Abstract accepted for 2018 European Society of Medical Oncology Annual Meeting
Cash runway into first quarter of 2020
“As we concluded the first half of 2018, we also arrived at a point of inflection for our company. Since my arrival at
“The body of data that we have generated with tilsotolimod continues to demonstrate the potential positive difference this drug can make in patients who have not benefited from existing immuno-therapy. Our mission from here is to explore the entirety of the opportunity both in melanoma and additional tumor types in order that we can offer hope to as many patients as possible,” continued Milano.
“As it relates to the proposed merger that was recently terminated, we made an aggressive attempt to pursue a strategy that we believe would have strengthened our company, provided additional diversification and ultimately create more value for our shareholders. Throughout that process, my faith in the value of
Milano further added, “To our long-term shareholders, I understand that these have been challenging times. I’ve worked through these moments more than once during my career. I appreciate the loyalty you’ve shown our company and I assure you that your loyalty serves as a great motivator for our entire team to deliver success in the future.”
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 metastatic melanoma:
- Trial initiated in the first quarter of 2018;
- 26 of the planned 80 sites across 12 countries have been activated for the randomization of patients into the trial;
- 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 for tilsotolimod in combination with ipilimumab for the treatment of patients with unresectable or metastatic melanoma following failure of PD-1 inhibitor treatment in fourth quarter of 2017.
ILLUMINATE 204 – Phase 1/2 trial of intratumoral tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:
Ipilimumab Combination Arm – Phase 2 Expansion Ongoing at RP2D of 8 mg
- Enrollment (up to 60 patients) completion expected by year end 2018;
- Recently increased trial sites open to enrollment to 8 (2 additional planned);
- Abstract accepted for the upcoming
ESMO2018 Congressmeeting in Munich, Germany, October 20, 2018.
ILLUMINATE-204 Key Findings Presented at
- 21 patients treated with the 8 mg dose of tilsotolimod in combination with ipilimumab have had disease evaluations;
- Confirmed RECIST v1.1 responses (including 2 Complete Response [CR]) were observed in 8 of these 21 subjects (38.1%);
- Six of 8 responses are ongoing (1 CR ongoing for nearly 2 years); median duration of response for these 8 has not yet been reached;
- Overall 15 patients out of 21 evaluable for efficacy (71.4%) experienced disease control (CR, PR, or SD);
- The combination regimen is 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; and
- 15/26 patients (57.7%) with lesions accessible only by image-guided injection (5 deep visceral lesions and 10 lymph nodes) were included.
Pembrolizumab Combination Arm – Phase 1 Dose Escalation Ongoing - Update
- Enrollment in the last dosing cohort (32 mg) ongoing; and
- The previously reported partial response (PR) in 1 of the first 6 patients in the 16 mg cohort of intratumoral tilsotolimod in combination with pembrolizumab has evolved into a confirmed complete response (CR).
ILLUMINATE 101 – Phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors:
- Completed enrollment in first three dosing cohorts [11 patients treated with 8 mg dose of tilsotolimod, 8 patients treated with 16 mg dose of tilsotolimod, 8 patients treated with 23 mg dose of tilsotolimod; and enrollment continues in the final cohort (32 mg)];
- One patient in cohort 1 (8 mg) continues in follow-up; one patient in cohort 2 (16 mg) continues tilsotolimod monotherapy and one patient continues in follow-up; two patients in cohort 3 (23 mg) continue tilsotolimod therapy and two patients continue in follow-up. 6 of 8 planned patients for cohort 4 (32 mg) enrolled; and
- First patient enrolled into the refractory melanoma cohort continues at a dose of 8 mg of tilsotolimod as monotherapy.
Investigator Sponsored Trials (IST)
During the second quarter of 2018, the company announced that it had entered into a clinical development support agreement with
- 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 study of intratumoral tilsotolimod in combination with IV pembrolizumab in patients with NSCLC. The principal investigator initiating this trial is Arafat Tfayli, MD, Professor of Clinical Medicine, Director of Hematology/Oncology Fellowship Program at the
American University of BeirutMedical Center (AUBMC), Lebanon; and
- 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 are
Bas Koster, MD and Tanja de Gruijl, PhD at The VU University Medical Center, Amsterdam, the Netherlands.
On January 21, 2018, the company entered into an Agreement and Plan of Merger (the Merger Agreement) with
At a special meeting of BioCryst stockholders held on
In accordance with the Merger Agreement, BioCryst paid the company a fixed expense reimbursement amount of
Second Quarter Results
Net loss applicable to common stockholders for the three months ended
Harnessing the approach of the earliest researchers in immunotherapy and Idera’s experience in developing proprietary immunology technologies, 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.
|Idera Pharmaceuticals, Inc.
Condensed Statements of Operations
(In thousands, except per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and Development||10,880||17,891||24,436||29,376|
|General and Administrative||5,583||3,888||12,562||7,969|
|Total Operating Expenses||16,463||21,779||36,998||37,345|
|Loss from Operations||(16,300)||(21,592)||(36,580)||(36,780)|
|Other Income (Expense), Net||269||121||454||252|
|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||27,133||18,676||26,012||18,657|
|Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
|June 30,||December 31,|
|Cash, Cash Equivalents and Investments||$||94,046||$||112,629|
|Total Stockholders' Equity||85,066||107,695|
|Total Liabilities and Stockholders' Equity||$||99,514||$||118,417|
Idera Pharmaceuticals Contact:
VP, Investor Relations
Phone (617) 679-5515
Source: Idera Pharmaceuticals, Inc.