On October 4, 2021 -NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that new data from two clinical trials evaluating the company’s lead asset NT-I7 (efineptakin alfa) will be presented during poster sessions at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting, to be held both in person in Washington, D.C. and on a virtual platform on November 10-14, 2021 (Press release, NeoImmuneTech, OCT 4, 2021, View Source [SID1234590755]). The data come from clinical studies evaluating NT-I7, a novel long-acting human IL-7, 1. in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a treatment for advanced solid tumors, and 2. given concurrently with adjuvant chemotherapy in patients with high-grade gliomas.

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Details related to the poster presentations are as follows:

Title: Preliminary Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced Pancreatic Cancer
Lead Author: Aung Naing, M.D., The University of Texas MD Anderson Cancer Center
Abstract Number: 408
Poster Session: 11/12/2021 – 11/14/2021, 7:00 am – 5:00 pm

Title: Initial Biomarker and Clinical Data of a Phase 2a Study of NT-I7, a Long-Acting Interleukin-7, plus Pembrolizumab: Cohort of Subjects with Checkpoint Inhibitor-naïve Advanced MSS-Colorectal Cancer
Lead Author: Richard D. Kim, M.D., Moffitt Cancer Center
Abstract Number: 404
Poster Session: 11/12/2021 – 11/14/2021, 7:00 am – 5:00 pm

Title: NT-I7, a long-acting interleukin-7, promotes expansion of CD8 T cells and NK cells and immune activation in patients with newly diagnosed high-grade gliomas after chemoradiation
Lead Author: Jian Campian, M.D., Ph.D., Mayo Clinic
Abstract Number: 396
Poster Session: 11/12/2021 – 11/14/2021, 7:00 am – 5:00 pm

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On October 4, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that it will present updates across three oncology programs at various stages of development (Press release, SQZ Biotech, OCT 4, 2021, View Source [SID1234590754]). The data will be presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 10-14, 2021, in Washington, D.C., and virtually.

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"We are excited to share new preclinical data on our AAC and eAPC platforms, as well as initial data on the engineering of tumor infiltrating lymphocytes," said Armon Sharei, Ph.D., Chief Executive Officer at SQZ Biotechnologies. "These data further highlight our potential to create multiple cell therapies leveraging diverse biology to combat cancer."

POSTER PRESENTATIONS

Title: RBC-Derived, Activating Antigen Carriers (SQZ AACs) Prime Potent T Cell Responses and Drive Tumor Regression In Vivo
Presenter: Katarina Blagovic, PhD
Abstract Number: 156

Title: Generating Enhanced Tumor Infiltrating Lymphocytes Through Microfluidic Cell Squeezing
Presenter: Devin Bridgen, PhD
Abstract Number: 165

Title: SQZ eAPCs Generated from PBMCs by Delivery of Multiple mRNAs Encoding for Antigens, Costimulatory Proteins, and Engineered Cytokines
Presenter: Michael F. Maloney, PhD
Abstract Number: 211

Full text of the abstracts will be available on the SITC (Free SITC Whitepaper) website at 8:00 a.m. ET on Tuesday, November 9, and posters will be available on the company’s website at 7:00 a.m. ET on November 12. Live poster presentations will be on November 12 and 13 from 7:00 a.m. – 8:30 p.m. ET.

On October 4, 2021 Checkmate Pharmaceuticals Presented the Corporate Presentation (Presentation, Checkmate Pharmaceuticals, OCT 4, 2021, View Source [SID1234590743])

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On October 4, 2021 AnPac Bio-Medical Science Co., Ltd. (Nasdaq:ANPC, "AnPac Bio," the "Company" or "we"), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, reported it has achieved a significant milestone and positive result in its general population cancer risk assessment tests and subsequent follow-up study on enrolled individuals whom obtained further check-ups and diagnosis at healthcare providers using their cancer and disease diagnostic tools (Press release, Anpac Bio, OCT 4, 2021, View Source [SID1234590731]). As of September 30, 2021, healthcare providers have confirmed 2,067 cancer, pre-cancer, and disease cases, which includes 22 identified types of cancer, 25 identified types of pre-cancer, and multiple other related diseases. An initial analysis showed that confirmed cases are strongly correlated to CDA test score, confirming that the CDA test is an effective method to initially screen the population for risks associated with cancer.

