1stOncology™: Cancer Intelligence Service – Page 5904 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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."

DEFENCE’S SUCCESSFULL STUDY ON THE ACCUVAC-PT007 VACCINE TARGETING CERVICAL CANCER

On November 23, 2022 Defence Therapeutics Inc. ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immuneoncology vaccines and drug delivery technologies, reported the successful completion of its Good Laboratory Practice ("GLP") studies on the AccuVAC-PT007 vaccine candidate specifically designed to target cervical cancer (Press release, Defence Therapeutics, NOV 23, 2022, View Source [SID1234626256]). GLP studies conducted on rodents demonstrate a full spectrum of safety and tolerability with no signs of complications.

Cervical cancer normally occurs when epithelial cells of the cervix are infected with the human papillomavirus (HPV), one of the most common sexually transmitted disease. Although HPV infections can resorb, infections escaping the immune system ultimately led to genital warts leading to advanced cancers that are hardly treated with standard of care. Currently, vaccination targeting HPV directly can protect from cervical cancer. However commercially available vaccines (containing a mix of 9 HPV-derived L1 proteins) are not designed to protect from all HPV subtypes and the vaccine on the market cannot be used to treat pre-established cervical cancer. Defence focused on this "gap" by engineering AccuVAC-PT007, a protein-based vaccine containing a single oncoprotein (E7) linked to AccumTM for enhanced antigen presentation by the immune system. This vaccine can not only be used to protect from HPV (prophylactic use), but it is the only experimental vaccine capable of curing established cervical cancer when combined to immune-checkpoint inhibitors. The AccuVac may be a solution.

Using the AccumTM platform, Defence developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. AccuVAC-PT007 was previously shown to provide complete protection against cervical cancer (prophylactic vaccination) as shown in our press release dated on May 17, 2022. These ground-breaking observations led to the testing of AccuVAC-PT007 as a treatment with pre-established cervical cancer (therapeutic vaccination). Pre-clinical studies conducted on rodents, as reported in our press release dated on June 27, 2022, showed that the co-delivery of AccuVAC-PT007 with several immune-checkpoint blockers (antiPD-1, anti-CTLA4 or anti-CD47) lead to potent control of tumor growth with a more pronounced effect observed with anti-CD47, one of the latest immune-checkpoint blockers undergoing clinical development.

"The successful completion of the GLP studies clearly demonstrate the safety and tolerability profile of our AccuVAC-PT007 vaccine. With only one oncoprotein (E7) linked to our AccumTM, we would significantly reduce the manufacturing cost and more importantly our vaccine would have the capacity to cure established cervical cancer. It is another strong example of Defence’s AccumTM technology versatility. And it also shows how dedicated we are in developing efficiently vaccines to eradicate tumors. Our AccuVAC-PT007 vaccine is now ready for a Phase I Clinical Trial or partnership/licence with a Pharma", adds Mr. Plouffe, the CEO of Defence Therapeutics.

Besides cervical cancer, HPV can cause cancer of the vulva, vagina, penis, or anus. It can also cause cancer in the back of the throat (called oropharyngeal cancer) and can include the base of the tongue and tonsils. In addition, patients with weak immune systems may be unable to fight off a given HPV infection, which brings forward another important ailment with unmet medical needs. This is an opportunity for the AccuVAC-PT007 that Defence has developed.

Cervical cancer has a high mortality rate (nearly 50%), which can be reduced by diagnosis and prevention. A report from 360ResearchReports projected that the global Cervical Cancer Treatment market size is expected to expand at a CAGR of 4.8% during the forecast period, reaching USD 11 Billion by 2027.