Sun Pharma, Philogen Ink Global Commercialization Deal for Fibromun, an Anti-Cancer Immunotherapy

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Sun Pharma and Philogen have agreed to terms on a global exclusive commercialization, license, and supply agreement for Fibromun (L19TNF), an anti-cancer immunotherapy. As per the deal, Philogen will complete the trials, seek marketing approval, and handle manufacturing, while Sun Pharma will lead the commercialization globally. Both companies will receive post-commercialization profits, with Sun Pharma receiving 55 and Philogen receiving 45 in a 55:45 ratio. At this time, no other financial terms have been shared.¹

“Fibromun’s progress through development has been quite encouraging and it has potential to be an important option for treatment of soft-tissue sarcomas and other cancers with significant unmet medical needs. This partnership expands our clinical pipeline into oncology in alignment with our current portfolio in skin cancers. We keenly look forward to providing this treatment option globally in due course of time,” said Dilip Shanghvi, chairman, managing director, Sun Pharma, in a press release.

In 2023, Philogen released data on Fibromun in combination with lomustine for the treatment of glioblastoma. These follow-up data, published in Science Translational, show that the combination treatment demonstrated significant promise in both preclinical and early clinical trials, curing orthotopic glioma-bearing mice and producing durable responses and substantial tumor shrinkage in patients with recurrent glioblastoma. Additionally, the mechanism of action revealed that Fibromun transformed "cold" tumors into "hot," making them more recognizable to the immune system through enhanced tumor DNA damage signaling, increased immunogenicity, and immune cell infiltration.²

Data released in 2020 from the Phase I/II GLIOSTAR trial also demonstrated that treatment with Fibromun led to selective tumor necrosis and prolonged disease stabilization, with a favorable safety profile.³

According to the American Association of Neurological Surgeons, glioblastoma has an incidence of 3.21 per 100,000 people. It is considered the most common malignant brain and other central nervous system tumor, accounting for 47.7% of all cases. It is more common in men, with the median diagnosis age being 64 years. Only 40% of patients survive a year after being diagnosed, while 17% survive two years after diagnosis.⁴ According to the American Brain Tumor Association, glioblastomas represent about 14% of all primary brain tumors, with more than 12,000 glioblastoma cases being diagnosed in the United States annually.⁵

“We are pleased to extend our collaboration with Sun Pharma, a leading global pharmaceutical company, from our existing partnership on Nidlegy to Fibromun. This collaboration will focus on the global commercialization of Fibromun, a new immunotherapy that has the potential to serve patients with soft tissue sarcoma and certain malignant forms of brain tumors (e.g., glioblastoma), for which limited therapeutic alternatives exist,” said Dario Neri, CEO, CSO, Philogen, in the press release. “Our group has published data reflecting the promising therapeutic activity of Fibromun in glioblastoma, inducing long-lasting anti-tumor responses in a subset of patients. We have also announced that an independent monitoring board has evaluated safety and efficacy data of the pre-planned interim analysis of our Phase III clinical trial in soft tissue sarcoma and recommended continuing the study as planned by the protocol. In view of these promising developments, both companies are committed to the development and commercialization of Fibromun, making it widely available to patients who may benefit from it.”

Prior to the agreement to commercialize Fibromun, the companies announced back in May that they entered into a similar agreement for Nidlegy in Europe, Australia, and New Zealand. The drug treats locally advanced, fully resectable melanoma in the neoadjuvant setting.¹

References

1. Sun Pharma and Philogen enter into a global Exclusive Commercialization, License, and Supply Agreement for Commercializing the specialty product FIBROMUN. Sun Pharma. October 1, 2024. Accessed October 3, 2024. https://sunpharma.com/wp-content/uploads/2024/10/Press-Release-Commercializing-specialty-product-FIBROMUN.pdf

2. Philogen Publishes New Data on a Fibromun-based treatment combination in Science

3. Translational Medicine in collaboration with the University Hospital Zürich. Philogen. May 24, 2023. Accessed October 3, 2024. https://www.philogen.com/philogen/wp-content/uploads/2023/05/230524_Philogen_STM_Press_Release.pdf

4. Philogen Announces Publication of Malignant Brain Tumor Study Results in Science Translational Medicine. PR Newswire. October 8, 2020. Accessed October 3, 2024. https://www.prnewswire.com/news-releases/philogen-announces-publication-of-malignant-brain-tumor-study-results-in-science-translational-medicine-301148285.html

5. Glioblastoma Multiforme. AANS. April 15, 2024. Accessed October 3, 2024. https://www.aans.org/patients/conditions-treatments/glioblastoma-multiforme/#:~:text=Prevalence%20and%20Incidence&text=Glioblastoma%20has%20an%20incidence%20of,17%25%20in%20the%20second%20year.

5. Glioblastoma (GBM). ABTA. Accessed October 3, 2024. https://www.abta.org/tumor_types/glioblastoma-gbm/