A Phase 1, Open-label, Single-arm Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of TNFa and IL-2 Coding Oncolytic Adenovirus TILT-123 in Combination With Lymphocyte-depleting Chemotherapy and Tumor-infiltrating Lymphocytes in Melanoma Patients.

This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients.

Start Date01 Jun 2025

Sponsor / Collaborator

TILT Biotherapeutics Oy

NCT06125197

/ RecruitingPhase 1

A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Immune Checkpoint Inhibitor Refractory Non-Small Cell Lung Cancer

This is an open label, Phase 1, dose escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab in patients with immune checkpoint inhibitor refractory non-small cell lung cancer.

Start Date23 Jul 2024

Sponsor / Collaborator

TILT Biotherapeutics Oy

[+1]

NCT05222932

/ RecruitingPhase 1

A Phase I Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and IL-2 Coding Oncolytic Adenovirus TILT-123 and Avelumab in Solid Tumor Patients (Melanoma and SCCHN) Refractory to or Progressing After Anti-PD(L)1

This is a phase 1, dose-escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with avelumab in patients with advanced solid tumors refractory to or progressing after anti-PD(L)1.

Start Date08 Mar 2023

Sponsor / Collaborator

TILT Biotherapeutics Oy

100 Clinical Results associated with Igrelimogene litadenorepvec

100 Translational Medicine associated with Igrelimogene litadenorepvec

100 Patents (Medical) associated with Igrelimogene litadenorepvec

Literatures (Medical) associated with Igrelimogene litadenorepvec

01 Mar 2025·Cell Reports Medicine

Safety and efficacy of combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus TILT-123 in metastatic melanoma

Article

Author: Vestergaard, Cecilie ; Albieri, Benedetta ; Cervera-Carrascon, Victor ; Kistler, Claudia ; Quixabeira, Dafne C A ; Lorentzen, Torben ; Santos, João M ; Clubb, James H A ; Ellebaek, Eva ; Holmstroem, Rikke B ; Dreno, Brigitte ; Borch, Troels H ; Jirovec, Elise ; Khammari, Amir ; Haybout, Lyna ; Westergaard, Marie C W ; Arias, Victor ; Pakola, Santeri A ; Met, Özcan ; Donia, Marco ; Hemminki, Akseli ; Monberg, Tine J ; Kudling, Tatiana V ; Hendel, Helle W ; Lorentzen, Cathrine ; Havunen, Riikka ; Sorsa, Suvi ; Eefsen, Rikke L ; Svane, Inge Marie

Tumor-infiltrating lymphocytes (TILs) are effective in the treatment of metastatic melanoma (MM), but toxicity limits its application. TILT-123 (igrelimogene litadenorepvec) is an oncolytic adenovirus producing interleukin-2 (IL-2) and tumor necrosis factor (TNF) upon replication. In this phase 1 trial, 17 patients with metastatic checkpoint inhibitor-resistant melanoma are treated with TILT-123 and TILs without preconditioning chemotherapy or postconditioning IL-2. The treatment is safe and feasible. According to computed tomography (CT), the objective response rate is 11.7% (2/17) and disease control is observed in 35% (6/17), including a partial response lasting >8 months and a durable complete response in a mucosal melanoma patient. According to positron emission tomography (PET), disease control is observed in 7/15 (47%) with minor or partial responses in 4/15 (27%). In the initial TILT-123 monotherapy phase of the trial, disease control is observed in 6/17 (35%) and 10/16 (63%) in CT and PET, respectively. The study demonstrates good tolerability and preliminary efficacy.

