NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Bidding war? Yes, I think that’s certainly possible, maybe even likely . . . Gilead just announced more setbacks, this time for magrolimab in solid tumors. While some cell therapy treatments have shown limited success in blood cancers (lymphomas, myelomas, and leukemia) solid tumors are proving to be far more difficult to overcome. This really demonstrates just how impressive Northwest Bio’s accomplishment in Glioblastoma really is, and why they are likely to be highly sought after.

Gilead reviewing drug acquired in $5B buyout after latest setback
The FDA issued a partial hold on four tests of magrolimab in solid tumors, as Gilead evaluates the program’s future.
Published Feb. 16, 2024
Ben Fidler

Gilead Sciences is evaluating the future of a cancer drug acquired in a multibillion-dollar deal following a new setback the company reported late Thursday.

In a statement, Gilead said it paused enrollment in four mid-stage trials of the drug, known as magrolimab, in different types of solid tumors. The Food and Drug Administration subsequently ordered a partial hold on these trials. The suspension also applies to investigator-run tests of magrolimab, the company said.

Gilead didn’t specify why it stopped recruiting study participants. However, one week ago, the company disclosed a regimen involving magrolimab was associated with an increased risk of death in a late-stage trial in leukemia. Gilead ended that study, and the agency halted all other tests of magrolimab in blood cancers.

Gilead said it is “reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.”

The announcement is yet another disappointment for magrolimab, which Gilead acquired when it paid $5 billion for biotechnology company Forty Seven in 2020.

Gilead bought Forty Seven to bolster its oncology business amid a surge of industry interest in drugs like magrolimab, which block a mechanism cancer cells use to evade the immune system. Gilead viewed these drugs as a cornerstone for cancer drug combinations and pushed magrolimab into mid- and late-stage trials in leukemia and myelodysplastic syndrome as well as solid tumors.

Magrolimab has since faced myriad delays and trial stoppages over safety concerns. It failed Phase 3 trials in myelodysplastic syndrome and leukemia, proving ineffective in both cases.

Meanwhile, some pharmaceutical companies have backed away from the drug class, which are known as CD47 inhibitors. Pfizer still has one in Phase 2 testing that was acquired via its buyout of Trillium Therapeutics. Biotech ALX Oncology is also testing a CD47 drug in mid-stage studies.

Gilead’s struggles come as Wall Street scrutinizes the company’s business development strategy under CEO Daniel O’Day.

Partnerships with biotechs Galapagos and Arcus Biosciences haven’t paid dividends, and a drug acquired in its $21 billion buyout of Immunomedics hasn’t performed as well as expected.

Earlier this week, the company paid $4.3 billion to acquire liver drug developer Cymabay Therapeutics.

The four studies Gilead paused are evaluating magrolimab in colorectal, breast, and head and neck cancers, as well as in solid tumors more broadly. Patients who benefit from treatment can continue to receive the drug after again given their consent, the company said.

https://www.biopharmadive.com/news/gilead-fda-halt-magrolimab-solid-tumor-trials/707745/

When considering potential partners for Northwest Bio, most would agree that Merck does have a distinct advantage due to the combination trial at UCLA; however, I’ve also thought that Gilead could be one of the many companies that will be interested in partnering with, or acquiring Northwest Bio when the time comes, and they certainly bring more than a checkbook to the table. Recently, Gilead’s CEO said, “the company will continue to be opportunistic about pursuing business development within its three focus areas of virology, oncology, and inflammation, and it will look at later-stage deals.”

Although Gilead does not have a checkpoint inhibitor, like Merck or Bristol Myers, to combine with DCVax, Gilead has demonstrated a willingness to acquire immuno-oncology companies, most notably, Kite Pharma for $12B, Forty Seven for $5B, and Immunomedics for $21B. They obviously recognized the promise of cell therapy very early on, and were willing to take the risk to pioneer the commercialization of one of the first CAR-T cell treatments (Yescarta) with their Kite acquisition, and have proven the commercial viability of cell therapy.

Gilead allows its Kite subsidiary to stand alone, and it has become a leader, with two approved cell therapies (Yescarta and Tecartus) in over 20 countries, and has developed significant expertise and resources. They know better than most other Bio Pharma companies what it takes to successfully commercialize a cell therapy, and they’ve built multiple state-of-the-art manufacturing facilities designed specifically for cell therapy production, negotiated extremely expensive ($400k plus) insurance reimbursements, established international cold-chain distribution networks, developed relationships with hospitals and over 400 authorized treatment centers, and have an international personalized customer care network.

Gilead has been battling its CAR-T competitors ever since their $12B Kite acquisition in 2017, fighting for market share in each new indication, in a relatively small, 2nd and 3rd-line setting in every market around the world, for a treatment that requires patient hospitalization, has serious potential safety issues, and uses a very complex, expensive, and lengthy manual manufacturing process; in other words, it has been a continual struggle to get to where they are (around $1.5B in sales) after six years. And on top of that, in the past few years, they’ve shelled out almost $30B for other oncology acquisitions that haven’t really paid off.

So what must Gilead’s CEO think when he evaluates Northwest Bio in comparison? A company with a (soon-to-be) approved cell therapy, with no safety issues, that not only treats Glioblastoma, the most difficult to treat solid-tumor cancer in the world, but is also applicable to other solid tumors, and will be added to the standard of care (front-line), with orphan status, so it will own the entire brain-tumor market around the world, can be administered in an out-patient setting, and oh, it also has its own patented, completely automated manufacturing process, that can be scaled to meet mass-market demand, that is less than half the cost of CAR-T cell therapy treatments. Think about what that might be worth to him.

One more thought, something else that a company with expertise in T-cell therapy may be interested in, is that other patented automated manufacturing system that Northwest Bio also owns, courtesy of the Flaskworks acquisition; the simple but brilliant, BATON system. That’s the automated system that co-cultures a patient’s own dendritic cells with the patient’s own T-cells, so it uses a natural process (rather than engineered) to present all of the antigen targets, specific to each patient’s own tumor, to the T-cells. That system was designed to make a personalized T-cell therapy for solid tumors, however, with Northwest Bio’s dendritic cell knowledge, it could be adapted to make both a dendritic cell therapy, and a T-cell therapy, so both could be administered to the patient.

And by the way, almost everything that was said about Gilead’s expertise in cell therapy and manufacturing . . . the same could be said about Bristol Myers. So yes, I definitely think there may be more than one company interested in partnering with, or acquiring Northwest Bio.