A Phase I Trial Assessing the Safety and Efficacy of an Anti-tumor Immunity Priming Strategy Combining Intratumoral Tilsotolimod, a TLR-9 Agonist, Together With Intratumoral Ipilimumab and Intravenous Nivolumab in Patients With Advanced Cancers

Open label, phase Ib study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab.
The trial will be divided into two parts:
PART A:
the first part will assess the safety of two regimen and will recruit patients with all types of injectable solid malignancies
PART B:
the second part will include 3 expansion cohorts of 15 patients:
* B1: anti-PD-1 refractory advanced NSCLC cohort
* B2: anti-PD-1 refractory advanced melanoma cohort
* B3: immunotherapy naïve microsatellite stable colorectal cancer (MSS CRC) cohort

Start Date10 Apr 2020

Sponsor / Collaborator

Institut Gustave Roussy EURL

CTIS2023-509461-20-00

/ Not yet recruitingPhase 2

A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in clinical cT3-4N0M0 Melanoma (Intrim 1 study)

Start Date22 Jan 2020

Sponsor / Collaborator-

NCT04126876

/ RecruitingPhase 2IIT

A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is

Start Date22 Jan 2020

Sponsor / Collaborator

Stichting Onderzoek Cancer Center Amsterdam

[+1]

100 Clinical Results associated with Tilsotolimod

100 Translational Medicine associated with Tilsotolimod

100 Patents (Medical) associated with Tilsotolimod

Literatures (Medical) associated with Tilsotolimod

20 May 2025·JOURNAL OF CLINICAL ONCOLOGY

Randomized, Open-Label, Phase III Study of Tilsotolimod in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced Refractory Melanoma (ILLUMINATE-301)

Article

Author: Grob, Jean-Jacques ; Chunduru, Srinivas ; Rahimian, Shahram ; Lebbe, Celeste ; Loquai, Carmen ; de la Cruz, Luis ; In, Gino K. ; Walker, John W.T. ; Guida, Michele ; Kapiteijn, Ellen ; Ascierto, Paolo A. ; Maio, Michele ; Negrier, Sylvie ; Robert, Caroline ; Diab, Adi ; Guidoboni, Massimo ; Leccia, Marie-Therese ; Abdel-Wahab, Reham ; Dalle, Stephane ; Butler, Marcus O. ; Krajsova, Ivana ; Arenberger, Petr ; Mortier, Laurent ; Haferkamp, Sebastian ; Atkinson, Victoria

PURPOSE:

There are limited treatment options for advanced melanoma that have progressed during or after immune checkpoint inhibitor therapy. Intratumoral (IT) immunotherapy may improve tumor-specific immune activation by promoting local tumor antigen presentation while avoiding systemic toxicities. The phase 3 ILLUMINATE-301 study (ClinicalTrials.gov identifier: NCT03445533 ) evaluated tilsotolimod, a Toll-like receptor-9 agonist, with or without ipilimumab in patients with anti–PD-1 advanced refractory melanoma.

METHODS:

Patients with unresectable stage III-IV melanoma that progressed during or after anti–PD-1 therapy were randomly assigned 1:1 to receive 24 weeks of tilsotolimod plus ipilimumab or 10 weeks of ipilimumab alone. Nine IT injections of tilsotolimod were administered to a single designated lesion over 24 weeks. Intravenous ipilimumab 3 mg/kg was administered once every 3 weeks from week 2 in the tilsotolimod arm and week 1 in the ipilimumab arm. The primary end point was efficacy measured using objective response rate (ORR; independent review) and overall survival (OS).

RESULTS:

A total of 481 patients received tilsotolimod plus ipilimumab (n = 238) or ipilimumab alone (n = 243). ORRs were 8.8% in the tilsotolimod arm and 8.6% in the ipilimumab arm, with disease control rates of 34.5% and 27.2%, respectively. Median OS was 11.6 months in the tilsotolimod arm and 10 months in the ipilimumab arm (hazard ratio, 0.96 [95% CI, 0.77 to 1.19]; P = .7). Grade ≥3 treatment-emergent adverse events occurred in 61.1% and 55.5% of patients in the tilsotolimod and ipilimumab arms, respectively.

