MDA5 stimulants(interferon induced with helicase C domain 1 stimulants), RIG-I stimulants(Retinoic acid-inducible gene I stimulants), TLR3 agonists(Toll like receptor 3 agonists)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases+ [3]

Active Indication

Basal Cell CarcinomaUnresectable MelanomaColorectal Cancer+ [15]

Inactive Indication

metastatic non-small cell lung cancer

Originator Organization

Highlight Therapeutics SL

Active Organization

Highlight Therapeutics SLMerck Sharp & Dohme LLC

Inactive Organization

Merck Sharp & Dohme Corp.

License Organization

Merck & Co., Inc.

Highlight Therapeutics SL

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Structure/Sequence

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Clinical Trials associated with BO-112

CTIS2024-511801-51-00

/ RecruitingPhase 2

SPOTLIGHT 204: A Multicenter, Phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma - BOT-112-204

Start Date10 Dec 2024

Sponsor / Collaborator-

NCT06422936

/ RecruitingPhase 2

SPOTLIGHT 204: a Multicenter, Phase 2b, Open-label, Non-randomized, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Intra-lesional BO-112 in Patients with Resectable Primary Low and High Risk Basal Cell Carcinoma

This is a multicenter, phase 2b, open-label, non-randomized, clinical trial to evaluate safety, tolerability, pharmacodynamics and preliminary efficacy of intra-lesional BO-112 in patients with resectable primary low and high risk basal cell carcinoma.
* primary endpoint is complete visual and pathological response [at surgery] on patient level assessed by central review
* secondary endpoints are
1. Occurrence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death on patient level.
2. Pathological response [at surgery] on patient level assessed by the investigator and central review, respectively, and visual response [during the study and at surgery] on patient level assessed by the investigator and central review, respectively.
3. Recurrence [at 12 and 24 months] after surgery on patient level assessed by the investigator.

Start Date27 May 2024

Sponsor / Collaborator

Highlight Therapeutics SL

NCT05265650

/ Unknown statusPhase 1/2IIT

Phase Ib/II Open-label Clinical Study of Intratumoral Administration of BO-112 in Combination With Radiotherapy and Nivolumab in Patients With Metastatic PD- 1/PD-L1 Refractory Non-small Cell Lung Cancer

This is a study of repeated IT administrations of BO-112 in combination with ablative radiotherapy (SABR) and concurrent nivolumab in patients with metastatic PD-1/PD-L1-refractory NSCLC.

Start Date13 Jun 2022

Sponsor / Collaborator

Clínica Universidad de Navarra

[+1]

100 Clinical Results associated with BO-112

100 Translational Medicine associated with BO-112

100 Patents (Medical) associated with BO-112

Literatures (Medical) associated with BO-112

01 Apr 2024·Journal for immunotherapy of cancer

Efficacy of LCMV-based cancer immunotherapies is unleashed by intratumoral injections of polyI:C

Article

Author: Quintero, Marisol ; Russo-Cabrera, Joan Salvador ; Alvarez, Maite ; Ardaiz, Nuria ; Gomar, Celia ; Di Trani, Claudia Augusta ; Berraondo, Pedro ; Lauterbach, Henning ; Gonzalez-Gomariz, Jose ; Arrizabalaga, Leire ; Aranda, Fernando ; Bella, Angela ; Fernandez-Sendin, Myriam ; Schippers, Timo ; Orlinger, Klaus K ; Melero, Ignacio

Background:

Lymphocytic choriomeningitis virus (LCMV) belongs to the Arenavirus family known for inducing strong cytotoxic T-cell responses in both mice and humans. LCMV has been engineered for the development of cancer immunotherapies, currently undergoing evaluation in phase I/II clinical trials. Initial findings have demonstrated safety and an exceptional ability to activate and expand tumor-specific T lymphocytes. Combination strategies to maximize the antitumor effectiveness of LCMV-based immunotherapies are being explored.

Methods:

We assessed the antitumor therapeutic effects of intratumoral administration of polyinosinic:polycytidylic acid (poly(I:C)) and systemic vaccination using an LCMV-vector expressing non-oncogenic versions of the E6 and E7 antigens of human papillomavirus 16 (artLCMV-E7E6) in a bilateral model engrafting TC-1/A9 cells. This cell line, derived from the parental TC-1, exhibits low MHC class I expression and is highly immune-resistant. The mechanisms underlying the combination’s efficacy were investigated through bulk RNA-seq, flow cytometry analyses of the tumor microenvironment, selective depletions using antibodies and clodronate liposomes, Batf3 deficient mice, and in vivo bioluminescence experiments. Finally, we assessed the antitumor effectiveness of the combination of artLCMV-E7E6 with BO-112, a GMP-grade poly(I:C) formulated in polyethyleneimine, currently under evaluation in clinical trials.

