NKGen Biotech To Present SNK01 Clinical Data at the 2022 ASCO Annual Meeting

On May 26, 2022 NKGen Biotech Inc., a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that clinical data from its ongoing SNK01 (NK cell therapy) phase I trial, in patients with advanced solid tumors, will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3 – 7, 2022 in Chicago, Illinois (Press release, NKGEN Biotech, MAY 26, 2022, View Source [SID1234615095]).

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Results will be presented in a poster discussion entitled: Interim analysis of a phase I study of SNK01 (autologous non-genetically modified natural killer cells with enhanced cytotoxicity) and avelumab in advanced refractory sarcoma (abstract: 11517; poster: 422), on Sunday, June 5, 2022, 8:00 am – 11:00 am; Discussion 11:30 am – 1:00 pm CDT; Sarcoma session, sarcoma track, Room S404.
The SNK01 phase I, open label, dose escalation trial (NCT03941262), in patients with advanced solid tumors refractory to conventional treatment, demonstrated antitumor activity and an acceptable safety profile.

Key highlights

SNK01 combined with avelumab showed efficacy in 17 advanced stage cancer patients (all heavily pre-treated with a median of 5 lines of prior therapy)
Best ORR is 11.7% with 2 PR and 7 SD
Median PFS is 11.3 weeks; four patients (23.5%) have PFS of > 41 weeks
Median OS is 24.9 weeks
PFS and OS are expected to increase as patients continue on the trial
SNK01 combined with avelumab was safe and well-tolerated and appears to have some clinical activity against several types of heavily pre-treated advanced sarcomas, independent of PD-L1 status
SNK01 may also keep rapidly progressing disease stable while allowing additional treatment with cytotoxic chemotherapy
Two additional posters will also be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting:

Preliminary analysis of a phase I study of SNK01 (Autologous non-genetically modified natural killer cells with enhanced cytotoxicity) monotherapy in patients with advanced solid tumors (abstract: 2644, poster: 298)
The combination of CD16A/EGFR innate cell engager, AFM24, with SNK01 autologous natural killer cells in patients with advanced solid tumors (abstract: TPS2675, poster: 326b)
Abstracts presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at www.asco.org

Investigational Adagrasib Delivers Positive Results in Registration-Enabling Study of Patients with KRASG12C-Mutated Advanced Non-Small Cell Lung Cancer

On May 26, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported positive results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib 600 mg BID in patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy (Press release, Mirati, MAY 26, 2022, View Source [SID1234615094]). Findings will be presented on June 3 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, as an oral presentation during the "Lung Cancer – Non-Small Cell Metastatic" session from 2:24 to 2:36 PM ET/ 1:24 to 1:36 PM CT (Abstract #9002).

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Summary of Clinical Results from Phase 2 Registration-Enabling Study
As of October 15, 2021, 116 patients were enrolled and treated in the study. Of the patients enrolled, 98% had prior treatment with a PD-1/L1 inhibitor following or in combination with chemotherapy. Median follow up was 12.9 months.
Of the patients evaluable for response (n=112), initial results showed that the objective response rate (ORR) by Blinded Independent Central Review (BICR) was 43%, the disease control rate (DCR) was 80%, the median duration of response (DOR) was 8.5 months (95% confidence interval [CI]: 6.2 – 13.8), and the median progression-free survival (PFS) was 6.5 months (95% CI: 4.7 – 8.4).
With a January 15, 2022 data cutoff, the median overall survival (OS) was 12.6 months (95% CI: 9.2 – 19.2).
The safety profile of adagrasib in this study was consistent with prior reports and no new safety signals were observed. The most frequent treatment related adverse events (TRAEs) included gastrointestinal events and fatigue. The majority of TRAEs were Grade 1–2 (53%) with Grade 3–4 TRAEs observed in 43% of patients. Two Grade 5 TRAEs were observed. TRAEs led to discontinuation of therapy in only 7% of patients.
"The positive and encouraging data from this trial further support the scientific rationale for targeting the KRASG12C mutation with adagrasib, which fully and continually inhibits mutant KRASG12C throughout the entire dosing period," says Alexander I. Spira, M.D., Ph.D., FACP, Co-Director, Virginia Cancer Specialists Research Institute. "This important dataset demonstrates positive clinical activity with adagrasib across molecular and clinical subgroups, including patients with treated and stable CNS metastases."

