On October 29, 2021 Signet Therapeutics, a biopharmaceutical startup focusing on developing innovative targeted cancer drugs using novel disease models, reported it has completed seed-2 round of approximately 10 million US dollars (Press release, Signet Therapeutics, OCT 29, 2021, View Source [SID1234592207]).

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The new round was led by 5Y Capital (Morningside Venture), with participation from Yael Capital, Blue Ocean Capital, and existing investors Tiantu Capital and Sky9 Capital. The new funding will advance Signet’s two first-in-class oncology programs toward clinical trials. In addition, Signet plans to expand its platform of disease models to other cancer areas and empower target discovery and pharmacodynamics studies at other pharmaceutical companies on a greater scale. Founded in 2020, Signet has raised a seed round of ￥60 million in CNY (equivalent to approximately $10 million), totaling two rounds of around $20 million within its first year.

Dr. Haisheng Zhang, CEO of Signet Therapeutics, and his core team members were from Dana-Farber Cancer Institute, Harvard Medical School, one of the world’s leading cancer research institutions. Traditional in vitro studies use cell lines that cannot accurately model patient’s drug performance, often returning misleading bioactivity results that misguide the screening and optimization of lead compounds, which could result in clinical failure. Leveraging years of oncology and functional biology and genomic research expertise, Signet developed a unique platform of novel disease models based on real-world cancer genomics data to simulate drug effects in 3D organ tissues that bear a closer resemblance to human biology and produce pharmacodynamics data with higher relevance to clinical performance.

Gastric cancer is the third leading cause of cancer death in the world. Close to one-third of the cases are of the diffusive gastric cancer (DGC) subtype, which is associated with poor prognosis and a low response rate to existing cancer therapies and medicines. Using its novel disease models platform, Signet made the groundbreaking discovery of a promising new target for DGC. It launched a drug discovery program with the leading AI drug R&D company XtalPi and, in March 2021, announced the identification of a pre-clinical candidate in over six months.

As Signet quickly advance its first-in-class DGC pipeline toward clinical trials, it has recently expanded its drug discovery program with XtalPi to another novel cancer target discovered by Signet. The two companies hope to build upon their existing success in combining XtalPi’s AI drug discovery capabilities with Signet’s customized novel disease models to quickly discover and validate candidates with potent bioactivity and a desirable drug property profile that can translate to enhanced clinical performance.

On October 29, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) reported that it will host a conference call and live webcast on Monday, November 1, 2021, at 8:30 a.m. Eastern Time to report its third quarter 2021 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, OCT 29, 2021, View Source [SID1234593969]).

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A live webcast will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours of the event. The conference call can be accessed by dialing (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1699563.

On October 29, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Friday, November 5, 2021 to report its third quarter 2021 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, OCT 29, 2021, View Source [SID1234592192]).

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To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 3287324. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On October 29, 2021 Apollo Intelligence reported that Despite the FDA’s recent hold on select chimeric antigen receptor (CAR) T-cell clinical trials for cancer treatments using allogeneic products, new data show US oncologists, hematologists, and hematology-oncologists remain highly enthusiastic about the potential for CAR T-cell therapies for their patients (Press release, Apollo Intelligence, OCT 29, 2021, View Source [SID1234592208]).

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Data were sourced on October 20-21, 2021, by InCrowd, real-time market insights company and a brand of Apollo Intelligence (Apollo), global insights innovator for the life sciences industry, as part of InCrowd’s Instant Insights series on timely topics.

Allogenic CAR T-cell therapies—using cells from sources other than the patient — are promising because they potentially enable access to off-the-shelf treatments, versus autologous CAR T-cell therapies which use cells taken from the patient. On October 8, the FDA placed a select hold on allogenic CAR T-cell clinical trials conducted by one manufacturer following reports of a chromosomal abnormality in one patient of the manufacturer’s allogenic CAR T-cell trial.

Despite the FDA’s action, InCrowd found that 72% of cancer specialist respondents are excited about the future of CAR T-cell therapy in general.

Sixty-two percent believe other allogenic CAR T-cell clinical trials will emerge and succeed.
Forty-two percent said these allogenic CAR T-cell trials will reconvene as soon as soon as more data is released.
Only 12% of US cancer specialists said the FDA’s hold causes them concern with all gene therapy technologies.
Just 13% said allogenic CAR T-cell therapy is not a viable therapy to research further.
Two-thirds (67%) of respondents agree that the FDA’s hold on the select allogenic CAR T-cell therapy clinical trials had no impact on their perception of allogenic CAR T-cell therapy in general.

"The InCrowd Instant Insights data show that the FDA’s actions had very little impact on oncologists’ perceptions of allogeneic or autologous CAR T-cell therapy and gene therapy in general," said Daniel S. Fitzgerald, CEO of Apollo Intelligence, parent company to InCrowd. "It’s encouraging to see that cancer specialists in the US remain optimistic about the promise of CAR T-cell therapies for helping their patients."

The one-minute InCrowd survey included n=76 US oncologists, hematologists, and hematology-oncologists responding on October 20-21, 2021. Respondents reported that they were at least somewhat knowledgeable about new and emerging cancer treatments such as CAR T-cells, bispecific T cell engager (BiTE) antibodies, and antibody-drug conjugates (ADC.) For more visit InCrowd.

On October 29, 2021 Alphamab Oncology (stock code: 9966.HK) reported, a pivotal clinical study of PD-L1/CTLA-4 bispecific antibody KN046 in China (ENREACH-LUNG-02) recently completed the first drug administration (Press release, Alphamab, OCT 29, 2021, View Source [SID1234592178]).

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ENREACH-LUNG-02 is a multi-center, open-label, randomized-controlled phase II/III clinical study. Phase III study is planned to be carried out in about 50 research centers, recruiting about 486 patients, with OS and PFS as co-primary endpoints. To evaluate the efficacy of KN046 combined with lenvatinib versus docetaxel in patients with advanced NSCLC who have progressed on anti-PD-(L)1 treatment.

The principal investigator Professor Caicun Zhou, Director of the Department of Oncology from Shanghai Pulmonary Hospital Affiliated to Tongji University, commented, "In recent years, major progress has been made in lung cancer treatment, especially immunotherapies have brought significant clinical benefits to patients. However, there is still no effective option for PD-(L)1 refractory NSCLC patients. Through ENREACH-LUNG-02 study, we look forward to bringing new treatment options to these patients with huge unmet needs."

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism CTLA-4 domain fused with a PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg（suppress tumor immunity） clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown promising data in terms of survival for patients. Alphamab Oncology has received FDA clearance to enter later stage trials of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.