December 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data demonstrating the benefits of using the Guardant360 liquid biopsy test to help guide targeted therapy options for patients with advanced breast cancer at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-11 (Press release, Guardant Health, DEC 6, 2021, View Source [SID1234596514]). These studies were based on data from the GuardantINFORM real-world clinical genomic platform, which features extensive de-identified genomic data and aggregated commercial payer claims from advanced cancer patients who received the Guardant360 liquid biopsy assay.

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Data from one study (Abstract P5-13-29) confirmed that patients with BRCA1/2 reversion mutations, thought to cause acquired therapeutic resistance, experienced worse survival outcomes when treated with a PARP inhibitor as compared to patients without reversion mutations. The study also validates recent advancements in homologous recombination deficiency (HRD) assessment in the Guardant360 lab developed test (LDT), detecting additional inactivating alterations in BRCA1/2, including copy number loss and large genomic rearrangements. These data further demonstrate the Guardant360 test’s ability to reliably identify patients with advanced breast cancer who are most likely to benefit from PARP inhibitor treatment.

Another study (Abstract P1-18-07) using the GuardantINFORM platform demonstrated that, for advanced breast cancer patients with PIK3CA mutations identified using the Guardant360 liquid biopsy and subsequently treated with alpelisib, there was no significant difference in treatment outcomes regardless of whether they had clonal or subclonal PIK3CA mutations. This suggests patients with these mutations may benefit from alpelisib targeted therapy irrespective of mutation clonality.

"These studies further support the tremendous value that our Guardant360 liquid biopsy test and GuardantINFORM real-world clinical genomic platform bring to physicians, and most importantly the patients they treat," said Helmy Eltoukhy, Guardant Health Co-CEO. "Guardant360 identifies mutations driving the cancer, which enables the physician to match a patient with the right precision therapy without the need for a tissue biopsy, which can be difficult and time-consuming, potentially delaying treatment for patients with advanced breast cancer."

Full List of Guardant Health Presentations:

Analytical and clinical validation of a ctDNA assay for detecting copy number loss and structural rearrangement variants contributing to homologous recombination and repair (HRR) deficiency (Abstract Number: P5-13-29)
Impact of PIK3CA mutation (PIK3CA-mt) clonality on alpelisib (ALP) activity based on real-world evidence (RWE) following liquid biopsy testing (Abstract Number: P1-18-07)
SOLTI-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain (Abstract Number: OT2-06-01)
Early changes in circulating tumor DNA and its effect on clinical outcomes in patients with advanced breast cancer receiving the CDK4/6 inhibitor palbociclib: Genotyping results from POLARIS (Abstract Number: P1-18-05)
The full abstracts can be found at the official SABCS website here.

About the Guardant360 Liquid Biopsy Test

The Guardant360 liquid biopsy test is part of the market leading Guardant360 portfolio that offers oncologists end-to-end testing solutions from treatment selection to treatment response monitoring. Since it was first introduced, the Guardant360 liquid biopsy test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 250 peer-reviewed publications including over 60 clinical outcomes studies. It has been trusted by more than 9,000 oncologists with more than 200,000 tests performed to date.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

On December 6, 2021 Recursion (NASDAQ: RXRX), a clinical-stage biotechnology company decoding biology to radically improve lives by industrializing drug discovery, development and beyond through disruptive innovation, reported expansion of the company’s existing strategic collaboration in fibrosis with Bayer AG (Press release, Recursion Pharmaceuticals, DEC 6, 2021, View Source [SID1234596535]). The expanded collaboration will include Recursion’s powerful inferential search capabilities based on its growing maps of human cellular biology, giving Bayer the ability to further accelerate the work already underway in expanding the universe of novel fibrotic hypotheses. Recursion and Bayer may now work on more than a dozen programs in total of relevance to fibrotic disease. All projects will remain subject to the previously agreed upon economics, where each potential program could generate more than $100 million in commercial milestone payments plus royalties on future sales.

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Inferential search enables Recursion to materially expand the depth and breadth of the drug discovery space in a more efficient fashion – reducing time and costs to better operationalize the process. In the expanded collaboration, the company will leverage the Recursion Map, a collection of actionable scientific insights derived from the application of machine learning solutions on massive relatable datasets, to explore hundreds of billions of biological relationships that span whole-genome genetic perturbations, hundreds of soluble factors, and hundreds of thousands of pharmacological perturbations. Inferred relationships of interest will be validated in Recursion’s wet-labs and digital vivariums to rapidly advance therapeutic hypotheses and generate data which is fed back into Recursion’s Operating System to improve future predictions.

"Our collaborations are centered around the goal of delivering better drugs to patients faster than we could on our own," said Recursion Co-Founder & CEO Chris Gibson, PhD. "At Recursion, we believe inferential search is the future of drug discovery and have made key advances in this space. We have a deep respect for and trust in our colleagues at Bayer and are looking forward to including these new tools in our collaboration and potentially expanding the number of programs we go after together – all for the benefit of patients."

"The speed and scale of progress made in a short period of time on a number of fibrotic disease models with our collaborators at Recursion has been impressive," said Philip Larsen, Senior Vice President and Global Head of Research and Early Development at Bayer. "Fibrotic diseases are an important cause of morbidity and mortality worldwide. We look forward to the continued collaboration and adding inferential search to further accelerate our mission to deliver transformative therapies for patients with fibrotic diseases of the lung, kidney, heart and more."

