– Company to Provide ILLUMINATE 204 Data Update in the First Half of
– Cash runway into first quarter of 2020 –
“The third quarter of 2018 was marked by continued focus and execution throughout our company advancing the tilsotolimod ILLUMINATE 301 trial toward approval in our lead indication in anti-PD-1 refractory or relapsed metastatic melanoma. We also made significant progress framing our plans to expand the development of tilsotolimod to additional tumor types,” stated
“Over these past several years, through all of the preclinical studies, translational data collections and ultimately our early clinical experiences, it’s becoming clearer to us that the potential utility of tilsotolimod is not limited to melanoma and is certainly not limited by the location or type of tumor,” continued Milano. “We look forward to providing our next clinical update from the ILLUMINATE 204 trial in the first half of December as well as laying out our expansion plans for the program in the beginning of 2019.”
“The majority of our company’s focus is and will remain towards maximizing the opportunity with, and more importantly, the number of patients that can benefit from, tilsotolimod. At the same time, we recognize and embrace the concept of continuing to build
Clinical Development Program Updates:
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE 301 – Randomized Phase 3 trial of intratumoral tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory/relapsed metastatic melanoma:
- Trial initiated in the first quarter of 2018;
- 42 of the planned up to 110 sites across 12 countries have been activated for the randomization of patients into the trial;
- ILLUMINATE 301 Trials in
Progress(TiPS) presentation on trial design featured at the 2018 Congressof the European Society of Medical Oncology( ESMO);
- Planned enrollment of approximately 300 patients with Overall Response Rate (“ORR”) and Overall Survival as primary endpoints; and
U.S. Food and Drug Administrationgranted Fast Track Designation in fourth quarter of 2017 for tilsotolimod in combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma following failure of PD-1 inhibitor treatment.
ILLUMINATE 204 – Phase 1/2 trial of intratumoral tilsotolimod in combination with either ipilimumab or pembrolizumab in patients with PD-1 refractory/relapsed metastatic melanoma:
Ipilimumab Combination Arm – Phase 2 Recruitment Ongoing
- Enrollment continues at 10 U.S. clinical trial sites;
- Two additional sites planned for initiation in
- ILLUMINATE 204 Trial Data update presented at
ESMO2018 demonstrated both abscopal effect as well as the potential of intratumoral tilsotolimod to overcome known resistance mechanisms to ipilimumab treatment as a monotherapy.
- Earlier this year at the
American Society of Clinical Oncology( ASCO) Annual Meeting, the company presented clinical efficacy and safety data from the first 21 evaluable patients demonstrating:
- Confirmed RECIST v1.1 responses (including 2 Complete Responses [CR]) were observed in 8 of these 21 subjects (38.1%);
- Overall 15 patients out of 21 evaluable for efficacy (71.4%) experienced disease control (CR, PR, or SD);
- The combination regimen was generally well tolerated. 6/26 subjects (23%) had immune-related toxicities indicating that IMO-2125 + ipilimumab does not appear to add toxicity versus ipilimumab alone;
- Injection-related toxicities were grade 1-2 transient fever and flu-like symptoms lasting <48 hours;
- 15/26 patients (57.7%) with lesions accessible only by image-guided injection (5 deep visceral lesions and 10 lymph nodes) were included; and
- The company plans to provide a data update on up to 35 evaluable patients in first half of
Pembrolizumab Combination Arm – Phase 1 Dose Escalation Ongoing
- Enrollment in the last dosing cohort (32 mg) ongoing with one patient remaining to complete enrollment (priority enrollment has been towards the ipilimumab combination arm of ILLUMINATE 204).
- One patient in the cohort testing 16mg intratumoral tilsotolimod in combination with pembrolizumab continues on study with a confirmed complete response (CR).
ILLUMINATE 101 – Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:
- Completed enrollment in all four dose ranging cohorts; 41 patients enrolled;
- Continuing enrollment into the refractory melanoma cohort at the 8 mg dose of intratumoral tilsotolimod as monotherapy;
- Translational data continues to be collected, analyzed and is planned to be submitted for presentation at a medical oncology conference in 2019.
Investigator Sponsored Trials (IST)
- A Phase 1/2 open label study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and IV nivolumab in a protocol open to multiple tumor types including non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck and urothelial carcinoma. The principal investigator initiating this trial is Aurélien Marabelle, MD, PhD, Clinical Director of the Cancer Immunotherapy Program at Institut Gustave Roussy, Villejuif,
- A Phase 2 placebo-controlled study of intradermal administration of tilsotolimod in patients with T3/T4 primary melanoma scheduled to undergo a combined re-excision and sentinel node biopsy (SNB) procedure. The principal investigators initiating this trial are
Bas Koster, MD and Tanja de Gruijl, PhD at The VU University Medical Center, Amsterdam, the Netherlands.
During the quarter, the following Corporate Organizational Changes were announced:
Howard Pienappointment to Idera’s Board of Directors on September 18, 2018, filling the seat previously held by Julian Baker. Bryant D. Limjoined Ideraas General Counsel and Secretary to the Board of Directors, effective September 10, 2018;
- Chief Financial Officer Louis J. Arcudi III’s planned departure from the company related to the company’s consolidation to PA headquarters, effective
October 31, 2018;
- Vice President of Finance
John J. Kirby’sappointment as Principal Financial Officer and Principal Accounting Officer, effective October 31, 2018; and
Third Quarter Results
Net loss applicable to common stockholders for the three months ended
Harnessing the approach of the earliest researchers in immunotherapy and the Company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company’s strategy, future operations, collaborations, cash resources, financial position, future revenues, projected costs, prospects, clinical trials, plans and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Condensed Statements of Operations
(In thousands, except per share data)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||8,860||10,912||32,912||40,288|
|General and administrative||3,984||3,919||11,849||11,888|
|Merger-related costs, net||(3,836||)||-||1,245||-|
|Total operating expenses||12,025||14,831||49,023||52,176|
|Loss from operations||(11,880||)||(14,667||)||(48,460||)||(51,447||)|
|Other income (expense), net||275||137||729||389|
|Net loss per common share applicable
to common stockholders — basic and diluted
|Weighted-average number of common shares
used in computing net loss per share applicable to
common stockholders — basic and diluted
Condensed Balance Sheet Data
|September 30,||December 31,|
|Cash and cash equivalents||$||82,462||$||112,629|
|Total stockholders' equity||74,866||107,695|
|Total liabilities and stockholders' equity||$||85,230||$||118,417|
Idera Pharmaceuticals Contact:
VP, Investor Relations
Phone (484) 348-1677
Source: Idera Pharmaceuticals, Inc.