On May 28, 2024 Eikon Therapeutics, Inc., a pioneering biotechnology company that leverages advanced engineering to enhance drug discovery and development, reported that multiple abstracts highlighting its clinical-stage TLR 7/8 co-agonist (EIK1001) and PARP1-selective inhibitor (EIK1003) programs will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago May 31 – June 4, 2024 (Press release, Eikon Therapeutics, MAY 28, 2024, View Source [SID1234643760]).

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The oral presentation (Abstract: 2521) highlights safety and preliminary efficacy data from a clinical study (NCT03486301) of EIK1001, a Toll-like receptor 7/8 (TLR7/8) co-agonist, in combination with pembrolizumab in participants with advanced solid tumors. The new data show that EIK1001 was well-tolerated with a manageable safety profile, and showed encouraging preliminary efficacy across several tumor types in combination with pembrolizumab. Responses were observed even in heavily pretreated patients not anticipated to respond to pembrolizumab monotherapy. Anthony W. Tolcher, MD, FASCO, of New Experimental Therapeutics (NEXT), will deliver the presentation on June 2, 2024 at 12:42 PM CDT.

"We are encouraged by the promising data emerging from our lead clinical programs," said Roy D. Baynes, MB.BCh., Ph.D., Chief Medical Officer of Eikon Therapeutics. "The safety and preliminary efficacy results for EIK1001, in combination with pembrolizumab and with atezolizumab, underscore the potential of these promising approaches. We highlight also the advancement of EIK1001 into front-line combinations with standard-of-care pembrolizumab and chemotherapy in non-small cell lung cancer, and of our PARP1-selective inhibitor, EIK1003, into phase 1 studies in cancers selected for specific genotypes."

In addition, three posters will be presented and include:

Title: A first-in-human (FIH), phase 1/2, dose-escalation, dose-optimization, and dose-expansion study of PARP1-selective inhibitor EIK1003 (IMP1734) in participants with advanced solid tumors.
Abstract Number: TPS3191 (Poster Bd# 320b)
Abstract Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date/Time: June 1, 2024, 9:00 AM – 12:00 PM CDT
Presenter: Guru Sonpavde, MD, Medical Director of Genitourinary Oncology, Assistant Director of the Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research, AdventHealth Cancer Institute.

Title: Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors.
Abstract Number: 2618 (Poster Bd# 97)
Abstract Session: Developmental Therapeutics—Immunotherapy
Date/Time: June 1, 2024, 9:00 AM – 12:00 PM CDT
Presenter: Manish Patel, MD, Director of Drug Development, Florida Cancer Specialists & Research Institute/Sarah Cannon Research Institute.

Title: A phase 2 study of EIK1001, a Toll-like receptor 7/8 (TLR7/8) agonist, in combination with pembrolizumab and chemotherapy in patients with stage 4 non-small cell lung cancer.
Abstract Number: TPS8667 (Poster Bd# 521b)
Abstract Session: Lung Cancer—Non-Small Cell Metastatic
Date/Time: June 3, 2024, 1:30 PM – 4:30 PM CDT
Presenter: Dan Costin, MD, FACP, Director, White Plains Hospital, Center for Cancer Care.

Eikon will also host a booth in the exhibition hall (#32116) at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

On May 28, 2024 SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, reported the dosing of the first patient in its Phase 1, first-in-human clinical trial evaluating SOT201, a next-generation PD-1-targeting immunocytokine (Press release, SOTIO, MAY 28, 2024, View Source [SID1234643759]). The VICTORIA-01 study will evaluate the safety, tolerability and initial efficacy of SOT201 monotherapy for the treatment of advanced solid tumors.

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"While anti-PD-1 therapeutics have been a great advance in cancer medicine, still only a minority of patients respond to them. Additionally, even patients successfully treated frequently acquire resistance to these therapies, leading to cancer progression. Novel treatments are needed to overcome these therapeutic limitations," said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. "The initiation of the VICTORIA-01 study demonstrates SOTIO’s continued dedication to deliver innovative immunotherapies that can address the challenges of solid tumor treatment. We look forward to further researching the potential that SOT201 holds for patients who have not seen success with other available treatments."

SOT201 is an antibody-cytokine fusion protein that could improve upon the efficacy of approved checkpoint inhibitors by combining PD-1 targeting with IL-15 immune stimulation in a single therapeutic construct. This combined action of SOT201 makes it promising as a potent standalone therapy that could be especially useful for the treatment of patients with primary or acquired resistance to checkpoint inhibitors (CPIs). The preclinical profile of SOT201 supports its potential to offer best-in-class antitumor activity and broad clinical applicability.

