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Yahoo
23-06-2025
- Business
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TuHURA Biosciences, Inc. and Kineta, Inc. Stockholders Approve Proposed Merger and All Related Proposals
TAMPA, Fla. and SEATTLE, June 23, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced with Kineta, Inc. (OTC Pink:KANT) ("Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, that TuHURA stockholders approved all of the proposals set forth at the Company's Special Meeting of Stockholders held today, June 23, 2025 (the "TuHURA Special Meeting"). The proposals included an increase of the Company's authorized shares to 200 million shares and a proposal to reincorporate the Company in Delaware. Additionally, Kineta stockholders approved the proposed merger (the "Merger") with TuHURA at Kineta's Special Meeting of Stockholders held today, June 23, 2025 (the "Kineta Special Meeting"). The parties anticipate that the Merger will close as soon as possible following the satisfaction or waiver of any remaining closing conditions. The final voting results of the TuHURA Special Meeting and the Kineta Special Meeting will be reported in Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit and connect with TuHURA on Facebook, X, and LinkedIn. About Kineta Kineta, Inc. (OTC Pink: KANT) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients' lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. Kineta's immuno-oncology pipeline includes KVA12123, a novel VISTA blocking immunotherapy currently in a Phase 1/2 clinical trial in patients with advanced solid tumors, and a preclinical monoclonal antibody targeting CD27. For more information on Kineta, please visit Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 has demonstrated strong tumor growth inhibition as both a monotherapy and in combination with other checkpoint inhibitors in preclinical models. KVA12123 provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung carcinoma (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer. In February 2024, Kineta announced a significant corporate restructuring to substantially reduce expenses and preserve cash. The restructuring included a significant workforce reduction and the suspension of enrollment of new patients in its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. At that time, Kineta also announced that it was exploring strategic alternatives to maximize stockholder value. IMPORTANT ADDITIONAL INFORMATION REGARDING PROPOSED MERGER WITH KINETA In connection with the Merger, TuHURA filed with the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-4, dated February 7, 2025 (the "Registration Statement"), which was declared effective on May 14, 2025 and which contains a joint proxy statement of Kineta and TuHURA and a prospectus of TuHURA (the "Joint Proxy Statement/Prospectus"), and TuHURA and Kineta may file with the SEC other relevant documents regarding the Merger. Investors and securityholders of TuHURA and Kineta are urged to read the Joint Proxy Statement/Prospectus and such other materials carefully because they contain important information about TuHURA, Kineta and the Merger. This press release is not a substitute for the definitive Joint Proxy Statement/Prospectus or any other documents that TuHURA may file with the SEC or send to securityholders in connection with the Merger. A definitive copy of the definitive Joint Proxy Statement/Prospectus was mailed to Kineta and TuHURA stockholders beginning May 23, 2025. Investors and stockholders may obtain free copies of the documents filed or that will be filed with the SEC by TuHURA through the website maintained by the SEC at The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA's website at or upon written request to: TuHURA, 10500 University Drive, Suite 110, Tampa, Florida 33612. NO OFFER OR SOLICITIATION This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include, without limitation, (i) the risk that the conditions to the closing of the Merger are not satisfied; (ii) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement; (iii) uncertainties as to the timing of the consummation of the Merger and the ability of each of TuHURA and Kineta to consummate the Merger; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the Merger; (v) unexpected costs, charges or expenses resulting from the Merger; (vi) competitive responses to the Merger; (vii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Merger; (viii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (ix) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (x) risks associated with the possible failure to realize certain anticipated benefits of the Merger, including with respect to future financial and operating results; and (xi) other risks and uncertainties described in detail in TuHURA's and Kineta's respective registration statements, reports and other filings with the SEC, which are available on TuHURA's and Kineta's respective websites, and at The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA and Kineta do not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Monique KosseGilmartin GroupMonique@ View original content to download multimedia: SOURCE TuHURA Biosciences, Inc. Sign in to access your portfolio
Yahoo
09-06-2025
- Business
- Yahoo
FDA Removes Partial Clinical Hold on TuHURA Biosciences' Phase 3 Accelerated Approval Trial for IFx-2.0 in Advanced or Metastatic Merkel Cell Carcinoma
