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Isofol provides update on the AGENT study

On August 31, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL) reported that, having received access to additional data, the company does not consider it justified to continue conducting the AGENT study (Press release, Isofol Medical, AUG 31, 2022, View Source [SID1234618815]). Review of study data will continue until the company can compile the final study report which is estimated to take place during the fourth quarter of 2022. At the same time, Isofol’s board of directors has decided to evaluate possible courses of action for the company’s future in order to maximize its value.

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The information in the press release is intended for investors.

On August 3, 2022, Isofol presented top line results showing that the AGENT study did not meet its primary or key secondary endpoints. Isofol has subsequently taken several operational measures and received additional data from the study. The status of the company and the AGENT study is as follows:

Based on further analysis of AGENT study data Isofol’s assessment is that the conclusions related to the endpoints objective response rate (ORR) and progression-free survival (PFS) that were presented in connection with top line results on August 3 will not change.
Further analysis has also shown a preliminary indication of a non-significant detrimental trend in the endpoint of overall survival (OS) for the experimental arm of the study compared with the control arm. This was one of the safety goals of the AGENT study.
However, the analysis indicates that both arms of the AGENT study performed well for all-comer patients with non-operable metastatic colorectal cancer (mCRC), irrespective of mutational status, in relation to today’s standard of care.
The company will continue to further analyze the study data as it becomes available in order to compile a final study report. This report will consist of, among other things, analysis of subgroups and gene expression as well as additional safety data. The ambition remains to present detailed study data at a scientific congress or in a scientific publication during 2023.
Therefore, Isofol’s overall assessment is that it is no longer justified to continue conducting the AGENT study. Patients who are still being treated in the experimental arm of the study will therefore be offered the opportunity to switch to standard of care and follow-up of patients will thereby be terminated.
Several measures have been implemented to use financial resources in an appropriate and cost-effective way in order to protect the company’s financial standing.
In light of this, Isofol’s board of directors has decided to evaluate possible courses of action for the company’s future in order to maximize its value.
Isofol intends to keep the stock market informed regarding the AGENT study’s results and the company’s future on a continual basis, and expects to be able to provide a new status update in the beginning of the fourth quarter of 2022.

This is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at  17:40 CEST on August 31, 2022.

About the AGENT Study
The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients.

The study was designed to show superiority for arfolitixorin over leucovorin. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells.

In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

Guardant Health Expands Strategic Collaboration With Merck KGaA, Darmstadt, Germany, to Help Accelerate Development of Precision Oncology Therapeutics

On August 31, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported an expanded collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, operating its biopharmaceuticals business in the U.S. and Canada as EMD Serono, to further leverage the GuardantINFORM real-world evidence (RWE) platform to help accelerate development efforts for Merck KGaA, Darmstadt, Germany‘s precision oncology pipeline (Press release, Guardant Health, AUG 31, 2022, View Source [SID1234618814]). The expanded strategic collaboration will focus on therapy development for core cancer indications with significant unmet need.

"Expanding our collaboration with Merck KGaA, Darmstadt, Germany, represents a great opportunity to help accelerate the development of their pipeline of potentially transformative cancer medicines," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "We are excited to see how further leveraging the GuardantINFORM real-world evidence platform can help them bring much-needed cancer therapies to patients more quickly."

Under the expanded collaboration, Merck KGaA, Darmstadt, Germany, will work closely with data scientists at Guardant Health on a variety of therapy development initiatives that utilize the genomics and clinical information accessible through the GuardantINFORM platform.

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 225,000 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.

Scantox acquires Adlego Biomedical and Timeline Bioresearch – strengthening its position as the leading Nordic provider of pre-clinical research services

On August 31, 2022 Scantox A/S ("Scantox" or the "Company"), the leading Nordic GLP-compliant pre-clinical contract research organization ("CRO"), headquartered in Denmark and since 2021 owned by Impilo, reported the acquisitions of Swedish Timeline Bioresearch AB in Lund ("Timeline Bioresearch") and Adlego Biomedical AB in Stockholm ("Adlego Biomedical") (Press release, Adlego Biomedical, AUG 31, 2022, View Source [SID1234618813]).

Timeline Bioresearch and Adlego Biomedical possess leading capabilities in efficacy and explorative research services and bring highly complementary service offerings to Scantox’s stronghold in pharmacology and regulatory toxicology. Moreover, the acquisitions represent important first steps towards broadening the Company’s portfolio of services, to support its growing customer base earlier in the drug development process.

Jeanet Løgsted, CEO of Scantox, comments: "Since the successful re-establishment of Scantox as an independent Company in 2021, we have embarked on an exciting and ambitious growth journey under Impilo’s ownership. We are thrilled about the support from our loyal and growing customer base and are well positioned to continue to enjoy the solid increase in outsourcing from pharma, biotech, and medical device companies, paving the way for strong continued profitable growth. With the acquisitions of Timeline Bioresearch and Adlego Biomedical, we welcome two companies that are known for their solid expertise within the fields of efficacy models, with highly competent staff, specialized techniques, and equipment. Their portfolio of research capabilities aligns perfectly with the current and future direction of Scantox, where a constant focus on the highest scientific and technical quality, as well as ethical standards, is at the core."

