NKGen Biotech Publishes Phase 1 Interim Analysis Results of SNK02 Allogeneic NK Cell Therapy in Advanced Solid Tumors at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 23, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported an online publication, titled "Interim Analysis of a Phase I Study using Cryopreserved Non-genetically Modified Allogeneic Natural Killer Cells With Enhanced Cytotoxicity (SNK02) in Patients with Advanced Solid Tumors without Lymphodepletion" at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024 (Press release, NKGEN Biotech, MAY 23, 2024, View Source [SID1234643610]).

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This Phase 1 clinical trial is a multi-center, open-label study evaluating the safety and tolerability of SNK02 in participants with pathologically confirmed solid tumors refractory to standard of care therapy. The study drug, SNK02, is a first-in-kind, cryopreserved allogeneic non-genetically modified NK cell product with significant anti-tumor cytotoxicity and over 90% expression of CD16, NKG2D, NKp46, and DNAM-1, that can be consistently produced on a large commercial scale. SNK02 was administered as an intravenous infusion (IV), weekly for eight weeks in patients with advanced solid tumors. The starting dose was 6×109 SNK02 cells. We hypothesized that higher doses of SNK02 (to overcome autodigestion) could be delivered frequently without the need for lymphodepletion and that it might demonstrate activity against solid tumors that have failed multiple prior standard-of-care treatment options. The primary endpoint was safety based on adverse events (AEs), vitals, laboratory tests, and physical exams. Tolerability of SNK02 and maximum tolerated dose were also evaluated.

"Interim data from our Phase 1 clinical study utilizing our second NK cell therapy product, SNK02, demonstrated that the treatment was well-tolerated as a monotherapy in patients with solid tumors refractory to standard of care therapy," said Paul Y. Song, MD, Chairman and CEO of NKGen. "We are particularly excited because SNK02 has the potential to be a first-in-class cryopreserved allogeneic NK cell therapy for solid tumors that does not require lymphodepletion before administration, which may lead to better overall synergy in future combination regimens especially with immune checkpoint inhibitors where a robust T-cell response is needed. Using our proprietary allogeneic manufacturing and cryopreservation processes, we are capable of producing hundreds of thousands of potential doses of enhanced NK cell therapies from materials collected from a single donor. Thus, our potential to treat a significant number of cancer patients with SNK02 is remarkably high. We are pleased to see such promising Phase 1 trial results for both of our unique cell therapy candidates: autologous SNK01 for neurodegenerative disease and allogeneic SNK02 for cancer."

For additional information on the SNK02 clinical trial, please visit View Source using the identifier NCT05990920.

Highlights from the online publication include:

Five patients with advanced refractory solid tumors were enrolled in the trial.
Patients had received an average of 4 lines of prior therapy.
Median age was 64 (range 44 – 71) and 3 were male.
The subtypes were 1 leiomyosarcoma, 1 angiosarcoma, 1 endometrial adenocarcinoma, 1 undifferentiated pleomorphic sarcoma, and 1 colorectal adenocarcinoma.
Four of five patients completed 8 cycles of SNK02. The best objective response of stable disease (tumor stopped growing) was demonstrated in 100% of patients that completed the 8 cycles.
Out of the 36 doses administered through Cycle 8, there were 17 Grade 1, 3 Grade 2, and 1 Grade 3 adverse events (AEs) related to investigational product (IP). The Grade 3 AE of increased fatigue resolved after 1 day with no intervention required.
There was 1 death on study, which was deemed unrelated to the IP.
Auto-antibodies appeared to develop around cycle 5 and appeared to correlate with AEs.
SNK02 was well tolerated as a monotherapy and appears to have some clinical activity against pretreated solid tumors despite the lack of lymphodepletion. SNK02 will continue to be studied as a monotherapy and in potential combination treatment regimens with monoclonal antibodies and immune checkpoint inhibitors.

A copy of the ePublication will be available on the Scientific Publications page of the Company’s website at View Source

About SNK02

SNK02 is a novel cell-based, donor-derived ex vivo expanded allogeneic natural killer ("NK") cell, immunotherapeutic drug candidate. NKGen Biotech, Inc. is developing SNK02 for the treatment of a broad range of cancers.

Nimbus Therapeutics Presents New Positive Monotherapy Phase 1/2 Clinical Data of HPK1 Inhibitor in Treatment of Advanced Solid Tumors at 2024 ASCO Annual Meeting

On May 23, 2024 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, reported the presentation of new positive data from the company’s ongoing Phase 1/2 clinical trial of NDI-101150, a novel, oral small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor in development for the treatment of advanced solid tumors (NCT05128487) (Press release, Nimbus Therapeutics, MAY 23, 2024, View Source [SID1234643609]). Results are being highlighted in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.