Results:

Intratumoral injection of poly(I:C) enhanced the antitumor efficacy of artLCMV-E7E6 in both injected and non-injected tumor lesions. The combined treatment resulted in a significant delay in tumor growth and often complete eradication of several tumor lesions, leading to significantly improved survival compared with monotherapies. While intratumoral administration of poly(I:C) did not impact LCMV vector biodistribution or transgene expression, it significantly modified leucocyte infiltrates within the tumor microenvironment and amplified systemic efficacy through proinflammatory cytokines/chemokines such as CCL3, CCL5, CXCL10, TNF, IFNα, and IL12p70. Upregulation of MHC on tumor cells and a reconfiguration of the gene expression programs related to tumor vasculature, leucocyte migration, and the activation profile of tumor-infiltrating CD8+T lymphocytes were observed. Indeed, the antitumor effect relied on the functions of CD8+T lymphocytes and macrophages. The synergistic efficacy of the combination was further confirmed when BO-112 was included.

Conclusion:

Intratumoral injection of poly(I:C) sensitizes MHClowtumors to the antitumor effects of artLCMV-E7E6, resulting in a potent therapeutic synergy.

31 Dec 2023·Oncoimmunology

Intratumoral neoadjuvant immunotherapy based on the BO-112 viral RNA mimetic

Article

Author: Glez-Vaz, Javier ; Alvarez, Maite ; Garasa, Saray ; Gomis, Gabriel ; Quintero, Marisol ; Olivera, Irene ; Molina, Carmen ; Berraondo, Pedro ; Cirella, Assunta ; Ochoa, Maria C. ; Bolaños, Elixabet ; Gonzalez-Gomariz, Jose ; azpilikueta, arantza ; luri-Rey, carlos ; Rodriguez-Ruiz, Maria E ; Teijeira, Alvaro ; Melero, Ignacio

BO-112 is a poly I:C-based viral mimetic that exerts anti-tumor efficacy when intratumorally delivered in mouse models. Intratumoral BO-112 synergizes in mice with systemic anti-PD-1 mAbs and this combination has attained efficacy in PD1-refractory melanoma patients. We sought to evaluate the anti-tumor efficacy of BO-112 pre-surgically applied in neoadjuvant settings to mouse models. We have observed that repeated intratumoral injections of BO-112 prior to surgical excision of the primary tumor significantly reduced tumor metastasis from orthotopically implanted 4T1-derived tumors and subcutaneous MC38-derived tumors in mice. Such effects were enhanced when combined with systemic anti-PD-1 mAb. The anti-tumor efficacy of this neoadjuvant immunotherapy approach depended on the presence of antigen-specific effector CD8 T cells and cDC1 antigen-presenting cells. Since BO-112 has been successful in phase-two clinical trials for metastatic melanoma, these results provide a strong rationale for translating this pre-surgical strategy into clinical settings, especially in combination with standard-of-care checkpoint inhibitors.

01 Jan 2023·Journal for immunotherapy of cancer

Intratumoral BO-112 in combination with radiotherapy synergizes to achieve CD8 T-cell-mediated local tumor control

Article

Author: Barrio-Alonso, Celia ; Quintero, Marisol ; Alvarez, Maite ; Sánchez-Mateos, Paloma ; Rodríguez López, Inmaculada ; Perez-Gracia, Jose Luis ; Escuin-Ordinas, Helena ; Serrano-Mendioroz, Irantzu ; Garate-Soraluze, Eneko ; Arbea Moreno, Leire ; Diaz Pascual, Victor ; Sanmamed, Miguel F ; Rodriguez-Ruiz, Maria E ; Melero, Ignacio

Background:

Radioimmunotherapy combines irradiation of tumor lesions with immunotherapy to achieve local and abscopal control of cancer. Most immunotherapy agents are given systemically, but strategies for delivering immunotherapy locally are under clinical scrutiny to maximize efficacy and avoid toxicity. Local immunotherapy, by injecting various pathogen-associated molecular patterns, has shown efficacy both preclinically and clinically. BO-112 is a viral mimetic based on nanoplexed double-stranded RNA (poly I:C) which exerts immune-mediated antitumor effects in mice and humans on intratumoral delivery. BO-112 and focal irradiation were used to make the proof-of-concept for local immunotherapy plus radiation therapy combinations.

