On September 5, 2022 Lunit (KRX: 328130.KQ) reported the presentation of five abstracts highlighting the effectiveness of its AI-biomarker platform – Lunit SCOPE – at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, held in Paris from September 9 to 13 (Press release, Lunit, SEP 5, 2022, View Source [SID1234619003]).

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ESMO is a professional organization for medical oncology, with more than 25,000 members representing oncology professionals from over 160 countries worldwide.

One of Lunit’s abstracts focuses on the assessment of tumor purity directly from H&E whole slide images by using Lunit SCOPE AI technology (AI-P) and concordance between AI-P and variant allele frequency (VAF)[1] as determined by next-generation sequencing (NGS). The study showed a strong correlation between the assessment of tumor purity using Lunit SCOPE and VAF across 23 cancer types. The result validates the effectiveness of Lunit SCOPE as a valuable tool to assess tumor purity easily and quickly from H&E slides.

Another study conducted with Dr. SooYoun Cho, Dr. EunYoon Cho and Dr. SangYong Song of Samsung Medical Center, evaluates the performance of Lunit SCOPE HER2 in pathological practices for breast cancer patients. This joint study showed that Lunit’s HER2 scoring and tumor-infiltrating lymphocytes (TIL) analysis solution supports the prediction of clinical response for HER2-positive early breast cancer patients treated with neoadjuvant chemotherapy (NAC).

In addition, Lunit will also present clinical findings that demonstrate the accuracy of Lunit SCOPE PD-L1 CPS. After classifying PD-L1 Combined Positive Score (CPS) levels in 543 urothelial carcinoma (UC) cases, the AI-powered CPS analyzer showed an equivalent level of accuracy to that of pathologists.

Another study from Lunit reveals the capability of the AI-powered TIL and PD-L1 CPS analysis solution to be utilized as a predictive biomarker for immune checkpoint inhibitor (ICI) response in neuroendocrine neoplasms (NEN).

The last study shows that Lunit SCOPE can discover novel targets for antibody-drug conjugates (ADC) by precisely analyzing linked NGS and IHC data in tumors, highlighting the potential of multimodal analysis linking molecular and visual methods.

Meet the Lunit team in person at ESMO (Free ESMO Whitepaper) at booth #249.

"Through these studies, Lunit has validated that the Lunit SCOPE suite can expand its range of impact across more types of cancer, to address an expanding number of clinical and research questions," said Brandon Suh, CEO of Lunit. "We intend to continue our research activities and present groundbreaking studies at global cancer congresses every year."

On September 5, 2022 Dizal reported the promising safety and pharmacokinetic data from the global Phase I study of DZD1516 in patients with HER2 positive metastatic breast cancer (HER2+ MBC) who relapsed from multiple prior treatments at the 2022 European Society for Medical Oncology Annual Meeting (Press release, Dizal Pharma, SEP 5, 2022, View Source [SID1234619002]).

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Nearly 60% of patients with advanced HER2-positive breast cancer develop brain metastasis and the prognosis is extremely poor. DZD1516 is an oral, full blood-brain barrier (BBB) penetrant selective HER2 inhibitor for the treatment of HER2-positive metastatic breast cancer.

The Phase I study is enrolling HER2+ MBC patients who relapsed from or were intolerant to the standard of care (SoC). The primary objective is to evaluate the safety of DZD1516 and to define maximum tolerated dose (MTD). As of February 20, 2022, DZD1516 was explored in 22 HER2+ MBC patients from the USA and China, among whom nearly 70% had CNS metastases at baseline. Key findings are as follows:

DZD1516 was well tolerated at doses ≤ 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. Thus, 250 mg was defined as MTD.
In patients, mean Kpuu,CSF was 2.1 for DZD1516 across the dose range, indicating full penetration of DZD1516 through human BBB.
18 patients had completed ≥ 1 post treatment RECIST assessment. With a median of 7 lines of prior systemic treatment (86% treated with HER2 TKI), the best antitumor efficacy in intracranial, extracranial and overall lesions was stable disease.
"Patients with HER2 positive breast cancer and brain metastasis have poor outcomes due to the limited therapies," said Dr. Xiaolin Zhang, CEO of Dizal, "Based on these promising findings, we will further explore the potential of DZD1516 as a new treatment option for this underserved patient population."