The Company also presented results from an exploratory, retrospective subgroup analysis from the Phase 2 NSCLC cohort of the KRYSTAL-1 study evaluating adagrasib in patients with KRASG12C-mutated NSCLC and stable, previously treated central nervous system (CNS) metastases (n=33). These results showed CNS-specific activity, including a 33% intracranial (IC) ORR by response assessment in neuro-oncology-brain metastases (modified RANO-BM). The IC DCR was 85% (95% CI: 68 – 95).

"The exploratory, retrospective subgroup analysis of adagrasib in patients with stable and previously treated CNS metastases showed intracranial tumor regression," added Dr. Spira. "These data are encouraging and contribute to the rapidly advancing science seeking to better understand how KRASG12C inhibitors like adagrasib can help improve patient outcomes."

Updated Findings from Pooled Analysis of KRYSTAL-1 NSCLC Cohorts
In addition to these results, the Company reported updated findings from a pooled analysis in a total of 132 patients from the KRYSTAL-1 study, including the registrational Phase 2 and Phase 1/1b NSCLC cohorts evaluating adagrasib at a dose of 600mg BID.

As of October 15, 2021, results from this pooled analysis showed an ORR of 44% and a disease control rate of 81% based on central independent review. The median DOR was 12.5 months and the median PFS was 6.9 months. With a January 15, 2022 data cutoff, (median duration of follow-up of 15.9 months) the median OS was 14.1 months. The safety and tolerability profile was consistent with the above reported findings for adagrasib in patients with advanced NSCLC. The Company plans to present full results from this pooled analysis at a future medical congress.

"The data from the registrational lung cancer cohort of KRYSTAL-1, including the clinical activity shown in patients with stable, previously treated CNS metastases, further support adagrasib’s unique profile," says Charles M. Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "Mirati is at the forefront of KRAS research, and we are pleased with the meaningfully positive clinical outcomes patients are experiencing with adagrasib, both in previously treated lung cancer and in other tumor settings."

On June 6, 2022, during an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, the Company will present new, late-breaking results from the Phase 1b cohort of the KRYSTAL-1 study evaluating adagrasib in active, untreated CNS metastases (Abstract #LBA9009).

The adagrasib New Drug Application is currently being reviewed by the U.S. Food and Drug Administration (FDA) for Accelerated Approval (Subpart H) as a treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy. Adagrasib has also received Breakthrough Therapy Designation status from the FDA for the same indication. The Company has an ongoing confirmatory Phase 3 trial, KRYSTAL-12, evaluating adagrasib versus docetaxel who have been previously treated for metastatic NSCLC with a KRASG12C mutation.

Virtual Investor Event
Mirati Therapeutics will host an Investor Event on Monday, June 6, 2022, at 8:00 PM ET/7:00 PM CT.

Company executives will provide an overview of the adagrasib clinical data presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting and the Company’s broader lung cancer strategy, including in earlier lines of therapy.

Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

Central Nervous System (CNS) Metastases in KRAS-Mutated Lung Cancer
The brain, along with the bone, adrenals, and liver are common sites of extra-thoracic metastases in NSCLC.[1]−3 CNS metastases occur in 27−42% of patients with KRASG12C-mutated NSCLC at diagnosis.1,4−6 Additionally, patients with CNS metastases and KRAS-mutated NSCLC may have poor outcomes, with median overall survival (OS) of approximately five months.7-9

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24–48 hours. Adagrasib is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

Mirati has an Expanded Access Program (EAP) for investigational adagrasib for the treatment of eligible patients with KRASG12C-mutated cancers, regardless of tumor type, including patients with treated or untreated CNS metastases, in the U.S. Learn more about the EAP at Mirati.com/expanded-access-policy.

Mersana Therapeutics to Present at Upcoming Investor Conferences

On May 26, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at three upcoming investor conferences (Press release, Mersana Therapeutics, MAY 26, 2022, View Source [SID1234615093]). Details are as follows:

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Cowen’s 3rd Annual Oncology Innovation Summit

Jefferies Global Healthcare Conference

The JMP Securities Life Sciences Conference

A live webcast of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.

MEI Pharma and Kyowa Kirin Announce Acceptance of Abstract for Presentation at the American Society of Clinical Oncology Annual Meeting 2022

On May 26, 2022 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that an abstract highlighting data and information from the Phase 2 TIDAL study evaluating the intermittent dosing of zandelisib, an investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, will be presented during a poster discussion session at the upcoming American Society of
Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting to be held June 3 – 7, 2022 (Press release, Kyowa Hakko Kirin, MAY 26, 2022, View Source [SID1234615092]).

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Kinnate Biopharma Inc. to Present Trial Design for its Pan-FGFR Inhibitor Product Candidate, KIN-3248, at ASCO 2022

On May 26, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported the presentation of the design and rationale of a Phase 1 trial-in-progress (KIN-4802, NCT05242822) evaluating the Company’s pan-FGFR inhibitor product candidate, KIN-3248 (Press release, Kinnate Biopharma, MAY 26, 2022, View Source [SID1234615091]). The details will be presented during a poster session on June 6, 2022, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place in Chicago, IL, June 3-7.

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"A major limitation of approved and clinical-stage FGFR treatments is the emergence of secondary, on-target resistance mutations that reduce duration of response, highlighting the urgency to further research and develop more efficacious next-generation therapies for these patients," said the trial’s co-investigator and presenter Lipika Goyal, MD, a faculty member in Gastrointestinal Medical Oncology at Mass General Cancer Center. "We are pleased to share additional details of this two-part Phase 1 trial-in-progress evaluating KIN-3248 at this year’s ASCO (Free ASCO Whitepaper) conference."

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is a multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other selected adult solid tumors. This trial is currently enrolling across multiple sites in the United States.

"Unfortunately, acquired resistance to FGFR inhibitors frequently emerges during therapy for patients with FGFR-driven cancers, creating an urgent need to develop more effective and durable targeted therapies for these patients," said Richard Williams, MBBS, Ph.D., Chief Medical Officer of Kinnate. "We are pleased with the recent initiation of this first-in-human trial of KIN-3248, in collaboration with Mass General Cancer Center and other participating sites, and are grateful to the patients and physicians involved, without whom this research would not be possible."

In addition, in an abstract published in the ASCO (Free ASCO Whitepaper) meeting proceedings, the Company also shared updates from its preclinical in vitro and in vivo preclinical studies evaluating KIN-2787 in combination with binimetinib. In these studies, KIN-2787 demonstrated significant combination benefit in NRAS-mutant melanoma models. Taken together with its unique selectively, these data support the use of KIN-2787 in combination therapy in this patient segment. Melanoma tumor cell lines bearing NRAS Q61 alterations demonstrated synergistic benefit with KIN-2787 combined with binimetinib. Daily KIN-2787 plus binimetinib treatment in NRAS-altered melanoma xenograft models resulted in significant tumor growth inhibition benefit relative to either agent alone and was associated with added MAPK pathway biomarker suppression. A Phase 1/1b dose escalation and expansion clinical trial evaluating the safety and efficacy of KIN-2787 is ongoing (NCT04913285).

Abstracts accepted for the ASCO (Free ASCO Whitepaper) Annual Meeting include:

For additional information, visit the ASCO (Free ASCO Whitepaper) Annual Meeting webpage: View Source

Kinnate will also host an exhibit at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting at booth number 3047.