BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.
This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).

Start Date29 Sep 2023

Sponsor / Collaborator

Ascendis Pharma A/S

NCT05081609 / RecruitingPhase 1/2

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

TransCon IL-2 β/γ is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This is a first-in-human, open-label, Phase 1/2, dose escalation and dose expansion study of TransCon IL-2 β/γ as monotherapy or in combination therapy in adult participants with advanced or metastatic solid tumors. Given the unique PK profile enabled by the TransCon technology, TransCon IL-2 β/γ presents the opportunity to enhance the therapeutic index of current IL-2 therapy.

Start Date11 Jan 2022

Sponsor / Collaborator

Ascendis Pharma Oncology Division A/S

NCT04799054 / Active, not recruitingPhase 1/2

Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

TransCon TLR7/8 Agonist is an investigational drug being developed for treatment of locally advanced or metastatic solid tumors. This Phase 1/2 study will evaluate TransCon TLR7/8 Agonist as monotherapy or in combination with pembrolizumab in dose escalation and dose expansion. Participants will receive intratumoral (IT) injection of TransCon TLR7/8 Agonist every cycle. The primary objectives are to evaluate safety and tolerability, and define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab.

Start Date18 Mar 2021

Sponsor / Collaborator

Ascendis Pharma Oncology Division A/S

100 Clinical Results associated with TransCon TLR7/8 Agonist(Ascendis Pharma)

100 Translational Medicine associated with TransCon TLR7/8 Agonist(Ascendis Pharma)

100 Patents (Medical) associated with TransCon TLR7/8 Agonist(Ascendis Pharma)

197

Literatures (Medical) associated with TransCon TLR7/8 Agonist(Ascendis Pharma)

01 Jul 2024·Journal of Cellular Biochemistry

TLR4/7‐mediated host‐defense responses of gingival epithelial cells

Article

Author: Tada, Ryohei ; Chiba, Norika ; Matsuguchi, Tetsuya ; Ohnishi, Tomokazu

AbstractGingival epithelial cells (GECs) are physical and immunological barriers against outward pathogens while coping with a plethora of non‐pathogenic commensal bacteria. GECs express several members of Toll‐like receptors (TLRs) and control subsequent innate immune responses. TLR4 senses lipopolysaccharide (LPS) while TLR7/8 recognizes single‐strand RNA (ssRNA) playing important roles against viral infection. However, their distinct roles in GECs have not been fully demonstrated. Here, we analyzed biological responses of GECs to LPS and CL075, a TLR7/8 agonist. GE1, a mouse gingival epithelial cell line, constitutively express TLR4 and TLR7, but not TLR8, like primary skin keratinocytes. Stimulation of GE1 cells with CL075 induced cytokine, chemokine, and antimicrobial peptide expressions, the pattern of which is rather different from that with LPS: higher mRNA levels of interferon (IFN) β, CXCL10, and β‐defensin (BD) 14 (mouse homolog of human BD3); lower levels of tumor necrosis factor (TNF), CCL5, CCL11, CCL20, CXCL2, and CX3CL1. As for the intracellular signal transduction of GE1 cells, CL075 rapidly induced significant AKT phosphorylation but failed to activate IKKα/β‐NFκB pathway, whereas LPS induced marked IKKα/β‐NFκB activation without significant AKT phosphorylation. In contrast, both CL075 and LPS induced rapid IKKα/β‐NFκB activation and AKT phosphorylation in a macrophage cell line. Furthermore, specific inhibition of AKT activity abrogated CL075‐induced IFNβ, CXCL10, and BD14 mRNA expression in GE1 cells. Thus, TLR4/7 ligands appear to induce rather different host‐defense responses of GECs through distinct intracellular signaling mechanisms.

