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Biopharma Co. Posts Positive Data in Ph. 1 Cancer Trials
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Nkarta Inc. shares traded over 120% higher after the company reported positive dosing data from two separate Phase 1 clinical trials evaluating the use of natural killer cell therapies to target r/r acute myeloid leukemia and myelodysplastic syndrome and r/r B cell malignancies.

Biopharmaceutical firm Nkarta Inc. (NKTX:NASDAQ), which is engaged in developing engineered natural killer cell therapies for use in treatment of cancer, today announced "positive preliminary Phase 1 data from independent dose finding studies of its two lead chimeric antigen receptor (CAR) natural killer (NK) cell therapy candidates, NKX101 and NKX019, in two distinct groups of hematologic malignancies."

Nkarta's President and CEO Paul J. Hastings commented, "We're excited to see our CAR NK co-lead candidates, NKX101 and NKX019, show such striking early single-agent activity in heavily pretreated patient populations, with an exceptional safety profile without the side effects associated with CAR T cell therapies…These encouraging data across multiple indications further validate Nkarta's best-in-class NK cell platform, as we seek to transform cancer treatment by bringing together the safety advantages of NK cells with an off-the-shelf modality designed to make the benefits of cell therapy accessible in a community setting."

The company reported that in its single arm, open-label, multi-center, Phase 1 dose escalation clinical trial of NKX101 (allogeneic CAR NK cells targeting NKG2D ligands) for use as a multi-cycle monotherapy in treatment of relapsed / refractory (r/r) acute myeloid leukemia (AML) and intermediate, high and very high myelodysplastic syndrome (MDS), "three of five patients with heavily pre-treated AML who received the higher dose level in a three-dose regimen achieved a complete response (60% CR) with hematologic recovery, with two of the three responses MRD (minimal residual disease) negative."

Nkarta noted that so far 17 AML patients and 4 MDS patients have been enrolled and dosed in the study. Trial participants had all received prior treatments with a median of three prior lines of therapy and all 17 AML patients had undergone prior treatment with venetoclax. The company described NKX101 as "an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target NKG2D ligands on cancer cells."

Marcello Rotta, M.D., Colorado Blood Cancer Institute (CBCI), a part of the Sarah Cannon Cancer Institute at Presbyterian/St. Luke's Medical Center, and investigator in the NKX101 clinical trial remarked, "r/r AML is a historically hard-to-treat disease, and given the lack of effective treatments, people with cancer and those who treat them are faced with few options…Complete responses with corresponding MRD negativity in r/r AML using engineered NK cells, as seen in these preliminary findings, is encouraging."

The firm mentioned that in a separate Phase 1 clinical study of NKX019 conducted in the U.S. and Australia as a multi-dose, multi-cycle monotherapy for treatment for r/r B cell malignancies, "three of six patients treated at the higher dose level in a three-dose regimen showed a complete response (50% CR), including one patient with aggressive diffuse large B cell lymphoma (DLBCL) and one patient with mantle cell lymphoma (MCL)."

The company listed that thru April 21, 2022, it had enrolled and dosed a total to 13 patients in the study, of which 10 of them were diagnosed with non-Hodgkin lymphoma (NHL), with 5 of those having aggressive large B cell lymphoma (LBCL) and many presenting aggressive disease symptoms including extensive lesions throughout the body. Prior to enrollment, participants in the study had received a median of 4 prior lines of therapy. Nkarta explained that "NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses NK cells engineered to target the B-cell antigen CD19, a clinically validated target for B-cell cancer therapies."

Michael Dickinson, M.D., Lead, Aggressive Lymphoma disease group, Clinical Hematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, and investigator in the NKX019 trial l stated, "The curative potential of CAR T cell therapy is truly remarkable, but many eligible patients are still not cured, and the safety and logistical challenges of approved autologous CAR T therapy are barriers…The NKX019 trial exemplifies the continued progress of our field. NKX019 showed clear activity, in patients with a range of NHL histologies, without the sort of toxicities expected of other cellular therapies, supporting continued exploration of this CAR NK candidate."

The company indicated that it is proceeding with enrollment of additional patients in both dose-finding studies. In each of the trials, patients as currently being given three-dose regimens of 1.5 billion NK cells per dose. Nkarta stated that as data and program updates become available it will present the information at future medical meetings.

Nkarta is a clinical-stage biotech firm based in South San Francisco, Calif. that is working to create and develop allogeneic, off-the-shelf natural killer (NK) cell therapies for use in treating cancer. The company is striving to improve the efficacy of cell therapy enabling it to have higher potency, better tolerance and greater availability to patients with hematologic and solid tumor malignancies.

Nkarta is building a pipeline of future treatment candidates designed to attack deep anti-tumor activity. The company utilizes its cell expansion and cryopreservation platform and proprietary cell engineering technologies in combination with CRISPR-based genome engineering capabilities. The company focuses its efforts on deploying Natural Killer (NK) cell therapies to target and destroy tumor cells. NK cells are considered to be the immune system's first natural defenses against pathogens and diseases.

Nkarta started off the day with a market cap of around $256.5 million with approximately 33.01 million shares outstanding and a short interest of about 5.6%. NKTX shares opened 86% higher today at $14.49 (+$6.72, +86.49%) over Friday's $7.77 closing price. The stock has traded today between $14.05 and $18.46 per share and is currently trading at $17.10 (+$9.33, +120.08%).

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