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The Phase 1/2 multicenter, open-label trial is designed to assess NDI-101150 as a monotherapy (50-200 mg dose) and in combination with 200 mg pembrolizumab in the treatment of adults with advanced solid tumors. The results being presented at the ASCO (Free ASCO Whitepaper) Annual Meeting include updated data from 44 patients in the dose escalation cohorts (n=38 on monotherapy, n=6 on combination therapy) and additional data from 15 patients in the dose expansion cohorts. Results, as of March 18, 2024, showed:

Treatment with NDI-101150 monotherapy was associated with clinical benefit in five out of 30 (16.7%) response-evaluable patients.
One patient with renal cell carcinoma (RCC) in the dose escalation cohort exhibited a complete response, and one patient with RCC in the dose expansion cohort exhibited a partial response. Both patients were pre-treated with multiple lines of therapies including checkpoint inhibitors.
Three patients with RCC, pancreatic cancer and endometrial cancer, respectively, maintained durable stable disease (SD) for more than six months while on treatment (21 months for the patient with RCC).
In the RCC patient population, six out of eight response-evaluable patients had a best overall response of SD or better.
NDI-101150 showed an increase in activated CD8+ T cells and dendritic cell infiltration in on-treatment patient biopsies compared to archival biopsies, consistent with nonclinical studies of NDI-101150 showing immune cell infiltration and robust anti-tumor activity in murine syngeneic tumor models.
NDI-101150 is well-tolerated and the overall safety of NDI-101150 remains acceptable.
"We are encouraged by these results being presented at ASCO (Free ASCO Whitepaper) and additional observations to date showing monotherapy clinical benefit and an acceptable safety profile of NDI-101150, further validating HPK1 as a differentiated next-generation immunotherapy target for people living with advanced solid tumors in need of new effective treatment options," said Nathalie Franchimont, M.D., Ph.D., Chief Medical Officer at Nimbus. "HPK1 inhibition is a promising therapeutic approach as it is shown to activate T cells, B cells and dendritic cells to mount a robust anti-tumor response, whereas currently approved checkpoint inhibitors activate T cells. NDI-101150 is a potent and highly selective HPK1 inhibitor that has the potential to achieve significant tumor growth inhibition and make a meaningful difference for patients."

The study abstract is available on the ASCO (Free ASCO Whitepaper) website here and the details of the poster presentation are as follows:

Title: Phase 1/2 Trial of the HPK1 Inhibitor NDI-101150 as Monotherapy and in Combination with Pembrolizumab: Clinical Update

Lead Author: Marcus Noel, M.D.

Date: Saturday, June 1, 2024

Time: 9:00 a.m. – 12:00 p.m. CT

Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology

Abstract Number: 3083

Mythic Therapeutics to Present Data from Phase 1 KisMET-01 Study on MYTX-011 at the American Society of Clinical Oncology (ASCO) Annual Meeting

On May 23, 2024 Mythic Therapeutics, a clinical-stage biotechnology company committed to the development of next-generation antibody-drug conjugate (ADC) therapies for the treatment of a wide range of cancers, reported that it will present initial dose escalation results from its Phase 1 KisMET-01 study evaluating its investigational cMET-targeting ADC, MYTX-011, in patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Mythic Therapeutics, MAY 23, 2024, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-to-present-data-from-phase-1-kismet-01-study-on-mytx-011-at-the-american-society-of-clinical-oncology-asco-annual-meeting [SID1234643608]).

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"We are pleased to present clinical data showcasing the potential of our lead program, MYTX-011, for patients impacted by non-small cell lung cancer," said Gilles Gallant, BPharm, Ph.D., FOPQ, Chief Development Officer at Mythic Therapeutics. "The initial dose escalation results from our ongoing KisMET-01 trial mark an important milestone in our journey, and we look forward to sharing these results with the scientific community at ASCO (Free ASCO Whitepaper)."

Details of the presentation are as follows:

Title: MYTX-011 in patients with previously treated locally advanced or metastatic NSCLC: Initial dose escalation results in the phase 1 KisMET-01 study.
Presenter: Melissa Johnson, M.D., Director, Lung Cancer Research, Sarah Cannon Research Institute
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: Monday, June 3, 1:30 – 4:30 PM CDT
Location: Hall A | On Demand
Poster Board Number: 422
Published Abstract Number: 8558

About MYTX-011

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology which is designed to allow ADCs to actively navigate inside of cells, potentially increasing delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles. MYTX-011 is currently being evaluated in the Phase 1 KisMET-01 clinical trial, a first-in-human, open-label, multi-center, dose escalation and dose expansion study enrolling patients with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

Mural Oncology Presents Clinical Data from ARTISTRY-3 at the American Society of Clinical Oncology Annual Meeting

On May 23, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported data from ARTISTRY-3, a clinical trial designed to evaluate the effects of less frequent intravenous dosing (LFIV) of nemvaleukin alfa (nemvaleukin), in advance of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place May 31-June 4 in Chicago (Press release, Mural Oncology, MAY 23, 2024, View Source [SID1234643607]).

