CD19 CAR-NK therapy shows complete responses in late-stage lymphoma

CULVER CITY - ImmunityBio (NASDAQ:IBRX), a $2.34 billion market cap biotech company showing remarkable revenue growth of over 4,000% in the last twelve months, reported that its CD19 CAR-NK cell therapy has achieved complete responses in the first two patients with late-stage Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma, in its QUILT-106 Phase I trial. According to InvestingPro data, analysts anticipate continued sales growth for the company in the current year.

The first patient achieved a complete response with CD19 CAR-NK monotherapy alone, while the second patient showed a complete response when the therapy was combined with rituximab. The second patient’s remission has been maintained for six months and is ongoing, according to the company.

Both patients were heavily pretreated before receiving the immunotherapy regimen, which was administered without chemotherapy. The company noted that all infusions were delivered in an outpatient setting with no significant toxicities reported.

The QUILT-106 trial is evaluating the safety and preliminary efficacy of CD19 CAR-NK cell therapy alone and in combination with rituximab in patients with relapsed or refractory CD19+CD20+ B-cell non-Hodgkin lymphoma. The study has enrolled 13 patients across three sites in South Africa, including three with WM. While the company maintains a healthy current ratio of 4.11, indicating strong short-term liquidity, InvestingPro analysis shows the company is currently burning through cash with an EBITDA of -$269.07 million in the last twelve months.

Eligible participants in the trial have active disease after at least two chemotherapy-based treatment lines. The study design includes an initial cycle of CD19 CAR-NK cell monotherapy followed by a one-week safety observation period before a second cycle combining CD19 CAR-NK with rituximab.

"The preliminary findings provide the first evidence that novel immunotherapy combinations without chemotherapy lymphodepletion can provide deep and durable remissions in WM even after multiple prior treatments," said Dr. Jackie Thomson from Wits University Donald Gordan Medical Center in Johannesburg, according to the press release.

WM is generally considered incurable with existing treatment options, making these early results potentially significant for patients with limited therapeutic alternatives.

A third WM patient has been enrolled in the study as recruitment continues to further evaluate the therapy’s efficacy. Trading at $2.47, ImmunityBio’s stock currently appears fairly valued according to InvestingPro Fair Value metrics. Subscribers can access 7 additional ProTips and comprehensive financial analysis to better understand the company’s growth trajectory and market position.

In other recent news, ImmunityBio has achieved several significant milestones. The company received authorization from the U.S. Food and Drug Administration (FDA) for Expanded Access to ANKTIVA, a treatment for lymphopenia in adults with refractory or relapsed solid tumors. This authorization marks a crucial development as ANKTIVA is the first therapy with a defined mechanism to restore natural killer and T cells without increasing immunosuppressive regulatory T cells. H.C. Wainwright reaffirmed its Buy rating for ImmunityBio, citing recent regulatory achievements, including the RMAT designation and Expanded Access authorization from the FDA.

Piper Sandler upgraded ImmunityBio’s stock rating from Neutral to Overweight, raising the price target to $5.00, acknowledging the company’s advancements in ANKTIVA and other therapies. BTIG also maintained a Buy rating with a $6.00 price target, noting the strong performance and anticipated sales growth of ANKTIVA. The analysts highlighted the increasing availability of ANKTIVA through the Expanded Access Program in urology practices. Despite a setback with a Refusal to File letter from the FDA for ANKTIVA in BCG unresponsive papillary NMIBC, ImmunityBio is progressing with a Phase III trial, expecting to release data next year.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.