01 Jan 2025·Journal for ImmunoTherapy of Cancer

Transient lymphocyte count decrease correlates with oncolytic adenovirus efficacy in humans: mechanistic and biomarker findings from TUNIMO phase I trial

Article

Author: Pellinen, Teijo ; Quixabeira, Dafne C A ; Kistler, Claudia ; Pakola, Santeri A ; Cervera-Carrascon, Victor ; Hemminki, Akseli ; Clubb, James H A ; Haybout, Lyna ; Arias, Victor ; Taipale, Kristian ; Kudling, Tatiana V ; van der Heijden, Mirte ; Santos, Joao M ; Havunen, Riikka ; Jirovec, Elise ; Peltola, Katriina ; Sorsa, Suvi ; Alanko, Tuomo ; Sormunen, Jorma

Background:

Oncolytic viruses (OVs) are promising immunotherapeutics to treat immunologically cold tumors. However, research on the mechanism of action of OVs in humans and clinically relevant biomarkers is still sparse. To induce strong T-cell responses against solid tumors, TILT-123 (Ad5/3-E2F-d24-hTNFa-IRES-hIL2, igrelimogene litadenorepvec) was developed. TILT-123 encodes two transgenes: tumor necrosis alpha (TNFa) and interleukin-2 (IL-2). TUNIMO (NCT04695327) was a phase I clinical trial using TILT-123 in patients with advanced solid tumors aiming to assess the safety, efficacy, and immunological effects of TILT-123. Research presented in this study evaluated the immunological effects of TILT-123 in the TUNIMO trial by using biological samples collected from the patients during the study, with an objective to leverage the findings to develop possible biomarkers of response and gain insights into possible synergistic combination treatments.

Methods:

20 patients with advanced solid tumors were treated with TILT-123. Response to therapy was assessed with contrast-enhanced CT and fluorodeoxyglucose positron emission tomography, along with overall survival (OS) calculation. Biological samples from patients were collected in the form of blood and tumor biopsies. Collected samples were analyzed with immunohistochemistry, transcriptomics, proteomics, and flow cytometry.

Results:

TILT-123 induced cyclical decreases in blood lymphocyte count, and more substantial blood lymphocyte count correlated with better radiographical response and longer OS. Lymphocyte count findings were confirmed with external control dataset of 96 patients. More substantial lymphocyte count change was linked to stronger immune activation in plasma proteome after intravenous TILT-123 and the presence of TILT-123 mRNA in tumors. Regarding other assays. tumor biopsies profiled showed increased amounts of CD8+ T cells, CD4+ T cells and NK cells after intravenous TILT-123, but not after intratumoral TILT-123. Transcriptional differences were seen in tumors after intravenous therapy and intratumoral therapy, with patients benefitting therapy showing stronger downregulation of immune activation at all time points.

Conclusions:

TILT-123 therapy induced accumulation of effector lymphocytes in tumors. Peripheral lymphocyte count decrease is a promising biomarker for assessing oncolytic adenovirus therapy response.

01 Dec 2024·Immuno-oncology technology

Durable complete response after combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus (TILT-123) in a patient with metastatic mucosal melanoma

Article

Author: Quixabeira, D C A ; Westergaard, M C W ; Havunen, R ; Kudling, T ; Donia, M ; Jirovec, E ; Clubb, J ; Ellebaek, E ; Sorsa, S ; von Buchwald, C ; Monberg, T J ; Santos, J M ; Pakola, S ; Cervera-Carrascon, V ; Albieri, B ; Eefsen, R L ; Haybout, L ; Svane, I M ; Hemminki, A ; Kistler, C

Background:

Despite significant advancements in the treatment of malignant melanoma, metastatic mucosal melanoma remains a therapeutic challenge due to its complex pathogenesis, distinct pathological characteristics, and limited response to immunotherapy. Combining different immunotherapeutic approaches offers a potential strategy to address these challenges. Tumor-infiltrating lymphocyte (TIL) therapy and oncolytic virus therapy represent promising treatment modalities that may synergize with each other.

Patient and methods:

We present a case of a 48-year-old woman with metastatic sinonasal mucosal melanoma who achieved a durable complete pathological response following treatment with multiple injections of the oncolytic virus TILT-123 (igrelimogene litadenorepvec) and a single infusion of TILs, without preconditioning chemotherapy or postconditioning interleukin-2.

