Taris Biomedical and Janssen Pharmaceutical Collaborate to Advance Early-Stage Bladder Cancer Treatment with Proprietary TARIS Drug Delivery System

On December 20, 2019, Johnson & Johnson announced its bid to acquire TARIS Biomedical, with TARIS remaining in the United States as part of Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) in the field of oncology R&D and therapeutics.

Janssen Pharmaceuticals has been exploring cancer treatments by inhibiting the process of cellular carcinogenesis, with a focus on localized and more targeted therapies. The division aims to treat patients with early-stage cancer by blocking cellular carcinogenesis, thereby improving ultimate therapeutic outcomes. Johnson & Johnson has taken an interest in TARIS Biomedical’s novel targeted drug-delivery technology, hoping to jointly transform local treatment approaches for bladder cancer. TARIS also recognizes Janssen Pharmaceuticals’ profound expertise and innovative capabilities in oncology, anticipating that its robust targeted therapeutic methods may revolutionize the way TARIS treats its patients.

Currently, the Taris team is focused on optimizing candidate drugs and collaborating with Janssen’s R&D scientists to advance future clinical programs utilizing TARIS technology.

TARIS Biomedical is a biomedical company founded in 2008, originating from the Massachusetts Institute of Technology (MIT) biological laboratories, with the aim of addressing unmet clinical needs in the field of urological diseases. After securing investment, the company began to translate its advanced medical technologies into commercial applications.

Michael Cima, a Professor of Materials Science and Engineering at the Massachusetts Institute of Technology (MIT), co-founded Taris with Robert S. Langer. Co-founder Michael Cima earned his Ph.D. in Chemical Engineering from the University of California, Berkeley, and later joined the faculty of MIT’s Department of Materials Science and Engineering. He is also a researcher at the MIT Koch Institute for Integrative Cancer Research. He is actively engaged in developing materials and engineering systems aimed at improving human health, holds more than 40 patents, and is an author or co-author of over 190 peer-reviewed scientific publications.

According to statistics from the U.S. Centers for Disease Control and Prevention (CDC), approximately 57,000 men and 18,000 women are diagnosed with bladder cancer annually in the United States, with about 12,000 men and 5,000 women dying from the disease each year. Bladder cancer is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). NMIBC is the most common type, whereas MIBC is characterized by higher rates of recurrence and mortality, a greater propensity for metastasis, and elevated case fatality, making it a key focus of bladder cancer research.

Previously, the treatment of bladder cancer was mainly based on surgical therapy, with chemotherapy and radiotherapy as auxiliary means. There has been no significant innovation in this field. TARIS hopes to achieve safer and more durable treatments through its advanced technology.

TARIS Biomedical is dedicated to developing novel drug delivery technologies for the treatment of urological diseases, including bladder cancer, and has independently developed the TARIS System.

The TARIS system is a silicone-based drug delivery device that can be implanted into the body and removed from the bladder via minimally invasive procedures. This system enables direct drug release to bladder tumors, facilitating the evaluation of novel local therapies for patients with bladder cancer and other types of cancer. Bladder cancer genes are prone to activating mutations, and the long-term accumulation of abnormal genotypes leads to the emergence of malignant phenotypes. The TARIS system delivers combination therapy in a tailored manner, making it effective for treating various types of bladder cancer.

Chris Cutie, Global Head of Medical Affairs at TARIS, introduced that the TARIS system enables the delivery of chemotherapy and targeted therapies to the bladder at relatively high concentrations, surpassing the levels achievable with oral or injectable medications.

Initially, Taris Biomedical focused on the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). To this end, the company’s first clinical program was LiRIS, designed for the local treatment of IC/BPS. LiRIS delivers lidocaine directly to the bladder of patients with interstitial cystitis/bladder pain syndrome over an extended period, thereby alleviating the pain and debilitating symptoms associated with the condition.

In 2014, Taris sold this leading clinical program to healthcare company Allergan for $587 million.

In October 2015, Flagship Pioneering, together with Polaris Partners and new investor RA Capital Management, invested a total of $32 million in TARIS Biomedical.

At the time, Taris emerged as a new company focused on developing a urology product portfolio, dedicated to addressing unmet clinical needs in the treatment of bladder cancer and overactive bladder (OAB) by building a pipeline of products for these indications. Meanwhile, Taris expanded its leadership team and board of directors, adding Dr. Chris Cuite from the Medical Affairs department to the leadership team and appointing two additional executives with extensive experience in the life sciences industry.

Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence, significantly impacting patients’ daily lives. TAR-302 is Taris Biomedical’s flagship development program for the treatment of OAB, targeting patients with idiopathic OAB who are refractory to oral therapies. TAR-302 delivers trospium chloride directly into the bladder over several months, achieving local drug concentrations several times higher than those attained with conventional oral treatments.

In May 2019, TARIS Biomedical initiated a new clinical study of TAR-302, aimed at helping patients with overactive bladder achieve sustained and effective symptom control. The company believes that TAR-302 has the potential to improve efficacy and reduce side effects compared with current oral therapies.

Furthermore, TAR-200, a product developed by TARIS Biomedical, has entered the clinical trial phase. It enables targeted therapy through the continuous intravesical release of the chemotherapeutic agent gemcitabine in patients with muscle-invasive bladder cancer (MIBC). In MIBC, the tumor has invaded the muscularis propria. For cases where the tumor has not yet metastasized to other tissues, radical cystectomy (RC), involving the en bloc removal of the bladder and the tumor, is generally considered. This procedure is typically accompanied by pelvic lymph node dissection (PLND) to clear lymph nodes from both sides of the pelvis and along the iliac vessels. Additionally, systemic therapy is required to address micrometastatic disease outside the surgical field. The NCCN Guidelines strongly endorse the role of cisplatin-based neoadjuvant chemotherapy and recommend its administration prior to surgery for patients who are medically fit.

In July 2019, TARIS Biomedical partnered with Bristol-Myers Squibb (BMS), a global leader in biopharmaceuticals, to conduct clinical trials of TAR-200. The study evaluated the therapeutic efficacy of TAR-200 in combination with BMS’s PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in subjects with muscle-invasive bladder cancer. Previously, BMS’s Opdivo became the first PD-1 inhibitor approved for marketing in China.

The study participants were all scheduled to undergo cystectomy but were either ineligible for or declined cisplatin-based neoadjuvant chemotherapy. The investigational drug was administered to subjects with muscle-invasive bladder cancer to assess safety and tolerability. Postoperative histopathological analysis demonstrated significant antitumor activity and favorable tolerability.

Previously, the FDA had granted TAR-200 Fast Track designation for patients with muscle-invasive bladder cancer who may not be suitable candidates for cystectomy.

Since its establishment in 2008, TARIS Biomedical has completed eight rounds of financing, raising a total of $113 million. The most recent round was a Series B financing in December 2017, in which Yonghua Capital, together with six other investors including Flagship Pioneering and Bristol-Myers Squibb, invested $25 million. The funds were used to advance clinical treatments for bladder cancer and overactive bladder.

Currently, Janssen Pharmaceuticals is exploring the application of TARIS technology for the treatment of cancer types other than bladder cancer. Peter Lebowitz, Global Therapeutic Area Head of Oncology at Janssen, stated, “TARIS technology provides a best-in-class clinical trial platform for evaluating novel local therapies in patients with bladder cancer. Together with the Taris team, we look forward to advancing comprehensive treatment regimens to halt the early carcinogenic process of bladder cancer and improve patient outcomes.”

Flagship is a venture capital firm founded in 2000, with investment focus primarily in biotechnology, healthcare, and information technology. Since its inception in 2000, the firm has launched and nurtured more than 100 science-based companies. To date, it has secured over $3 billion in total committed capital.