Johnson & Johnson (NYSE:JNJ) announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. (Momenta), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion.

This acquisition provides an opportunity for the Janssen Pharmaceutical Companies of Johnson & Johnson to broaden its leadership in immune-mediated diseases and drive further growth through expansion into autoantibody-driven disease. The transaction will include full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. Nipocalimab gives Janssen the opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation from the U.S. Food and Drug Administration. Momenta’s expertise in FcRn mechanisms is especially important for nipocalimab as it supports and accelerates the development of a medicine designed to target a number of autoantibody-driven conditions across several of Janssen’s established therapeutic areas. Janssen expects nipocalimab to contribute to its goals of achieving above-market growth over the mid and long term.

Autoimmune diseases driven partially or completely by autoantibodies represent a novel area where Janssen can significantly improve health outcomes for patients. In autoantibody-driven diseases, the body’s antibodies attack or damage its own proteins, cells and tissues, often with devastating consequences. Autoantibody-driven diseases include Myasthenia Gravis, Hemolytic Diseases of the Fetus and Newborn, warm Autoimmune Hemolytic Anemia, and other serious dermatologic, rheumatic, neurologic, hematologic and renal diseases. An estimated 2.5 percent of the population, or approximately 195 million people worldwide, suffer from some form of autoantibody-driven disease, many of which are orphan and rare diseases.

With competitively differentiated, parallel development programs and full worldwide commercial rights for nipocalimab, Janssen will have the potential to introduce multiple  launches, many as first-in-class indications with potential for significant peak year sales, some of which could exceed $1 billion, supporting Janssen’s goal of continuing to deliver above-market performance over the long term.

“This acquisition broadens Janssen’s leadership in autoimmune diseases and provides us with a major catalyst for sustained growth. Autoantibody-driven diseases are often serious, and patients are underserved by current treatment options,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. “We’re excited by the opportunity to further advance patient care by combining Johnson & Johnson’s world-class R&D, commercial and supply chain capabilities with Momenta’s talented people, pipeline and deep expertise in this important area.”

In addition to Momenta’s employees and lead asset nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets. The acquisition was driven by the significant opportunity seen in nipocalimab, along with the scientific capability Janssen is acquiring with the Momenta team. Janssen’s plans for additional assets in the Momenta pipeline will be determined as more data become available and could offer further upside potential.

“Nipocalimab, and the rest of Momenta’s pipeline, built over many years by outstanding scientists who have turned important insights into actionable biology, expands and complements our portfolio by giving us clinical-stage and discovery-stage compounds in autoantibody biological pathways. Combining Momenta’s discoveries with our 20-year heritage in immunology, global scope, and scientific and medical expertise, we see a real opportunity to create an entire ‘pipeline in a pathway,’ ” said Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, Johnson & Johnson. “We are excited about the significant potential to expand on Momenta’s excellent progress in rare diseases, and to increase our impact on patients both within and beyond our current focus areas.”

Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts. This site will increase Johnson & Johnson’s existing innovation footprint and capabilities in the greater Boston area given Momenta’s talented scientists, suite of proprietary technologies, sophisticated laboratories and proximity to top talent in this innovation hub.

Source: Janssen Pharmaceutical Companies of Johnson & Johnson (Press release)

BISC Global is pleased to announce the opening of a new branch in Basel, Switzerland. The new Basel location complements the global presence with its current offices in Belgium, and USA (Boston and San Francisco).

“We are thrilled to be expanding our footprint into the vibrant research community of Basel” said Maarten Braspenning, CEO of BISC Global. “As a bioinformatics, statistics and machine learning consulting company with a global view and local approach, we believe Switzerland is a key location for the next step in our company’s growth. We look forward to supporting the local pharma and biotech companies, as well as the research institutes and universities that call Switzerland home.”

As the go-to bioinformatics consulting company, BISC Global will offer high quality services for data-analysis, visualization, interpretation and storage. Dr. Remco Foppen will be leading the effort to help the Swiss research community to make the most of their data.

“I am excited to support the Swiss research community with varied bioinformatic tools, and Swiss bioinformaticians with a career at BISC Global” said Remco Foppen, Business Manager Switzerland at BISC Global.

Founded in 2017, BISC Global has grown to be a Top 10 Bioinformatics Consulting and Services Firm supporting world’s leading pharmaceutical and biotech companies. Through our offices in Ghent, Belgium; Basel, Switzerland; Boston, MA; and San Francisco, CA; BISC Global provides data-analytics, custom tool/pipeline development, and cloud solutions delivered on-site or remotely. By leveraging our global workforce of expert consultants, we support analysis across multiple domains, including machine learning (data mining, pattern recognition, image analysis, (un)supervised learning, neural networks, deep learning, etc.), bioinformatics (single-cell transcriptomics, metabolomics, metagenomics, epigenomics, etc.), and statistics (experimental design, mathematic modelling, signal-to-noise enhancement, and independent data cross validation).