Results:

Immunohistochemical analysis and single-cell sequencing revealed interesting alterations in injected and noninjected tumors as well as in peripheral blood, during the treatment course, suggesting that TILT-123 facilitated TIL engraftment into the tumor, ultimately leading to a complete response.

Conclusions:

This case underscores the potential of combined immunotherapeutic approaches as a promising strategy for patients with metastatic mucosal melanoma.

News (Medical) associated with Igrelimogene litadenorepvec

13 May 2025

·www.globenewswire.com

TILT Biotherapeutics Announces Closing of USD 25 Million Series B Financing

Initiates Phase 2 platinum-resistant ovarian cancer trialHELSINKI, May 13, 2025 (GLOBE NEWSWIRE) -- TILT Biotherapeutics (Tiltbio), a clinical-stage biotechnology company developing intravenously delivered cancer immunotherapies, announces it has raised USD 25.6 million (EUR 22.6 million) in a Series B financing. The financing was supported by existing investors; the European Innovation Council (EIC) Fund, Lifeline Ventures, Finnish Industry Investment (TESI), and Stephen Industries Inc Oy. It will support a Phase 2 clinical trial of Tiltbio’s lead product, TILT-123, in patients with platinum-resistant epithelial ovarian cancer, a Phase 1b trial in melanoma in combination with TILs and other Phase 1b trials. The Company recently published data from its Phase 1a clinical trial (PROTA) in platinum-resistant ovarian cancer in Nature Communications (1), which was also presented at AACR (2). The data showed that treatment was well tolerated with an excellent safety profile and promising efficacy observed in some patients. Disease control was achieved in 64% of evaluable patients (9/14) while the overall response rate was 20% at the highest dose level. Median progression-free survival and overall survival were 98 and 190 days respectively. Interim results from ongoing Phase 1b trials are expected to read out in H2 2026. Tiltbio’s founder and CEO, Akseli Hemminki, said: “We are delighted to have secured our Series B financing and thank our investors for their continued support. We’ve been making good progress in ovarian cancer and this financing will support the roll out of our Phase 2 clinical trials. We’re excited to have already opened the first site in the USA and are looking forward to dosing our first patients soon and opening at least five more sites this year.” He continued, “Ovarian cancer continues to be an unmet medical need despite recent therapies being approved. There are no oncolytic viruses or checkpoint inhibitors currently approved for use in this indication. We are committed to our mission to transform the treatment options for patients with ovarian cancer with TILT-123.” TILT-123 (Igrelimogene litadenorepvec), an oncolytic adenovirus armed with tumor necrosis factor (TNF) and interleukin-2 (IL-2), is designed to enhance the efficacy of T-cell therapies and immune checkpoint blockade. Tiltbio has a collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318). Reference (1) Nature Communications paper: “The oncolytic adenovirus TILT-123 with pembrolizumab in platinum resistant or refractory ovarian cancer: the phase 1a PROTA trial.”(2) American Association for Cancer Research (AACR) Annual Meeting 2025 poster link: ‘Clinical immunology correlates in platinum resistant or refractory ovarian cancer patients treated with chimeric oncolytic adenovirus encoding TNF and IL-2 (TILT-123) in combination with pembrolizumab’ Notes to Editors About TILT Biotherapeutics TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary oncolytic adenoviruses armed with molecules including cytokines that can activate T cells and destroy cancer cells. The company’s patented TILT® technology can be delivered intravenously, locoregionally, or intratumorally. It modifies the tumor microenvironment and has a broader systemic effect. By making cold tumors hot, it eliminates cancer’s ability to evade immune responses, thereby enhancing immune checkpoint inhibitors or T-cell therapies such as tumor infiltrating lymphocyte (TIL) and CAR T therapies. Over eighty patients have been treated in five international trials sponsored by the company with excellent safety profiles and promising initial efficacy responses observed in some patients. The company’s pioneering approach has been recognized by industry leaders. It has two collaborations with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318) and in refractory non-small cell lung cancer (NCT06125197). The company is also collaborating with Merck KGaA (Darmstadt, Germany) and investigating TILT-123 in combination with Bavencio® (avelumab). Based in Helsinki, Finland, and with an office in Boston, the company was established over a decade ago as a spin-out from the University of Helsinki. To date Tiltbio has secured over EUR 72 million in financing from investors including the European Innovation Council (EIC) Fund, Lifeline Ventures, Finnish Industry Investment (TESI), Stephen Industries, angel investors, Business Finland, the EIC Accelerator programme, and the U.S. Department of Defense. Media contacts TILT Biotherapeutics COO Aino Kalervoaino@tiltbio.com Scius CommunicationsKatja Stout+447789435990katja@sciuscommunications.com Daniel Gooch+447747875479daniel@sciuscommunications.com

