Janssen’s global head of R&D opens up on CAR-T research, data science and beyond

Johnson & Johnson’s Janssen division (NYSE:JNJ) was among the first drug companies to prioritize oncology research.

The company has more than three decades of experience in the domain. Recently, CAR-T therapy has become “one of the most exciting areas of research for cancer and other diseases for the company, said Mathai Mammen, global head of R&D for Janssen, in a recent interview.

In the following Q&A, Mammen provides an overview of the company’s CAR-T research while also touching on its work to revise the treatment of epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). He also touches on new potential indications for Nipocalimab, a fully-human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody, and dishes on the company’s investment in data science in the development of drugs and vaccines.

Drug Discovery & Development: Could you provide a brief overview of Janssen’s work on CAR-T (including ciltacabt…

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Why demand for J&J and AstraZeneca COVID-19 vaccines remains unclear

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and others. 

The European Medicines Agency (EMA) did, however, advise that the vaccine bear a warning describing a risk of rare blood clots. 

Although the J&J vaccine had been authorized in the E.U., nations there have not yet used it. After U.S. authorities paused the use of the vaccine, Johnson & Johnson decided to suspend the distribution of the product voluntarily. 

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J&J reportedly asked COVID-19 vaccine developers to study blood clot risks  

[Image courtesy of Wikipedia]

Johnson & Johnson (NYSE:JNJ) privately contacted other COVID-19 vaccine makers last week to gauge their interest in studying blood clot risks, according to a Wall Street Journal report. Specifically, the company asked whether its rivals — AstraZeneca, Moderna and Pfizer— had new information about blood clots following vaccination and if they were interested in forming an external panel to examine the issue, according to the article citing anonymous sources. 

None of the four companies have confirmed nor denied the report. 

J&J researchers did state in NEJM that there is insufficient evidence to link six cases of cerebral venous sinus thrombosis (CVST) paired with low platelet counts to the company’s COVID-19 vaccine. Approximately seven million people in the U.S. have received the vaccine. 

AstraZeneca (LON:AZN) is said to have been interested in allying wit…

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A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines

Transmission electron micrograph of two Adenovirus particles. Image courtesy of Wikipedia.

After regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), some regulatory authorities wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

The history of using viruses as vectors dates back to the mid-1970s when scientists Dr. J. Michael Bishop and Dr. Harold Varmus demonstrated that gamma-retroviruses could acquire cellular genes. 

Researchers began creating adenoviral vectors in the 1980s, testing replication-de…

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6 assumptions about COVID-19 vaccines as AstraZeneca and J&J face safety scrutiny

[Photo by Daniel Schludi on Unsplash]

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus. 

But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed blood clot disorders. 

Officials in both the EU and the U.S. suspect there could be a link between adenovirus-based COVID-1 vaccines and blood clotting problems such as cerebral venous sinus thrombosis. Authorities in both countries have either temporarily halted or constrained the use of adenovirus vaccines. 

Russia’s Sputnik V and China’s CanSino Biologics also have COVID-19 vaccines based on an adenovirus platform.

1. The blood clotting problems seems rare but more common in women

Even though blood clotting problems have gotten a substantial amount of att…

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Johnson & Johnson to test COVID-19 vaccine in adolescents 

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate. 

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older. 

Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18. 

Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents. 

The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a vari…

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Russia reports 91.6% efficacy for its Sputnik V COVID-19 vaccine

Sputnik V in vials. Image from Mos.ru via Wikipedia.

The Sputnik V COVID-19 vaccine could be more efficacious than those from AstraZeneca (LON:AZN) or Johnson & Johnson (NYSE:JNJ) based on interim trial results.

The two-dose Sputnik vaccine was 91.6% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe and moderate disease in a study involving 19,866 participants.

The data were published in The Lancet. No data, however, was available on the impact of SARS-CoV-2 variants on the vaccine’s efficacy.

By comparison, the single-dose JNJ vaccine was 57% to 72% effective at preventing moderate to severe disease, depending on the geography. The vaccine was least effective in South Africa, where 95% of infections were the result of a more-infectious variant circulating there.

AstraZeneca’s (LON:AZN) two-dose vaccine was between 62% and 90% effective, depen…

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Johnson & Johnson to acquire Momenta for $6.5B

Johnson & Johnson (NYSE:JNJ) announced today that it entered into an agreement to purchase Momenta Pharmaceuticals (NSDQ:MNTA) for $6.5 billion.

New Brunswick, N.J.-based Johnson & Johnson will stump up the $6.5 billion in an all-cash transaction for the developer of novel therapies for immune-mediated diseases, according to a news release.

Momenta felt the full effect of the news of the acquisition breaking, as shares of MNTA were trading up 69.2% at $52.13 per share in late-afternoon trading today.

The acquisition is seen by Johnson & Johnson as an opportunity for its Janssen Pharmaceutical subsidiary to broaden its work in immune-mediated disease and drive growth through expansion into autoantibody-driven diseases.

Included in the acquisition are the full global rights to Momenta’s nipocalimab (M281) anti-FcRn antibody, for which Janssen plans to pursue indications across autoimmune diseases with unmet medical needs in materna…

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European initiative launched to develop COVID-19 treatment

The Corona Accelerated R&D in Europe (CARE) consortium today announced its launch to accelerate the development of COVID-19 treatments.

Supported by the Innovative Medicines Initiative, the new consortium has collected $92.7 million (€77.7 million) in grant funding in an effort to conduct a five-year project, bringing together 37 partners from Belgium, China, Denmark, France, Germany, the Netherlands, Poland, Spain, Switzerland, the UK and the U.S.

Leading the initiative is VRI-Inserm,  Johnson & Johnson‘s (NYSE:JNJ) Janssen Pharmaceutical and Takeda Pharmaceutical (TSE:4502;NYSE:TAK)  as the companies integrate partners’ COVID-19 projects that have been ongoing since February.

CARE aims to combine the researchers to accelerate the discovery and development of solutions for the current COVID-19 pandemic, as well as future coronavirus outbreaks, with the most promising drug candidates set to advance to clinical trials in humans after testing…

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J&J accelerates development of its COVID-19 vaccine candidate

Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September.

“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,” said Dr. Paul Stoffels, J&J’s chief scientific officer.

“Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic,” Stoffels said.

The randomized, double-blind, placebo-controlled Phase 1/2a study will take place in the U.S. and Belgium …

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