The VICTORIA-01 study is a Phase 1, open-label, dose escalation study of SOT201 which will assess its safety, tolerability, and preliminary efficacy as a monotherapy for patients aged 18 years or above with advanced unresectable or metastatic solid tumors (NCT06163391). The study is now enrolling patients at The University of Texas MD Anderson Cancer Center in Houston, Texas, led by principal investigator Dr. Aung Naing. Additional clinical sites across Europe – including in Belgium, Czech Republic and Spain – will initiate enrollment in the coming months.

On May 28, 2024 Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, reported it will present new data from its Phase 1 DRAGON proof-of-concept trial of SRK-181 in combination with pembrolizumab in patients with advanced solid tumors in an oral presentation during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held May 31 – June 4 in Chicago (Press release, Scholar Rock, MAY 28, 2024, View Source [SID1234643758]). Those data will be discussed further during a webcast on June 4th at 7 a.m. CDT/8 a.m. EDT that includes Jing Marantz, M.D., Ph.D., Chief Medical Officer at Scholar Rock, and Dr. Toni Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute (DFCI).

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"We continued to observe encouraging responses and tolerability in heavily pretreated patients across multiple cancer types, providing further evidence of SRK-181’s potential to overcome resistance to immune checkpoint inhibitors," said Jay Backstrom, M.D., M.P.H., President and Chief Executive Officer of Scholar Rock. "In addition, biomarker data indicated that treatment with SRK-181 is associated with an enhanced proinflammatory microenvironment and increased anti-tumor activity. Together, these new data provide further validation of the selective approach of our TGFβ platform. We look forward to sharing additional updated data at ASCO (Free ASCO Whitepaper)."

Data highlights are as follows:

– SRK-181 continued to be well tolerated in the dose expansion portion of the DRAGON trial (Part B).

– Encouraging responses were observed across multiple cancer types, including clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), melanoma (MEL), and urothelial carcinoma (UC).

– Biomarker data showed that the SRK-181 + pembrolizumab treatment combination created an enhanced proinflammatory microenvironment in anti-PD-(L)1 resistant patients.

– Patients with ccRCC whose tumors were infiltrated at baseline by CD8+ T cells and/or regulatory T cells showed positive correlations between infiltration of each cell type and response rate. This positive correlation between baseline infiltration status type and response rate suggests a potential patient selection strategy.

These results will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in an oral presentation, details of which can be found below.

Title: Phase 1 study (DRAGON) of SRK-181 (linavonkibart), a latent TGFβ1 inhibitor, combined with pembrolizumab in anti-PD1 resistant patients with advanced solid tumors: Updated results of expansion part
Oral Session: Developmental Therapeutics—Immunotherapy
Presenter: Ulka N. Vaishampayan, MD, Division of Hematology/Oncology, University of Michigan
Location: Hall D2
Date/Time: June 3, 1:50 p.m. CDT

Conference Call Information
Scholar Rock will host a conference call on June 4 at 8 a.m. EDT that can be accessed by registering in advance at the Events and Presentations page of Scholar Rock’s website. Members of Scholar Rock’s executive management team will be joined by Dr. Toni Choueiri, M.D., Director of the Lank Center for Genitourinary (GU) Oncology at Dana-Farber Cancer Institute (DFCI).

The abstracts for these presentations are available on ASCO (Free ASCO Whitepaper)’s website View Source The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.

For conference information, visit View Source

About SRK-181
SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. (2) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. Enrollment of the DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) was completed in December 2023, and patients who remain on the study continue to be treated. The trial enrolled patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On May 28, 2024 NeoGenomics, Inc. (NASDAQ: NEO), a leading oncology testing services company, reported that it will showcase its versatile lung solution and its COMPASS Hematopathology Services portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in Chicago, May 31–June 4 (booth #31093) (Press release, NeoGenomics Laboratories, MAY 28, 2024, View Source [SID1234643757]).

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"With cancer cases on the rise, we’ve seen tremendous growth in FDA-approved targeted therapies and immunotherapies, making proper test selection critical for precision medicine-based patient management," said Chris Smith, CEO of NeoGenomics. "Our wide breadth of testing solutions represents a significant milestone in our mission to empower clinicians with the tools needed to deliver the best possible care to patients, whether it’s early or advanced stage, and whether there is tissue or not."