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Nemvaleukin, Mural’s lead candidate, is an investigational, engineered interleukin-2 (IL-2) cytokine designed to capture and expand the therapeutic benefits of high-dose native IL-2 while mitigating the cytokine’s hallmark toxicities. In ARTISTRY-1, the company sought to recapitulate the results of high-dose IL-2 by mimicking its dosing regimen with five daily intravenous (IV) infusions (days 1-5) per three-week cycle. In the ARTISTRY-3 trial, the company evaluated escalating LFIV infusions, all of which were generally well tolerated. The safety profile in all dosing schedules evaluated was consistent with nemvaleukin’s known mechanism of action, and no dose limiting toxicities were observed. Despite administering higher doses per three-week dosing cycle than in previous trials evaluating nemvaleukin with daily infusions, no new safety signals were identified. The desired pharmacodynamic (PD) effects were also seen across all evaluated doses. Expansion of antitumor CD8+ T cells and natural killer (NK cells) was observed concurrent with minimal expansion of immunosuppressive regulatory T cells (Tregs).

"Nemvaleukin demonstrated deep and durable responses in previous trials, so we sought an adapted dosing schedule to make treatment administration easier on patients and providers alike. All dosing schedules tested in ARTISTRY-3 demonstrated the desired pharmacodynamic effects, including expansion of immune-stimulating NK and CD8+ cells, with only minimal expansion of immunosuppressive Tregs. Notably, despite significantly increasing the doses, we observed no new tolerability issues compared to previous studies of nemvaleukin," said Sarina Piha-Paul, MD, Associate Professor, Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and the poster’s lead author.

After a comprehensive review of the safety, pharmacokinetics, PD, and efficacy data across the evaluated schedules and doses, and in collaboration with Mural’s safety review committee, Mural selected a 30 µg/kg dose on day 1 and day 8 as the recommended phase 2 dose. Mural believes that this seven-day window offers more time for patient recovery and allows for more flexibility both for patients and providers.

The new less frequent dosing regimen with the 30 µg/kg dose, which delivers twice the dose of nemvaleukin over a three-week cycle as the standard five-day dosing regimen, is being evaluated as both a single agent and in combination with pembrolizumab in patients with cutaneous melanoma in cohort 3 and cohort 4 of Mural’s ARTISTRY-6 clinical trial. Mural expects to provide preliminary data readouts from cohort 3 in the first half of 2025 and from cohort 4 in the second half of 2025.

"ARTISTRY-3 was designed to assess whether a more patient-friendly dosing schedule could maximize the dose of nemvaleukin without any additional tolerability issues. The data presented at ASCO (Free ASCO Whitepaper) demonstrated PD proof of mechanism and promising tolerability across all three dosing schedules. We are immediately incorporating this new dosing regimen into additional cohorts of ARTISTRY-6, our phase 2 trial of nemvaleukin," said Caroline Loew, Ph.D., CEO of Mural Oncology. "IL-2 has proven to be efficacious in cutaneous melanoma and these open label cohorts of the ARTISTRY-6 trial may yield an early signal regarding the potential of our alternative dosing both as a monotherapy therapy and in combination with pembrolizumab."

The details for the presentation are as follows, and the poster will be available on June 1 at View Source

Recommended Phase 2 Dose (RP2D) of Nemvaleukin Alfa in Patients With Advanced Solid Tumors Treated With Less Frequent Intravenous Dosing (ARTISTRY-3)

Session: Developmental Therapeutics – Immunotherapy

Date and time: June 1, 2024, 9 a.m. CDT

Abstract #: 2587

Speaker/lead author: Sarina Piha-Paul, MD

About Nemvaleukin

Nemvaleukin alfa is a novel, engineered cytokine designed to leverage antitumor effects of the IL-2 pathway while mitigating its hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin demonstrated deep and durable responses in both monotherapy and combination therapy in ARTISTRY-1, Mural Oncology’s first Phase 1/2 trial of nemvaleukin.

Nemvaleukin is currently being evaluated in two potentially registrational trials in platinum- resistant ovarian cancer and mucosal melanoma.

