharmaceuticals; aims to develop next-gen radioconjugates
AstraZeneca has announced its acquisition of Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing next-generation radioconjugates (RCs) for cancer treatment. This strategic move reflects AstraZeneca's commitment to revolutionizing cancer therapy, aiming to replace conventional treatments like chemotherapy and radiotherapy with more precise and effective options.
RCs have emerged as a promising approach in cancer treatment, delivering radioactive isotopes directly to cancer cells using targeted molecules such as antibodies, peptides, or small molecules. This targeted delivery offers several potential advantages over traditional radiotherapy, including reduced damage to healthy cells and improved access to tumors.
The acquisition of Fusion Pharmaceuticals enhances AstraZeneca's oncology portfolio with Fusion's pipeline of RCs, notably FPI-2265, the most advanced program targeting prostate-specific membrane antigen (PSMA) for metastatic castration-resistant prostate cancer (mCRPC). FPI-2265 is currently undergoing Phase II clinical trials.
Moreover, the acquisition brings Fusion's expertise in actinium-based RCs, along with advanced capabilities in research and development, manufacturing, and supply chain management. This move also reinforces AstraZeneca's commitment to Canada, as Fusion will continue its operations as a wholly owned subsidiary of AstraZeneca, with operations remaining in both Canada and the US.
Novo Nordisk to Purchase Cardior Pharmaceuticals, Enhancing Cardiovascular Disease Pipeline
Novo Nordisk and Cardior Pharmaceuticals disclosed today their agreement for Novo Nordisk to acquire Cardior for up to 1.025 billion Euros, comprising an initial payment and additional sums contingent upon attaining specific developmental and commercial milestones.
Cardior stands as a frontrunner in discovering and advancing therapies targeting RNA to prevent, rectify, and reverse heart-related ailments. The company's therapeutic strategy focuses on distinctive non-coding RNAs, serving as a foundation for tackling fundamental causes of cardiac disorders with the objective of delivering enduring benefits to patients.
The deal encompasses Cardior's primary compound CDR132L, presently undergoing phase 2 clinical trials for heart failure treatment.
This acquisition marks a significant stride in Novo Nordisk's endeavor to establish a foothold in cardiovascular disease. Novo Nordisk is committed to constructing a purposeful, impactful portfolio of treatments, leveraging both internal and external innovations to address the substantial unmet demands prevalent in cardiovascular disease, the leading global cause of mortality.
CDR132L is engineered to arrest and partially reverse cellular abnormalities by specifically obstructing abnormal levels of the microRNA molecule miR-132, potentially resulting in sustained enhancement of heart functionality.
AbbVie Ventures into Landos Biopharma Acquisition, Expanding Focus on Inflammatory and Autoimmune Conditions
AbbVie and Landos Biopharma have reached a definitive agreement wherein AbbVie will acquire Landos, a clinical-stage biopharmaceutical firm dedicated to pioneering novel oral treatments for patients grappling with autoimmune ailments.
Landos' primary investigational asset, NX-13, stands as a groundbreaking oral NLRX1 agonist (a constituent of the NOD-like receptor family) featuring a dual-action mechanism that combats inflammation while promoting epithelial restoration. NLRX1 plays a pivotal role in regulating immunometabolism and inflammation, influencing various pathways implicated in the pathogenesis of inflammatory bowel disease (IBD).
The ongoing randomized controlled Phase 2 NEXUS clinical trial, assessing NX-13 in ulcerative colitis (UC), is actively enrolling participants across the United States and Europe (NCT05785715).
Per the agreement's stipulations, AbbVie will procure Landos at $20.42 per share in cash upon closure, totaling approximately $137.5 million collectively, alongside one non-tradable contingent value right per share, valued at up to $11.14 per share, amounting to an additional roughly $75 million in aggregate, contingent upon achieving a clinical development milestone. The proposed transaction is slated for completion in the second quarter of 2024, contingent upon customary closing conditions, including approval by Landos' shareholders. NEXUS serves as a Phase 2 proof-of-concept trial examining NX-13's efficacy in patients afflicted with moderate to severe UC. It is designed as a randomized, multicenter, double-blind, placebo-controlled study with multiple dosage arms spanning a 12-week induction period, involving 80 patients with moderate to severe UC, followed by a long-term extension (LTE) phase. Participants will be randomized to receive either 250 mg or 750 mg immediate-release NX-13 or placebo. The primary aim of the trial is to assess the clinical effectiveness, safety profile, and pharmacokinetics of oral NX-13 vis-à-vis placebo.