On September 9, 2024 NiKang Therapeutics Inc. ("NiKang"), a clinical-stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported that preliminary data from its ongoing Phase 1/2 clinical trial evaluating NKT2152 for the treatment of previously treated advanced clear cell renal cell carcinoma (ccRCC) will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress on September 13, 2024, in Barcelona, Spain (Press release, NiKang Therapeutics, SEP 9, 2024, View Source [SID1234646463]).

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"This oral presentation marks an important milestone in the clinical development of NKT2152, a highly selective, potent and orally available HIF2α inhibitor with a potential best-in-class profile. The findings strengthen our belief that deep inhibition of HIF2α can lead to meaningful clinical benefits in patients at dose levels that are generally well tolerated," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "These data demonstrate NKT2152’s robust anti-tumor activity in heavily pretreated, high risk advanced ccRCC patients. They also support the hypothesis that NKT2152’s potency and improved systemic exposure have the potential to enhance the current standard of care."

Details for the presentation are as follows:

Presentation Title: NKT2152, a novel oral HIF2α inhibitor, in participants (pts) with previously treated advanced clear cell renal cell carcinoma (accRCC): Preliminary results of a Phase 1/2 study
Session Title: Proffered paper session 1: GU tumors, non-prostate
Session Date and Time: Friday, September 13, from 14:00 – 15:30 CET (8:00 – 9:30am ET)
Presentation Number: 1690O
Presenter: Eric Jonasch, MD (MD Anderson Cancer Center, Houston, TX)
Location: Santander Auditorium – Hall 5

After the oral presentation, the full presentation will be available at Science & Pipeline – NiKang Therapeutics (www.nikangtx.com).

About NKT2152

NKT2152 is a potent, selective and orally available small molecule HIF2α inhibitor which binds to HIF2α allosterically and disrupts the HIF2α/HIF1β transcription factor complex, thereby reducing the production of proteins which lead to tumorigenesis. NKT2152 is currently under evaluation in a Phase 1/2 clinical study in ccRCC as a single agent (NCT05119335) and a Phase 2 clinical study in ccRCC in combination with palbociclib and sasanlimab (NCT05935748). A third clinical study, sponsored by F. Hoffman-La Roche Ltd., evaluating the combination with standard-of-care atezolizumab (Tecentriq) and bevacizumab (Avastin) in first-line unresectable/advance hepatocellular carcinoma (HCC) (NCT04524871) is planned.

On September 9, 2024 Novocure (NASDAQ: NVCR) reported that it will present a real-world analysis of usage of its Tumor Treating Fields (TTFields) therapy and survival outcomes in newly diagnosed glioblastoma (ndGBM) patients at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, September 13 – 17, Barcelona, Spain (Press release, NovoCure, SEP 9, 2024, View Source [SID1234646462]).

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The results of the real-world analysis suggest higher TTFields therapy device usage is significantly associated with improved survival outcomes in a broad population of ndGBM patients.

Novocure’s ESMO (Free ESMO Whitepaper) 2024 Data Presentation Details:

Poster #459: Association of Tumor Treating Fields Device Usage with Survival in Newly Diagnosed GBM: A Real-World Analysis of Patients in the US
Authors: Jennifer M. Connelly, Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, United States; Santiago Cabezas-Camarero, Department of Medical Oncology, Hospital Universitario Clínico San Carlos (IdISSC), Madrid, Spain; Nick Avgeropoulos, Novocure, Inc., Portsmouth, NH, United States; Patrick Conlon, Novocure, Inc., Portsmouth, NH, United States; Gordon Chavez, Novocure, Inc., Portsmouth, NH, United States; Ori Farber, Novocure, Ltd., Haifa, Israel
Date: Monday, September 16

Abstracts are available on the ESMO (Free ESMO Whitepaper) website, esmo.org/meeting-calendar/esmo-congress-2024/programme.

Novocure has also sponsored an ESMO (Free ESMO Whitepaper) Colloquium, The Role of Alternating Electric Fields in the Therapeutic Management of Patients with Advanced Non-Small Cell Lung Cancer, which will be held Monday, September 16, 13:00 – 14:30 CEST, in the Oviedo Auditorium, Hall 3.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On September 9, 2024 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, reported that updated data from the clinical trial of botensilimab and balstilimab in refractory sarcomas will be featured in a mini oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 13-17, 2024, in Barcelona, Spain (Press release, Agenus, SEP 9, 2024, View Source [SID1234646461]).

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The presentation will feature updated efficacy and safety data from the large, ongoing Phase 1 trial, highlighting the potential of this combination therapy in treating patients with refractory sarcomas, including visceral angiosarcoma and leiomyosarcoma, populations with limited therapeutic options. Botensilimab, a novel investigational Fc-enhanced CTLA-4 inhibitor, and balstilimab, an investigational PD-1 antibody, have shown promising clinical responses in multiple tumor types, including "cold" tumors that are typically unresponsive to standard therapies.