Company anticipates initiating its Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as first-line treatment for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) Agreement with U.S. Food and Drug Administration (FDA), later in June 2025 Resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025 TAMPA, Fla., June 9, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA. "We are grateful for the collaborative interaction with the reviewers at the Office of Therapeutic Products (OTP) and the Oncology Center of Excellence (OCE), including their quick response time and, importantly, their helpful recommendations going forward," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences. "The removal of the partial clinical hold allows TuHURA to begin the trial's initiation and activation of clinical sites for the Phase 3 accelerated approval trial of IFx-2.0," continued Dr. Bianco. "We are also pleased that the removal of the partial clinical hold represents the achievement of the second milestone funding condition under our recently announced private placement, thereunder trigging the payment to the Company of an additional $2.23 million under the financing." The Company's Phase 3 accelerated approval trial of IFx-2.0, will be conducted under an SPA Agreement with the U.S. FDA, and will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda® compared to Keytruda® plus placebo in the first line treatment of patients with advanced or metastatic MCC. Keytruda® is currently approved in MCC under accelerated approval based on Overall Response Rate (ORR). The pivotal trial for IFx-2.0 is expected to enroll 118 across approximately 22 to 25 U.S. sites. Trial participants will be randomized on a 1:1 basis and receive Keytruda® in both arms, for up to two years, or until disease progression or Keytruda® related toxicities. The primary endpoint for the trial is ORR with a key secondary endpoint of Progression Free Survival (PFS). Other secondary endpoints are safety, duration of response, and overall survival. Accelerated approval is based on the successful achievement of the ORR primary endpoint. PFS, the key secondary endpoint, if successfully achieved, without a detrimental effect on overall survival, could satisfy the requirement for regular approval without the requirement for a post approval confirmatory trial (in contrast to most accelerated approval trials). About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. Following its proposed merger with Kineta, Inc., if completed, the Company expects to advance Kineta's novel VISTA inhibiting antibody into a randomized Phase 2 trial in NPM1 mutated r/r AML in combination with a menin inhibitor. In addition to its innate immune agonist product candidate, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit and connect with TuHURA on Facebook, X, and LinkedIn. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding, TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial, its tumor microenvironment modulators development program, its potential acquisition by merger of Kineta Inc. and the statements about Kineta's VISTA-101 development program, and any developments or results in connection with the foregoing and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: Monique KosseGilmartin GroupMonique@ View original content to download multimedia: SOURCE TuHURA Biosciences, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-04-2025
- Business
- Yahoo
Merkel Cell Carcinoma Market to Grow Rapidly at a CAGR of 8.7% During the Study Period (2020-2034)
The Merkel cell carcinoma market is poised for steady growth, with a strong CAGR projected from 2024 to 2034. This expansion across the 7MM will be driven by the launch of innovative therapies, including IFx-2.0, NIDLEGY, and ITI-3000. LAS VEGAS, April 9, 2025 /PRNewswire/ -- DelveInsight's Merkel Cell Carcinoma Market Insights report includes a comprehensive understanding of current treatment practices, Merkel cell carcinoma emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Merkel Cell Carcinoma Market Report According to DelveInsight's analysis, the market size for Merkel cell carcinoma was found to be USD 411 million in the 7MM in 2023. According to estimates, among the currently marketed drugs, BAVENCIO (avelumab) as first-line therapy held the largest market share, generating approximately USD 290 million in revenue across the 7MM in 2023. According to DelveInsight's estimates, in 2023, there were approximately 9K incident cases of MCC in the 7MM. Of these, the United States accounted for 37% of the cases. Leading Merkel cell carcinoma companies developing emerging therapies, such as TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., and others are developing novel Merkel cell carcinoma drugs that can be available in the Merkel cell carcinoma market in the coming years. The promising Merkel cell carcinoma therapies in the pipeline include IFx-2.0, NIDLEGY (L19-IL2/L19-TNF), ITI 3000, PH 762, KT 253, MCLA 145, and others. Discover which therapies are expected to grab the major Merkel cell carcinoma market share @ Merkel Cell Carcinoma Market Report Merkel Cell Carcinoma Overview Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer that originates from Merkel cells, which are neuroendocrine cells involved in touch sensation. While its exact causes are not completely understood, several risk factors have been identified, including prolonged exposure to ultraviolet (UV) radiation, advanced age, and a weakened immune system; additionally, infection with the Merkel Cell Polyomavirus (MCPyV) is associated with many cases of MCC. Clinically, MCC often presents as a rapidly growing, firm, and painless nodule that may appear red, violet, or flesh-colored, typically on sun-exposed areas such as the head, neck, or extremities. Diagnosis usually begins with a detailed physical examination and imaging studies to assess the extent of the lesion, but a definitive diagnosis is made through a biopsy followed by histopathological and immunohistochemical analyses, which help distinguish MCC from other similar skin tumors. Merkel Cell Carcinoma Epidemiology Segmentation The Merkel cell carcinoma epidemiology section provides insights into the historical and current Merkel cell carcinoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Merkel cell carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of MCC Gender-specific Incident Cases of MCC Stage-specific Incident Cases of MCC Etiology-specific Incident Cases of MCC Total Metastatic Cases of MCC Merkel Cell Carcinoma Treatment Market Treatment for localized Merkel cell carcinoma typically involves surgery and