Lymfactin (adAptVEGF-C adenoviral vector) / Herantis - LARVOL DELTA

Donor-site safety in microvascular lymph node transfer for breast cancer-related lymphedema using reverse lymphatic mapping-A prospective study. (PubMed, J Plast Reconstr Aesthet Surg) - "This prospective study demonstrated that groin VLNT with reverse lymphatic mapping appears safe and does not increase the risk of secondary donor-site lymphedema within one year postoperatively."

Journal • Breast Cancer • Oncology • Pain • Solid Tumor

Phase II study shows potential benefit of adenoviral vascular endothelial growth factor C (VEGF-C) and lymph node transfer in lymphedema. (PubMed, Plast Reconstr Surg) - "This study was one of the few studies to objectively show a positive effect of VLNT in a prospective clinical multicenter setting. It was also the first-ever randomized prospective clinical study showing a quantitatively positive effect of a medical therapy on the edema of lymphedema although failing to show differences between groups in primary outcome measures."

Clinical • Journal • P2 data • Breast Cancer • Gene Therapies • Inflammation • Oncology • Solid Tumor • VEGFC

A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: Herantis Pharma Plc. | Active, not recruiting ➔ Terminated; Lack of efficacy

Combination therapy • Trial termination • Viral vector • Inflammation • Solid Tumor

Phase 1 Lymfactin® Study: 24-month Efficacy and Safety Results of Combined Adenoviral VEGF-C and Lymph Node Transfer Treatment for Upper Extremity Lymphedema. (PubMed, J Plast Reconstr Aesthet Surg) - "During 24 months' of follow-up, the results indicate that Lymfactin® is well tolerated. The most promising findings were a 46% reduction in excess arm volume and a nonsignificant volume increase after garment removal at 12 months, suggesting that there is potential for the reduction of lymphedema."

Journal • P1 data • Breast Cancer • Inflammation • Oncology • Solid Tumor • VEGFC

Lymfactin, an investigational adenoviral gene therapy expressing VEGF-C, is currently studied in a double-blind, randomized, placebo-controlled, multicenter, phase 2 clinical study in patients suffering from breast cancer associated secondary lymphedema (BCAL) (SABCS 2019) - "Due to the nature of the study, there are no set formal statistical hypotheses for the efficacy endpoints, but suitable inferential statistics can be used when feasible.Present accrual and target accrual: A total of 40 patients are planned to be included in the clinical study. By the end of June 2019, 15 patients have been enrolled.Contact: Outi Lahdenperä, MDCMOHerantis Pharma PlcE-mail: outi.lahdenpera@herantis.com Tel: +358 40 511 3194"

Clinical • P2 data • VEGFA

Phase 1 Lymfactin Study: Short-term Safety of Combined Adenoviral VEGF-C and Lymph Node Transfer Treatment for Upper Extremity Lymphedema. (PubMed, J Plast Reconstr Aesthet Surg) - "After 12 months' follow-up, results indicate that Lymfactin is well tolerated. The study continues with a 36-months efficacy and 5 years safety follow-up of the patients. The oncological safety aspects of Lymfactin will require a longer follow-up period."

Clinical • Journal • P1 data • Breast Cancer • Dermatology • Gastroenterology • Gastrointestinal Disorder • Gene Therapies • Oncology • Pain • Respiratory Diseases

Clinical Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema (AdeLE) (clinicaltrials.gov) - P2; N=39; Active, not recruiting; Sponsor: Herantis Pharma Plc.; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • VEGFA

Herantis Pharma Plc completes patient recruitment and treatment in phase 2 AdeLE trial in breast cancer associated lymphedema (PRNewswire) - “Herantis Pharma Plc…announced today that patient recruitment in the Company's Phase 2 clinical trial AdeLE (‘Adenoviral gene therapy for the treatment of LymphEdema’) has been completed. All of the 39 patients with breast cancer associated lymphedema have been randomized to receive either Lymfactin® or placebo treatment, and their treatments have been completed according to the study protocol….Herantis expects to unblind the study and announce its top-line results in the first quarter of 2021.”

Enrollment closed • P2 data

"Our Lymfactin(R) poster ready for prime time at #SABCS19 !" (@HerantisPharma)

Herantis Pharma Plc announces half year financial report January 1 - June 30, 2019 (unaudited) (GlobeNewswire, Herantis Pharma Oyj) - "Pipeline expansion with next generation xCDNF....The company continues to invest in its ongoing drug development programs in the treatment of Parkinson's disease...'As a team, Herantis’ focus is on the successful execution of two randomized...clinical studies in Parkinson’s disease...We are also seeking strategically to expand our pipeline and advance corporate development discussions.'...The study is conducted at three university hospitals in Finland and Sweden, and its topline results are expected to be announced in 2019....Furthermore, the European Union has awarded the Company a grant of €6.0 million for the project TreatER. The TreatER project comprises the Phase 1-2 clinical study of Herantis’ CDNF for the treatment of Parkinson’s disease."

Clinical • Clinical data • Commercial

Herantis Pharma Announces 12-Month Follow-Up Review from Phase 1 Lymfactin Trial in Breast Cancer-Associated Lymphedema (GlobeNewswire, Herantis Pharma Oyj) - P1, N=15; NCT02994771; Sponsor: Herantis Pharma; “Herantis Pharma Plc…announced today the topline results from the 12-month follow-up review of the Phase 1 Lymfactin® trial in breast cancer-associated lymphedema. The study’s data monitoring committee (DMC) concluded that the treatment continues to be safe and well-tolerated in all patients with no severe adverse events. Lymfactin®, the novel gene therapy of Herantis that aims to repair the damaged lymphatic system in breast-cancer associated lymphedema patients, is currently in a multi-center Phase 2 clinical study AdeLE in Sweden and Finland….’Following the positive safety data, we look forward to a more in-depth investigation of the benefits of Lymfactin® in the ongoing Phase 2 AdeLE study, for which we expect initial results by the end of 2020.’”

Clinical data