Recognizing the benefits of concurrent testing, as supported by the National Comprehensive Cancer Network (NCCN) guidelines, NeoGenomics’ comprehensive lung offering allows for complementary tissue and liquid biopsy testing. The test portfolio provides a comprehensive approach to diagnosis, therapy selection, prognosis, and clinical trial options tailored to each patient’s unique needs, addressing the disease’s complexities:

Early Stage NSCLC is the industry’s first therapy selection panel for early-stage non-small cell lung cancer (NSCLC), delivering actionable insights within seven days.
DNA & RNA Lung is a 50-gene NGS panel enriched with MSI and TMB analysis to facilitate precise therapy selection and clinical trial matching.
InvisionFirst Lung is a liquid biopsy assay that detects 37 genes crucial to NSCLC treatment. It surpasses tissue-based assays in actionable alterations and is available for patients without viable tissue samples.
Comprehensive Solid Tumor test analyzes 517 genes via DNA and RNA next-generation sequencing, providing clinicians with a complementary understanding of the patient’s cancer profile to guide optimal treatment options.
NeoGenomics will also feature COMPASS, a suite of single-order sample-to-diagnosis services for hematological malignancies. With over 100 subtypes of leukemias, lymphomas, and myelomas, reaching a definitive diagnosis requires the time and expertise to manage ever-evolving clinical guidelines and testing criteria. COMPASS provides an all-in-one assessment with actionable diagnostic and prognostic information unique to the patient.

In addition to highlighting these solutions, NeoGenomics will present a poster, titled "Comparative analysis of actionable gene reporting in targeted panels versus comprehensive NGS testing for solid tumor samples," during the Quality Care/Health Services Research poster session on June 3, 2024 (Abstract #11185; Poster Board #380).

On May 28, 2024 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported that it has entered a clinical collaboration with MEDSIR (www.medsir.org), a Spanish and US-based, international and innovative research organization in clinical oncology (Press release, MedSIR, MAY 28, 2024, View Source [SID1234643756]). The study will evaluate the safety and efficacy of Debio 0123 (Debiopharm’s investigational, potential best-in-class WEE1 inhibitor) together with sacituzumab govitecan (Trodelvy; an antibody-drug conjugate [ADC] owned and commercialized by Gilead Sciences, Inc. [Gilead]). Sites for this Phase 1b/2 investigator-initiated trial in patients with previously treated advanced breast cancer will be opened in Europe, UK, and the USA.

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Hormone receptor-positive (HR+)/HER2- is the most common type of breast cancer and it accounts for 70% of all breast cancers. It groups estrogen-receptor (ER) and/or progesterone-receptor (PR) expressing cells. Almost one in three cases of early-stage breast cancer eventually become metastatic, and among patients with HR+/HER2- metastatic disease, the five-year relative survival rate is 30%. As patients with HR+/HER2- metastatic breast cancer become resistant to endocrine-based therapy, their primary treatment option is limited to single-agent chemotherapy. For patients treated with single-agent chemotherapy, the prognosis remains poor [1]. Despite having a more favorable outcome than other breast cancer subtypes like HER2-positive and triple-negative breast cancers (TNBC), relapse still occurs and there remains a high unmet medical need for this patient population [2-3]. TNBC is an aggressive type of breast cancer that accounts for 10-15% of all breast cancers. It is called "triple negative" as it does not express ER, PR or HER2 receptors. Because of its aggressive nature, TNBC has a high risk of metastasis either at diagnosis or at time of relapse after initial curative therapy, which explains the poor prognosis many TNBC patients face. Compared to other types of breast cancer, the relapse rate as well as the mortality rate in the 5 years after diagnosis is significantly higher [4-5].

"It’s great to see companies like Debiopharm that are open to investigating novel combination strategies to support breast cancer patients. I look forward to seeing potential benefits for patients" Dr. Tim Robinson, Principal Investigator, University of Bristol.

Sacituzumab govitecan is a Trop-2-directed ADC currently approved globally for patients with 2L metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer The clinical trial will enroll patients with HR[+]/HER2[-] metastatic breast cancer and metastatic TNBC, and will be sponsored by MEDSIR, and fully funded by Debiopharm. Gilead will provide supply of sacituzumab govitecan.

"We are honored to develop this Investigator Sponsor Trial (IST) in collaboration with Debiopharm and Gilead to explore new approaches to breast cancer treatment. Together, we’re committed to advancing patient care and fostering important partnerships in the oncology field. I believe our work with Debio 0123 and sacituzumab govitecan holds great promise for patients" said Dr. Javier Cortés, MEDSIR Senior Scientific Lead.

The foundations for this clinical trial were set by the promising preclinical data suggesting an existing synergy between Debiopharm’s Debio 0123 and Gilead’s sacituzumab govitecan. These results will be disclosed at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting 2024 under the title "Anti-tumor activity of Debio 0123 in combination with sacituzumab govitecan in preclinical models of breast cancer" [6].

About Debio 0123

Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cell cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently investigated in clinical trials for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers.