Will ADC Therapeutics’ Lymphoma Drug Get FDA Nod?

ADC Therapeutics SA (ADCT), whose lead candidate faces FDA scrutiny next month, has lost nearly 55 percent of its share price value and trades around $25.

ADC Therapeutics is a clinical-stage oncology-focused biotechnology company developing antibody-drug conjugates or ADCs for patients suffering from hematological malignancies and solid tumors.

The lead drug candidate is Lonca, a CD-19 targeted ADC for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). CD19 is a clinically validated target for the treatment of B-cell malignancies.

Diffuse large B-cell lymphoma, the most common type of non-Hodgkin lymphoma, is an aggressive (fast-growing) type and it develops in lymph nodes, thyroid, liver, bone, breast or any other organ of the body.

Roche’s Polivy, Karyopharm’s Xpovio, MorphoSys’ Monjuv, Kite Pharma’s Yescarta and Novartis’ Kymriah, to name a few, are some of the approved treatment options for diffuse large B-cell lymphoma.

In clinical trials, Lonca as a single agent demonstrated an overall response rate of 48.3% and a complete response rate of 24.1%. The drug candidate, proposed as a third-line treatment of DLBCL, is under priority review by the FDA, with a decision expected on May 21, 2021.

Lonca is also being tested as earlier lines of therapy in DLBCL as well as in additional indications.

A pivotal phase II portion of a phase I/II trial evaluating Lonca in combination with Ibrutinib for the treatment of patients with relapsed or refractory DLBCL or Mantle Cell Lymphoma, dubbed LOTIS 3, is enrolling patients.

A confirmatory phase III trial of Lonca in combination with Rituximab in second-line transplant-ineligible patients with DLBCL, dubbed LOTIS 5, is also underway.

A pivotal phase II trial of Lonca in relapsed or refractory follicular lymphoma and a dose-finding study of Lonca in combination with R-CHOP in first line treatment of DLBCL are planned for this year. R-CHOP, a combination of five drugs, is a standard first-line treatment for non-Hodgkin’s lymphoma.

The market opportunity for Lonca is estimated to be roughly $580 million in the DLBCL treatment landscape and $200 million in the follicular lymphoma space, according to Morgan Stanley.

Next up in the pipeline is Cami, an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25, which is expressed on activated T cells.

Cami is under a phase II pivotal trial in relapsed or refractory Hodgkin lymphoma. Interim data presented from this trial last year showed significant single-agent clinical activity in a heavily-pretreated patient population – demonstrating an Overall Response Rate of 83.0% and Complete Response Rate of 38.3%.

The pivotal phase II trial of Cami in Hodgkin lymphoma is fully enrolled, and additional interim data are anticipated in the first half of this year.

Cami is also being explored in a phase Ib trial in solid tumors in combination with Merck’s Keytruda.

In addition to Lonca and Cami, ADC Therapeutics’ pipeline of candidates include ADCT-602 and ADCT-601, two early clinical programs in hematology and solid tumors, respectively; ADCT-901, a novel antibody drug conjugate targeting KAAG1 in solid tumors, for which an Investigational New Drug (IND) application is planned this year; and an early research pipeline of six additional programs in preclinical development.

Balance Sheet

The company has incurred losses since inception, and as of December 31, 2020, its accumulated losses totaled $694.8 million. Being a clinical-stage company, no revenue has been generated from the sale of products.

Cash balance at year-end 2020 was about $430 million.

Switzerland based ADC Therapeutics made its debut on the New York Stock Exchange last May. The stock has thus far hit a low of $21.51 and a high of $56.59.

ADCT closed Thursday’s (Apr.1, 2021) trading at $25.52, up 4.55%.

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