Methods:

Murine transplantable tumor cell lines (TS/A, MC38 and B16-OVA) were used to show increased immunogenic features under irradiation, as well as in bilateral tumor models in which only one of the lesions was irradiated or/and injected with BO-112. Flow cytometry and multiplex tissue immunofluorescence were used to determine the effects on antitumor immunity. Depletions of immune cell populations and knockout mice for the IFNAR and BATF-3 genes were used to delineate the immune system requirements for efficacy.

Results:

In cultures of TS/A breast cancer cells, the combination of irradiation and BO-112 showed more prominent features of immunogenic tumor cell death in terms of calreticulin exposure. Injection of BO-112 into the tumor lesion receiving radiation achieved excellent control of the treated tumor and modest delays in contralateral tumor progression. Local effects were associated with more prominent infiltrates of antitumor cytotoxic tumor lymphocytes (CTLs). Importantly, local irradiation plus BO-112 in one of the tumor lesions that enhanced the therapeutic effects of radiotherapy on distant irradiated lesions that were not injected with BO-112. Hence, this beneficial effect of local irradiation plus BO-112 on a tumor lesion enhanced the therapeutic response to radiotherapy on distant non-injected lesions.

Conclusion:

This study demonstrates that local BO-112 immunotherapy and focal irradiation may act in synergy to achieve local tumor control. Irradiation plus BO-112 in one of the tumor lesions enhanced the therapeutic effects on distant irradiated lesions that were not injected with BO-112, suggesting strategies to treat oligometastatic patients with lesions susceptible to radiotherapy and with at least one tumor accessible for repeated BO-112 intratumoral injections.

News (Medical) associated with BO-112

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

13 Apr 2022

·www.biospace.com

Global Roundup: A CAR-T Partnership and CDR-Life Nabs $76M to Engage Solid Tumors

