Shares of biotech companies involved in the development of monoclonal antibody cancer therapies were moving all over the place on Friday. Both U.S.-based Summit Therapeutics (SMMT +1.09%) and BioNTech (BNTX +1.55%) were down significantly, plunging 36.1% and 15.4%, respectively, in Friday's trading.
The severe moves were likely related to a Chinese rival in the PD-1/VEGF bispecific antibody area, Akeso (AKES.F +0.00%), receiving FDA approval for a cancer drug that utilizes similar technology, as well as an additional approval in China. As a result, Akeso shares were up 11.7% on Friday.
Of note, Akeso is also a close partner of Summit, making the divergent moves all the more interesting.
NASDAQ: SMMT
Key Data Points
Akeso's penpulimab-kcqx gets approval, as does Ivonescimab in China
Today, Akeso announced that the Food and Drug Administration (FDA) had approved penpulimab-kcqx, Akeso's first internally developed biologic drug, for the treatment of nasopharyngeal carcinoma (NPC), a type of cancer that develops near one's sinuses. In addition, Akeso also disclosed it had received approval for ivonescimab by China's National Medical Products Administration (NMPA) for use against PD-L1-positive non-small cell lung cancer.
Of note, bispecific antibodies use proteins to block receptors in immune cells that cancers target to stop the immune system from responding, while also stimulating immune cells to fight cancer cells.
It's odd that Summit is plunging so much, given that Ivonescimab is its drug, which Summit developed in partnership with Akeso. However, only Akeso has the rights to the drug in China.
Earlier this week, Summit disclosed positive phase 3 trial data for ivonescimab in combination with chemotherapy in a Chinese trial. In response, the stock skyrocketed. Today, that trial's results were cited by the NMPA as grounds for approval. However, the U.S. approval process may be more lengthy. Given that Summit is still awaiting FDA approval for ivonescimab in the U.S. Europe, Canada, and Japan, where it has rights, investors may be selling Summit's stock after its big run earlier this week and buying Akeso, since Akeso may receive revenue and profit from the drug quicker.
The negative reaction for Summit may also be that Akeso may be able to bring penpulimab-kcqx to other cancers or that its other in-house developed cancer drugs could potentially compete with ivonescimab. That being said, Akeso's FDA-approved drug is currently targeted for NPC, not lung cancer.
BioNTech is famous for developing one of the mRNA vaccines for COVID-19, but it also has significant bispecific antibody pipeline aimed at fighting cancer. BioNTech augmented its bispecific antibody cancer platform last fall when it acquired Biotheus for $800 million, which currently has a late-stage monoclonal antibody drug BNT327/PM8002 aimed at several types of cancers. Given that a competitor already has FDA approval and that BioNTech's drugs are still in late-stage trials, investors may also be selling BioNTech for Akeso's stock as well.
Keep an eye on this space
The good news is that cancer patients will soon be able to take advantage of two new drugs, ivonescimab as well as Penpulimab-kcqx. The bad news for investors is that competition in this exciting field is fierce, and the financial outlook for each of these companies as a result of developing these drugs is highly uncertain. Thus, the fast-changing competitive field in these exciting biotechnologies feeds the boom-and-bust action you've seen this week with Summit, and really with BioNTech in the COVID versus post-COVID periods.
Investors in these stocks should be very aware that early-stage biotech stocks have huge upside but also bust potential, and to invest within your risk tolerance accordingly.