About the ARTISTRY-3 Clinical Trial

ARTISTRY-3 is a Phase 1/2 open-label trial of IV nemvaleukin in patients with selected advanced solid tumors who have previously received standard of care treatment(s). The trial is evaluating doses between 10 µg/kg and 40 µg/kg across three dosing regimens: once per three-week dosing cycle; days 1 and 8 of a three-week dosing cycle; and days 1 and 4 of a three-week dosing cycle.

Iovance Biotherapeutics Announces Clinical Data in Frontline Advanced Melanoma at ASCO 2024 Annual Meeting

On May 23, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma, as well as translational data, for the upcoming 2024 ASCO (Free ASCO Whitepaper) Annual Meeting to be held May 31 – June 4, 2024, at McCormick Place in Chicago, IL and online (Press release, Iovance Biotherapeutics, MAY 23, 2024, View Source [SID1234643606]).

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Clinical Data in Frontline Advanced Melanoma (Cohort 1A in IOV-COM-202 Trial)
Positive results from Cohort 1A in the IOV-COM-202 trial were published in an abstract1 and will be highlighted in an upcoming oral presentation at ASCO (Free ASCO Whitepaper). Unprecedented response rates, as well as deep and durable responses, were observed in patients with frontline advanced melanoma who were naïve to immune checkpoint inhibitor (ICI) therapy. These results strongly support the ongoing Phase 3 TILVANCE-301 clinical trial.

ASCO Oral Presentation Highlights

A recent data cut included 23 patients with a median follow up of 21.7 months.2
Confirmed ORR was 65.2%, including 7 (30.4%) complete responses and 8 (34.8%) partial responses by RECIST v1.1.
All evaluable patients demonstrated regression of their target lesions.
Nearly all responses remained ongoing. The duration of response was 12+ months for 8 responders (53.3%) and 6+ months for 11 responders (73.3%).
As a one-time treatment, lifileucel’s safety profile was differentiated from continuous ICI combination regimens.
Treatment-emergent adverse events were consistent with the underlying disease and known safety profiles of pembrolizumab monotherapy, nonmyeloablative lymphodepletion, and interleukin-2.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "The compelling response rates, including a 30.4% complete response rate, and depth and durability of responses for lifileucel in combination with pembrolizumab strongly support our strategy in frontline advanced melanoma. Expanding TIL cell therapy into earlier treatment settings is a top priority for Iovance. The positive data are highly encouraging for the anticipated ORR results in our ongoing TILVANCE-301 trial. A planned early interim analysis of ORR, a dual primary endpoint in TILVANCE-301, may support an accelerated approval in the frontline setting, with full approval supported by progression free survival."

The clinical and safety data from Cohort 1A continue to reinforce the rationale for the TILVANCE-301 trial. TILVANCE-301 is a global, randomized, registrational Phase 3 trial to support accelerated and full U.S. approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma. In addition, the ORR endpoint in TILVANCE-301 supports full approval of lifileucel monotherapy (Amtagvi) in post-anti-PD-1 melanoma. The U.S. Food and Drug Administration (FDA) has agreed to the design of the TILVANCE-301 trial, including dual-primary endpoints of ORR and progression free survival. Iovance plans to conduct an early interim analysis of ORR as the potential basis for regulatory submission and approvals.

Iovance Presentation and Posters at ASCO (Free ASCO Whitepaper) Annual Meeting

Oral Presentation: Efficacy and safety of lifileucel, an autologous tumor-infiltrating lymphocyte cell therapy, and pembrolizumab in patients with immune checkpoint inhibitor-naive unresectable or metastatic melanoma: updated results from IOV-COM-202 Cohort 1A (Abstract 9505)
Session: Melanoma/Skin Cancers
Friday, May 31, 2024, 2:45 p.m. – 5:45 p.m. CDT
Poster: IOV-3001, a modified interleukin-2 fusion protein, for potential use in tumor-infiltrating lymphocyte cell therapy regimens (Abstract 2552)
Session: Developmental Therapeutics-Immunotherapy
Saturday, June 1, 2024, 9:00 a.m. – 12:00 p.m. CDT
Poster: Dynamics of circulating cytokines and chemokines during and after tumor-infiltrating lymphocyte cell therapy with lifileucel in advanced melanoma patients
Session: Melanoma/Skin Cancers (Abstract 9594)
Saturday, June 1, 2024, 1:30 p.m. – 4:30 p.m. CDT
ASCO 2024 Webcast
Iovance executives and key opinion leaders (KOLs) will discuss ASCO (Free ASCO Whitepaper) data highlights and perspectives on the Amtagvi commercial launch during an audio webcast on Friday, May 31, 2024 at 6:15 p.m. CDT (7:15 p.m. EDT). To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com for one year.