RM-1995 / Rakuten Medical - LARVOL DELTA

Rakuten Medical Closes $119 Million Series E Financing to Further Develop its Alluminox Platform (PRNewswire) - "Rakuten Medical...announced the completion of a $119 million Series E preferred stock financing, including $45 million in new capital and the conversion of $74 million of convertible promissory notes with accrued interest. Rakuten Medical intends to further develop its proprietary Alluminox platform and contribute to the future of patients and healthcare around the world by allocating the funds raised for the following business priorities: Continuing efforts to accelerate its global Phase 3 clinical trial...; Supporting ongoing clinical trials and initiating new studies for Alluminox treatment using its three key assets (ASP-1929, RM-1995, and RM-0256), including combination therapy with anti-PD-1, which has shown promising early data that Rakuten Medical believes warrant additional clinical studies..."

Financing • Head and Neck Cancer

RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Rakuten Medical, Inc. | N=36 ➔ 0 | Trial completion date: Sep 2024 ➔ Jan 2023 | Recruiting ➔ Withdrawn | Trial primary completion date: Jul 2024 ➔ Jan 2023

Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial withdrawal • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

A phase 1, first-in-human, drug dose-escalation study of RM-1995 photoimmunotherapy, as monotherapy or combined with pembrolizumab, in patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma. (ASCO 2022) - P1 | "Key exclusion criteria are: tumor sites located in sensitive or vital anatomic structures or invading a major blood vessel (unless treated to prevent hemorrhage); and other clinically significant or uncontrolled disease processes. An estimated 18 patients will be enrolled into each portion of the study."

Clinical • Monotherapy • P1 data • Head and Neck Cancer • Hematological Disorders • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • CD8 • IL2RA

RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Rakuten Medical, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Rakuten Medical, Inc.

Monotherapy • New P1 trial • Head and Neck Cancer • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer

Rakuten Medical Announces FDA Acceptance of an Investigational New Drug (IND) Application for RM-1995, a Conjugate of IR700 and anti-CD25 Antibody (PRNewswire) - "Rakuten Medical...announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application to begin clinical studies of RM-1995 photoimmunotherapy in patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma....The drug portion of the treatment, RM-1995, is a conjugate of a photoactivatable dye (IRDye® 700DX [IR700]) and a monoclonal antibody specific for cell-surface interleukin 2 (IL-2) receptor α-chain (CD25). The device portion of the treatment is a laser device system (PIT690 Laser System) used to activate IR700 by illumination with 690nm nonthermal red light."

IND • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer