On November 9, 2021 Carevive Systems ("Carevive") the leading oncology-focused health technology company centered on understanding and improving the experience of patients with cancer, reported that it has entered into a clinical research collaboration with NorthShore University HealthSystem (NorthShore) to utilize Carevive’s Patient Reported Outcomes Mobile Platform (PROmpt) system in the collection of critical patient data (Press release, Carevive Systems, NOV 9, 2021, View Source [SID1234594940]). Part of Carevive OPT-IN, a consortium of clinician investigators utilizing PROmpt, the NorthShore partnership will capture real-world patient data that will help improve the overall patient experience during treatment. PROmpt will summarize clinical, anecdotal, and demographic information associated with patient treatment, in an effort to positively improve patient outcomes.

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"The patient information accumulated during our collaboration with NorthShore will enable the PROmpt system to collect patient data in real-time that is critical to understanding both medical and quality of life needs of cancer patients, and learn where care improvements are necessary," said Debra Wujcik, PhD, RN, FAAN, VP, Research and Clinical Operations with Carevive. "Our PROmpt platform offers a highly efficient and fully-integrated data capture system that allows our clinical partners at NorthShore to gather knowledge about the entire patient experience and use that information to make the necessary care and treatment modifications. It is our hope that the patient registries developed during these studies will enable us to impact future patient care within other clinical settings."

The PROmpt patient self-assessment platform system, allows cancer patients the ability to receive important information once they report they are experiencing a new symptom. This information will help guide each patient on their care journey and on what steps to take next with their clinical care team. Using the PROmpt system, clinicians now have the tools to care and monitor patients remotely using the system’s platform. The data capture consists of a simple-to-use process that includes a direct patient registration, initial and weekly surveys, automated program response, and clinical notification. Each data set retrieved through this process will be used by NorthShore’s clinicians to not only improve overall patient care, but to also tailor modifications that are unique to each patient and address those impediments to treatment success.

"Carevive’s integrated patient platform holds great promise in capturing and understanding the data that is essential for the development of successful cancer treatment programs by our clinical teams," stated Nicklas Pfanzelter, M.D. and Oncologist, NorthShore University HealthSystem. "Our alliance with Carevive underscores NorthShore’s commitment to those cancer patients receiving treatment within our hospital network and, also those newly-diagnosed who may present themselves in the future. We look forward to partnering with Carevive and the application of our integrated clinical and technical capabilities to help improve cancer treatment."

Anyone interested in learning more about Carevive OPT-IN or benefits of the PROmpt system, can visit the Carevive website.

On November 9, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third-quarter financial results (Press release, Kronos Bio, NOV 9, 2021, View Source [SID1234594992]).

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"As we approach the end of the year, we look forward to reporting interim data from the ongoing Phase 1/2 study of our internally discovered CDK9 inhibitor, KB-0742, capping off a year of significant progress," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "In addition to continued execution across our clinical stage programs, I am also pleased with the progress we are making with our pipeline – particularly the addition of two new discovery programs, which underscore the capabilities of our product engine."

Pipeline Progress
Kronos Bio reported it has initiated two new discovery programs, each focused on a distinct target or node identified through the company’s research and mapping of the MYC and AR transcriptional regulatory networks (TRNs).

Target 1: MYC TRN. Dysregulation of the MYC TRN is a hallmark of cancer and occurs in a large percentage of cancers. The company’s existing development candidate, KB-0742, targets CDK9 and is being evaluated in a Phase 1/2 clinical study. KB-0742 is intended to target MYC dysregulation in the context of MYC genomic amplification, which occurs in 30% of all solid tumors. The new Target 1 program is aimed at modulating a protein-protein interaction in the MYC TRN with the objective of treating additional MYC-dysregulated cancers beyond those targeted by KB-0742.
Target 2: AR TRN. Dysregulation of the AR (androgen receptor) TRN is a primary driver of prostate cancer. Although therapies that directly inhibit the androgen receptor already exist, many patients with prostate cancer ultimately develop resistance to these therapies and patients with castration-resistant prostate cancer (CRPC) have a particularly poor prognosis. This new program aims to overcome resistance to current therapies by targeting an AR cofactor that selectively modulates the AR TRN in the context of CRPC.
The company anticipates identifying a lead candidate and submitting an Investigational New Drug (IND) application out of one of its discovery programs in 2023.
Additionally, Kronos Bio yesterday announced a multi-year collaboration with Tempus, a leader in artificial intelligence and precision medicine. The agreement will provide Kronos Bio with access to real-world patient genomic and transcriptomic data and data analytics tools, with the goal of accelerating the development of the company’s current and future clinical portfolio.

Third-Quarter Company Highlights

Kronos Bio presented preclinical data characterizing the pharmacokinetic (PK) and pharmacodynamic (PD) profile of KB-0742 in a poster 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) in October 2021. These data build on results first shared at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting earlier this year. The new data demonstrated a favorable preclinical PK profile and human PK projection that support the intermittent dosing schedule for patients in the Phase 1/2 study.
The U.S. Food and Drug Administration cleared the company’s IND for lanraplenib, a next-generation spleen tyrosine kinase (SYK) inhibitor. This allows Kronos Bio to proceed with its planned Phase 1b/2 clinical trial of the compound in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib.
Upcoming Milestones