Phase 2Phase 1Clinical ResultImmunotherapyAACR

13 May 2025

·firstwordpharma.com

Tiltbio nabs $25M to launch mid-stage study of oncolytic virus

Tilt Biotherapeutics raised €22.6 million ($25.6 million) in a series B on Tuesday to advance its experimental oncolytic adenovirus therapy into a Phase II trial for platinum-resistant ovarian cancer (PROC). Armed with TNFα and IL-2, the adenovirus — dubbed TILT-123 — is designed to be given in combination with T cell–based therapies such as tumour-infiltrating lymphocytes (TILs) or checkpoint inhibitors to boost their efficacy. The round, which brings the Finnish biotech's total funding to over €72 million, was backed by the European Innovation Council Fund, Finnish Industry Investment, Stephen Industries Inc Oy and Lifeline Ventures; the latter led Tiltbio's €22-million financing in 2023.Combo dataThe fresh capital comes on the heels of Tiltbio's presentation at the American Association for Cancer Research (AACR) meeting last month.In the PROTA Phase I study, patients with PROC were given TILT-123 in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab). Of 14 evaluable patients, nine achieved disease control (64%); median progression-free survival was 98 days, with a median overall survival of 190 days. In the five-patient high-dose cohort, the drug duo led to an overall response rate of 20%. "Ovarian cancer continues to be an unmet medical need despite recent therapies being approved," CEO Akseli Hemminki said. "We’ve been making good progress in ovarian cancer and this financing will support the roll out of our Phase II clinical trials. We’re excited to have already opened the first site in the US and are looking forward to dosing our first patients soon and opening at least five more sites this year.”Tiltbio is exploring other cancers outside of ovarian. Tuesday's funding will help launch a Phase Ib study dosing TILT-123 in combination with TILs in patients with melanomaThe biotech is also evaluating Keytruda plus TILT-123 in patients with refractory non–small-cell lung cancer. In addition, Tiltbio previously inked a partnership with Merck KGaA to study TILT-123 with PD-L1 inhibitor Bavencio (avelumab).

Phase 2Clinical ResultPhase 1AACR

05 Dec 2024

·www.globenewswire.com

TILT Biotherapeutics Provides Update on International Clinical Trial Progress with Intravenous Delivery Regimen for Cancer Immunotherapies