CONCLUSION:

Combining IT tilsotolimod with ipilimumab did not significantly improve the ORR or OS compared with ipilimumab alone in patients with anti–PD-1 advanced refractory melanoma.

01 Dec 2022·Clinical cancer research : an official journal of the American Association for Cancer Research

Tilsotolimod Exploits the TLR9 Pathway to Promote Antigen Presentation and Type 1 IFN Signaling in Solid Tumors: A Multicenter International Phase I/II Trial (ILLUMINATE-101)

Author: Mahadevan, Daruka ; Agarwala, Sanjiv ; Borazanci, Erkut ; Schachter, Jacob ; Chunduru, Srinivas ; Hendler, Daniel ; Murthy, Ravi ; Rahimian, Shah ; Minderman, Hans ; Algazi, Alain ; Lotem, Michael ; Bernatchez, Chantale ; Hennemeyer, Charles ; Kaplan, Nadia ; Woodhead, Gregory ; Maurice-Dror, Corinne ; Hultsch, Rolf ; Haymaker, Cara ; Puzanov, Igor ; Diab, Adi ; Babiker, Hani ; Subbiah, Vivek ; Anderson, Peter M.

Abstract:

Purpose::

Tilsotolimod is an investigational synthetic Toll-like receptor 9 (TLR9) agonist that has demonstrated antitumor activity in preclinical models. The ILLUMINATE-101 phase I study explored the safety, dose, efficacy, and immune effects of intratumoral (it) tilsotolimod monotherapy in multiple solid tumors.

Patients and Methods::

Patients with a diagnosis of refractory cancer not amenable to curative therapies received tilsotolimod in doses escalating from 8 to 32 mg into a single lesion at weeks 1, 2, 3, 5, 8, and 11. Additional patients with advanced malignant melanoma were enrolled into an expansion cohort at the 8 mg dose. Objectives included characterizing the safety, establishing the dose, efficacy, and immunologic assessment. Blood samples and tumor biopsies of injected and noninjected lesions were obtained at baseline and 24 hours after treatment for immune analyses.

Results::

Thirty-eight and 16 patients were enrolled into the dose escalation and melanoma expansion cohorts, respectively. Deep visceral injections were conducted in 91% of patients. No dose-limiting toxicities (DLT) or grade 4 treatment-related adverse events were observed. Biopsies 24 hours after treatment demonstrated an increased IFN pathway signature and dendritic cell maturation. Immunologic profiling revealed upregulation of IFN-signaling genes and modulation of genes for checkpoint proteins. In the dose escalation cohort, 12 (34%) of 35 evaluable patients achieved a best overall response rate (ORR) of stable disease (SD), whereas 3 (19%) of 16 evaluable patients in the melanoma cohort achieved stable disease.

Conclusions::

Overall, tilsotolimod monotherapy was generally well tolerated and induced rapid, robust alterations in the tumor microenvironment.See related commentary by Punekar and Weber, p. 5007

01 Dec 2022·Clinical cancer research : an official journal of the American Association for Cancer Research

Intratumoral Therapy to Make a “Cold” Tumor “Hot”: The Jury Is Still Out

Communications

Author: Weber, Jeffrey S. ; Punekar, Salman R.

Tilsotolimod, an oligodeoxynucleotide TLR9 agonist, administered intratumorally, has been clinically evaluated. This compound has demonstrated the ability to induce changes within the tumor microenvironment, to convert noninflamed cold tumors into inflamed hot tumors, with the hope that these tumors will be more responsive to immune checkpoint blockade.See related article by Babiker et al., p. 5079

News (Medical) associated with Tilsotolimod

19 May 2025

·www.prnewswire.com

Intra-tumoral Cancer Therapies Market to Show Tremendous Growth at a CAGR of 31.3% During the Study Period (2020-2034) | DelveInsight

As per DelveInsight's estimates, among the 7MM, the US captured the highest market of intra-tumoral cancer therapies of nearly USD 74 million in 2024, which is expected to increase due to the launch of emerging therapies such as CAN-2409, RP1 (vusolimogene oderparepvec), SP-002 (ASN-002), Bizaxofusp (MDNA55), and others. LAS VEGAS, May 19, 2025 /PRNewswire/ -- DelveInsight's Intra-tumoral Cancer Therapies Market report includes a comprehensive understanding of current treatment practices, emerging intra-tumoral cancer therapies, market share of individual therapies, and current and forecasted intra-tumoral cancer therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Intra-tumoral Cancer Therapies Market Report Currently, only three Intra-tumoral Cancer Therapies are approved; namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen), approved in the US and Europe in 2015, DELYTACT (teserpaturev/G47Δ; Daiichi Sankyo) approved in Japan in 2021, and HENSIFY in Europe in 2019. As per DelveInsight's analysis, the total market size of intra-tumoral cancer therapies in the 7MM was USD 109 million in 2024 and is projected to grow during the forecast period (2025-2034). In 2024, the total cases of selected indication (based on current landscape and pipeline activity) were 8.9 million in the 7MM, which is anticipated to increase by 2034. Leading intra-tumoral cancer therapies companies, such as Janssen, Stamford Pharmaceuticals, Ascend Biopharmaceuticals, Replimune, Highlight Therapeutics, Cytovation ASA, Intensity Therapeutics, Ascendis Pharma, Treovir, Matica Biotechnology, QBiotics, NanOlogy, Lokon Pharma AB, EpicentRx, Medicenna Therapeutics, Philogen S.p.A., Candel Therapeutics, Lytix Biopharma, Verrica Pharmaceuticals, CEI-SCI, and others, and others, are developing novel intra-tumoral cancer therapies that are expected to enter the intra-tumoral cancer therapies market in the coming years. Some of the key intra-tumoral cancer therapies in the pipeline include INT230-6, Vusolimogene oderparepvec (RP1), Nidlegy (Daromun), G207, Ilixadencel (INTUVAX), Tigilanol tiglate, SP-002 (ASN-002), BO-112, Bizaxofusp (MDNA55), and others. In March 2025, NANOBIOTIX announced topline data from the completed dose-escalation portion of a Phase I study, conducted under the sponsorship of The University of Texas MD Anderson Cancer Center, evaluating JNJ-1900 (NBTXR3) activated by radiation therapy as a second-line or later (2L+) treatment for patients with locally advanced NSCLC eligible for re-irradiation. In March 2025, NANOBIOTIX announced an amendment to its global licensing agreement with Janssen Pharmaceutica NV. The amendment removes NANOBIOTIX's funding obligation for NANORAY- 312 and releases Johnson & Johnson from select future potential milestone payments while safeguarding NANOBIOTIX's path to sustainable cash flow through significant potential milestone payments. In March 2025, Candel Therapeutics and IDEA Pharma announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel's lead asset, CAN-2409. In January 2025, Lokon Pharma AB announced that the Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the company's product candidate LOAd703 for the treatment of pancreatic cancer. In January 2025, Intensity Therapeutics announced that the Data Monitoring Committee (DMC) recommended the continuation of its Phase III sarcoma trial (INT230-6, INVINCIBLE-3) without modification based on data reviewed from July 2024 to December 2024. Some factors, such as the precedence of failure of emerging therapies, insufficient knowledge about Intra-tumoral Cancer Therapies , and several other drawbacks, might hinder the Intra-tumoral Cancer Therapies market growth. Discover which therapies are expected to grab the intra-tumoral cancer therapies market share @ Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Market Dynamics The intra-tumoral cancer therapies market dynamics are expected to change in the coming years. Various classes of intra-tumoral immunotherapies, including radioenhancer nanoparticles, recombinant fusion proteins, oncolytic therapy, gene therapy, synthetic dsRNA complexes, and others, are currently in preclinical and clinical development. These therapies increase drug concentration and availability within the tumor microenvironment while limiting systemic exposure and reducing the likelihood of immune-related side effects in other parts of the body. Intra-tumoral therapeutic strategies offer a powerful approach to in situ vaccine development, utilizing immune-stimulating agents to trigger local and systemic anti-tumor immune responses. Additionally, the ability of intra-tumoral immunotherapy combinations to elicit both T-cell and B-cell antitumor responses presents a potential strategy to overcome immune escape mechanisms, such as the loss of HLA-I expression on tumor cells, which are often associated with immune checkpoint therapy monoclonal antibody monotherapies. Furthermore, potential therapies are being investigated, and it is safe to predict that the treatment space will significantly impact the intra-tumoral cancer therapies market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the intra-tumoral cancer therapies market in the 7MM. However, several factors may impede the growth of the intra-tumoral cancer therapies market. The lack of standardized guidelines for intra-tumoral immunotherapy delivery results in variations in lesion selection, injection frequency, and needle technique, which directly affect treatment outcomes and safety. Patients are required to visit clinics for each dosing session, and the administration necessitates both trained radiologists and logistics support alongside skilled physicians. While research into intra-tumoral therapies has grown in recent years, several therapies, such as tilsotolimod/Ipilimumab, sotigalimab (APX005M), and vidutolimod (CMP-001), have failed clinical trials, impacting the market. Additionally, tumors with high intra-tumoral heterogeneity may lead to poorer clinical outcomes for patients. Intra-tumoral Cancer Therapies Therapeutics Market Although significant progress has been made in cancer treatment through methods like surgery, chemotherapy, radiation, immunotherapy, and targeted therapies, many of these treatments still face limitations such as systemic toxicity, inadequate tumor penetration, and poor targeting. These issues contribute to high mortality rates, underscoring the need for more precise and localized treatment options. Recently, cancer treatment strategies have increasingly focused on alternative delivery methods, including intra-tumoral administration. This approach is being actively researched, with several therapeutic candidates—such as immune receptor agonists, viral therapies, fusion proteins, monoclonal antibodies, and gene therapies—currently undergoing preclinical and clinical trials. Intra-tumoral immunotherapy, which involves directly delivering agents into or near the tumor site, is emerging as a promising approach. This strategy aims to boost localized immune responses while reducing systemic side effects. The first oncolytic virus, IMLYGIC (T-Vec; Amgen), was approved by the US FDA for treating unresectable melanoma lesions after surgery, following a Phase III trial. The European Commission approved the treatment of advanced melanoma in 2015. In 2019, Nanobiotix's HENSIFY (NBTXR3), a hafnium oxide nanoparticle therapy combined with radiation, received European approval for soft tissue sarcoma, with plans for data releases through 2025-2026 across multiple cancers. For STS the drug is approved in Europe but not yet launched. In Japan, DELYTACT (G47∆; Daiichi Sankyo) was granted conditional approval for malignant glioma, marking the first oncolytic virus for brain cancer, and is still under evaluation for its clinical benefits. IMLYGIC from Amgen is the first and only FDA-approved viral therapy that is injected directly into melanoma tumors. Despite the initial hype for this exciting intra-tumoral mode of cancer gene therapy, IMLYGIC's debut did not translate into much commercial success in the melanoma market. Limitations of the intra-tumoral administration, no statistically significant benefit in overall survival (OS), and the intense competition from immune checkpoint inhibitors (ICIs) due to their efficacy and manageable side effects are some of the main factors for ithe nsignificant revenues of this novel therapy. Learn more about the FDA-approved intra-tumoral cancer therapies @ Intra-tumoral Cancer Therapies Treatment Key Emerging Intra-tumoral Cancer Therapies and Companies The emerging pipeline of intra-tumoral cancer therapies is robust, including drugs from key players such as Candel Therapeutics (CAN-2409), Lytix Biopharma/Verrica Pharmaceuticals (LTX-315 [VP-315]), CEI-SCI (MULTIKINE), Philogen (Daromun [NIDLEGY; a combo of L19IL2 + L19TNF]), Replimune (RP2 and RP1 [vusolimogene oderparepvec]), Highlight Therapeutics (BO-112), Cytovation ASA (CY-101), Intensity Therapeutics (INT230-6), Ascendis Pharma (TransCon IL-2 β⁄γ), Treovir/Matica Biotechnology (G207), QBiotics (Tigilanol tiglate), NanOlogy (NanoPac), EpicentRx (AdAPT-001), Medicenna Therapeutics (Bizaxofusp [MDNA55]), and others. RP1 (vusolimogene oderparepvec), Replimune's lead product candidate, is based on a proprietary strain of Herpes Simplex Virus (HSV) engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor killing potency, immunogenicity, and activation of a systemic antitumor immune response. In November 2024, Replimune announced that the FDA granted Breakthrough Therapy Designation (BTD) to RP1 in combination with nivolumab for the treatment of advanced melanoma in adult patients who have previously received an anti-PD1 regimen. Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and which are mixed prior to intralesional administration. In July 2024, Philogen and Sun Pharmaceutical announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy. CAN-2409 (Candel Therapeutics) is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV thymidine kinase (HSV-tk) gene to a patient's specific tumor and induce an individualized, systemic immune response against the tumor. In March 2025, according to the company's corporate highlights, the preparations for Biologics License Application (BLA) for CAN-2409 in prostate cancer are underway, with submission expected in Q4 2026. The anticipated launch of these emerging therapies are poised to transform the intra-tumoral cancer therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the intra-tumoral cancer therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about intra-tumoral cancer therapies clinical trials, visit @ Intra-tumoral Cancer Therapies Intra-tumoral Cancer Therapies Overview Cancer is a highly diverse disease, with its signs, symptoms, and treatments varying across different types, making it crucial to create targeted therapies for individual patients. Current treatment options for cancer include immunotherapy, radiotherapy, chemotherapy, targeted drug therapies, and more. While these approaches have improved OS and patient outcomes, they still have limitations and are not effective for everyone. Researchers are therefore working to develop new treatments that can overcome these challenges, with intra-tumoral cancer therapies emerging as a promising strategy. Intra-tumoral immunotherapy represents an innovative approach, where sophisticated antibodies are directly injected into tumors instead of being administered intravenously. This method focuses on delivering immunostimulatory agents straight into primary or metastatic tumor sites to initiate or enhance an antitumor immune response. Normally, the immune system detects and eliminates early tumors, but in immunosuppressive tumor environments, malignant cells can proliferate undetected. Regulatory T cells (Tregs), drawn to the tumor by chemokines, suppress Antigen-Presenting Cells (APCs) that would otherwise trigger an immune attack on tumor antigens. Moreover, tumor cells often release anti-inflammatory and regulatory cytokines like TGF-β and IL-10, which promote tumor growth and inhibit dendritic cell (DC) activation. To counteract this immunosuppressive environment, immunostimulants can be introduced. These agents work by attracting immune cells to the tumor or by activating the immune system to recognize and destroy cancer cells. Immunostimulants activate immune cells in the presence of tumor antigens, allowing them to travel to lymph nodes, where they stimulate tumor antigen-specific T cells through cross-presentation. These activated T cells can then return to the tumor or spread to distant tumors, leading to the targeted destruction of cancer cells. Intra-tumoral Cancer Therapies Epidemiology Segmentation In 2024, the total indication-wise treated cases of Intra-tumoral Cancer Therapies were 3.3 million in the 7MM, which is anticipated to increase by 2034. The intra-tumoral cancer therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of Selected Indications Indication-wise Target Patient Pool of Intra-tumoral Cancer Therapies Indication-wise Treated Cases of Intra-tumoral Cancer Therapies Scope of the Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Therapeutic Assessment: Intra-tumoral current marketed and emerging therapies Intra-tumoral Cancer Therapies Market Dynamics: Conjoint Analysis of Emerging Intra-tumoral Cancer Therapies Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Intra-tumoral Cancer Therapies Market Access and Reimbursement Discover more about intra-tumoral cancer therapies in development @ Intra-tumoral Cancer Therapies Clinical Trials Table of Contents Related Reports Oncolytic Virus Market Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of oncolytic virus, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus companies, including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichio Sankyo, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug ApprovalFast TrackLicense out/in

