On September 17, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the New Drug Application (NDA) of Serplulimab Injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with carboplatin and albumin-bound paclitaxel for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) has been accepted by China’s National Medical Products Administration (NMPA) (Press release, Shanghai Henlius Biotech, SEP 17, 2021, View Source [SID1234587913]).

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The NDA is based on the results from a randomised, double-blind, global multi-centre Phase 3 clinical trial in patients with locally advanced or metastatic squamous non-small cell lung cancer patients to compare Serplulimab Injection in combination with chemotherapy versus chemotherapy in respect of efficacy and safety. The study results demonstrated that Serplulimab can significantly extend the progression-free survival (PFS) of patients with good safety. In April 2021, the NMPA accepted and officially granted priority review for the NDA of Serplulimab Injection for the treatment of unresectable or metastatic microsatellite instability-high solid tumours that fail to respond to the standard therapy.

Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University Medical School, said, "This is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrated that the predefined primary study endpoint had been reached, providing evidence of safety and efficacy. This milestone takes us one step closer to bringing a much-needed treatment option to patients living with sqNSCLC. We are hoping that approval of Serplulimab comes soon."

"Serplulimab Injection is an innovative anti-PD-1 mAb independently developed by Henlius, and sqNSCLC is its second listed indication after MSI-H," said Mr. Jason Zhu, Chief Medical Officer and Senior Vice President of Henlius. "Underpinned by the patient-centric strategy, we focus on addressing the clinical needs of high-incidence cancers worldwide and in China. We remain committed to implementing our ‘Combo+Global’ differentiation strategy with Serplulimab as the backbone, promoting immuno-oncology combination therapies and MRCT, speeding up the development of products in lung cancer and gastrointestinal cancer, and bringing a more hopeful future to patients worldwide."

On September 17, 2021 InnoCare Pharma (HKEX: 09969) and Keymed Biosciences (HKEX: 02162) reported that the Investigational New Drug (IND) of CM355, a CD20xCD3 bispecific antibody developed by a joint venture between the two companies called Tiannuojiancheng Pharma, has been cleared by the China’s National Medical Products Administration (NMPA) (Press release, InnoCare Pharma, SEP 17, 2021, View Source [SID1234587912]).

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CM355 binds to CD20 on the tumor cells and CD3 on the T cells, redirects and activates T cells to eradicate tumor cells through T-cell Directed Cellular Cytotoxicity (TDCC) in the treatment of CD20+ B-cell malignancies.

Non-Hodgkin lymphomas are the main type of CD20+ B-cell malignancies, accounting for 80%-90%, which include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "With the rapid growth of China’s economy and aging population, the incidence of lymphoma is continuing to rise. InnoCare and Keymed are both in-house innovation driven hi-tech companies committed to addressing unmet clinical needs. I am excited to see that the CD20xCD3 antibody developed through our collaboration has been approved for clinical trials. We will work together to accelerate the clinical trial to benefit patients sooner."

Dr. Chen Bo, Co-founder, Chairman and CEO of Keymed Biosciences, said: "This is the first IND-approved therapy developed by our nTCE bispecific antibody platform. B-cell malignancies are currently one of the most common types of cancers in the clinics, and pose a serious threat to public health. Preclinical studies show that CM355 is very effective in the B-cell malignancies treatment. We will work with InnoCare and investigators to advance CM355 studies."

On September 3, 2021, InnoCare and Keymed Biosciences signed a strategic cooperation agreement at the 2021 China International Fair for Trade in Services to strengthen R&D collaboration between the two parties, aiming at developing First-in-class and Best-in-class innovative large molecular drugs to benefit patients.

On September 17, 2021 Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA testing, reported new data being presented by the company and its collaborators on the use of the Signatera personalized molecular residual disease (MRD) technology at the 2021 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place September 16–21, 2021 (Press release, Natera, SEP 17, 2021, View Source [SID1234587911]).

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In three new studies, Natera will present the real-world clinical performance of Signatera in esophageal and gastric cancers, the power of ctDNA dynamics for assessing treatment response in uveal melanoma and the correlation of CHIP mutations with patient outcomes.

"Results from our study indicate that ctDNA is highly predictive of relapse in patients with gastroesophageal cancer," said Brandon Huffman, M.D., clinical oncology fellow at Dana Farber Cancer Institute and Massachusetts General Hospital Cancer Center, and first author of the study. "Most gastroesophageal cancers recur after definitive treatment, and patients with advanced disease have a poor overall prognosis. This study addresses a huge need for tools to better identify patients at risk of recurrence and to inform disease management."

"This data underscores the value of tumor-informed MRD assessment in GI cancers," said Alexey Aleshin, M.D., Natera’s VP of medical affairs, oncology. "It also highlights the potential for Signatera to improve upon radiographic imaging as a clinical endpoint, which can accelerate drug development and improve patient care."

Details about the presentations are as follows:

Performance of a tumor-informed circulating tumor DNA assay from over 260 patients with over 800 plasma time points in esophageal and gastric cancer
On-Demand ePoster: 1415P
Presenter: Griffin L. Budde, Natera, Inc.

This study used Signatera for the detection and quantification of ctDNA in a prospective real-world cohort of 886 plasma samples from 269 patients with gastroesophageal cancer. Serial time points were collected in a subset of patients to monitor ctDNA levels after curative intent therapy. Analysis showed tumor-informed ctDNA status is highly predictive of relapse in patients with stage I-IV disease, with ctDNA detected in 93.3% of samples at baseline.