Recursion first deployed inferential search internally in July 2020 within the oncology space. In early 2021, Recursion transitioned nearly all new internal discovery efforts to use inferential search. Based on progress achieved to date, Recursion has demonstrated that a program can advance from inference to in vivo validation in less than six months. Through the collaboration expansion, Recursion will bring this powerful new technology to Bayer in order to accelerate and expand the ongoing work the teams have undertaken together in fibrosis.

On December 5, 2021 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported on December 3 that the ongoing phase III study AGENT will not reach 300 PFS events with current censoring rules based on FDA decision (Press release, Isofol Medical, DEC 5, 2021, View Source [SID1234596455]). Following this announcement, Isofol invites investors, analysts, and media to an audiocast (in English) with a Q&A-session on December 6, at 08:00 a.m. CET.

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The presentation will be held by Isofol’s CEO Ulf Jungnelius and CMO Roger Tell in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

Date and time
December 6, 2021, at 08:00 a.m. CET

Webcast link
View Source

Phone number
Call in details will be made available at the following link in good time before the start of the presentation:
View Source

The presentation will also be available on Isofol’s website after the broadcast.

On December 5, 2021 Jacobio Pharma (1167.HK) reported that it has received the Investigational New Drug (the "IND") approval of the combination therapy of KRAS G12C inhibitor JAB-21822 and Cetuximab injection from the Center for Drug Evaluation of China (the "CDE") on Dec 3, 2021 (Press release, Jacobio Pharmaceuticals, DEC 5, 2021, View Source [SID1234596458]).

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After received the approval, Jacobio will start a phase I/II, open-label, multi-center, dose-escalation and expansion clinical trial in China. The clinical trial is aiming to explore the safety, tolerability and preliminary efficacy of the combination therapy of JAB-21822 and Cetuximab in KRAS G12C mutant patients with advanced colorectal cancer.

Jacobio’s preclinical study shows that the combination therapy of JAB-21822 and Cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, make tumor regression, and delay tumor re-growth after the cessation of using the drug.

JAB-21822 has been approved for five clinical trials in China and the United States, including mono therapies and combination therapies with either PD-1 antibody or Cetuximab to treat KRAS G12C mutant patients with advanced solid tumors including non-small cell lung cancer and colorectal cancer.

About JAB-21822

JAB-21822 is the Jacobio’s in-house innovative small molecule anti-cancer drug, which is designed to target KRAS G12C mutation. JAB-21822 has best-in-class potential among KRAS G12C inhibitors and has been approved for clinical trials in China and the United States. Internal pre-clinical head-to-head studies have shown that JAB-21822 has a superior pharmacokinetic (PK) profile and favorable tolerability as well as potential for a superior dosing profile compared with its competitors.

About Cetuximab

Cetuximab is an IgG1 monoclonal antibody against the EGF receptor. The cetuximab injection used in the clinical trial of the combination therapy is an approved treatment for RAS wild type patients with metastatic colorectal cancer, head and neck cancers and other diseases.

On December 5, 2021 KDx Diagnostics, Inc. (KDx), and Lister Hospital (East and North Hertfordshire NHS Trust), Stevenage, UK, reported the launch in the United Kingdom (UK) of KDx’s URO17 test for detection of bladder cancer (Press release, KDx Diagnostics, DEC 5, 2021, View Source [SID1234596460]). This non-invasive urine test for bladder cancer is highly sensitive for identifying bladder cancer in patients with hematuria and recurrent bladder cancer during post-treatment monitoring.

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There are over 197,000 newly diagnosed cases of bladder cancer in Europe, and 430,000 globally, with 81,000 cases in the US alone. Accurate detection of new bladder cancer is difficult and expensive, requiring invasive camera-based testing methodology. Excitingly, KDx’s URO17 test has demonstrated 100% sensitivity and over 90% specificity in detecting bladder cancer in multiple peer-reviewed studies.

"We are excited to have the non-invasive URO17 test available in the UK to determine with high confidence whether a patient has bladder cancer. Testing has shown the URO17 urine test can detect the presence or absence of bladder cancer with high sensitivity. We are confident that the application of URO17 in clinical practices can significantly improve patient care in the UK," said Nam W. Kim, Ph.D., KDx’s CEO, and CTO.

"Bladder cancer is expensive cancer to treat due to a high rate of recurrence, and it often requires invasive procedures to diagnose. KDx’s URO17 urine test is revolutionizing how bladder cancer is detected, managed, and treated. We are excited that Lister Hospital in Stevenage is now a Core Lab offering URO17 test and that patients from all over the UK will have access to this test," said Sholeh Jahanfard, President and COO of KDx Diagnostics Inc.

Mr. Nikhil Vasdev – Consultant Urological Surgeon at Lister Hospital and Associate Medical Director for cancer services at East and North Hertfordshire NHS Trust, which runs the hospital – was the chief investigator and the lead author of a paper describing a recent study on URO17. "We are pleased to be the first NHS trust in the UK and Europe to make URO17 test available for patients," said Mr. Vasdev, who is also a Senior Clinical Lecturer at the University of Hertfordshire. "Our ability to detect bladder cancer simply, accurately, and non-invasively using URO17 will greatly improve detection at an early stage when it can be treated most effectively while minimizing the number of unnecessary and invasive procedures in patients who are suspected of having bladder cancer," he added.

Dr. Michael Chilvers – Medical Director at East and North Herts NHS Trust, said: "I am really pleased that the partnership between KDx and this Trust has led to this major step forward in the non-invasive detection of bladder cancer, and undoubtedly to improved outcomes for our patients."