On August 31, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the 2022 Wells Fargo Healthcare Conference on Wednesday, September 7, 2022 at 11:35 a.m. ET and the H.C. Wainwright 24th Annual Global Investment Conference (Press release, BioCryst Pharmaceuticals, AUG 31, 2022, View Source [SID1234618817]). A pre-recorded fireside chat for the H.C. Wainwright conference will be made available Monday, September 12, 2022, at 7:00 a.m. ET.

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Links to live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

On August 31, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, and Quotient Sciences, a drug development and manufacturing accelerator, reported a partnership to support the development and clinical testing of PF614-MPAR (Press release, Ensysce Biosciences, AUG 31, 2022, View Source [SID1234618816]).

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PF614-MPAR is a novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose.

Quotient Sciences is currently using its integrated Translational Pharmaceutics platform to identify a PF614-MPAR formulation that allows conversion into oxycodone within the prescribed dose range but reduces conversion to oxycodone at higher than prescribed dose levels in an overdose scenario.

The formulation will be an optimized composition that balances dose and release rate, with the candidate formulations being tested in the clinic having been selected from emerging clinical data in order to achieve the desired exposure profile, allowing formulation optimization in humans rather than preclinical species.

Mark Egerton, PhD, CEO of Quotient Sciences, said: "We are pleased to be partnering with Ensysce to accelerate the development of their PF614-MPAR program. Quotient Sciences’ ability to integrate formulation and clinical services under a single organization will expedite Ensysce’s development timeline and provide patients who are suffering with a safer option for pain relief faster."

Lynn Kirkpatrick, PhD, CEO of Ensysce Biosciences, commented: "Opioids have been a longstanding and important type of treatment for moderate to severe pain, but they are prone to abuse and overdose. This widespread problem for patients and society results in significant cost to the healthcare system, which we are trying to address with our two proprietary technology platforms."

"The PF614-MPAR program is designed to fill a great unmet need for effective pain medications that reduce the risk of abuse and specifically prescription drug overdose. This partnership serves as validation of our mission and ultimately our platforms. We continue to make strong progress towards our clinical development of PF614 and are excited to partner with Quotient Sciences to develop PF614- MPAR, as we believe we will be bringing to market important therapeutic options for those in severe pain."

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).

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.

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"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.

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]).

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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."