Data Presented at ESMO-IO supports the potential of personalized treatment strategies to improve clinical trial outcomesHELSINKI, Finland, Dec. 05, 2024 (GLOBE NEWSWIRE) -- TILT Biotherapeutics (TILT), a clinical-stage biotechnology company developing intravenously delivered cancer immunotherapies, announces it will be presenting data at the European Society of Medical Oncology Immuno-Oncology Congress (ESMO-IO) 2024. The oral presentation discloses the impact of different biological features on treatment efficacy in patients treated with the oncolytic virus Igrelimogene litadenorepvec or ‘TILT-123’(1). The study used single-cell sequencing analysis to identify immunological markers in peripheral blood mononuclear cells that were related with better outcomes, including higher baseline levels of cytotoxic effector cells. Additionally, TILT-123 treatment supported the formation of immunological memory. TILT will also present data relating to the fully intravenous dosing of TILT-123 (2). These findings have the potential to support future clinical development strategy. In addition, TILT is progressing its plans for international Phase II trials of TILT-123 in ovarian cancer, to be administered intravenously, and expects Phase Ib clinical results by H2 2025. TILT Biotherapeutics’ founder and CEO, Akseli Hemminki, said: “This year we’ve made significant progress in the clinical development of TILT-123, and have now treated over 60 patients in five international trials, including our first patients in leading US cancer centres. Our data, presented at ESMO-IO this month, provides further support on the mechanism of action of our oncolytic immunotherapy. Our progress in IV administration, alongside our manufacturing process scale up work, supports our mission to make TILT-123 accessible to patients with hard-to-treat solid cancers.” TILT-123, an oncolytic adenovirus armed with tumor necrosis factor alpha (TNFα) and interleukin-2 (IL-2), is designed to enhance the efficacy of T-cell therapies, including immune checkpoint blockade or adoptive cell transfer. TILT’s approach uses oncolytic viruses to selectively replicate in and lyse cancer cells, while simultaneously stimulating immune responses towards the tumor. Reference (1) ESMO-IO Abstract 353: “Single-cell profiling of peripheral blood mononuclear cells from patients treated with oncolytic adenovirus armed with TNFα and IL-2 revealed pre-existing immunity as a predictor of therapy outcomes”. (2) ESMO-IO Abstract 458: “Effect of split intravenous dosing of oncolytic adenovirus TILT-123 on normal tissue versus tumor macrophages and virus bioavailability in patients with advanced solid tumors”. Notes to Editors About TILT Biotherapeutics TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary oncolytic adenoviruses armed with molecules including cytokines that can activate T cells and destroy cancer cells. The company’s patented TILT® technology can be delivered intravenously, locoregionally, or intratumorally. It modifies the tumor microenvironment and has a broader systemic effect. By making cold tumors hot, it eliminates cancer’s ability to evade immune responses, thereby enhancing T-cell therapies such as immune checkpoint inhibitors, tumor infiltrating lymphocyte (TIL) therapy, and CAR T therapies. TILT’s lead asset, TILT-123 also known as Igrelimogene litadenorepvec, is a 5/3 chimeric serotype adenovirus armed with two human cytokines: TNF alpha and IL-2. Over sixty patients have been treated in five international trials sponsored by the company with promising initial efficacy responses observed in some of the patients. The company’s pioneering approach has been recognized by industry leaders. It has two collaborations with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318) and in refractory non-small cell lung cancer (NCT06125197). The company is also collaborating with Merck KGaA (Darmstadt, Germany) and investigating TILT-123 in combination with Bavencio® (avelumab). Based in Helsinki, Finland, and with an office in Boston, the company was established over a decade ago as a spin-out from the University of Helsinki. It has funding from Lifeline Ventures, Finnish Industry Investment (TESI), angel investors, Business Finland, the European Innovation Council, and the U.S. Department of Defense. Media contacts TILT BiotherapeuticsCOO Aino Kalervoaino@tiltbio.com Scius CommunicationsKatja Stout+447789435990katja@sciuscommunications.com Daniel Gooch+447747875479daniel@sciuscommunications.com