Australia’s Chimeric Therapeutics has partnered with WuXi ATU on two autologous CAR T-cell therapies for solid tumors. Switzerland-based CDR-Life closed a $76 million Series A. Australia’s Chimeric Therapeutics has partnered with WuXi ATU , a global contract testing and manufacturing organization focusing on the company’s two autologous CAR T-cell therapies for solid tumors. Chimeric’s first CAR-T is CHM 2101 and is in preclinical development for gastrointestinal (GI) cancers. CHM 2101 will leverage WuXi ATU’s end-to-end closed-loop CAR T process development, Good Manufacturing Practice (GMP) manufacturing and testing platform, aiming to accelerate development towards its planned first-in-human study. CHM 1101 is being evaluated in a single-site Phase I clinical trial for recurrent or progressive glioblastoma patients. CHM 1101 will also leverage WuXi ATU’s scalable manufacturing and analytical testing capacity to enable potential future expansion of the program to multiple additional clinical trial sites and additional solid tumor indications, including metastatic melanoma. This partnership is expected to enable Chimeric to accelerate clinical manufacturing readiness for new CAR T assets and scale its CAR T manufacturing in order to support multiple, simultaneous, multi-center CAR T clinical trials in the future. “We are very excited to enter into this partnership with WuXi ATU,” Jennifer Chow, chief executive officer of Chimeric Therapeutics said in a statement. “With its extensive experience in cGMP manufacturing and analytical testing, as well as its seamless platform process for CAR T-cell production, WuXi ATU is uniquely positioned to support the acceleration and expansion of the CHM 1101 and CHM 2101 development programs.” Elsewhere around the globe: Trinity Biotech : Ireland’s Trinity Biotech secured a $45 million strategic investment and partnership with Korea-based MiCo Ltd., an in vitro diagnostics company. Funds are expected to be used to repay an $81.25 million loan and reduce annual interest costs of $4 million. Trinity also hopes that this investment will facilitate its exploring lower-cost debt funding options. SciRhom Gmbh: Based in Germany, SciRhom nominated the anti-iRhom2 antibody, which will advance into clinical development. This first-in-class drug candidate has demonstrated “outstanding preclinical efficacy” in treating rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Having completed the comprehensive characterization of the molecule, SciRhom will now enter into IND-enabling activities. SciRhom’s drug candidate inhibits the cell surface-localized protein iRhom2, a critical regulator of the protease TACE. By interfering with this complex, the anti-iRhom2 antibody allows the simultaneous blockade of several pro-inflammatory signaling pathways without impairing protective functions. Captor Therapeutics: Based in Poland, Captor announced the molecular targets of one of its core pipeline projects, which focuses on developing TPD therapy for hepatocellular carcinoma (HCC). Preclinical data have shown that CT-101 induces degradation of Eukaryotic peptide chain release factor GTP-binding subunit ERF3A (GSPT1), Sal-like protein 4 (SALL4) and another undisclosed neo-substrate with an essential function in tumorigenesis. XORTX Therapeutics : Alberta, Canada-based XORTX, received a no objection letter (NOL) from Health Canada regarding the company’s upcoming XRX-OXY-101 clinical bridging pharmacokinetics study. The study will determine which formulation results in the best circulating oxypurinol concentrations and the effect of food on the formulation. The study is expected to support a New Drug Application filing in the U.S. and Europe. Revive Therapeutics : Toronto’s Revive Therapeutics announced the Data Safety and Monitoring Board will assess the current clinical and safety data of the ongoing Phase III study of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19 in order to advise whether or not the trial should be halted early due to efficacy. Numinus Wellness: Across Canada in Vancouver, Numinus Wellness announced plans to acquire all outstanding shares of Novamind Inc. for $26.2 million. The combined company will operate 13 wellness following the Transaction to become a leading psychedelic-assisted therapy provider in North America. Achilles Therapeutics : Based in the U.K., Achilles announced the manufacturing expansion of its facility at the Cell & Gene Therapy Catapult in Stevenage and received the go-ahead from the UK Medicines and Healthcare products Regulatory Agency. The Catapult facility is now GMP certified to produce clinical grade doses of cNeT. The approach will initially support Achilles’ proprietary VELOS manufacturing process. Separately, the company entered into a partnership agreement for clinical manufacturing with the Center for Breakthrough Medicines in Pennsylvania. Recce Pharmaceuticals: Back Down Under, Recce Pharmaceuticals announced that the Intellectual Property Department of the Hong Kong Special Administrative Region granted a patent for its “Anti-Virus Agent and Method for Treatment of Viral Infection,” which furthers marketing and manufacturing exclusivity to February 2037. MediWound : Israel-based MediWound announced data from its Phase II study of EscharEx was highlighted in a poster and oral presentation at the 35th Symposium on Advanced Wound Care (SAWC) spring conference. The poster entitled: “Results from an Ongoing Open Phase 2 Study Assessing the Safety, Efficacy and Pharmacological Effects of Bromelain-based Enzymatic Debridement on Biofilm, Microbial loads and Cytokines in patients with DFU and VLU,” featured data from an ongoing Phase II study that showed EscharEx to debride wounds and promote wound area reduction, while reducing biofilm and bacterial bioburden safely and effectively. Sotio Biotech: Sotio, which is based in Prague, announced interim safety and efficacy results from the ongoing Phase 1/1b AURELIO-03 study of SOT101, an IL-15 superagonist, in combination with Keytruda in patients with advanced/metastatic solid tumors. The data showed that the combination was well tolerated, and most patients saw a clinical benefit. Highlight Therapeutics: Based in Spain, Highlight announced positive results from a Phase II study of intratumoral administration of BO-112 with Keytruda in patients with advanced melanoma whose disease had progressed on first-line anti-PD1-based therapy. BO-112 is a dsRNA agonist targeting anti-PD1 resistance, which has demonstrated anti-cancer activity in previous Phase Ib studies. ITM Isotope: Germany-based ITM announced a global clinical supply agreement with Pennsylvania’s Molecular Targeting Technologies Inc., which provides the U.S. company with ITM’s medical radioisotope no-carrier-added lutetium-177 for the preclinical and clinical development of that MTTI’s own radiopharmaceutical candidate lubetate for cancers. CDR-Life Inc.: Switzerland-based CDR-Life closed a $76 million Series A financing round that will support the advancement of its lead program, CDR404, a first of its kind dual MAGE-A4 T cell engager which targets solid tumors across multiple indications. The finances will support the development of CDR404 through potential clinical proof-of-concept readout as well as expansion of the pipeline leveraging the company’s M-gager technology. The Series A was led by Jeito Capital and RA Capital Management. Other participants include Omega Funds.

Phase 2Phase 1Clinical ResultPhase 3Immunotherapy

30 Mar 2021

·www.mobihealthnews.com

Quibim works with Highlight Therapeutics to improve immunotherapy in melanoma with AI

Quibim, a global medical imaging analysis specialist, has joined Highlight Therapeutics, a clinical-stage company specialising in immuno-oncology, to assess the efficacy of new immunotherapy treatments in advanced melanoma skin cancer using AI in a Phase II clinical trial in Spain. The alliance will analyse the information contained in radiological scans and correlate these findings with biological changes in patients who are treated with pembrolizumab and BO-112, a synthetic double stranded RNA that is administered as intratumoral therapy in advanced melanoma. WHY IT MATTERS Assessing efficacy in terms of response rate and correlating it with tumour biomarkers will help better understand different patterns of response, a task that remains challenging in immunotherapy, especially with intratumoral treatments. The study will use Quibim’s AI-fed whole-body imaging ecosystem to correlate radiomic signatures with immunohistochemistry biomarkers to identify those patients who will benefit the most from immunotherapy. THE LARGER TREND Global incidence of melanoma has reached epidemic proportions and cases are expected to grow to almost half a million by 2040, according to the World Health Organisation. The trial will bring much needed evidence on those patients who may benefit the most from the new approach and improve treatment for melanoma, by helping overcome current pitfalls in treatment response evaluation. ON THE RECORD “We are facing the unmet medical need of treating patients who have developed progressive disease to immunotherapy,” said Dr Sonia Macia, medical director of Highlight Therapeutics. “We will try to overcome this resistance by adding BO-112 to pembrolizumab, an approved anti-PD1 drug, which is currently indicated in the treatment of several solid tumours. Confirming the biological changes in injected lesions and correlating these findings with imaging features may help us predict which patients will have a better response to therapy.” “Quibim is committed to the discovery of new imaging biomarkers that can later be applied in clinical practice,” commented Dr Ángel Alberich-Bayarri, Quibim CEO and Co-founder. “Oncology and more specifically immunotherapy are key areas where quantitative imaging plays a pivotal role. Having objective measures can help improve the evaluation of treatment response and save lives, by identifying early on who will benefit the most from a specific approach.”

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100 Deals associated with BO-112

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Indication	Highest Phase	Country/Location	Organization	Date
Basal Cell Carcinoma	Phase 2	Israel	Highlight Therapeutics SL	27 May 2024
Basal Cell Carcinoma	Phase 2	Spain	Highlight Therapeutics SL	27 May 2024
metastatic non-small cell lung cancer	Phase 2	Spain	Highlight Therapeutics SL	13 Jun 2022
Non-Small Cell Lung Cancer	Phase 2	Spain	Highlight Therapeutics SL	13 Jun 2022
Unresectable Melanoma	Phase 2	France	Highlight Therapeutics SL	30 Dec 2020
Unresectable Melanoma	Phase 2	France	Merck Sharp & Dohme LLC	30 Dec 2020
Unresectable Melanoma	Phase 2	Spain	Merck Sharp & Dohme LLC	30 Dec 2020
Unresectable Melanoma	Phase 2	Spain	Highlight Therapeutics SL	30 Dec 2020
Colorectal Cancer	Phase 2	Spain	Highlight Therapeutics SL	-
Stomach Cancer	Phase 2	Spain	Highlight Therapeutics SL	-

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04570332 (SPOTLIGHT203, AACR2022) Manual	Phase 2	Locally Advanced Melanoma	42	Pembrolizumab+BO 112 (Global )	kyinfswjsv(dqhsohdfph) = znjjvrwpwp xtxqvqutcu (tlrqcezslx ) View more	Positive	15 Jun 2022
NCT04570332 (SPOTLIGHT203, AACR2022) Manual	Phase 2	Locally Advanced Melanoma	42	Pembrolizumab+BO 112 (Mucosal)	kyinfswjsv(dqhsohdfph) = jhodhkhlfd xtxqvqutcu (tlrqcezslx ) View more	Positive	15 Jun 2022
NCT04570332 (AACR2022)	Phase 2	Refractory Melanoma	42	BO-112 plus pembrolizumab	cdifhxnsrc(mynbyjgxyu) = xoqjkedvfs tgweenjnut (szioaokmuo ) View more	-	15 Jun 2022
AACR2021	Phase 2	colon cancer liver metastasis \| Gastrooesophageal junction cancer	69	BO-112	dvlmbllvmd(awdqimqrtd) = qwixdmclwp scfzegmvkp (ptffbahvht )	-	01 Jul 2021
NCT04570332 (AACR2021)	Phase 2	Melanoma	40	BO-112 in combination with pembrolizumab	dyunvzpqrz(hrhvpeszzu) = zbhxvhczjc bzvqtjcblu (tjmujdhafc ) View more	-	01 Jul 2021
NCT02828098 (ESMO2018)	Phase 1	Solid tumor	28	BO-112 Monotherapy	ekudwuizwq(itovuqvzcf) = uiajpstaxt fxxdfbuvqr (qebdaxyryu ) View more	Positive	20 Oct 2018
NCT02828098 (ESMO2018)	Phase 1	Solid tumor	28	Combination BO-112+anti PD-1	ekudwuizwq(itovuqvzcf) = rabbokltce fxxdfbuvqr (qebdaxyryu )	Positive	20 Oct 2018

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