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.
May 02, 2024
Novartis to acquire Mariana Oncology, aims to strengthen its radioligand therapies portfolio
Novartis has recently announced its agreement to acquire Mariana Oncology, a biotech company headquartered in Watertown, Massachusetts, specializing in pioneering radioligand therapies (RLTs) for cancer treatment. Mariana Oncology focuses on developing innovative RLTs aimed at addressing the pressing needs of cancer patients.
The acquisition encompasses Mariana Oncology's diverse portfolio of RLT programs, ranging from lead optimization to early development, targeting various solid tumour indications, including breast, prostate, and lung cancer. Notably, one of the key development candidates included in this acquisition is MC-339, an actinium-based RLT under investigation for small-cell lung cancer.
RLTs, also known as radiopharmaceuticals, represent a form of precision medicine that combines a tumour-targeting ligand with a therapeutic radioisotope. By binding to specific receptors on the surface of tumor cells, RLTs deliver radiation directly to the cancerous cells, minimizing damage to surrounding healthy tissue. This targeted approach holds promise for inhibiting tumor growth and potentially inducing cell death.
Novartis already boasts two approved RLTs for specific patient populations suffering from metastatic castration-resistant prostate cancer and certain types of gastroenteropancreatic neuroendocrine tumors. Furthermore, the company's robust pipeline includes multiple programs at various stages of development, focusing on prostate cancer and other promising therapeutic areas. Novartis is actively exploring new isotopes, combinations with complementary mechanisms of action, and expansion into new disease areas to drive innovation in RLT therapies.
Through this acquisition, Novartis aims to strengthen its position in the field of oncology and accelerate the development of novel RLTs to address the unmet needs of cancer patients worldwide.
May 23, 2024
AbbVie Completes Acquisition of Landos Biopharma, Enhancing Pipeline with Innovative IBD Treatment
AbbVie has completed its acquisition of Landos Biopharma, integrating the company and its promising investigational treatments into AbbVie's robust pipeline.
The centrepiece of this acquisition is NX-13, a pioneering oral NLRX1 agonist, which belongs to the NOD-like receptor family. NX-13 is currently undergoing Phase 2 clinical trials aimed at treating moderate to severe ulcerative colitis (UC) through the NEXUS study (NCT05785715). This therapeutic candidate works by modulating immunometabolism and inflammation, potentially addressing the root causes of inflammatory bowel diseases (IBD) such as UC and Crohn's disease (CD). NX-13's unique dual mechanism combines anti-inflammatory properties with the promotion of epithelial repair, offering a new treatment strategy for these conditions.
The NEXUS trial is a Phase 2, proof-of-concept study designed to evaluate the efficacy of NX-13 in patients with moderate to severe UC. This trial is a randomized, multicenter, double-blind, placebo-controlled, multiple-dose study spanning 12 weeks and involving 80 participants. Patients are assigned to receive either 250 mg or 750 mg of immediate-release NX-13 or a placebo. The primary focus of the trial is to assess the clinical efficacy, safety, and pharmacokinetics of NX-13 compared to the placebo (NCT05785715).
With this acquisition, AbbVie aims to advance the development of NX-13, which holds the promise of delivering a novel therapeutic option for patients suffering from UC and CD.
Merck to acquire EyeBio
Merck to acquire EyeBio with a $1.3 billion upfront payment and potential future milestone payments totaling up to $1.7 billion, making the overall deal worth $3 billion.
EyeBio is advancing a pipeline of clinical and preclinical candidates aimed at preventing and treating vision loss due to retinal vascular leakage, a known risk factor for retinal diseases. The company’s leading candidate, Restoret (EYE103), is an investigational, potentially first-in-class tetravalent, tri-specific antibody that functions as an agonist of the Wnt signaling pathway. Following positive results from the open-label Phase 1b/2a AMARONE study in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret is expected to proceed to a pivotal Phase 2b/3 trial for DME in the latter half of 2024.
Restoret is administered via intravitreal injection and seeks to stop retinal vascular leakage by activating the Wnt pathway, with the objective of restoring and maintaining the blood-retinal barrier. Preclinical evidence suggests that Wnt pathway activation in the retina may decrease vascular leakage.
Eyebiotech Limited (EyeBio) is a clinical-stage, privately held biotech company focused on ophthalmology, committed to developing and delivering new therapies to protect, restore, and enhance vision in patients with serious eye diseases.
June 04, 2024
AstraZeneca Completes Acquisition of Fusion Pharmaceuticals Inc.
AstraZeneca today announced the successful acquisition of Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company specializing in next-generation radioconjugates (RCs). This acquisition is a significant step in AstraZeneca's mission to revolutionize cancer treatment, aiming to replace traditional therapies like chemotherapy and radiotherapy with more targeted approaches.
Strategic Benefits
The acquisition enhances AstraZeneca’s oncology portfolio by integrating Fusion's advanced RC pipeline, including FPI-2265, a promising new therapy for metastatic castration-resistant prostate cancer (mCRPC). Additionally, this acquisition brings new expertise in actinium-based RCs and strengthens AstraZeneca's research, development, manufacturing, and supply chain capabilities. It also solidifies AstraZeneca’s commitment to Canada, expanding its operational footprint in the region.
Operational Changes
Following the acquisition, Fusion Pharmaceuticals is now a wholly owned subsidiary of AstraZeneca, maintaining its operations in Canada and the United States.
Financial Details
As per the definitive agreement, AstraZeneca, through a subsidiary, acquired all outstanding shares of Fusion Pharmaceuticals at $21.00 per share in cash at closing. Additionally, there is a non-transferable contingent value right of $3.00 per share, payable upon achieving a specified regulatory milestone before August 31, 2029.
The combined upfront payment and potential contingent payment total approximately $2.4 billion.
AstraZeneca also acquired Fusion's cash, cash equivalents, and short-term investments, amounting to $211 million as of March 31, 2024. Consequently, Fusion shares will be delisted from the Nasdaq Stock Market, deregistered under the U.S. Securities Exchange Act of 1934, and Fusion has applied to cease being a reporting issuer under Canadian securities laws.
This acquisition underscores AstraZeneca's dedication to transforming cancer treatment and improving patient outcomes through innovative and targeted therapies.
AbbVie and FutureGen Sign Agreement for Development of New IBD Therapy
AbbVie and FutureGen Biopharmaceutical (Beijing) Co., Ltd. have entered into a license agreement to develop FG-M701, an advanced TL1A antibody aimed at treating inflammatory bowel disease (IBD). Currently, FG-M701 is in the preclinical development phase.
FG-M701 is a completely human monoclonal antibody that targets TL1A, a recognized therapeutic target in IBD. This antibody is specially designed to offer superior functional properties compared to earlier TL1A antibodies, with the goal of enhancing efficacy and reducing dosing frequency for IBD treatment.
According to the agreement, AbbVie will have the exclusive global rights to develop, produce, and market FG-M701. FutureGen will receive an initial payment and near-term milestone payments totaling $150 million. Additionally, FutureGen stands to gain up to $1.56 billion from clinical development, regulatory, and commercial milestones, along with tiered royalties reaching low double digits based on net sales.
Lilly to Acquire Morphic, Enhancing Treatment Options for Inflammatory Bowel Disease
Eli Lilly and Morphic Holding have entered into a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical firm focused on developing oral integrin therapies for chronic conditions.
Lilly’s acquisition of Morphic aims to bolster its immunology pipeline, particularly with the addition of Morphic's leading program, MORF-057. This selective oral small molecule inhibitor targets the α4β7 integrin and is designed to treat inflammatory bowel disease (IBD).
Currently, MORF-057 is being tested in two Phase 2 studies for ulcerative colitis and one Phase 2 study for Crohn's disease. The goal is to improve patient outcomes and broaden the available treatment options for IBD sufferers.
Beyond MORF-057, Morphic is advancing a preclinical pipeline that includes therapies for autoimmune diseases, pulmonary hypertensive diseases, fibrotic conditions, and cancer.
Morphic, a biopharmaceutical company, is dedicated to developing a wide array of oral integrin therapies aimed at treating serious chronic illnesses. These include not only autoimmune and cardiovascular diseases but also metabolic disorders, fibrosis, and cancer.
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