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.

On May 28, 2024 AbCellera (Nasdaq: ABCL) reported that executives from the Company will present at the Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024, at 12:20 p.m. Pacific Time (3:20 p.m. Eastern Time) (Press release, AbCellera, MAY 28, 2024, View Source [SID1234643755]).

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A live audio webcast of the presentation may be accessed through a link that will be posted on AbCellera’s Investor Relations website. A replay will be available through the same link following the presentation.

On May 28, 2024 Cantex Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions for which new treatments are urgently needed, reported that Cantex’s azeliragon, a well-tolerated once-a-day pill that inhibits "RAGE" (the receptor for advanced glycation end products), will be featured in four abstracts at this year’s 2024 ASCO (Free ASCO Whitepaper) Annual Meeting to be held in Chicago (Press release, Cantex, MAY 28, 2024, View Source [SID1234643754]).

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"The 2024 ASCO (Free ASCO Whitepaper) Annual Meeting represents an important opportunity to meet with the leading oncology researchers from around the world and showcase the progress of azeliragon clinical investigations at leading cancer centers in several difficult-to-treat cancers," said Stephen G. Marcus, M.D., Cantex’s Chief Executive Officer.

2024 ASCO (Free ASCO Whitepaper) Annual Meeting Abstracts:

Title: A phase I/II open label study to assess safety and preliminary evidence of a therapeutic effect of azeliragon in patients refractory to first-line treatment of metastatic pancreatic cancer.
Abstract #: TPS4212

Title: Azeliragon, a RAGE inhibitor, in combination with temozolomide and radiotherapy in patients with newly diagnosed glioblastoma: Phase Ib/II CAN-201 NDG trial design.
Abstract #: TPS2096

Title: RAGE inhibition to decrease cancer therapy related cardiotoxicity in women with early breast cancer (RAGE).
Abstract #: TPS619

Title: A phase I/II study to assess safety and preliminary evidence of a therapeutic effect of azeliragon combined with stereotactic radiation therapy in patients with brain metastases (ADORATION).
Abstract #: TPS2093

About Azeliragon

Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of the receptor for advanced glycation end products (known as RAGE) with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ: VTVT) from which Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated.

Cantex has ongoing Phase II clinical trials in pancreatic cancer, glioblastoma, brain metastasis, breast cancer, and a Phase 3 trial in hospitalized patients with pneumonia to prevent acute kidney injury. These trials are based on azeliragon’s robust preclinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.

Azeliragon has U.S. Food and Drug Administration (FDA) orphan drug designation for the treatment of pancreatic cancer and glioblastoma. FDA Orphan Drug Designation provides Cantex with seven years of azeliragon marketing exclusivity from the time of product launch for the orphan indication, and several other important benefits, including assistance in the drug development process, tax credits for clinical costs, and exemptions from certain FDA fees.