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Final data from the AGENT study confirms topline results

On November 25, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that analysis of the AGENT study’s final data confirmed topline results presented on August 3, 2022 (Press release, Isofol Medical, NOV 25, 2022, View Source [SID1234624419]). Moreover, no predictive gene expressions for clinical response could be identified. Isofol is continuing its efforts to terminate the AGENT study in line with applicable ethical and regulatory requirements, complete the final study report for submission to regulatory agencies and prepare a manuscript for a scientific publication. Isofol is in parallel continuing to investigate possible future paths forward for the company.

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The information in the press release is intended for investors.

On August 3, 2022, Isofol presented topline results showing that the AGENT study met neither its primary endpoint nor key secondary endpoint. Based on analysis of additional study data that Isofol obtained since then, the company can today confirm that the AGENT study’s final data confirms the conclusions that were communicated in conjunction with topline results and study updates from August 31 and September 7, namely that:

Neither the primary endpoint of objective response rate (ORR) nor the key secondary endpoint of progression-free survival (PFS) were met.
With regards to safety data, there were no differences between the study arms with the exception of a non-statistically significant detriment in overall survival (OS) in the arfolitixorin arm.
There were no significant differences in any major subgroups.
There were preliminary indications that the risk of death was 11 percent greater in the experimental arm compared with the control arm.
Data surrounding gene expression was also analyzed during the fourth quarter. Conclusions from this analysis did not identify any predictive biomarkers.

"All in all, the final study results did not show any clinical or business value for Isofol either. We remain greatly disappointed. The company’s management and board of directors will continue to diligently work together to investigate possible options for Isofol’s future," said Ulf Jungnelius, CEO of Isofol.

Isofol’s work to terminate the AGENT study, which currently involves detailed quality control and regulatory documentation from the study sites involved, is continuing, and is estimated to be completed by the turn of the year.

Isofol intends to publish key data from the study in a scientific publication to enable the medical community to fully leverage the lessons learned from the study. The preparation of a manuscript for scientific publication is ongoing and the intention is to submit it to a peer-reviewed journal in oncology during the first quarter of 2023.

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 that arfolitixorin was better than leucovorin and that the results would be statistically significant. 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).

Notice Concerning Joint Venture Collaboration for Kyowa Kirin International plc’s Established Medicines Portfolio

On November 24, 2022 Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, and Grünenthal GmbH (CEO: Gabriel Baertschi), a global, science-based, privately-owned pharmaceutical company, reported that they have signed a Joint Venture Collaboration for Kyowa Kirin International’s established medicines portfolio (Press release, Kyowa Hakko Kirin, NOV 24, 2022, View Source [SID1234624414]). The Joint Venture Collaboration comprises 13 brands across 6 therapeutic areas primarily focused on pain management, including Abstral and PecFent for breakthrough cancer pain, Moventig for opioid-induced constipation, and Adcal-D3 for osteoporosis. The Joint Venture Collaboration is subject to obtaining customary approvals and clearances, including anti-trust and works councils as legally required. Completion of the deal is anticipated for Q2 2023.

The total revenues of the portfolio in 2021 were approximately €200 million. The products are marketed through affiliates in seven major European countries and through a network of partners in various additional territories worldwide. Grünenthal has agreed to pay approximately €80 million upfront plus royalties over the term of the collaboration. Grünenthal will make an additional payment upon purchase of the remaining share and the intellectual property (IP) of the portfolio.

"As a leader in pain management, and with our proven track record in growing established brands, we believe we can help even more patients benefit from this unique group of medicines", said Gabriel Baertschi, Chief Executive Officer, Grünenthal. "This portfolio of established brands matches very well with Grünenthal’s geographical footprint and therapeutic areas."

Abdul Mullick, President of Kyowa Kirin International said, "Our search for a partner included three key priorities: a team who shares our commitment to patients and to our employees, a partner who is looking to support our growth agenda, and a company with which we can establish a close, collaborative partnership that promises benefits for all our stakeholders while operating at the highest ethical standards. This collaboration will bring a renewed focus, the resources and the commercial infrastructure required to grow the established medicines portfolio to deliver life-changing value to more patients."

Subject to approval, Grünenthal will own a 51 percent majority share in the new company. Kyowa Kirin will own a 49 percent share and will initially retain the IP related to the portfolio.

