Novartis AG is pushing ahead with one of its most ambitious cancer therapies, a treatment that the Swiss drugmaker has said has blockbuster potential as it extends that technology to a wider pool of tumor-ridden patients.
Europe’s second-biggest drugmaker is planning to test its CAR-T treatments — which involve extracting immune cells and genetically engineering them to hunt and kill cancer cells before returning them to the patient’s body — on lethal cancers of the brain, pancreas, colon, ovary and lung.
The company has also doubled its investment in manufacturing for these treatments.
The efforts put Novartis in a race with Juno Therapeutics Inc, Kite Pharma Inc and Bluebird Bio Inc to master the technology, part of a class of therapies that harness the body’s defense system to attack tumors.
Novartis’ initial target is an acute form of leukemia in children, and it expects to seek approval from the US Food and Drug Administration (FDA) early this year.
Analysts have estimated the therapy, CTL019, will cross US$1 billion in annual sales in five years.
“This could be the most efficacious immune therapy as yet developed, and it’s just early days with this technology,” Novartis Institutes for BioMedical Research president Jay Bradner said in an interview at the company’s headquarters in Basel, Switzerland.
Novartis is trying to catch up to rivals including Merck & Co and Roche Holding AG in cancer immunotherapies.
The company, which last year invested about US$9 billion in research and development, has more than 30 cancer assets under development and is “investing massively” in immuno-oncology, Novartis oncology chief executive Bruno Strigini said.
Still, questions arose about Novartis’ commitment to CAR-T research after the drugmaker said in August last year that the work would no longer be housed in a separate division, a restructuring that included cutting 120 jobs.
The CAR-T sector itself has faced its share of skeptics: Use of the treatments beyond certain blood cancers and the feasibility of large-scale manufacturing of such personalized cancer therapies are yet to be proven. And while the experimental treatments have shown dramatic results, they have also led to severe side effects, and in some cases death.
Novartis is confident about the balance between the safety and efficacy of its therapies, Strigini said. The next step would be to seek approval for the use of its CAR-T therapies in patients with diffuse large B-cell lymphoma, a type of blood cancer that afflicts a larger group of people.
That is likely to happen by the end of this year, he said.
Beyond that, Novartis, working with the University of Pennsylvania, is also exploring using its treatments on so-called solid tumors, said Glenn Dranoff, who leads immuno-oncology efforts at the Novartis Institutes.
CAR-T therapy has been shown to work against cancers in the blood, but has yet to be proven against solid tumors, or cancers that occur in bones, muscle and organs.
There is no doubt that treating solid tumors with CAR-T cells will be more challenging, partly because T cells have to make a bigger effort to get into the tumor from the blood, said Marcela Maus, director of cellular immunotherapy at Massachusetts General Hospital’s cancer center.
And there may be better approaches, she added.
“T-cell therapies are a new platform — the trick now will be extending it to more cancers and having a better understanding of how and which patients can benefit the most,” Maus said.
Competitors are also seeing signs of success.
Kite in December last year said it was seeking FDA approval for its CAR-T therapy in a type of lymphoma.
The same month, Juno said most patients with a form of blood cancer responded to its experimental treatment with manageable side effects, which might help invigorate the company after a different trial was halted due to patient deaths.
Bradner, who joined Novartis a year ago from Harvard Medical School and the Dana-Farber Cancer Institute, said the company does not expect any regulatory surprises for its therapy based on discussions so far.
More than 80 percent of patients went into remission in a mid-stage study published in December evaluating its CAR-T therapy in children and young adults with acute lymphoblastic leukemia, a fast-growing disease, he said.
Some patients are likely to be free of the disease for five years or more following treatment with CAR-T, Bradner added.
“It’s tantalizingly close to ‘cure,’ though it’s hard to know with certainty when that happens or how frequently patients will have a long interval where they can feel and be cancer free,” Maus said.
Among the rows of vibrators, rubber torsos and leather harnesses at a Chinese sex toys exhibition in Shanghai this weekend, the beginnings of an artificial intelligence (AI)-driven shift in the industry quietly pulsed. China manufactures about 70 percent of the world’s sex toys, most of it the “hardware” on display at the fair — whether that be technicolor tentacled dildos or hyper-realistic personalized silicone dolls. Yet smart toys have been rising in popularity for some time. Many major European and US brands already offer tech-enhanced products that can enable long-distance love, monitor well-being and even bring people one step closer to
Malaysia’s leader yesterday announced plans to build a massive semiconductor design park, aiming to boost the Southeast Asian nation’s role in the global chip industry. A prominent player in the semiconductor industry for decades, Malaysia accounts for an estimated 13 percent of global back-end manufacturing, according to German tech giant Bosch. Now it wants to go beyond production and emerge as a chip design powerhouse too, Malaysian Prime Minister Anwar Ibrahim said. “I am pleased to announce the largest IC (integrated circuit) Design Park in Southeast Asia, that will house world-class anchor tenants and collaborate with global companies such as Arm [Holdings PLC],”
TRANSFORMATION: Taiwan is now home to the largest Google hardware research and development center outside of the US, thanks to the nation’s economic policies President Tsai Ing-wen (蔡英文) yesterday attended an event marking the opening of Google’s second hardware research and development (R&D) office in Taiwan, which was held at New Taipei City’s Banciao District (板橋). This signals Taiwan’s transformation into the world’s largest Google hardware research and development center outside of the US, validating the nation’s economic policy in the past eight years, she said. The “five plus two” innovative industries policy, “six core strategic industries” initiative and infrastructure projects have grown the national industry and established resilient supply chains that withstood the COVID-19 pandemic, Tsai said. Taiwan has improved investment conditions of the domestic economy
Sales in the retail, and food and beverage sectors last month continued to rise, increasing 0.7 percent and 13.6 percent respectively from a year earlier, setting record highs for the month of March, the Ministry of Economic Affairs said yesterday. Sales in the wholesale sector also grew last month by 4.6 annually, mainly due to the business opportunities for emerging applications related to artificial intelligence (AI) and high-performance computing technologies, the ministry said in a report. The ministry forecast that retail, and food and beverage sales this month would retain their growth momentum as the former would benefit from Tomb Sweeping Day