Presentation Details:

Abstract Title: Updated efficacy and safety of botensilimab plus balstilimab in patients with refractory metastatic sarcoma from an expanded phase 1 study

Abstract Number: 1726MO

Presenting Author: Breelyn A. Wilky, MD, University of Colorado Cancer Center

Session: Mini Oral Session, Sarcoma

Session Date and Time: Friday, September 13th, 2024, at 4:00 p.m. – 5:30 p.m. CEST (10:00 a.m. – 11:30 a.m. ET)

Complete abstracts are available through the ESMO (Free ESMO Whitepaper) Congress program. The presentation will also be available in the publications section of the Agenus website following the ESMO (Free ESMO Whitepaper) Congress on Friday, September 13th.

About Botensilimab

Botensilimab is an investigational human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

On September 9, 2024 Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the Cantor Global Healthcare Conference in New York, NY on Thursday, September 19, 2024, at 9:45 a.m. E.T (Press release, Nuvation Bio, SEP 9, 2024, View Source [SID1234646460]).

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A live webcast of the presentation will be available on the Nuvation Bio website at View Source An archived recording will be available for 90 days following the event.

On September 9, 2024 Bayer reported encouraging results from the expansion part of the ongoing Phase I/II SOHO-01 study evaluating the safety and preliminary efficacy of BAY 2927088 in advanced HER2-mutant non-small cell lung cancer (NSCLC). Data were presented during the Presidential Symposium at the IASLC 2024 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer, taking place in San Diego, United States, from September 7-10, 2024 (Press release, Bayer, SEP 9, 2024, View Source [SID1234646459]).

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"The encouraging results from the expansion phase of the SOHO-01 trial demonstrate the potential of this targeted therapy to advance outcomes for patients with HER2-mutant NSCLC, a type of lung cancer with limited treatment options and poor prognosis," said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. "The development of BAY 2927088 underscores our ongoing commitment in lung cancer and our continued drive to develop precise and personalized healthcare solutions in disease areas with the highest unmet needs."

"HER2-mutant NSCLC is a challenging disease that can predominantly affect individuals who are young and never smoked a cigarette. Given the current lack of therapeutic options, there is an immediate need for effective, manageable treatments," said SOHO-01 lead trialist, Xiuning Le, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, TX. "BAY 2927088 showed promising preliminary efficacy in both response rate and duration, and a manageable safety profile, which emphasizes the importance of ongoing innovation to elevate the standard of care."

The objective of the expansion phase of the study was to determine the safety, tolerability, and pharmacokinetics of BAY 2927088 in patients with HER2-mutant NSCLC. These data support the ongoing investigation of BAY 2927088 in patients with advanced NSCLC harboring HER2 mutations. Just recently Bayer announced that the first patient has been enrolled in the global Phase III SOHO-02 trial, an open-label, randomized, multicenter clinical trial, assessing the efficacy and safety of investigational agent BAY 2927088 as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC), whose tumors have activating HER2 mutations.

Detailed Results from SOHO-01
SOHO-01 is an ongoing, open-label, multicenter Phase I/II study. Results from patients with advanced NSCLC harboring a HER2-activating mutation with disease progression after ≥1 systemic therapies for advanced disease, and who are naïve to HER2-targeted therapy were presented. In the trial, patients received oral BAY 2927088 20 mg twice daily. Forty-three out of forty-four patients enrolled were evaluable for efficacy, with a confirmed objective response rate (ORR) of 72.1% (n=31; 95% CI 56.3, 84.7) including 1 complete response (2.3%). Median duration of response (DOR) and progression-free survival (PFS) were 8.7 months (95% CI 4.5, not estimable) and 7.5 months (95% CI 4.4, 12.2), respectively. In patients with HER2 YVMA insertions, the most frequent mutation, ORR was 90.0%, DoR was 9.7 months, and PFS was 9.9 months.

The safety profile of BAY 2927088 was found to be manageable, and consistent with previous reports. Treatment-related adverse events (TRAEs) were reported in 95.5% of patients, with grade 3 TRAEs reported in 40.9%. Diarrhea was the most common TRAE (86.4%, 25.0% grade 3), followed by rash (43.2% grade 1 or 2) and paronychia (25.0% grade 1 or 2). Three patients (6.8%) discontinued due to TRAEs.

About BAY 2927088
BAY 2927088 is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring HER2 activating mutations. BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Investigational agent BAY 2927088 is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

About Breakthrough Therapy Designation
This Breakthrough Therapy designation for BAY 2927088 is supported by preliminary clinical evidence from the Phase I/II, open-label, multicenter first-in-human study (NCT05099172) evaluating the safety, pharmacokinetics and preliminary efficacy of BAY 2927088 in adult patients with advanced NSCLC harboring HER2 or EGFR. The Breakthrough Therapy designation is a process designed to expedite the development and review of novel medicines that are intended for the prevention or treatment of serious, life-threatening diseases or conditions that severely impact the quality of life for which there is no existing treatment, or where sufficient evidence indicates advantages of the novel drug over available treatment options.

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.