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Protara Therapeutics Announces Trials in Progress Poster Presentation for the ADVANCED-1 Trial in NMIBC at the 2022 American Society of Clinical Oncology Annual Meeting

On May 26, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it will present a Trials in Progress poster related to its ADVANCED-1 Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, Illinois and virtually from June 3 through June 7, 2022 (Press release, Protara Therapeutics, MAY 26, 2022, View Source [SID1234615097]). The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).

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"There is a significant need for new treatment options for patients with NMIBC, one of the most recurrent and difficult to treat cancers," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. "Based on its mechanism of action, and promising clinical data from its predecessor therapeutic OK-432, we believe that TARA-002 may address this pressing area of high unmet need. We look forward to continuing to advance this trial and exploring TARA-002’s full potential in NMIBC."

Details of the poster presentation are as follows:

Title: A Phase 1a/b safety study of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer (ADVANCED-1)
Abstract Number: TPS4620
Session Title: Genitourinary Cancer—Kidney and Bladder
Session Date and Time: Saturday, June 4, 2022, from 2:15 PM – 5:15 PM EDT
Location: In-Person & Online | McCormick Place, Hall A

ADVANCED-1 is a Phase 1 dose-finding, open-label trial (NCT05085977 and NCT05085990) evaluating TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a recommended dose for a planned Phase 2 clinical trial.

A copy of the abstract is available at View Source

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins (IL)-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor, are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

PMV Pharmaceuticals Announces Initial PC14586 Phase 1 Clinical Data to be Presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

May 26, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP; "PMV Pharma"), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported the online publication of the abstract for its lead program, PC14586, accepted as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held June 3-7, 2022 in Chicago, Illinois (Press release, PMV Pharma, MAY 26, 2022, View Source [SID1234615096]).

The published abstract describes preliminary outcomes from 29 patients, including 21 efficacy evaluable, from the ongoing Phase 1/2 PYNNACLE trial of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. These initial data from our Phase 1/2 tumor agnostic study enrolled patients across multiple tumor types over a broad range of doses. The preliminary clinical pharmacokinetics data showed dose proportional increases in Cmax and AUC. In addition, the safety profile was encouraging as PC14586 was well-tolerated.

The oral presentation at ASCO (Free ASCO Whitepaper) containing updated data from the trial will be presented by Ecaterina Ileana Dumbrava, M.D., of the University of Texas MD Anderson Cancer Center. PC14586 is a first-in-class precision oncology small molecule investigational therapy that selectively targets the p53 Y220C mutation in solid tumors.

"Patients whose tumors carry a p53 mutation are known to have a poor prognosis. The patients who were enrolled in our study had very limited or no other standard treatment options available to them. Early efficacy and safety data from this Phase 1/2 trial provide the potential of a p53 therapy," said David Mack, Ph.D., President and CEO, PMV Pharma. "We look forward to Dr. Dumbrava’s presentation of these data at ASCO (Free ASCO Whitepaper) and continuing to progress the PC14586 development program."

Details of the oral presentation are as follows:

Investor Event

PMV Pharma will host an investor event via webcast on June 7, 2022, at 6:30 PM CDT to discuss the PC14586 Phase 1 data. The event will feature a presentation by Dr. Dumbrava who will review the data presented at ASCO (Free ASCO Whitepaper) 2022. To listen to the webcast and view the accompanying slide presentation, please refer to the Events and Presentations section of the PMV Pharma website.

About PC14586

PC14586 is a first-in-class, small molecule p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

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]).

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).

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:

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.