Early reduction in ctDNA, regardless of best RECIST response, is associated with overall survival (OS) on tebentafusp in previously treated metastatic uveal melanoma (mUM) patients
Mini Oral Presentation: 1757O
Presenter: Alexander Shoushtari, M.D.
Date: Sunday, September 19, 2021, 13:40 CEST

Uveal melanoma is a rare type of melanoma of the eye, associated with frequent liver metastases. This study of 127 mUM patients used a custom ctDNA assay for the evaluation of tebentasfusp therapy. Baseline ctDNA levels significantly correlated with tumor burden, and by week 9, 70% of evaluable patients showed ctDNA reduction associated with greater mean tumor shrinkage. For tebentafusp, ctDNA reduction appeared more correlated with overall survival than RECIST response.

Association of clonal hematopoiesis of indeterminate potential with higher risk of disease progression
On-Demand ePoster: 1762P
Presenter: Derek Klarin, M.D.

Buffy coat samples derived from 2484 patients diagnosed with colorectal, breast, lung and other solid cancers were analyzed for the presence of CHIP mutations, which were detected in 16% of patients, with the majority having a single mutation. As expected, the frequency of CHIP increased with age and reached 20% in patients above 60 years, who were also more likely to have multiple CHIP variants compared to the younger patients. Although CHIP mutations are not tumor-derived and should not be used to monitor MRD burden, the presence of CHIP in MRD-positive cases was associated with poor patient outcomes and reduced time to recurrence.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On September 17, 2021 Lunit reported that its AI for tissue analysis has been applied in a clinical trial for drug development, accurately predicting the patients’ response to immunotherapy (Press release, Lunit, SEP 17, 2021, View Source;findings-presented-at-esmo-2021-301379353.html [SID1234587910]). Including this major finding, the company presented three studies at European Society for Medical Oncology(ESMO) Congress 2021.

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Lunit has been focusing on developing novel AI biomarkers that can be applied in cancer treatment. Since 2019, it has been validating the effectiveness of its AI-based tissue analysis platform ‘Lunit SCOPE’ that accurately predicts cancer patients’ response to immunotherapy.

The highlight of Lunit at ESMO (Free ESMO Whitepaper) 2021 is its announcement that Lunit SCOPE IO—one of Lunit SCOPE product lines—has been applied to a phase 1 clinical trial of a new drug for the first time. In a joint study with Y Biologics, a South Korean clinical-stage antibody biotech company, Lunit SCOPE IO accurately predicted immunotherapy response of all the patients who participated in the study.

"From 2019, Lunit has proven that response to immunotherapy varies depending on the spatial distribution of immune cells in cancer tissue, which has been the foundation for the AI platform ‘Lunit SCOPE IO’," said Chan-Young Ock, Chief Medical Officer of Lunit. "This study is the first case where Lunit SCOPE IO was applied to actual drug development clinical trials, and it is a meaningful study that demonstrated high potential for AI-powered biomarkers."

Lunit presented another study using Lunit SCOPE IO, validating the correlation between spatial information of tumor-infiltrating lymphocytes(TIL) and prognosis of colorectal cancer. The team analyzed 461 colorectal cancer data among TCGA data and showed that high TIL density in relation to tumor cells may improve prognostic power.

The company’s other major study was on Lunit SCOPE PD-L1, an AI-powered PD-L1 tumor proportion score(TPS) analyzer developed by Lunit. According to the study, assistance with Lunit SCOPE PD-L1 substantially improved pathologists’ consensus and found more patients who were eligible for immunotherapy.

"Although PD-L1 expression is the standard biomarker for advanced non-small cell lung cancer, manual evaluation of PD-L1 TPS by pathologists has practical limitations of interobserver bias and intensive labor," said Kyunghyun Paeng, Chief Product Officer of Lunit. "This study aimed to explore whether the AI-powered TPS analyzer could reduce the interobserver variation and increase the accuracy of analysis."

Three pathologists evaluated the PD-L1 TPS of 479 NSCLC data. Comparing the results of the analysis, the discordant rate in the subgroups of TPS <1% decreased from 32% to 10% when assisted with Lunit AI. Furthermore, 23 out of 81 were found to be eligible for immunotherapy even though they were evaluated to be TPS <1% by pathologists, meaning an additional 30% of patients could be treated with immunotherapy, who would otherwise have not been recommended for immunotherapy.

"We are now in the process of proving and creating the direction we want to achieve in the field of cancer treatment," said Brandon Suh, CEO of Lunit. "This year’s ESMO (Free ESMO Whitepaper) is particularly meaningful as one of our Lunit SCOPE products was used in a clinical trial for the first time and showed its predictable value. Our validation of AI-powered biomarkers for immunotherapy will be applied to many other drugs and larger clinical studies in the near future. In light of these positive results, Lunit SCOPE will be commercially made available by the end of this year."

Lunit Abstract Information at ESMO (Free ESMO Whitepaper) 2021

Virtual Meeting: E-Posters
September 16 – 21, 2021

Abstract 977P

Title: Interim results of phase I dose escalation study of YBL-006: A novel anti-PD-1 monoclonal antibody in advanced solid tumors

Abstract 398P

Title: AI-powered whole-slide image analysis of tumor-infiltrating lymphocytes for prediction of prognosis in colorectal cancer

Abstract 1805P

Title: Assistance with an artificial intelligence-powered PD-L1 analyzer reduces interobserver variation in pathologic reading of tumor proportion score in non-small cell lung cancer

On September 17, 2021 Tyra Biosciences, Inc. (Nasdaq: TYRA), a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer, reported the closing of its initial public offering of 12,420,000 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 1,620,000 additional shares, at an initial public offering price of $16.00 per share (Press release, Tyra Biosciences, SEP 17, 2021, View Source [SID1234587909]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Tyra, were $198,720,000 million. Tyra’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "TYRA."

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BofA Securities, Jefferies and Cowen acted as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on September 14, 2021. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by telephone at 877-821-7388; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.