09 Feb 2023

·endpts.com

Updated: AbbVie leaves some oncology programs out of 2023 pipeline highlights

In an investor update Thursday morning, AbbVie left eight programs out of its pipeline highlights it shared with investors, as compared to what exists on the R&D page of its website, last refreshed in December. A Phase III study of Rinvoq in Takayasu arteritis , a rare group of disorders in which blood vessels become inflamed, was not included. The JAK inhibitor is approved for indications like rheumatoid arthritis and carries with it a black box warning. There’s also the removal of late-stage veliparib in breast and ovarian cancers after multiple failures for the PARP inhibitor were announced years ago . A company spokesperson noted the programs remain ongoing. “The updates listed in the slide from this morning highlight our key programs of interest for the investment community and is not a comprehensive snapshot of our entire pipeline,” the spokesperson wrote in an email. Further down the pipeline, AbbVie was quiet on Phase II assets ABBV-4083 in filarial diseases and its Allergan-snagged AGN-231868 in dry eye. A different Allergan asset continues in dry eye, according to the Chicago-area pharma giant’s pipeline update Thursday. Down in Phase I, AbbVie left out four oncology drug candidates. The company reneged on solid and hematologic tumor assets ABBV-155 and ABBV-621 , an IV-infused drug candidate also known as eftozanermin alfa . Small cell lung cancer asset ABBV-011 no longer shows up on the pipeline, and the same goes for ABBV-368 in solid tumors. AbbVie previously nixed a Phase Ib study of ABBV-368 in combination with Idera’s (Aceragen as of last month) tilsotolimod. In its update, AbbVie reminded investors of its four regulatory submissions: Rinvoq for Crohn’s disease; the Genmab-partnered CD3xCD20 bispecific epcoritamab for relapsed/refractory diffuse large B-cell lymphoma; ABBV-951 for advanced Parkinson’s disease and Qulipta for chronic migraine prevention . Editor’s note: This article has been updated to include comment and additional context from an AbbVie spokesperson that the programs remain ongoing.

Phase 1Phase 3Phase 2Drug ApprovalClinical Trial Termination

29 Sep 2022

·endpts.com

As lead drug flopped and AbbVie collab dissolved, cancer biotech resorts to buying rare disease company

Ever since disappointing late-stage data on its cancer drug tanked Idera Pharmaceuticals’ stock last year (unhelped by an ill-fated collaboration with AbbVie ), execs have been tightening the belt while searching for something — anything — that may dig the company out of its hole. More than a year later, they finally found it. In an acquisition that is reminiscent of a reverse merger, Idera is buying private biotech Aceragen in an all-stock deal. Instead of cancer, Idera will now be focused on rare, orphan pulmonary and rheumatic diseases. Specifically, it’s placing its hopes on ACG-701 in cystic fibrosis and melioidosis, and ACG-801 in Farber disease. Together, the companies say their cash pool will provide runway into Q3 2023, by which time Aceragen expects to have read out key clinical data. “After a thorough evaluation of strategic alternatives, we and our Board of Directors believe this acquisition represents the highest potential value creation opportunity for Idera’s stockholders,” said Vincent Milano, Idera’s CEO, who will now hand his job to Aceragen CEO John Taylor and transition to a board chair role. Idera’s former lead asset, tilsotolimod, is a toll-like receptor 9 agonist that initially spurred promising response rates in melanoma but ultimately flunked a Phase III trial. Combinations with drugs from AbbVie and Bristol Myers Squibb didn’t produce good enough data, either, and AbbVie ultimately cut a trial short. While it had originally hoped to out-license the drug, Idera eventually opened up its scope for the strategy alternatives it could consider. The biotech estimates that Aceragen’s lead programs will have a combined annual peak sales potential of $650 million. But it’s still got a lot to prove.

Acquisition

100 Deals associated with Tilsotolimod

External Link

KEGG	Wiki	ATC	Drug Bank
D11504	-	-	DB16341

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 3	Netherlands	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	United States	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Australia	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Canada	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Czechia	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	France	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Germany	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Italy	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Netherlands	Idera Pharmaceuticals, Inc.	30 May 2018
Metastatic melanoma	Phase 3	Spain	Idera Pharmaceuticals, Inc.	30 May 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03445533 (ILLUMINATE-301, Pubmed \| J Clin Oncol)	Phase 3	Refractory Melanoma anti-PD-1	481	Tilsotolimod + Ipilimumab	tirvkqdrvr(uclqsfhdjd) = maruvwhfpw frmukbngdr (zhdjgturxw ) View more	Negative	20 May 2025
				Ipilimumab	tirvkqdrvr(uclqsfhdjd) = lfzjixvqlg frmukbngdr (zhdjgturxw ) View more
NCT03445533 (ILLUMINATE 301, ASCO 12024 \| ASCO 22024) Manual	Phase 3	Refractory Melanoma	481	Tilsotolimod+Ipilimumab	xcsbewkxvb(cngftubxoe) = fbfqtsfmrs sylyyzkdku (wlymixapnc ) View more	Negative	02 Jun 2024
				Ipilimumab	xcsbewkxvb(cngftubxoe) = zqahpnyhsk sylyyzkdku (wlymixapnc ) View more
NCT03445533 (ILLUMINATE-301 \| ILLUMINATE 301, CTgov)	Phase 3	Melanoma \| Metastatic melanoma	481	Ipilimumab (Arm A: Ipilimumab)	vhhqkjrzox: P-Value = 0.9394 View more	-	08 Nov 2022
				ipilimumab (Arm B: IMO-2125 Plus Ipilimumab)
NCT02644967 (ILLUMINATE-204 \| ENCORE-601, CTgov)	Phase 2	Metastatic melanoma	53	Ipilimumab+IMO-2125	sfamrdyapo = apqflczyfh pgwlgbyncv (yvluvxuxnl, hczuvogdhi - bayvlydzan) View more	-	03 Aug 2022
NCT03052205 (ILLUMINATE-101, Pubmed) Manual	Phase 1/2	Solid tumor \| Melanoma	54	Tilsotolimod (dose escalation)	ozjplcxiuu(difttzysbr) = No grade 4 treatment-related adverse events were observed. pgbfuhfjui (jodvjpoehb ) View more	Positive	02 Aug 2022
				Tilsotolimod (melanoma expansion cohorts)
NCT04126876 (Intrim, Biospace) Manual	Phase 2	Melanoma	-	tilsotolimod	jtliucxkgf(rgpogmyqhv): difference = -70	Positive	17 May 2022
				Placebo
NCT03445533 (ILLUMINATE-301, Corporate Publications) Manual	Phase 3	Melanoma	481	IPILIMUMAB+TILSOTOLIMOD	gjaswcafoi(oevifrffgw) = eqqkirzply iyapsdmwzy (yhipsauuoc ) View more	Negative	18 Mar 2021
				IPILIMUMAB	gjaswcafoi(oevifrffgw) = ksywobzlwo iyapsdmwzy (yhipsauuoc ) View more
NCT02644967 (ILLUMINATE-204, ESMO2020) Manual	Phase 1/2	Locally Advanced Melanoma	62	tilsotolimod+ipilimumab	qitbzhlxmu(ypbulcfuro) = qmaijfdkzl vqwqdbojpn (vvttfvvvao, 11.8 - 36.6) View more	Positive	18 Sep 2020
NCT00990938 (CTgov)	Phase 1	Hepatitis C	63	Placebo+Ribavirin (Placebo + Ribavirin)	hkaktssbcf = sknyctczky nmmmqnuofw (htmrhvggia, bmqlzjfwpx - icpphebkjq) View more	-	15 Feb 2019
				IMO-2125+Ribavirin (IMO-2125 0.08 mg/kg Weekly + Ribavirin)	hkaktssbcf = inanygeqfx nmmmqnuofw (htmrhvggia, usbfqwahvk - ksctyhpvak) View more
NCT00728936 (CTgov)	Phase 1	Hepatitis C	58	Saline placebo (Placebo)	yghltkqoiv = rhwjdjmyzv ueplxdmxkr (pimybpmvnf, iwltauegkw - caifaiziea) View more	-	15 Feb 2019
				IMO-2125 (IMO-2125 0.04 mg/kg q Week)	yghltkqoiv = oljzlhftic ueplxdmxkr (pimybpmvnf, twbjxdkxxo - uupcuohhuz) View more

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