Investors looking for stocks that can provide dramatic gains found what they were looking for with a pair of cancer drug developers. From the end of 2023 through the closing bell on Sept. 23, shares of Summit Therapeutics and Instil Bio marched over 700% higher.
These stocks have outperformed because the new drug candidates they're developing could become some of the most successful cancer treatments of their time.
Keytruda from Merck is a leading cancer immunotherapy that generated $25 billion in sales last year. Recent clinical trial data suggests candidates that Summit Therapeutics(NASDAQ: SMMT) and Instil Bio(NASDAQ: TIL) are working on can outperform Keytruda with a new mode of action.
Further success for either of these pre-commercial-stage drugmakers could push their stock prices through the roof, but it's far from guaranteed. Here's what you should know before you even think about investing in either one.
1. Summit Therapeutics
Shares of Summit Therapeutics gained more than 1,000% before sliding back to their present level. When the market closed on Sept. 23, the stock was up by 739.5% in 2024.
Summit Therapeutics stock is soaring because a lung cancer therapy licensed from Akeso called ivonescimab outperformed Keytruda in a phase 3 clinical trial. Ivonescimab is a bispecific antibody, which means it can bind to two targets at once.
One of the targets ivonescimab engages is the same programmed death ligand-1 (PD-1) checkpoint as Keytruda, Opdivo, Tecentriq, and several other blockbuster therapies. It also inhibits vascular endothelial growth factor A (VEGF-A), and the combination approach appears to make a big difference.
Summit's partner is running a head-to-head phase 3 trial called HARMONi-2 in China with newly diagnosed lung cancer patients. During a planned interim analysis, investigators measured a 49% reduction in the risk of disease worsening among patients randomized to receive ivonescimab versus Keytruda.
Last October, Summit Therapeutics began the 400-patient HARMONi-3 trial with first-line lung cancer patients located in North America. Unlike HARMONi-2, this study will test a combination of chemotherapy plus Keytruda against chemotherapy plus ivonescimab.
Combining Keytruda with chemo to treat first-line lung cancer patients is standard practice. A positive result from the HARMONi-3 trial could make ivonescimab the new standard and lead to over $10 billion in annual sales.
In May, Chinese regulators approved ivonescimab to treat second-line lung cancer patients in combination with chemotherapy. Summit's license doesn't include sales in China or Australia, but it's encouraging to know at least one government regulator has given the drug a green light.
Summit is beginning with lung cancer because it's the deadliest malignancy, but it won't stop there. The company recently reported encouraging response rates that suggest ivonescimab could also be used to fight solid tumors that originate in colons, breasts, heads, and necks.
2. Instil Bio
Instil Bio is another U.S. company that licensed a bispecific PD-1/VEGF antibody from a China-based partner. In this case, it was IMM2510 from ImmuneOnco, which Instil has tentatively named SYN-2510.
We don't have any head-to-head data for SYN-2510 versus Keytruda, but its similarity to ivonescimab was enough to push this stock through the roof. During the morning of Sept. 24, shares of the clinical-stage drugmaker were up 814% in 2024.
SYN-2510 and ivonescimab are similar but not the same. SYN-2510 engages PD-L1 on tumor cells, while ivonescimab targets PD-1 on immune cells. Also, SYN-2510 binds to multiple VEGF ligands beyond the VEGF-A ligand that ivonescimab is limited to.
SYN-2510 is far behind ivonescimab on a development timeline, but Instil Bio and ImmuneOnco have a plan to catch up. The partners recently announced a late-stage development strategy that includes a front-line lung cancer trial in China expected to begin later this year. Also this year, Instil expects to begin a phase 2 trial in the U.S. with SYN-2510 as a second-line lung cancer treatment.
Time to buy?
Summit Therapeutics' market cap has swelled to about $15.9 billion at recent prices. That's a big valuation for a company that doesn't have any products to sell. While there's a chance that ivonescimab can become a leading lung cancer treatment, any discouraging clinical trial data could pull the rug out from under Summit's stock price. It isn't a stock I'd be in a hurry to sell, but buying shares at this elevated valuation doesn't seem like a smart move either.
We don't know much about the bispecific antibody Instil Bio is developing, and this lack of clarity is reflected in its relatively tiny $451 million market cap at recent prices.
Investors without a strong risk tolerance want to avoid this stock too. If you can stomach the risk, though, a modest bet on Instil Bio could lead to a huge payoff if SYN-2510 or related candidates produce positive clinical trial results.
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Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Merck and Summit Therapeutics. The Motley Fool has a disclosure policy.