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AnPac Bio’s follow-up study involved (a) enrolling high, medium, and low risk groups of individuals based on their CDA test scores following CDA testing of a large, asymptomatic population, (b) recommending enrolled individuals to obtain follow-up check-ups at healthcare providers, (c) following up with enrolled individuals via phone interviews, and (d) analyzing interview results and data. As of September 30, 2021, 14,806 individuals in the high, medium and low risk groups were contacted and interviewed, and 2,067 individuals were confirmed as cancer, pre-cancer or other disease patients. Based on an initial analysis of the most recent follow-up data and results, CDA technology is an effective initial screening tool for asymptomatic general population for multiple cancer types, pre-cancer types and other related diseases. The confirmed cancer and pre-cancer cases detected 22 types of cancer and 25 types of pre-cancer, including esophageal cancer and thyroid cancers that currently lack effective biomarkers for early screening and detection.

The top five confirmed cancer types and pre-cancer types are as follows:

Types of Cancer Number of patients

Colorectal cancer 40

Lung cancer 32

Gastric cancer 27

Prostate cancer 24

Breast cancer 23

Types of pre-cancer Number of patients

Thyroid nodule/benign tumor 230

Pulmonary nodule 179

Lesions of the breast/ Hyperplasia of breast glands 135

Hysteromyoma 93

Gastroduodenal diseases 83

The above data demonstrates that CDA technology is also very effective in finding pre-cancer diseases as confirmed pre-cancer cases are much higher than those of confirmed cancer cases, which is very attractive and meaningful for cancer prevention. However, the confirmed cases are highly likely to be under-reported because (a) only cases from individuals that we were able to successfully contact are recorded, (b) some enrolled subjects did not give full final diagnosis results when contacted, and (c) as an on-going follow-up study, more confirmed cases will likely be developed and recorded over time.

Developing a viable pre-cancer and early-stage cancer screening technology is critical to detect cancer early and to save patient lives. However, its development and progress has been relatively slow, despite decades of heavy investments and efforts by leading scientists and research groups. One of the key factors has been the lack of leading detection experts to develop sensitive technologies for low level signal collection and processing. AnPac Bio has built a unique team of physicists, and experts with extensive experience from semiconductor and AI-based computational analysis to build the unique CDA technology platform.

Over the past 12 years, AnPac Bio’s team has innovated and developed biophysics-based detection technology, in which biophysical properties of blood are detected and analyzed for early-stage cancer screening and detection. The Company has been a staunch champion of the concept of multi-cancer detection through developing its CDA technology. The measurement of biophysical properties for cancer detection can detect multiple cancer types earlier, more cost effectively, with higher sensitivity and specificity, and through relatively simple sample requirements and test procedures. These features make AnPac Bio’s CDA technology perfectly suited for screening general population for cancer affordably.

Dr. Chris Yu, CEO and Chairman of AnPac Bio commented: "We are very pleased to reach the milestone of confirming over 2,000 cases and to achieve significant validation of CDA technology for general population cancer and pre-cancer risk assessment. This is truly a breakthrough technology in catching multiple cancer and pre-cancer types earlier to prevent cancer and provide better patient outcomes. We are very proud of our contributions to the battle against cancer and we are contributing to save lives now. We are already making a significant impact in the fight again cancer through our innovative ideas (multi-cancer detection), technology development and finding potential cancer and pre-cancer earlier on a daily basis. We believe our CDA technology’s results speak for themselves and expect that public health agencies and organizations seeking the most promising tools for detecting cancer and pre-cancer earlier will look closely at AnPac Bio."

On October 4, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the U.S. Food and Drug Administration (FDA) granted a seventh regulatory designation to lead drug candidate, repotrectinib (Press release, Turning Point Therapeutics, OCT 4, 2021, View Source [SID1234590753]).

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Breakthrough Therapy designation was granted for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and have no satisfactory alternative treatments. The company is planning to discuss next steps towards potential registration of repotrectinib in this patient population at a Type B meeting with the FDA anticipated in the first half of 2022.

"We are excited to receive our second Breakthrough Therapy designation and seventh overall regulatory designation for repotrectinib," said Athena Countouriotis, M.D., president and chief executive officer. "There remains an unmet medical need for NTRK-positive, TKI-pretreated advanced solid tumor patients where there are no targeted therapies currently approved. We look forward to presenting additional clinical data from our TRIDENT-1 study of repotrectinib during the AACR (Free AACR Whitepaper)-NCI-EORTC conference later this week, including a late-breaker plenary presentation where early clinical data from the NTRK EXP-5 and EXP-6 cohorts will be discussed."

Breakthrough Therapy designation is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for Breakthrough Therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Repotrectinib was previously granted Breakthrough Therapy designation in ROS1- positive metastatic non-small cell lung cancer (NSCLC) patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as four Fast-Track designations in: ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy; and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments. Repotrectinib was also granted an Orphan Drug designation in 2017.