About 1516

DZD1516 is designed as an oral, potent, reversible, highly selective, and full blood-brain barrier (BBB) penetrant HER2 tyrosine kinase inhibitor (TKI), with more than 300-fold selectivity for HER2 compared to wild-type EGFR. It is well tolerated at doses ≤ 250 mg, twice daily. And in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. In patients, mean Kpuu,CSF is 2.1 for DZD1516 across the dose range, indicating full penetration of DZD1516 through human BBB.

On September 5, 2022 Dizal reported positive topline results from the first pivotal study of sunvozertinib (DZD9008) in platinum-pretreated NSCLC Patients with EGFR exon20ins mutations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (Press release, Dizal Pharma, SEP 5, 2022, View Source [SID1234619001]). The trial met the primary endpoint, cORR, as assessed by Blinded Independent Central Review (BICR).

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Even though lung cancer is the second most common cancer and leading cause of cancer death globally, NSCLC patients with EGFR exon20ins mutation lack effective treatment options, especially those who develop brain metastases (BM) historically have worse outcomes. Sunvozertinib (DZD9008), which was granted Breakthrough Therapy Designation by both the US FDA and China CDE, is a rationally designed, oral, potent EGFR exon20ins inhibitor, with wild-type EGFR selectivity.

The topline result presented at 2022 ESMO (Free ESMO Whitepaper) was based on the latest data from WU-KONG6 study, the multicenter, single-arm, Phase II pivotal study conducted in China. As of 31 July 2022, the efficacy set included 97 platinum-pretreated NSCLC patients with EGFR exon20ins mutations. Key findings from efficacy set are as follows:

Parameter

Results in 300 mg cohort (N=97)

Confirmed ORR per BICR

59.8% (58/97)

Confirmed ORR in patients with baseline brain
metastasis per BICR

48.4% (15/31)

*Patients are still on treatment and responding.

Sunvozertinib also demonstrated a favorable safety profile. Of all 277 patients in the safety set, the most common treatment-related adverse events (TEAE) were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.

"The importance of advancing research on NSCLC with EGFR exon20ins mutation – a complicated and devastating disease – cannot be overstated, as available treatment options provide limited benefit especially to those develop brain metastasis," said Dr. Xiaolin Zhang, CEO of Dizal, "It is great news to our patients that sunvozertinib is showing such strong antitumor activities with a benign safety profile. This data further strengthens our confidence in sunvozertinib and reinforces its best-in-class position"

About sunvozertinib (DZD9008)

Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is an irreversible inhibitor targeting EGFR exon 20 insertion mutations as well as EGFR sensitizing T790M and uncommon mutations while maintaining selectivity against wild-type EGFR. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary endpoint, demonstrating superior antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. The confirmed ORR (cORR) at 300 mg was 59.8% by BICR. Patients with baseline brain metastasis showed significant response as well, with a confirmed ORR of 48.4%. (Data cut-off date: July 31, 2022). It is well tolerated with a manageable AE profile. Global pivotal studies are ongoing for ≥ 2nd line and 1st line treatment of NSCLC with EGFR exon20 insertion mutation in countries including China, U.S., EU, Australia, South Korea and other countries and regions.

About EGFR Exon20ins

Lung cancer is the leading cause of cancer death in the world. It is classified broadly as non-small cell lung cancer (NSCLC), accounting for 85% lung cancer cases, and small cell lung cancer (SCLC). EGFR mutation is common in NSCLC. About 4–12% of all EGFR mutations are insertions at exon 20 (EGFR exon20ins). Patients with EGFR exon20ins generally don’t respond to the first-, second- and third-generation EGFR tyrosine kinase inhibitors (TKIs).

On September 5, 2022 Bertis, a proteomics-based precision medicine technology development company (CEOs Dong-young Noh, Seung-man Han), reported on the 5th that the research results of their search for protein biomarkers for early diagnosis of high-grade serous ovarian cancer (HGSOC) were published in the September issue of the international scientific journal, Journal of Proteome Research (Press release, Bertis, SEP 5, 2022, View Source [SID1234619000]).1

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Ovarian cancer is the first leading cause of death among gynecological cancers. Most patients are asymptomatic in early stages, and as effective early diagnosis methods have not yet been secured, 70% of the cases are not detected until the cancer develops into stage 3 or higher.2, 3 After stage 3, the survival rate of the patient is drastically reduced. The 5-year survival rate is more than 76% in stage 1 and approximately 60% to 74% in stage 2, while the 5-year survival rate in early stage 3 is known to be 41%, 23% in late stage 3, and just 11% in stage 4.4 In particular, HGSOC is the most common type of ovarian cancer, accounting for 70% of all ovarian cancers. For decades, the overall survival rate of HGSOC has barely improved, and the need for the introduction of a standard testing method for early diagnosis has been emphasized.5, 6