The company plans to report interim safety, PK and PD data in Q4 2021 from the ongoing dose escalation phase of its Phase 1/2 clinical trial of KB-0742, which is being developed to treat MYC-amplified or over-expressing solid tumors.
Kronos Bio remains on track to dose the first patient in its planned Phase 3 clinical trial of entospletinib before the end of the year, with a data readout expected in the second half of 2023. This trial will assess measurable residual disease (MRD) negative complete response as the primary endpoint to support potential accelerated approval in patients newly diagnosed with NPM1-mutated AML and eligible for intensive induction chemotherapy.
The company expects to dose the first patient in the first of two planned Phase 1b/2 clinical trials of lanraplenib in the first quarter of 2022. This first trial will evaluate lanraplenib in patients with relapsed or refractory FLT3-mutated AML.
Kronos Bio plans to initiate a second Phase 1b/2 clinical trial of lanraplenib, in combination with venetoclax/azacitidine in patients newly diagnosed with NPM1-mutated and/or FLT3-mutated AML who are older than age 75 or not eligible for intensive induction chemotherapy in the first half of 2022.
Third Quarter Financial Highlights

Cash, Cash Equivalents and Investments: As of September 30, 2021, cash, cash equivalents and investments totaled $398.4 million.

R&D Expenses: Research and development expenses were $24.7 million for the third quarter of 2021, which includes non-cash stock-based compensation expense of $3.5 million.

G&A Expenses: General and administrative expenses were $9.0 million for the third quarter of 2021, which includes non-cash stock-based compensation expense of $3.6 million.

Net Loss: Net loss for the third quarter of 2021 was $33.6 million, or $0.61 per share, including non-cash stock-based compensation expense of $7.1 million.

On November 9, 2021 AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC, the "Company"), a biotechnology company with operations in China and the United States focusing on early cancer screening and detection, reported the pricing of an underwritten public offering of 1,301,928 of its American Depositary Shares ("ADSs") at a public offering price of $2.22 per share, for gross proceeds to the Company of approximately $2.9 million, before deducting the underwriting discount and other offering expenses payable by the Company (Press release, Anpac Bio, NOV 9, 2021, View Source [SID1234595377]). This includes the full exercise of the underwriter’s over-allotment option.

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EF Hutton, division of Benchmark Investments, LLC is acting as the sole book-running manager for the offering. The offering is expected to close on or about November 12, 2021, subject to customary closing conditions.

The shares of ADSs described above are being offered by AnPac Bio-Medical Science Co., Ltd. pursuant to a "shelf" registration statement on Form F-3 (File No. 333-256630) that became effective with the Securities and Exchange Commission (SEC) on June 7, 2021, the base prospectus contained therein and the accompanying prospectus supplement.

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

On November 8, 2021 Kronos Bio, Inc, a company dedicated to transforming the lives of those affected by cancer, and Tempus, a leader in artificial intelligence and precision medicine, reported a multi-year collaboration that provides Kronos Bio with access to Tempus’ real-world genomic and transcriptomic data and data analytics tools (Press release, Kronos Bio, NOV 8, 2021, View Source [SID1234643240]).

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Under the agreement, Kronos Bio will have access to a number of precision medicine tools, including Tempus’ modeling lab, which houses a growing repository of molecularly profiled organoids. Access to such data and tools will help Kronos Bio accelerate the preclinical and clinical development of its current and future portfolio, by for example, using organoid models to generate biomarker hypotheses that can be tested in the clinic or in virtual molecularly defined patient cohorts drawn from Tempus’ extensive data sets.

The collaboration builds on an earlier agreement announced in February under which Tempus is performing molecular characterization of tumor samples from patients enrolled in Kronos Bio’s Phase 1/2 clinical study of the company’s CDK9 inhibitor KB-0742. Tempus will retrospectively sequence and analyze these patient samples to assess the relationship between MYC copy number, MYC expression levels and clinical response. Tempus will also explore a path to developing a companion diagnostic.

The expanded relationship leverages Kronos Bio’s deep expertise in transcriptional regulation and Tempus’ next-generation-sequencing capabilities, as well as drawing on each company’s computational biology capabilities. Kronos Bio also has the option to join Tempus’ TIME Trial Network, which supports rapid patient identification, site activation and enrollment of select clinical trials.

"With a shared commitment to improving patient outcomes, we are building upon our existing work with Kronos Bio to advance the company’s portfolio of clinical programs, including lanraplenib and KB-0742," said Marc Yoskowitz, executive vice president and chief strategy officer for Life Sciences at Tempus. "We look forward to harnessing the strength of our entire platform to support the discovery and development of novel cancer therapeutics."

The capabilities provided under the expanded agreement offer Kronos Bio the opportunity to access real-world data to further refine current understanding of transcription regulatory networks (TRNs), which could help accelerate clinical development.

"This partnership will bring together Kronos Bio’s knowledge and experience with transcriptional regulatory networks and Tempus’ sequencing expertise and exceptional data analytics tools and organoid models," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, Clinical Development at Kronos Bio. "We are looking forward to working together now and in the future, as we continue to progress our current clinical candidates, test rational combinations, and bring forward new ones, with the goal of getting medicines to patients as quickly as possible."

On November 8, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Rob Ross, M.D., chief executive officer, will participate in a fireside chat at the upcoming Cowen Fifth Annual IO Next Summit on Monday, November 15, 2021 at 12:45 p.m. ET (Press release, Surface Oncology, NOV 8, 2021, View Source [SID1234594681]).

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The live audio and subsequent archived webcast of the fireside chat will be accessible from the Events & Presentations page of the company’s website.