03 Jun 2024·Angewandte Chemie International Edition

Activable Nano‐Immunomodulator Assembled from π‐Extended Naphthalenediimide for Precision Photothermal Immunotherapy

Article

Author: Ma, Zhaoyu ; Zhong, Wenbin ; Tan, Brynne Shu Ni ; Zhao, Yanli ; Yang, Jie ; Chen, Yun ; Ma, Mengmeng ; Yuan, Wei

AbstractA nano‐immunomodulator (R‐NPT NP) comprising a tumor microenvironment (TME) activable resiquimod (R848) and a π‐extended NIR‐absorbing naphthophenanthrolinetetraone (NPT) has been engineered for spatiotemporal controlled photothermal immunotherapy. R‐NPT NP demonstrated excellent photostability, while R848 promoted synergistic immunity as a toll‐like receptor 7/8 (TLR7/8) agonist. Upon accumulation at the tumor site, R‐NPT NP released R848 in response to redox metabolite glutathione (GSH), triggering dendritic cell (DC) activation. The photothermal effect endowed by R‐NPT NP can ablate tumors directly and trigger immunogenic cell death to augment immunity after photoirradiation. The synergistic effect of GSH‐liable TLR7/8 agonist and released immunogenic factors leads to a robust evocation of systematic immunity through promoted DC maturation and T cell infiltration. Thus, R‐NPT NP with photoirradiation achieved 99.3 % and 98.2 % growth inhibition against primary and distal tumors, respectively.

01 May 2024·Small

Chimeric Peptide‐Engineered Self‐Delivery Nanomedicine for Photodynamic‐Triggered Breast Cancer Immunotherapy by Macrophage Polarization

Article

Author: Tang, You-Zhi ; Li, Shi-Ying ; Zhang, Wei ; Liu, Yi-Bin ; Chen, Xia-Yun ; Liu, Qian-Qian ; Cen, Yi ; Yu, Bai-Xue ; Yan, Meng-Yi ; Huang, Chu-Yu

AbstractA systemic treatment strategy is urgently demanded to suppress the rapid growth and easy metastasis characteristics of breast cancer. In this work, a chimeric peptide‐engineered self‐delivery nanomedicine (designated as ChiP‐CeR) for photodynamic‐triggered breast cancer immunotherapy by macrophage polarization. Among these, ChiP‐CeR is composed of the photosensitizer of chlorine e6 (Ce6) and the TLR7/8 agonist of lmiquimod (R837), which is further modified with tumor matrix targeting peptide (Fmoc‐K(Fmoc)‐PEG8‐CREKA. ChiP‐CeR is preferred to actively accumulate at the tumor site via specific recognition of fibronectin, which can eradicate primary tumor growth through photodynamic therapy (PDT). Meanwhile, the destruction of primary tumors would trigger immunogenic cell death (ICD) effects to release high‐mobility group box‐1(HMGB1) and expose calreticulin (CRT). Moreover, ChiP‐CeR can also polarize M2‐type tumor‐associated macrophages (TAMs) into M1‐type TAMs, which can activate T cell antitumor immunity in combination with ICD. Overall, ChiP‐CeR possesses superior antitumor effects against primary and lung metastatic tumors, which provide an applicable nanomedicine and a feasible strategy for the systemic management of metastatic breast cancer.

News (Medical) associated with TransCon TLR7/8 Agonist(Ascendis Pharma)

03 Jun 2024

·www.biospace.com

Ascendis Pharma Presents New Data and Updated Results from Phase 1/2 IL-Believe Trial at ASCO 2024

- 40% of efficacy-evaluable patients (2 out of 5) in the initial cohort of patients with anti-PD-1 refractory melanoma treated with TransCon IL-2 β/γ in combination with TransCon TLR7/8 Agonist exhibited confirmed clinical responses with no new safety signals - 45% of efficacy-evaluable patients (5 out of 11) whose disease progressed on check-point inhibitors exhibited confirmed clinical responses when treated with TransCon IL-2 β/γ as monotherapy or in combination treatment COPENHAGEN, Denmark, June 03, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma, Inc. (Nasdaq: ASND) reported new and updated results from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β⁄γ in a poster presentation at ASCO 2024, the annual meeting of the American Society of Clinical Oncology being held in Chicago May 31–June 4, 2024. Data included the first presentation of Phase 2 dose expansion Cohort 4 (TransCon IL-2 β⁄γ in combination with TransCon TLR7/8 Agonist) in post anti-PD-1 melanoma and new analyses of patients from dose escalation cohorts with prior disease progression on checkpoint inhibitors, along with biomarker studies correlating cytotoxic immune cell expansion and clinical benefit. As of the April 16, 2024 data cutoff, confirmed clinical responses were observed in 40% (two out of five) of efficacy-evaluable patients from Cohort 4, suggesting potential synergy of Ascendis Pharma’s two novel immunotherapy agents. Of efficacy-evaluable patients with prior disease progression on checkpoint inhibitors to date in the IL-Believe Trial, confirmed clinical responses (per RECIST v1.1) were observed in 45% (five out of eleven) administered TransCon IL-2 β/γ doses ≥80 μg/kg every 3 weeks, suggesting clinical benefit in treatment-resistant settings. Monotherapy (n=4): 1 confirmed partial response (PR) in colorectal cancer Combination with pembrolizumab (n=2): 1 confirmed complete response and 1 confirmed PR in small-cell lung cancer Combination with TransCon TLR7/8 Agonist (n=5): 2 confirmed PRs in melanoma Biomarker analysis demonstrated comparable, cytotoxic immune expansion between TransCon IL-2 β/γ monotherapy and combination therapy with pembrolizumab, indicating that administration of TransCon IL-2 β⁄γ expands cytotoxic lymphocytes and elevates levels of cytokines and chemokines in the blood without the corresponding expansion of Tregs or eosinophils (markers of toxicity). A statistically significant correlation of clinical benefit with both CD8+ T cell expansion and activation was observed, directly linking this pharmacodynamic effect to clinical activity. In this trial, TransCon IL-2 β⁄γ alone or in combination with pembrolizumab or TransCon TLR7/8 Agonist was generally well tolerated with no new safety signals. “We are very encouraged by the clinical response and safety pro TransCon IL-2 β⁄γ and are pleased to see it working as designed to recruit and amplify the body’s immune response with sustained immune activation without a corresponding increase in markers of toxicity,” said Stina Singel, M.D., Ph.D., Ascendis Pharma’s Executive Vice President and Head of Clinical Development, Oncology. “These new data in a heavily pre-treated population who progressed on or did not benefit from prior checkpoint inhibitors support TransCon IL-2 β⁄γ as the first biased IL-2 cytokine therapy to show not only monotherapy activity in a convenient outpatient setting every 3 weeks but also a direct correlation between clinical benefit and expansion of CD8+ T cells. We look forward to additional data readouts expected later this year from larger, indication-specific cohorts.” TransCon IL-2 β⁄γ is an investigational long-acting prodrug with sustained release of an IL-2Rβ⁄γ-selective analog (IL-2 β⁄γ), designed to address the known limitations of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβ⁄γ with low Cmax. The Phase 1/2 IL-Believe Trial is investigating the safety and tolerability of TransCon IL-2 β⁄γ alone or in combination with the checkpoint inhibitor pembrolizumab and/or chemotherapy or TransCon TLR7/8 Agonist in participants with locally advanced or metastatic solid tumors. The recommended Phase 2 dose (RP2D) for TransCon IL-2 β⁄γ in the IL-Believe trial is 120 µg/kg administered intravenously every three weeks in an outpatient setting in both the monotherapy and combination-therapy arms. About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the potential synergy of TransCon IL-2 β⁄γ and TransCon TLR7/8 Agonist; (ii) the timing of data from indication-specific cohorts for TransCon IL-2 β⁄γ; (iii) the ability of TransCon IL-2 β⁄γ to address the known limitations of interleukin-2 (IL-2) cancer immunotherapy through prolonged activation of IL-2Rβ⁄γ; (iv) Ascendis’ ability to apply its TransCon technology platform to build a leading, fully integrated biopharma company; and (v) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; the impact of international economic, political, legal, compliance, social and business factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 7, 2024 and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © June 2024 Ascendis Pharma A/S. Investor Contacts: Media Contact: Tim Lee Melinda Baker Ascendis Pharma Ascendis Pharma +1 (650) 374-6343 +1 (650) 709-8875 tle@ascendispharma.com media@ascendispharma.com ir@ascendispharma.com Patti Bank ICR Westwicke +1 (415) 513-1284 patti.bank@westwicke.com

Clinical ResultASCOPhase 2ImmunotherapyPhase 1

24 Oct 2023

·www.prnewswire.com

Inimmune Collaborates with Boston Children'S Hospital to Develop Novel Adjuvants

MISSOULA, Mont., Oct. 24, 2023 /PRNewswire/ -- Inimmune Corporation, a clinical-stage biotechnology company focused on creating and developing innovative immunotherapeutics, announced that it has entered a research collaboration with Boston Children's Hospital (BCH) to develop novel and innovative small molecule vaccine adjuvants. An adjuvant is added to some vaccines to enhance the immune response, thereby creating a stronger and longer-lasting immunity against infections than the vaccine alone. The Precision Vaccines Program (PVP) at Boston Children's Hospital was awarded a Vaccine Adjuvant Development Program contract (75N93023C00040) from the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID) that can extend up to 5 years and $9 million to develop a small molecule TLR7/8 agonist adjuvant that will enhance the effectiveness of flu vaccines. Based in the Department of Pediatrics at Boston Children's Hospital, the PVP is an academic research program devoted to discovering and developing the next generation of vaccines tailored to vulnerable populations. "The Precision Vaccines Program is dedicated to pioneering the next generation of vaccines tailored to safeguard the most vulnerable among us. We are building a global network to revolutionize vaccine development, and we are excited to collaborate with Inimmune to enhance adjuvants,"said Ofer Levy, MD, Ph.D., Director of the PVP. David Dowling, Ph.D., a PVP faculty member who is joint principal investigator on the project stated: "Starting with protein-based flu vaccines, we're laying the groundwork for an approach that holds the potential to elevate not just this platform, but also other technologies, including mRNA vaccines, in the fight against infectious diseases." Inimmune prioritizes research into new classes of adjuvants and immunotherapies for vaccines and stand-alone indications and has a deep pipeline of rapidly advancing programs. This past summer, Inimmune successfully advanced a candidate immunotherapy for the treatment of allergic rhinitis into Phase I clinical trials. With this award, Inimmune will work collaboratively with Boston Children's investigators to advance the synthesis, formulation, and pre-clinical evaluation of new adjuvants to preclinical proof-of-concept at which stage commercial collaborations will be sought for further development. "At Inimmune, we continue to identify and develop novel and unique immunotherapeutics," said Dr. Juhienah Khalaf, Ph.D., Director of Chemistry and sub-principal investigator on the project at Inimmune. "By leveraging the drug discovery expertise and resources of Inimmune, PVP researchers will have the opportunity to maximize the potential therapeutic value of their novel adjuvants." About Inimmune: Inimmune Corp. (Missoula, MT) is a privately held biotechnology company focused on the discovery and development of innovative immunotherapeutics, vaccine adjuvants, and vaccines. Inimmune is harnessing the human immune system to create safe and effective treatments for allergy, infectious disease, autoimmunity and cancer. Their laboratories and offices are housed in the Montana Technology Enterprise Center (MonTEC) in Missoula. For more information on Inimmune's research and development of novel vaccine adjuvants and delivery systems, please visit . Contact: Media Relations Inimmune Corporation Phone: (406)-541-5913 Email: info@inimmune.com SOURCE Inimmune

VaccineImmunotherapy

16 Oct 2023

·www.globenewswire.com

Bolt Biotherapeutics to Present New Clinical Data from Completed Phase 1/2 Dose-Escalation Trial of BDC-1001 in HER2-Expressing Solid Tumors at the ESMO Congress 2023

REDWOOD CITY, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company pioneering novel immuno-oncology therapeutics for the treatment of cancer, today announced that updated clinical data from its Phase 1/2 dose-escalation study of BDC-1001 will be presented in a mini-oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023, being held in Madrid, Spain and virtually from October 20-24, 2023. BDC-1001 is an investigational Immune-Stimulating Antibody Conjugate (ISAC) in development for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive cancer. The ESMO presentation will include new results from the recently completed first-in-human Phase 1/2 dose-escalation study of BDC-1001 in patients with advanced HER2-expressing solid tumors. “The upcoming presentation at ESMO builds on the positive data we presented at ASCO 2023 with additional insights into efficacy, safety, and biomarkers. These data provide further support for the recommended Phase 2 dose (RP2D) being used in the ongoing Phase 2 study of BDC-1001,” said Edith A. Perez, Chief Medical Officer of Bolt Biotherapeutics. “We are proud of the significant progress we have made with BDC-1001 and these latest data reinforce that Boltbody™ ISACs can activate a patient’s immune system to fight cancer. We continue to advance BDC-1001 through the Phase 2 clinical studies in four HER2-positive solid tumor types.” Details about the presentation can be found below and on the ESMO website. Title: Recommended phase 2 dose (RP2D) selection and pharmacodynamic (PD) data of the first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced HER2-expressing solid tumorsPresenter: Bob Li, M.D., Ph.D., MPH, medical oncologist, and principal investigator at Memorial Sloan Kettering Cancer Center (MSK)Presentation Number: 657Time: Monday, October 23, 2023, 4:35 – 4:40 p.m. CET About BDC-1001Bolt Biotherapeutics’ lead program, BDC-1001, is a human epidermal growth factor receptor 2 (HER2) ISAC comprising a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist. Following the successful completion of the BDC-1001 dose-escalation trial for the treatment of patients with HER2-expressing solid tumors, Bolt is now conducting two Phase 2 clinical trials in the U.S., Europe, and South Korea: NCT04278144 for patients with colorectal, endometrial, and gastroesophageal cancers and NCT05954143 for patients with breast cancer. About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) PlatformBolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell, and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer. About Bolt Biotherapeutics, Inc.Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes BDC-1001, a HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC); BDC-3042, a myeloid-modulating antibody; and multiple Boltbody ISAC collaboration programs. BDC-1001 is currently in Phase 2 clinical development following the successful completion of a Phase 1 dose-escalation trial that demonstrated tolerability and early clinical efficacy. BDC-3042, an agonist antibody targeting Dectin-2, is expected to initiate a Phase 1 trial in the second half of 2023. In preclinical development, BDC-3042 demonstrated the ability to convert tumor-supportive macrophages to tumor-destructive macrophages. Bolt Biotherapeutics is also developing multiple Boltbody™ ISACs in strategic collaborations with leading biopharmaceutical companies. For more information, please visit https://www.boltbio.com/ Forward-Looking StatementsThis press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding the ability of BDC-1001 to address unmet patient needs, the potential for orphan drug designation to help with development, the benefits afforded by orphan drug designation, and advancement and success of our clinical trials, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2022. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website at www.sec.gov. Investor Relations and Media Contact:Maeve ConneightonArgot Partners(212) 600-1902boltbio@argotpartners.com

ImmunotherapyPhase 1Phase 2Orphan Drug

100 Deals associated with TransCon TLR7/8 Agonist(Ascendis Pharma)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cutaneous Squamous Cell Carcinoma	Phase 2	NL	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Cutaneous Squamous Cell Carcinoma	Phase 2	KR	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Cutaneous Squamous Cell Carcinoma	Phase 2	US	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Cutaneous Squamous Cell Carcinoma	Phase 2	TW	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	KR	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	TW	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	ES	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	NL	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	AU	Ascendis Pharma Oncology Division A/S	18 Mar 2021
Locally Advanced Malignant Solid Neoplasm	Phase 2	US	Ascendis Pharma Oncology Division A/S	18 Mar 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IL-Believe (Biospace) Manual	Phase 1/2	Small Cell Lung Cancer \| Melanoma \| Colorectal Cancer	-	TransCon IL-2 β⁄γ +TransCon TLR7/8 Agonist (melanoma)	(kylfljqygl) = hzfcihroxw zipwbujrys (pdhzuxcrnt )	Positive	03 Jun 2024
				TransCon IL-2 β/γ (colorectal cancer)	(iylspeqqxq) = bkeouwiryf aqfykecack (wkjfzfnigl )

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