rocapuldencel-T (CMN-001) / CoImmune, SCM Lifescience - LARVOL DELTA

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - P2b | N=16 | Terminated | Sponsor: CoImmune | N=120 ➔ 16 | Trial completion date: Mar 2024 ➔ Sep 2023 | Recruiting ➔ Terminated | Trial primary completion date: Mar 2024 ➔ Sep 2023; Strategic corporate decision

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A review of the clinical experience with CMN-001, a tumor RNA loaded dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma. (PubMed, Hum Vaccin Immunother) - "The synergy between CMN-001 and everolimus observed in the phase 3 study provides an opportunity to design a phase 2b study building on the mechanism of action of CMN-001 and underlying immune and clinical outcomes revealed in the earlier studies. The design of the phase 2b study combines CMN-001 with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC subjects."

Journal • Metastases • Review • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

CoImmune Announces Publication of Review of Clinical Development Program for CMN-001 in Metastatic Renal Cell Carcinoma (PRNewswire) - "CoImmune, Inc...today announced the publication of a review of the company's clinical development program evaluating CMN-001, a dendritic cell-based immunotherapy electroporated with autologous tumor RNA to treat metastatic renal cell carcinoma (mRCC). The review is published in Human Vaccines & Immunotherapeutics, a peer-reviewed journal sponsored by the International Society for Vaccines....The publication...reviews the early clinical development of CMN-001, including a previously completed multicenter Phase 3 clinical trial that demonstrated synergy between CMN-001 and an mTOR blocker, everolimus, in a retrospective data analysis."

Clinical data • P3 data • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Interim analysis of the phase 3 ADAPT trial evaluating rocapuldencel-T (AGS-003), an individualized immunotherapy for the treatment of newly-diagnosed patients with metastatic renal cell carcinoma (mRCC) (ESMO 2017) - P3; "The ADAPT trial is ongoing to further assess the long-term effects of this well-tolerated individualized immunotherapy."

Clinical • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - P2b | N=120 | Recruiting | Sponsor: CoImmune | Trial completion date: Mar 2022 ➔ Mar 2024 | Trial primary completion date: Mar 2022 ➔ Mar 2024

Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: GU Research Network, LLC; N=20 ➔ 0; Recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

Interim data analysis of the ADAPT trial using the modified intent to treat (mITT) population re-evaluates Rocapuldencel-T for clinical benefit over standard of care. (ASCO 2018) - P3; " The mITT includes 268 combo patients who received 1 dose of Roca + sunitinib and 141 SoC patients that received 1 cycle of sunitinib. The mITT combo subjects, all of whom received Roca therapy, are anticipated to be the population that could benefit from this treatment. This analysis demonstrated correlations between Roca mechanism of action and OS and longer follow-up time is warranted to assess potential efficacy of Roca."

Clinical • Oncology

Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma (clinicaltrials.gov) - P2b; N=120; Recruiting; Sponsor: CoImmune; Not yet recruiting ➔ Recruiting; Initiation date: Mar 2020 ➔ Jul 2020

Clinical • Enrollment open • Trial initiation date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Results of the ADAPT phase 3 study of Rocapuldencel-T in combination with sunitinib as first-line therapy in patients with metastatic renal cell carcinoma. (PubMed, Clin Cancer Res) - "Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immuno-therapy, DC vaccine produced IL-12 and higher numbers of T regulatory cells present in the peripheral blood of mRCC patients."