The research team at Bertis presented a new multi-biomarker panel candidate with 95% accuracy (100% sensitivity, 91% specificity) for the diagnosis of stage 1 to 3 HGSOC. The results of this research were published in the September issue of the Journal of Proteome Research on the 2nd by the American Chemical Society. In particular, the results were included as one of the supplementary cover articles in this issue with 16 papers listed.

In this study, the research team identified 18 candidate proteins after quantifying 1,847 serum proteins, the highest number ever reported as ovarian cancer biomarker research results, through Bertis’ technology platform to discover biomarker candidates. As a result of developing and evaluating a predictive model, the accuracy of the diagnostic value for stages 1 to 37 HGSOC was 95% (sensitivity 100%, specificity 91%) when 18 candidate proteins were combined with multiple biomarkers.

Un-beom Kang, Head of Bertis Biomarker Research Institute, who led this study, explained, "This study is significant in that it secured the results of in-depth blood proteome research based on Bertis’ advanced proteomics analysis technology, as well as presented a new biomarker panel with high accuracy for ovarian cancer," and added that, "We expect that based on data from this study, research and development to provide standardized testing for early diagnosis of ovarian cancer will be expedited and the creation of results will be accelerated."

"Proteomics analysis is an incredibly effective tool for understanding cancer and discovering new biomarkers for diagnosis and prognosis," said, Seung-man Han, Bertis’ CEO. "As a company that has led the discovery of biomarkers based on proteomics technology as well as the development of clinical solutions using it, we will do our best to contribute to the improvement of the diagnosis and treatment of major diseases through continuous research and development."

Bertis is a company that combines proteomics and bioinformatics to develop biomarkers for cancer and other various major diseases, as well as provides diagnosis and analysis solutions. It succeeded in commercializing proteomics technology with Mastocheck, the world’s first proteomics-based blood testing solution for early breast cancer diagnosis, and PASS (Pan-omics Analysis Service & Solution), an integrated analysis solution for Panomics. Currently, Bertis is researching and developing early diagnosis solutions for pancreatic cancer, ovarian cancer, etc.

On September 5, 2022 Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer and pre|CISION platforms, reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the company’s lead pre|CISION drug candidate, AVA6000, for treatment of soft tissue sarcoma (Press release, Avacta, SEP 5, 2022, View Source [SID1234618997]).

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AVA6000 is a form of the generic chemotherapy doxorubicin that has been modified using the pre|CISION technology so that it is activated predominantly in the tumour with the aim of sparing healthy tissue from exposure and improving the safety, tolerability and efficacy of the drug. Doxorubicin has a market size that is expected to grow to $1.38bn by 2024, and is widely used as part of the standard of care in several cancer types. Avacta has an ongoing Phase 1 clinical trial to assess the safety and pharmacokinetics of AVA6000 which has potential as a treatment for patients with a range of cancer types, including soft tissue sarcoma.

The FDA can grant ODD based on a review of preclinical data from investigational treatments for rare diseases, such as soft tissue sarcoma, which are defined as conditions affecting fewer than 200,000 people in the US. This designation qualifies the developer of the drug for certain incentives, including, seven years of market exclusivity upon drug approval from the FDA.

Soft-tissue sarcoma is a rare mesenchymal malignancy which accounts for less than 1% of all adult tumours. Despite the successful advancement of localised therapies, such as surgery and radiotherapy, these tumours can recur, often with metastatic disease. The American Cancer Society estimates that, in 2022 approximately 13,190 new soft tissue sarcomas will be diagnosed, and about 5,130 people are expected to die of the disease in the US.

Dr Alastair Smith, Chief Executive Officer of Avacta, commented: "We are delighted to receive Orphan Drug Designation from the FDA for AVA6000, which is a reflection of the high quality of the preclinical data and the potential benefit the pre|CISION platform can bring to cancer patients."

"This designation provides tax credits and other incentives for drug developers addressing rare diseases. Most notably the Orphan Drug Designation will give Avacta, if AVA6000 is approved for treatment of soft tissue sarcoma, seven years of market exclusivity in the US, which is a significant commercial advantage."