Merck, BioInvent Enroll First Patient In Solid Tumor Combo Trial

Merck (MRK) and BioInvent International have announced the enrollment of the first patient in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy Keytruda for patients with solid tumors.

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The trial’s objectives are to explore the safety and tolerability profile of the combination, to characterize the pharmacokinetic/pharmacodynamic (PK/PD) profile, and to determine the recommended dose.

It will be conducted in several sites across the US and Europe and will assess potential signs of anti-tumoral activity.

The Phase I/IIa trial is divided into part A, a dose escalation of BI-1206 in combination with the standard dose of Keytruda, and part B, which will explore the activity of the combination treatment in patients with advanced lung cancer, melanoma and other types of malignancies. Patients will be refractory to or have progressed on previous treatments with anti-PD1/PDL1 targeting agents.

BI-1206 is a first-in-class monoclonal antibody that targets FcgRIIb, the only inhibitory Fcg receptor, or in other words “the brakes” of the innate immune system. It is currently also being investigated in patients with non-Hodgkin lymphoma (NHL).

“We believe BI-1206’s potential ability to increase and enhance the response rates to anti-PD1 targeting agents such as Keytruda may be a powerful approach for the future treatment of a broad range of solid and liquid tumors” commented Martin Welschof, CEO of BioInvent.

Shares in Merck have pulled back 16% year-to-date, but the stock retains a bullish Strong Buy consensus. That breaks down into 9 recent buy ratings vs 3 hold ratings. Meanwhile the average analyst price target stands at $92 (20% upside potential).

RBC Capital’s Randall Stanicky is one of the analysts staying on the sidelines. He recently reiterated his hold rating with an $84 price target. (See Merck stock analysis on TipRanks)

“Our investment thesis on Merck is that Keytruda will remain the key growth driver for the business over the next several years, with other declining business segments continuing to throw off steady cash with which it can do strategic early-stage deals to augment its pipeline and diversify the business longer term” the analyst explained.