Source: BISC Global (Press release)

• AON-platform with focus on therapies nearing phase I trials for forms of Spinocerebellar Ataxia and Huntington Disease
• Other early discovery stage RNA editing platform focuses on RETT syndrome
• Funding led by LSP, co-led by Kurma Partners, supported by Pontifax, Droia Genetic Disease, Polaris Partners and Pureos Bioventures

Vico Therapeutics,a Leiden, the Netherlands, based biotech company focusing on the development of RNA modulating therapies for rare neurological disorders, today announced that it has raised $31 million (€27 million) in a Series A financing round. Vico will use this funding to further advance its late preclinical stage Antisense OligoNucleotides (AON) lead platform for the development of therapies for different forms of Spinocerebellar Ataxia (SCA) and Huntington Disease (HD) into first-in-human clinical trials in late 2021. Its early discovery RNA editing platform is directed towards RETT syndrome. The financing was led by Life Science Partners (LSP), co-led by Kurma Partners, and supported by Pontifax, Droia Genetic Disease, Polaris Partners and Pureos Bioventures and Idinvest Partners.

Vico’s lead asset is an investigational AON therapy targeting expanded (CAG) trinucleotide repeats that translate into abnormally long and toxic polyglutamine (polyQ) stretches in proteins that cause a series of neurodegenerative polyQ disorders like Spinocerebellar Ataxia type 1 (SCA1), type 3 (SCA3) and Huntington’s disease (HD).

It has been demonstrated to preferentially reduce the levels of mutant polyQ compared to wildtype proteins. This was confirmed in several established mouse models for SCA1, SCA3 and Huntington Disease, with a long-term and widespread distribution of the compound throughout the central nervous system. Based on these encouraging data combined with the broad applicability of the lead compound to multiple different brain disorders with high unmet medical need, Vico is advancing this program towards a first-in-human trial expected in late 2021.

Luc Dochez, Founder and Chairman of  Vico Therapeutics, stated: “This Series A funding will allow us to advance our lead program into the clinic and continue to build our capabilities as a leader in the development of novel therapies for serious CNS disorders. We see tremendous potential to advance the field and apply the breadth of our antisense oligonucleotide (AON) expertise to address severe neurological disorders. We are looking forward to accelerating the development of our platform technologies around AON technology and RNA-modulation/editing to bring best-in-class therapies to patients. The Vico team built this company around a unique synergy between state-of-the-art molecular biology, AON chemistry laboratories and industry experience in successfully developing drugs based on AON technology.”

Martijn Kleijwegt, managing partner at LSP, lead investor and board member, added: “Vico is building a leading team and has a cutting-edge infrastructure to engineer best-in-class therapies for severe neurological conditions and accelerate their advancement into human clinical trials. A major strength of Vico’s approach is the broad applicability to different polyQ diseases and the selectivity for mutant proteins.”

Vico’s Board will consist of Martijn Keijwegt, Managing Partner of LSP, Felice Verduyn-van Weegen, Investment Manager LSP, Rémi Droller, Managing Partner Kurma Partners, Silvia Noiman, Pontifax, Luc Dochez, Managing Partner, Droia Genetic Disease, Amy Schulman, Managing Partner Polaris Partners and Anja Harmeier, Partner Pureos Bioventures and Josh Mandel-Brehm, co-founder.

Source: VICO Therapeutics

• Companies to collaborate on mRNA vaccine and monoclonal antibody research programmes in infectious diseases
• GSK to make equity investment of £130m (€150m) in CureVac, and an upfront payment of £104m (€120m)

GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialisation of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform.

mRNA (messenger RNA) technology is a rapidly progressing, cutting-edge platform for the development of new vaccines and medicines, potentially expanding the range of diseases which can be prevented or treated, while also promising to significantly speed up development and manufacturing. mRNA enables protein synthesis in the human body, carrying the genetic code required for cells to manufacture and express proteins. By using mRNA technology in vaccines and medicines, specific proteins, or antigens, can be produced by the body’s own cells, enabling the human immune system to prevent or fight disease. 

CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSK’s existing scientific leadership in vaccines, including GSK’s own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSK’s growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.

Roger Connor, President GSK Vaccines, said: “GSK’s self-amplifying mRNA (SAM) vaccine technology has shown us the potential of mRNA technology to advance the science of vaccine development, and CureVac’s experience complements our own expertise. Through the application of mRNA technology, including SAM, we hope to be able to develop and scale up advanced vaccines and therapies to treat and prevent infectious diseases quicker than ever before.”  

Dr. Franz-Werner Haas, acting Chief Executive Officer of CureVac, added: “We are delighted to partner with GSK.  With this collaboration, we are gaining a world-class partner whose expertise and global footprint will allow us to further develop and translate the value of our platform into potential products for the world.”

The companies will combine their mRNA expertise on development opportunities across a range of infectious disease pathogens, selected with the potential to best leverage the advantages of this platform technology, while addressing significant unmet medical need and economic burden.  CureVac’s existing COVID-19 mRNA and rabies vaccines research programmes are not included in the collaboration announced today.

Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing close to a 10% stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.

CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.  

GSK will fund R&D activities at CureVac related to the development projects covered by the collaboration. CureVac will be responsible for the preclinical- and clinical-development through Phase 1 trials of these projects, after which GSK will be responsible for further development and commercialisation. CureVac will be responsible for the GMP manufacturing of the product candidates, including for commercialisation, and will retain commercialisation rights for selected countries for all product candidates.  

Source: GSK