Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study

Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology community. “Now, there are some highly respected physicians who’ve said, ‘This is a failed trial,’” said Dr. Peter Taylor, the Norman Collisson Professor of Musculoskeletal Sciences at the University of Oxford. “I think that’s an incorrect interpretation.”

Johnson & Johnson is also pursuing a host of other autoimmune indications for nipocalimab. The FDA has granted it Fast Track designation for hemolytic disease of the fetus and newborn (HDFN) and orphan drug status for HDFN while EMA granted it orphan medicinal product designation for HDFN.

Breaking down the data from IRIS-RA

Johnson …

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From Silicon Valley to the lab of tomorrow: Synfini’s leap to large chemistry models

Conceptual visualization of a molecular structure, not representative of a specific molecule. [Image courtesy of Adobe Stock]

During the COVID-19 pandemic in late 2020, the storied Silicon Valley institution SRI International secured a $4.3 million DARPA contract to develop a tool for generating therapeutic small molecules to combat biological threats. Not just known for innovations like the computer mouse and Siri, SRI International is also responsible for Synfini, a multimodal chemistry model akin to large language models like ChatGPT. In September 2023, the company spun out Synfini as an independent entity.

“The core group and project started about seven years ago at SRI International, and began as part of the DARPA Make-It program,” said Peter Madrid, co-founder and head of scientific development at Synfini. DARPA’s Make-It initiative aimed to automate small molecule discovery and synthesis. Thanks to the su…

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Johnson & Johnson drops 136-year old logo and renames Janssen

Johnson & Johnson is replacing its iconic cursive logo with a new look. [Logos courtesy of J&J]Johnson & Johnson has rebranded with a new logo and a new name for its Janssen pharmaceutical business one year after renaming its medical device business — and just weeks after spinning off its consumer health business.

New Brunswick, New Jersey–based Johnson & Johnson (NYSE: JNJ) has replaced its 136-year-old logo — based on the signature of co-founder James Wood Johnson — with a “more modern logo and brighter red, keeping the iconic ampersand,” J&J CEO Joaquin Duato said today in a post on LinkedIn. The change is meant to call attention to J&J’s focus on innovative medicine and medtech, he said.

“Each letter is drawn in one pen stroke, creating a contrast that delivers both a sense of unexpectedness and humanity,” the company said in a news release, adding that the “refreshed, bright, and contemporary [red] s…

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AbbVie and Janssen receive positive CHMP opinions for novel cancer therapies

Epcoritamab Image courtesy of Genmab

The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab.

Epcoritamab for relapsed/refractory diffuse large B-cell lymphoma

Epcoritamab is an investigational bispecific antibody for adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. CHMP made the decision after reviewing data from the pivotal EPCORE NHL-1 phase 1/2 trial showing an overall response rate of 63.1% with epcoritamab monotherapy in DLBCL patients. If approved, epcoritamab would be the first subcutaneous bispecif…

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10 pioneering companies implementing AI in drug discovery, development and beyond

[NicoElNino/Adobe Stock]

The pharma industry is embracing artificial intelligence (AI) to streamline drug discovery and development, although adoption remains early. The field, however, is rapidly expanding. The global AI in drug discovery market was worth about $1.1 billion last year but could grow at a 30% clip from 2023 to 2030, according to Grand View Research. 

In the years to come, AI could find use to discover an array of drug targets while improving drug developers’ ability to design molecules based on fine-grained criteria. Here, we spotlight several companies exploring the use of AI in drug discovery and drug development.

1. Exscientia

Oxford, UK–based Exscientia (Nasdaq: EXAI) has pioneered AI in small-molecule drug design. The company has expanded its AI-based platform to develop novel therapeutic antibodies through generative AI design. In early 2020, the company reported the first AI-d…

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Janssen exec discusses company’s precision neuroscience strategy and partnerships

[Aliaksandr Marko/Adobe Stock]

In mid-April, San Diego–based Pipeline Therapeutics announced a global license and development agreement with Janssen Pharmaceutica NV (NYSE:JNJ), focusing on PIPE-307, an investigational compound targeting nervous system disorders. As a pioneer in precision neuroscience, Pipeline Therapeutics aims to create targeted treatments for patients. PIPE-307, an oral, highly selective antagonist of the muscarinic M1 receptor, embodies this approach, having completed two phase 1 clinical trials and obtained FDA clearance for clinical development in relapsing-remitting multiple sclerosis (RRMS) patients. Janssen received a worldwide, exclusive license to research and develop PIPE-307 in all indications.

Under the agreement, Pipeline will receive $50 million upfront from Janssen, with the possibility of receiving an additional $25 million in equity investments from J&J and Pipeline’…

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AI in drug development: Janssen exploring potential of AI in everything from target discovery to clinical trials

As enterprise AI adoption surges, the life science industry stands at a pivotal juncture. “We are truly at a tipping point,” remarked Najat Khan, chief data science officer at Janssen, during the 2023 Stanford Drug Discovery Symposium. “It’s amazing how quickly we’ve been able to make progress across the whole value chain in terms of drug development,” she said. “The reality is that there’s a lot of hype, but there is already a lot that’s happening.”

While most Big Pharma companies are exploring AI applications, as a 2022 Clinical Trials Arena article noted. It’s easy to understand why. While developing a given drug might take more than a decade, AI could potentially enable the development of “drugs in one-tenth of the time, from being discovered to being able to treat patients,” wrote McKinsey partner Alex Deverson in late 2022.

Janssen is aiming to distinguish itself by building a team of “bilingual”…

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Janssen sees Blood Cancer Awareness Month as an opportunity to close the clinical trial diversity gap

Janssen (NYSE:JNJ) is working to highlight the importance of cancers such as leukemias, lymphomas and multiple myeloma for Blood Cancer Awareness Month in September.

Some 1.5 million people in the U.S. are currently living with or in remission from blood cancers, according to the Leukemia & Lymphoma Society. Roughly 35,000 people are diagnosed with multiple myeloma each year, according to the American Cancer Society.

In addition to highlighting the incidence of hematologic malignancies, Blood Cancer Awareness Month offers an opportunity to provide education about the need for improved clinical trial diversity. While the industry has made strides recently, people of color continue to be underrepresented in clinical trials. According to FDA data, in 2020, three-quarters of trial participants were white, while only 8% were Black. That same year, 11% of clinical trial participants were Hispanic.

According to the U.S. Census Bureau, 13.6% of the U.S. popu…

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Johnson & Johnson to pay $39M to settle New Hampshire opioid allegations

Johnson & Johnson and its U.S.-based subsidiary Janssen have reached a settlement agreement with the State of New Hampshire to resolve opioid allegations. 

J&J will pay $39 million and an additional roughly $1.5 million to New Hampshire under the deal, which relates to a suit filed in 2018. New Hampshire will be reimbursed for the latter sum because the state did not participate in a nationwide settlement fund. 

The company has announced a series of similar recent settlements of opioid allegations. Toward the beginning of the year, Johnson & Johnson and drug distributors agreed to pay $590 million in an opioid settlement agreement with U.S. tribes. In April, J&J reached a deal with West Virginia to pay $99 million to resolve opioid-related claims. In the same month, it reached an opioid deal worth $77 million with Alabama. Finally, in July, California Attorney General Rob Bonta announced a $26 billion settlement with J&J and other companies …

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Janssen gets positive CHMP opinion for Imbruvica for adults with untreated chronic lymphocytic leukemia

Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL).

In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic lymphocytic leukemia and Waldenström’s macroglobulinemia, also known as lymphoplasmacytic lymphoma.

CHMP’s recent positive opinion was based on the Phase 3 GLOW and Phase 2 CAPTIVATE studies.

Janssen noted in a press release that if the new indication is approved, Imbruvica will be the first oral, once-daily, fixed-duration, combination regimen for first-line treatment of CLL.

Janssen developed the drug with Pharmacyclics LLC, an AbbVie company.

Imbruvica is a Bruton’s tyrosine kinase inhibitor. Venetoclax is an apoptosis stimulant and proto…

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Evotec enters drug discovery alliance with Janssen

Evotec SE (Nasdaq:EVO) announced that it will work with Janssen Pharmaceutica NV, a subsidiary of the Janssen Pharmaceutical Companies (NYSE:JNJ), to identify drug targets and to partner on hit identification and lead optimization of chemical assets.

The partnership will center around Evotec’s end-to-end drug discovery and development platform.

“We are very proud to enter into this collaboration to explore unique approaches to high potential cell surface drug targets with novel therapeutic modalities and to deliver and make innovative therapeutic options available to patients,” said Dr. Cord Dohrmann, chief scientific officer of Evotec, in a press release.

Evotec could receive up to €210 million per project plus tiered royalties related to products ensuing from the partnership.

Earlier this year, Evotec announced a similar collaboration with Bristol Myers Squibb focused on protein degradation.

The company also announced a pact with the biop…

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Tremfya shows durable efficacy for psoriatic arthritis joint and axial symptoms 

Janssen (NYSE:JNJ) has released new data showing the efficacy of the IL-23 inhibitor Tremfya (guselkumab) for a variety of psoriatic arthritis (PsA) symptoms for up to two years.

Patients with active psoriatic arthritis treated with guselkumab in Phase 3 studies had consistent, long-term efficacy over two years. Specifically, patients who received the drug had improvements related to joint, skin, enthesitis, dactylitis, spinal pain and disease severity endpoints.

Janssen also noted that analyses of its clinical trial data revealed that guselkumab supported broad improvements in health-related quality of life (HRQoL), including metrics such as fatigue, pain and work productivity.

Janssen presented the data culled from the DISCOVER-1, DISCOVER-2, and COSMOS clinical trials at the 2022 Annual European Congress for Rheumatology (EULAR) meeting held June 1-4.

Data from the DISCOVER-2 study showed that patients who received guselkumab had improvement ac…

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