Clinical • Combination therapy • IO Biomarker • Journal • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD40LG • IL12A

Argos Therapeutics secures $25 million series D financing to commence phase 3 ADAPT study in patients with metastatic renal cell carcinoma (MRCC) in mid-2012 (Argos Therapeutics) - P3, N=450; ADAPT; Argos Therapeutics announced that it has secured a $25M series D financing to support the commencement of its P3 ADAPT study in pts with newly diagnosed, mRCC in mid-2012; ADAPT study is expected to commence in mid-2012 under a revised SPA agreement with the FDA

Anticipated P3 trial initiation • Oncology • Renal Cell Carcinoma

A rollover protocol for subjects previously treated with AGS-003 (clinicaltrials.gov) - P2, N=7; Enrolling by invitation; New P2 trial

New trial • Oncology • Renal Cell Carcinoma

Renal function before and after cytoreductive nephrectomy in a phase 3 randomized clinical trial (AUA 2016) - P3, N=1,433; NCT01582672; Sponsor: Argos Therapeutics; “The likelihood of having at least stage 3 CKD at surgery was lower for T stage 1 (OR 0.432, 95% CI: 0.192-0.969, p<0.042) and T stage 2 disease (OR: 0.303, 95% CI: 0.117-0.788, p<0.014) than for T stage 3…the median change after CN was -21.6 ml/min/1.73 m2. Of these patients, 160 (37.6%) developed CKD 3 or greater post CN in the setting of previously normal renal function.”

P3 data • Oncology • Renal Cell Carcinoma

Phase 3 trial of autologous dendritic cell immunotherapy (AGS-003) plus standard treatment of advanced renal cell carcinoma (RCC) (ADAPT) (clinicaltrials.gov) - P3, N=450; Not yet recruiting; New P3 trial

New trial • Renal Cell Carcinoma

Argos Therapeutic Arcelis immunotherapy AGS-003 in combination with sunitinib shows statistically significant correlation of immune system response to overall survival in phase 2 study in patients with advanced renal cell carcinoma (RCC) (PRNewswire) - P2, N=80; AGS-003-006; Results showed a significant correlation between anti-tumor memory T cell responses & OS; AGS-003 in combination with sunitinib overcame the immuno-suppressive environment of RCC & induced a tumor-specific multi-functional memory CTL response; Results were presented orally at the Global Technology Community's (GTC) 4th Immunotherapeutics & Immunomonitoring Conference in San Diego

P2 data presentation • Oncology • Renal Cell Carcinoma

Wake Forest Baptist clinical trial focuses on tumor vaccines for cancer treatment (Healthcanal) - P3, N=450; ADAPT; "Under an approved Special Protocol Assessment by the U.S. Food and Drug Administration. Stewart said he hopes to enroll at least 10 patients per year from Wake Forest Baptist...To date, more than 50 sites are participating and more than 30 subjects have been enrolled in North America. The study is expected to expand to more than 120 global sites by early fall, according to Argos Therapeutics Inc"

Clinical protocol • Renal Cell Carcinoma

A Rollover Protocol for Subjects Previously Treated With AGS-003 (clinicaltrials.gov) - P2; N=2; Active, not recruiting; Sponsor: Argos Therapeutics; Enrolling by invitation ➔ Active, not recruiting; Trial primary completion date: Dec 2015 ➔ Dec 2016

Enrollment closed • Trial primary completion date • Biosimilar • Oncology • Renal Cell Carcinoma

Prolonged survival with personalized immunotherapy (AGS -003) in combination with sunitinib in unfavorable risk metastatic RCC (mRCC) (ASCO-GU 2013) - P2, N=21; NCT00678119; Sponsor: Argos; “As previously reported, the median overall PFS was 11.2 months and the final median OS was 30.2 months. When analyzed by baseline Heng risk status, the median PFS was 19.4 months for intermediate (n=11) and 5.8 months for subjects with poor risk features (n=10) at baseline. The median OS is 39.5+ months for intermediate and 9.1 months for subjects with poor risk.”

P2 data • Oncology • Renal Cell Carcinoma

Immunotherapy of renal cell cancer (PubMed, Magy Onkol) - "The newest checkpoint agents, vaccination and pegylated interleukin-2 are also presented. The most promising clinical trials (CheckMate-025, AGS-003, IMA 901) and the on-going first line phase III trials are shown in metastatic clear cell renal carcinoma."

Journal