ImmunotherapyClinical Study

100 Deals associated with Igrelimogene litadenorepvec

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Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	United States	TILT Biotherapeutics Oy	17 May 2022
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	Finland	TILT Biotherapeutics Oy	17 May 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	TILT Biotherapeutics Oy	17 May 2022
Platinum-Resistant Ovarian Carcinoma	Phase 2	Finland	TILT Biotherapeutics Oy	17 May 2022
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	United States	TILT Biotherapeutics Oy	17 May 2022
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	Finland	TILT Biotherapeutics Oy	17 May 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 2	United States	TILT Biotherapeutics Oy	17 May 2022
Platinum-Sensitive Fallopian Tube Carcinoma	Phase 2	Finland	TILT Biotherapeutics Oy	17 May 2022
Platinum-Sensitive Ovarian Carcinoma	Phase 2	United States	TILT Biotherapeutics Oy	17 May 2022
Platinum-Sensitive Ovarian Carcinoma	Phase 2	Finland	TILT Biotherapeutics Oy	17 May 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04695327 \| NCT05271318 \| NCT04217473 (TUNINTIL \| TUNIMO \| PROTA, Pubmed \| J Exp Clin Cancer Res)	Phase 1	Advanced Malignant Solid Neoplasm	52	TILT-123 3 × 10^9 VP	awtalmxxiq(dhrpepzljo) = uzoebepaov bdstqqzjfp (zrlgznmqnz )	Positive	06 Nov 2024
	Phase 1	Advanced Malignant Solid Neoplasm	52	TILT-123 4 × 10^12 VP	awtalmxxiq(dhrpepzljo) = nidgxleaep bdstqqzjfp (zrlgznmqnz )	Positive	06 Nov 2024
NCT05271318 (PROTA, ASCO2024) Manual	Phase 1	Refractory Ovarian Carcinoma \| Platinum-Resistant Ovarian Carcinoma	14	PembrolizumabIgrelimogene litadenorepvec	xswelzpfuv(shtuamndmi) = Frequent grade 1-4 treatment-related AEs (>30% of patients) were anemia, nausea, lymphocyte count decreased, fever and diarrhea ujilypivvi (asevtrzifi )	Positive	24 May 2024
NCT05271318 (PROTA, ASCO2024) Manual	Phase 1		14	PembrolizumabosomIgrelimogene litadenorepvec		Positive	24 May 2024
NCT04695327 \| NCT05271318 \| NCT04217473 (TILT-123, ASCO2024)	Phase 1	Neoplasms	52	TILT-123	dlrzgzpwvj(oymglablwp) = increased in the patients´ serum cpiicfdwtm (gesnevwzhl )	Positive	24 May 2024
NCT05271318 (AACR2024) Manual	Phase 1	Ovarian Cancer	15	TILT-123+pembrolizumab	lzoidezqee(ltablrlsxa) = not observed byzdtuyimh (cyzewaskju ) View more	Positive	05 Apr 2024
NCT04695327 (TUNIMO, Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm	20	TILT-123	mfomlbugcz(cfjvrwbsby) = rdzmhafbub ohztuegnuq (wkssgcgzhu )	Positive	28 Mar 2024
NCT04217473 (ESMO_IO 12023 \| ESMO_IO 22023) Manual	Phase 1	Melanoma	16	TILT-123	zqrszqqadj(kjkrkcuhon) = The most frequently reported adverse events (AEs) related to TILT-123 were fever (63%) and pain at the injection site (44%) while most frequent AEs related to TIL therapy were fever (50%) and chills (24%). rsxrxdters (wsgbaetvon )	Positive	06 Dec 2023
NCT04695327 (TUNIMO , SITC 12023 \| SITC 22023) Manual	Phase 1	Solid tumor	20	TILT-123	ymgwkcjeeg(oaznsrqbtk) = not observed ltnqajluxp (hduseukxhb ) View more	Positive	31 Oct 2023
NCT04695327 \| NCT05222932 \| NCT05271318 \| NCT04217473 (SITC 12022 \| SITC 22022) Manual	Phase 1	Solid tumor	18	TILT-123	mhxufgdftk(cogwvecxml) = hcvflewnhf kbwuqhcalx (fdwqixzauf )	Positive	01 Nov 2022

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