Merck to acquire VelosBio, strengthening oncology pipeline with investigational antibody-drug conjugate

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Merck (MSD outside the US and Canada) will acquire San Diego’s VelosBio in a $2.75bn deal.

VelosBio is a privately held clinical-stage bio which is developing cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). Its lead investigational candidate is VLS-101, an antibody-drug conjugate (ADC) targeting ROR1 which is currently in Phase 1 and Phase 2 trials.

Dr. Roger M. Perlmutter, president, Merck Research Laboratories, said: “We continue to bolster our growing oncology pipeline with strategic acquisitions that both complement our current portfolio and strengthen our long-term growth potential.

“Pioneering work by VelosBio scientists has yielded VLS-101, which in early studies has provided notable evidence of activity in heavily pretreated patients with refractory hematological malignancies, including mantel cell lymphoma and diffuse large B-cell lymphoma.”

VelosBio’s tech

Founded in 2017, VelosBio develops both ADCs and bispecific antibodies (BiAbs) to target ROR1. It completed an oversubscribed Series B financing round in July, raising $137m and representing a total of $202m in gross proceeds from private financings in total.

VelosBio’s lead investigational candidate is VLS-101, an ADC which is currently being evaluated in a Phase 1 clinical trial for hematologic malignancies and a Phase 2 clinical trial for the solid tumors.

The Phase 2 trial, for the treatments of patients with solid tumors, was initiated last month and includes patients with triple-negative breast cancer (TNBC), hormone receptor-positive and/or HER2-positive breast cancer, and non-squamous non-small-cell lung cancer (NSCLC).

In early clinical trials, VLS-101 demonstrated a 'manageable safety profile and early signs of anti-tumor activity’. Results of a Phase 1 clinical trial, to be presented virtually at the 62nd American Society of Hematology Annual Meeting in December, showed that VLS-101 resulted in objective clinical responses, including complete responses, in 47% (n=7/15) of patients with mantle cell lymphoma (MCL) and 80% (n=4/5) of patients with diffuse large B-cell lymphoma.

Patients in this Phase 1 trial had been heavily pretreated with other anticancer medications, and their cancers had failed to respond or had relapsed after initially responding to these other anticancer medications.

VelosBio pipeline of ADCs and BiAbs, which also target ROR1, have the potential to complement VLS-101 by offering alternative methods of tumor cell killing, according to the company. Three candidates are in the preclinical stage.

The closing of the transaction, subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, is expected by the end of 2020.

Big deals in ADC

Merck is just the latest pharma giant to make a sizeable play in the antibody-conjugates space. Gilead made headlines in September with its $21bn deal to acquire New Jersey’s Immunomedics Inc: gaining its ADC platform (Trodelvy, IMMU-130 and IMMU-140).

In July, AstraZeneca entered into a global development and commercialisation agreement with Daiichi Sankyo Company for DS-1062, Daiichi Sankyo’s proprietary trophoblast cell-surface antigen 2 (TROP2)-directed ADC.

Merck, meanwhile, also acquired a $1bn equity stake in Seattle Genetics in September, which will see it develop Seattle Genetics’ ADC ladiratuzumab vedotin globally. This investigational ADC is currently in phase 2 clinical trials for breast cancer and other solid tumors.

Merck and Seattle Genetics are developing and commercialising the ADC globally, jointing developing and sharing costs and profits on a 50:50 basis. The two companies will evaluate ladiratuzumab vedotin both as monotherapy and in combination with Merck’s anti-PD-1 therapy Keytruda ​(pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors.