Rituximab

ImmunityBio’s off-the-shelf cell therapy has shown early promise in a small trial in a rare form of lymphoma. The ongoing Phase 1 study, named QUILT-106, has so far signed up four patients with Waldenström non-Hodgkin lymphoma, a B cell cancer. ImmunityBio’s program is an allogeneic CD19 chimeric antigen receptor natural killer (CAR-NK) cell therapy, and in the trial, it was combined with Biogen and Roche’s CD20-targeting antibody Rituxan. ImmunityBio said Friday that updated follow-up showed two complete responses — one ongoing at seven months and one at 15 months. The latter patient, whose bone marrow was about 95% replaced by tumor cells when they entered the trial, achieved a complete response after four doses of ImmunityBio’s cells plus Rituxan. The patient then had four more doses of the combination. All four patients enrolled so far remain in clinical disease control. All had previously failed on standards of care for the disease. The company’s stock $IBRX climbed about 30% in midmorning trading on Friday. Patients given ImmunityBio’s cell therapy didn’t have to undergo lymphodepletion, a process in which chemotherapy is used to quash the immune system so it doesn’t reject the subsequently administered donor cells. Avoiding lymphodepletion allowed the therapy to be administered in an outpatient setting, the biotech said. “Seeing complete responses persist beyond a year after treatment has stopped, in patients who had exhausted available options, represents a meaningful advance” for Waldenström patients, ImmunityBio’s founder Patrick Soon-Shiong said in a statement. No serious adverse events were seen in the trial. The study is continuing to enroll patients, with its protocol calling for a total of 10 subjects . The biotech is also working on a trial combining the CD19 cell therapy/Rituxan regimen with Anktiva, its IL-15 agonist, in forms of indolent lymphoma, including Waldenström’s macroglobulinemia. Anktiva was approved in April 2024 for patients with non-muscle invasive bladder cancer who hadn’t responded to Bacillus Calmette-Guérin, a common vaccine against tuberculosis that is also used as an immunotherapy for NMIBC. ImmunityBio said it plans to submit an approval application this year for an expanded indication in NMIBC patients who have not previously received BCG treatment. If approval here is granted, Anktiva could be used earlier in the treatment sequence than it currently is, growing its sales. The company said that the approval trial for this new use had enrolled faster than expected. More than 85% of the needed patients have already signed up.

Shares in ImmunityBio jumped over 37% on Friday after the company disclosed results from a small early-stage trial testing an off-the-shelf cell therapy in Waldenström macroglobulinemia, a rare and typically incurable form of non-Hodgkin lymphoma.The data, drawn from the ongoing QUILT-106 study, offered early evidence that the company's CD19 CAR-NK cells can induce durable complete responses in patients who failed current standards of care for the disease.QUILT-106 is evaluating an allogeneic CAR-NK product designed to target CD19-positive lymphoma cells, paired with the anti-CD20 antibody rituximab. Unlike conventional CAR-T approaches, ImmunityBio said its regimen does not require lymphodepleting chemotherapy or inpatient hospitalisation. Patients received the therapy in an outpatient setting over four cycles, for a total of eight doses, with responses assessed after the first two cycles.To date, four patients have been enrolled, all of whom remain in disease control, according to the company. Two of the patients are now evaluable for long-term follow-up and continue to show complete remission at seven and 15 months, respectively, after treatment ended. ImmunityBio noted that both had extensive disease at baseline, including one with approximately 95% bone marrow involvement and one with multiple lymphomatous bone lesions, yet achieved remission after only four doses of therapy."Seeing complete responses persist beyond a year after treatment has stopped, in patients who had exhausted available options, represents a meaningful advance for patients with this rare disease…and validates CAR-NK as a potential next-generation immunotherapy platform," said Patrick Soon‑Shiong, global chief medical and scientific officer."Separately, the company also said Friday that enrollment in its randomised registrational QUILT-2.005 study of Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette–Guérin (BCG) in first-line BCG-naïve non-muscle-invasive bladder cancer (NMIBC) has exceeded internal expectations, with more than 85% of patients enrolled. Soon Shiong said the trial is approaching "the final accrual of this important registrational" study, setting the stage for a potential FDA filing by the end of the year.Anktiva is an IL-15 agonist currently approved in the US for use with BCG in adult patients with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors. EU regulators recommended conditional approval of the regimen in this indication last month.