Grünenthal intends to purchase the remaining 49 percent share and the IP at the beginning of 2026.

About the portfolio

The portfolio includes medicines that deliver life-changing value for hundreds of thousands of patients. The portfolio is available in seven major European markets through affiliates and in various additional territories worldwide through a network of partners. Key products in the portfolio include Abstral and PecFent (Fentanyl) for breakthrough cancer pain, Moventig (Naloxegol) for opioid-induced constipation and Adcal-D3 (calcium and vitamin D3) for osteoporosis.

Licence Agreement with CWRU (Supplementary Announcement)

On November 24, 2022 Chimeric Therapeutics (ASX: CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, reported an additional information regarding an exclusive license agreement with Case Western Reserve University (CWRU) for the CORE-NK platform, invented by Dr David Wald (Press release, Chimeric Therapeutics, NOV 24, 2022, View Source [SID1234624413]).

The CORE-NK platform uses a novel, proprietary genetically-modified feeder cell line to activate and expand universal off-the-shelf allogeneic NK cell products derived from healthy donors. The expanded CORE-NK cells exhibit enhanced cytotoxicity, metabolism, and expression of activating receptors compared to fresh, activated NK cells.

Under the agreement, Chimeric gains exclusive global rights to the CORE-NK platform for oncology, where Chimeric and CWRU are currently advancing multiple product candidates in Dr Wald’s laboratory under the Sponsored Research Agreement announced on 2 November 2022. Chimeric also receives exclusive global rights to the CORE-NK platform for immune disorders and viral infectious diseases.

Chimeric’s exclusive global license from CWRU covers patent rights, knowhow, and biological materials in relation to therapeutic products for the NKF feeder cell line and CORE-NK manufacturing process in the fields of use, including access to regulatory documents for the first-in-human Phase 1 trial of CHM 0201.

The agreement is effective immediately, with a minimum term of 20 years (or until the later expiry of relevant patents or licenced product terms). The agreement may be terminated due to unresolved default of payment or performance by either party, or at the sole discretion of Chimeric. Upfront fees associated with the license agreement are not material and will be funded entirely from existing cash reserves. The agreement includes industry standard development milestones, patent costs, maintenance fees, and royalties on commercial net sales. Under the agreement, each party owns all of the rights, title and interest in results developed by them. Chimeric is entitled to use jointly developed results under the terms of the For personal use only agreement.

Hemispherian raises the first tranche of a Series A to fund the development of its novel cancer therapeutics

On November 24, 2022 Hemispherian AS ("Hemispherian" or the "Company"), a Norwegian preclinical pharmaceutical company focused on small molecule cancer therapeutics targeting the DNA damage response, reported the closure of the first tranche of its series A1 financing round (Press release, Hemispherian, NOV 24, 2022, View Source [SID1234624410]). The round raised NOK 30M (USD 2.9M). The proceeds will support the company’s drug development activities, expand its preclinical pipeline and advance its lead therapeutic compounds towards clinical development.

The round was led by the Dutch Investment Firm, Meneldor, who partnered with Norwegian and American investors. Among the Norwegian investors are Kistefos AS and Kvantia AS. Most of the earlier investors followed their seed investment, and the board chaired by Steven Powell, remains unchanged.

Close 100M RMB of Pre-B round financing was completed

On November 23, 2022, Xiling Lab reported the company successfully concluded a Pre-B round financing, securing nearly 100 million RMB. The financing round was a collaborative effort involving Chengdu International Biotwon No.1 Equity Investment Fund, Chengdu High-tech New Economy Venture Capital, Pengzhou Global Biomedical Technology Achievements Transformation Equity Investment Fund, CHTD Biomedical Park Management, as well as angel round investors CHDT Venture Capital and Shenzhen Jiuyuan Changqing Equity Investment Fund.

The funds will primarily support the IND application and Phase 1 clinical study of SMP-656, an ADC candidate drug developed by Xiling Lab, and the establishment of the XL-XDC technology platform. Dr. Jinkun Huang, the founder and CEO of Xiling Lab, expressed gratitude, stating, "We are immensely thankful to the investors for their support and recognition of Xiling Lab. Our mission is to revolutionize ADC cancer therapy, offering renewed hope to patients globally. Rooted in a profound understanding of chemistry and drug delivery, our ultimate goal is to pioneer groundbreaking ADC therapeutics capable of addressing and treating a spectrum of cancers."