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.

On October 4, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that the Company will present novel biomarker data from the ongoing phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10-14, 2021 in Washington D.C., and virtually (Press release, Candel Therapeutics, OCT 4, 2021, View Source [SID1234590752]).

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Poster details:

Title: Detection of viral antigen and immune activation after intra-tumor injection of CAN-3110 (ICP-34.5 expressing HSV-1 oncolytic virus) in patients with recurrent high-grade glioma
Abstract Number: 395
Primary Author/Presenter: Francesca Barone, MD, PhD, Vice President, Head of Research, Candel Therapeutics, Inc.
Date/Time: November 12, 2021, 7:00 am – 8:30 pm ET

Full text of the abstract will be released on the SITC (Free SITC Whitepaper) website at 8:00 a.m. ET on Tuesday, November 9, 2021. Details from the presentation will be available on the Candel website at View Source

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

For more information on this clinical study, please visit View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the local release of tumor-specific neoantigens. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

On October 4, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that it will present an oral presentation on its lead program, ST101, at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2021 (Press release, Sapience Therapeutics, OCT 4, 2021, View Source [SID1234590750]). The meeting is being held in a virtual format from October 7-10th, 2021.

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Oral presentation details are as follows:

Date/Time: Saturday, October 9, 2021, 4:00 pm-5:40 pm ET
Session: Plenary Session 6, New Drugs on the Horizon II
Abstract Number: #4993
Abstract/Presentation Title: ST101, a peptide targeting oncogenic transcription factor C/EBPβ: Initial safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) data from an ongoing phase 1 dose escalation study in patients with advanced metastatic solid tumors

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation for the treatment of glioma by the European Commission.

On October 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre reported an exclusive commercialization agreement for tabelecleucel (tab-cel) in Europe, Middle East, Africa, and other select emerging markets for Epstein-Barr virus (EBV)-positive cancers (Press release, Atara Biotherapeutics, OCT 4, 2021, View Source [SID1234590749]). Atara will retain full rights to tab-cel in other major markets, including North America, Asia Pacific, and Latin America.

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Under the terms of the agreement, Atara will receive an upfront payment of USD 45 million, and up to approximately USD 320 million in additional regulatory and sales milestone payments, plus significant double-digit tiered royalties as a percentage of net sales. Atara will continue to be responsible for the pivotal ALLELE study in PTLD as well as submitting the EU Marketing Authorization Application (MAA) for tabelecleucel in patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), which is on track for November 2021. Atara will also remain responsible for the Phase 2 multi-cohort study, which is evaluating tab-cel in six additional patient populations with the goal of label expansion in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre.

Atara is a leader in T-cell immunotherapy, leveraging its first-in-kind allogeneic off-the-shelf EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases. Tab-cel is the Company’s lead candidate in development for EBV-positive cancers, including EBV+ PTLD, where it is currently being investigated in adults and children in the Phase 3 ALLELE study. Tab-cel has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

"Pierre Fabre is a science-driven company that brings significant commercialization expertise through its integrated Oncology Business Unit, its deep knowledge of Bone Marrow Transplant centers and a track record of successful launches through partnerships," commented Pascal Touchon, President and CEO of Atara. "Our Companies’ complementary capabilities will expand access to tab-cel, a potentially transformative investigational allogeneic off-the-shelf T-cell immunotherapy, to patients worldwide who suffer from EBV+ PTLD and other EBV-driven cancers."

Pierre Fabre enjoys a 35-year long experience in oncology covering innovation, development, manufacturing and commercialization. Its Medical Care division has declared oncology as its main R&D and commercial priority, focusing on targeted therapies, biotherapies, and immuno-oncology. Its therapeutic areas include high unmet medical needs and cover colorectal, breast, lung cancers, melanoma, and pre-cancerous conditions like actinic keratosis. The company has also developed a strong know-how in leveraging global partnerships with biotechnology and pharmaceutical companies, as demonstrated by several successful collaborations in oncology.

"Tab-cel is a highly innovative immunotherapy with the potential to serve patients with high unmet need in rare conditions. This partnership with Atara epitomizes our corporate purpose: ‘every time we take care of one single person, we make the world better,’" said Eric Ducournau, CEO of Pierre Fabre. "We expect strong synergies with our existing capabilities in oncology across regulatory, distribution, medical, marketing and sales and look forward to bringing this advanced product to patients."

PJT Partners served as the exclusive financial advisor to Atara.

Atara Conference Call
In connection with this announcement, Atara will host a webcast and conference call today at 8:30 a.m. EDT. Analysts and investors can participate in the conference call by dialing 877-407-8291 for domestic callers and 201-689-8345 for international callers, using the conference ID 13723585. A live audio webcast can be accessed by visiting the Investors & Media – News & Events section of www.atarabio.com. An archived replay will be available on the Company’s website for 30 days.

About Tabelecleucel
Tabelecleucel (tab-cel) is an off-the-shelf, allogeneic T-cell immunotherapy in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur after a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). There are currently no approved treatments indicated to treat PTLD and if left untreated, PTLD can have life-threatening consequences.

Tab-cel is currently being investigated in the Phase 3 ALLELE study to assess efficacy and safety for the treatment of EBV+ PTLD in SOT and HCT after failure of standard of care.

Tab-cel has been granted Breakthrough Therapy Designation for EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Agency (EMA) for the same indication. Tab-cel has orphan drug designation in the U.S. and EU.