With the new acquisitions, Scantox has more than 160 employees and the Company is heading towards a strong financial closure of 2022, with turnover expected to exceed DKK 150 million on FY pro-forma basis.

Lone Bruhn Madsen, CEO of Timeline Bioresearch: "We are on a very positive track and by joining Scantox, current and new customers will benefit from a more integrated service offering, which will eventually streamline the progress of products through the research phase and pre-clinical development. We are indeed looking forward to leveraging the synergies across Scantox to deliver the best customized solutions to the market."

Urban Höglund, CEO of Adlego Biomedical: "We have successfully been serving mainly Swedish drug development companies with in-vivo evaluations of new products for more than a decade. It is now time to let our services reach other markets, and I believe that the partnership with Scantox will be beneficial in this respect. I also believe that it will be of great value to my staff to be part of a larger organization for mutual development of services."

As of 1 September 2022, the companies will be integrated and operate under the Scantox name.

Nicholas Hooge, Partner at Impilo and Head of its Danish operations, concludes: "Scantox is experiencing a fantastic momentum following the successful transition into an independent company in 2021, and the underlying growth fundamentals remain strong. These two acquisitions are important first steps in the execution of the Company’s long-term growth strategy, where inorganic expansion is at the core. Impilo is excited about the future consolidation potential in the sector and looks forward to continue working with Scantox to further expand its portfolio of services and to strengthen its position globally."

Lilly to Participate in Morgan Stanley 20th Annual Global Healthcare Conference

On August 31, 2022 Eli Lilly and Company (NYSE: LLY) reported that will attend the Morgan Stanley 20th Annual Global Healthcare Conference on Tuesday, Sept. 13, 2022 (Press release, Eli Lilly, AUG 31, 2022, View Source [SID1234618812]). Anat Ashkenazi, Lilly’s senior vice president and chief financial officer, will participate in a fireside chat at 11:10 a.m., Eastern time.

A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Medtronic announces partnership with BioIntelliSense for exclusive U.S. distribution of multi-parameter wearable for continuous remote patient monitoring from in-hospital to home

On August 31, 2022 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, reported it has entered into a strategic partnership with BioIntelliSense, a continuous health monitoring and clinical intelligence company, for the exclusive U.S. hospital and 30-day post-acute hospital to home distribution rights of the BioButton multi-parameter wearable for continuous, connected monitoring (Press release, Medtronic, AUG 31, 2022, View Source [SID1234618811]). The partnership enables the Medtronic Patient Monitoring business to offer access to a medical grade device that provides continuous vital sign measurements of general care patients in-hospital as well as post-discharge. This supports the simplification of care delivery through workflow automation, enabling proactive clinical intervention, and helping to address the implications of staffing shortages. Terms of the deal were not disclosed.

The BioButton medical grade device, measuring up to 1,440 vital sign measurements per day, including skin temperature, respiratory rate at rest, and heart rate at rest, is the exclusive multi-parameter wearable for the Patient Monitoring business. This device, combined with advanced analytics, has the potential to help enable clinicians to better detect early signs of patient deterioration or, conversely, identify stable patients who may be candidates for earlier hospital discharge. The rechargeable BioButton device also has configurable acute and post-acute modes to continuously monitor patients as they transition from higher to lower acuity settings.

"Our vision is to empower clinicians and patients with actionable insights to personalize care — anytime, anywhere," said Frank Chan, Ph.D., president of the Patient Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic. "Today, our solutions touch more than 100 million patients annually in hospitals. Through our collaboration with BioIntelliSense, we will support continuous, connected care from in-hospital to home and expand our reach to help more patients in more places than ever before."

With staffing shortages projected to reach 3.2 million healthcare workers by 20261, the Patient Monitoring business intends to continue to expand its HealthCast portfolio to improve workflow automation so clinicians can focus on what matters most — their patients. The HealthCast connectivity gateway helps increase workflow efficiency by connecting unconnected devices to the electronic medical records (EMR) and saves valuable staff time by reducing the burden of manual charting. The HealthCast VitalSync remote patient monitoring system enables clinicians to receive near real-time trend and alert data on web-enabled devices so they can act on patient deterioration earlier. With the addition of the BioButton multi-parameter wearable to the HealthCast portfolio, Medtronic can help even more general care patients inside and outside of the hospital, furthering our commitment to patient safety.

"In partnership with Medtronic, we are poised to accelerate continuous connected care models that offer a new level of clinical surveillance and workflow efficiencies for hospitals that are challenged in today’s environment of growing workforce shortages and cost of care management," said James Mault, M.D., founder and CEO of BioIntelliSense. "This advanced remote physiologic monitoring simplifies care delivery to facilitate personalized patient care, clinical workflow automation and proactive clinical interventions."