Good Day BIO: BIO members announce progress against cancers

A lot of news about biotech breakthroughs, from progress on cancer treatments to a new dengue vaccine. Plus, we look at the impact of COVID-19 on supply chains, and why we have a chance to reimagine them. (657 words, 3 minutes, 17 seconds)

Nkarta, Novartis announce progress against several cancers

BIO members Nkarta and Novartis announced positive results in several clinical trials of new cancer treatments—more biotech breakthroughs that benefit patients. 

“Natural killer” cells show 70% complete response: 7 in 10 non-Hodgkin lymphoma patients saw a “complete response” in a trial of higher doses of Nkarta’s NKX019, with effects lasting longer than six months for several patients and a good safety profile, Nkarta announced Monday.

Already shown to achieve complete remission in some patients, NKX019 treats cancer with chimeric antigen receptor “natural killer” cells (CAR NK cells), which may reduce side effects and offer other advantages compared to chimeric antigen receptor T cells, or CAR T.

Outperforming chemo: Novartis’ Kisqali achieved more prolonged progression-free survival benefits for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer as compared to chemotherapy, Novartis announced Tuesday.

Early treatment possibilities: In another Novartis trial, “Pluvicto met the primary endpoint of radiographic progression-free survival” in certain patients with an aggressive prostate cancer. Pluvicto is already approved for a later stage in treatment, but this trial shows it can be used earlier, “addressing a significant unmet need,” Novartis said.

“Biotech innovation never stops,” Paul Hastings, CEO of Nkarta and Chairman of BIO’s Board, has said. “We remain committed to improved access for patients through the integration of cell therapy into the broader outpatient setting,” he said Monday.

Read more about these breakthroughs.

More Health News:

AP: Speedier drug approvals hit slowdown as FDA faces scrutiny
“With less than a month remaining in the year, the FDA’s drug center has granted 10 accelerated approvals—fewer than the tally in each of the last five years, when use of the program reached all-time highs.”

Wired: The era of one-shot, multimillion-dollar genetic cures is here
“They don’t have to think about their hemophilia anymore,” says trial lead Steven Pipe, a hematologist at the University of Michigan Health System. “For all intents and purposes, this looks like a cure.”

WSJ Exclusive: New dengue vaccine approved in Europe
The approval of Takeda’s vaccine “is likely to speed its review in many countries outside Europe, such as Mexico, Argentina, and Thailand, where dengue is endemic. Indonesia approved the Takeda shot’s use last summer in people 6 to 45 years.”

COVID-19 forced us to reimagine drug supply chains – and that’s a good thing

The pharmaceutical supply chain’s weakest links became obvious during the pandemic, but we have an opportunity to strengthen them before the next medical emergency, said panelists (including BIO) during a virtual event organized by The Hill on Tuesday. 

The first signs: U.S. officials identified a reduction in exports of PPE from China—where leaders were apparently aware of an unusual outbreak—as early as autumn of 2019, U.S. Rep. Buddy Carter (R-GA) said.

Outsourcing “leaves us vulnerable to disruptions,” said BIO’s Chief Policy Officer, John Murphy. “You lose the ability to transport in the early stages of [an emergency] those raw materials to the production sites in Europe and the United States.”

Three areas for improving supply chains: identifying vulnerabilities in the U.S. supply chain, responding to those vulnerabilities, and ensuring resiliency after responses are put into place, panelists agreed.

But a total shift to onshoring is not the answer, Murphy noted. A completely U.S.-centered supply chain would not address global needs “in the case of a pandemic or in the case of broader global health policy challenges.”

So, how do we build resilience? “In a perfect world,” the supply chain would have the resilience to pivot from day-to-day production to meet new, emergency demands, Murphy said. “The government has a key role to play here” by more proactively managing national stockpiles to ensure they are up-to-date and ready to deploy. 

Read more and watch the highlights.

President Biden’s Thursday: Giving remarks at the White House on a stronger economy for union workers and retirees, with the Labor Secretary in attendance. 

What’s Happening on Capitol Hill: The House is set to pass the Respect for Marriage Act and National Defense Authorization Act while still struggling to achieve a spending bill.