radiation, while advanced cases often require systemic therapies such as immune checkpoint inhibitors like avelumab. Chemotherapy provides limited long-term benefits. Wide local excision is the primary approach for localized MCC, often accompanied by a sentinel lymph node biopsy to assess disease spread. However, in advanced stages, surgery becomes less effective as systemic progression takes over, emphasizing the need for improved treatments due to MCC's rarity and high recurrence risk. Chemotherapy, once a mainstay for advanced MCC, now plays a diminished role due to its limited long-term efficacy. Agents like etoposide and carboplatin may temporarily shrink tumors, but high relapse rates and significant side effects make them less favorable. Cytotoxic chemotherapy works by damaging DNA or disrupting cell division in rapidly proliferating cells, but while it has shown effectiveness in metastatic MCC, its impact on healthy cells leads to considerable adverse effects. Currently, several approved therapies focus on immune modulation. Key treatments include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. To know more about Merkel cell carcinoma treatment guidelines, visit @ Merkel Cell Carcinoma Management Merkel Cell Carcinoma Pipeline Therapies and Key Companies IFx-2.0: TuHURA Biosciences NIDLEGY (L19-IL2/L19-TNF): Philogen ITI 3000: Immunomic Therapeutics PH 762: Phio Pharmaceuticals/AgonOx KT 253: Kymera Therapeutics MCLA 145: Merus N.V. Discover more about Merkel cell carcinoma drugs in development @ Merkel Cell Carcinoma Clinical Trials Merkel Cell Carcinoma Market Dynamics The Merkel cell carcinoma market dynamics are expected to change in the coming years. With the increasing awareness and early detection of Merkel cell carcinoma, healthcare providers are now more proactive in diagnosing the disease, which in turn fuels demand for effective, targeted treatments. Recent regulatory approvals of novel therapies, such as checkpoint inhibitors, have not only improved patient outcomes but have also spurred further research and development investments from pharmaceutical companies. Additionally, the high unmet medical need in this niche area, coupled with supportive government policies and funding initiatives, continues to propel the growth and expansion of the Merkel cell carcinoma therapeutic market. Furthermore, potential therapies are being investigated for the treatment of Merkel cell carcinoma, and it is safe to predict that the treatment space will significantly impact the Merkel cell carcinoma 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 Merkel cell carcinoma market in the 7MM. However several factors may impede the growth of the Merkel cell carcinoma market. One major challenge is the rarity of the disease, which limits the availability of clinical trial participants and reduces incentives for pharmaceutical companies to invest in research. Additionally, the high costs of immunotherapies—the primary treatment option—pose affordability issues, leading to restricted patient access, especially in regions with limited healthcare coverage. Regulatory hurdles also slow the approval of novel therapies, as MCC lacks well-established treatment guidelines beyond immunotherapy. Furthermore, low disease awareness among healthcare providers and patients often results in delayed diagnosis, and worsening patient outcomes. Moreover, Merkel cell carcinoma treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Merkel cell carcinoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Merkel cell carcinoma market growth. Merkel Cell Carcinoma Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Merkel Cell Carcinoma Market CAGR 8.7 % Merkel Cell Carcinoma Market Size in 2023 USD 411 Billion Key Merkel Cell Carcinoma Companies TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., and others Key Pipeline Merkel Cell Carcinoma Therapies IFx-2.0, NIDLEGY (L19-IL2/L19-TNF), ITI 3000, PH 762, KT 253, MCLA 145, and others Scope of the Merkel Cell Carcinoma Market Report Therapeutic Assessment: Merkel Cell Carcinoma current marketed and emerging therapies Merkel Cell Carcinoma Market Dynamics: Key Market Forecast Assumptions of Emerging Merkel Cell Carcinoma Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Merkel Cell Carcinoma Market Access and Reimbursement Download the report to understand which factors are driving Merkel cell carcinoma market trends @ Merkel Cell Carcinoma Market Trends Table of Contents 1 Key Insights 2 Report Introduction 3 MCC Market Overview at a Glance 3.1 Market Share (%) Distribution of MCC by Therapies in the 7MM in 2020 3.2 Market Share (%) Distribution of MCC by Therapies in the 7MM in 2034 4 Executive Summary 5 Key Events 6 Disease Background and Overview 6.1 Introduction 6.2 Anatomy 6.3 Histology of MCC 6.4 Signs and Symptoms 6.5 Risk Factors 6.6 Types of MCC 6.7 Pathophysiology of MCC 6.8 Staging of MCC 6.9 Diagnosis 6.9.1 Differential Diagnosis of MCC 6.9.2 Diagnostic Algorithm 6.9.3 Diagnostic Guidelines and Recommendations for MCC 6.10 Treatment 6.10.1 Follow-up and Recurrence 6.10.2 Treatment Algorithm 6.10.3 Treatment Guidelines and Recommendations for MCC 7 Epidemiology and Market Methodology 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.2.1 Total Incident Cases of MCC 8.2.2 Gender-specific Incident Cases of MCC 8.2.3 Stage-specific Incident Cases of MCC 8.2.4 Etiology-specific Incident Cases of MCC 8.2.5 Progression Rate of MCC 8.3 Total Incident Cases of MCC in the 7MM 8.4 The United States 8.4.1 Total Incident Cases of MCC in the US 8.4.2 Gender-specific Incident Cases of MCC in the US 8.4.3 Stage-specific Incident Cases of MCC in the US 8.4.4 Etiology-specific Incident Cases of MCC in the US 8.4.5 Total Metastatic Cases of MCC in the US 8.5 EU4 and the UK 8.5.1 Total Incident Cases of MCC in EU4 and the UK 8.5.2 Gender-specific Incident Cases of MCC in EU4 and the UK 8.5.3 Stage-specific Incident Cases of MCC in EU4 and the UK 8.5.4 Etiology-specific Incident Cases of MCC in EU4 and the UK 8.5.5 Total Metastatic Cases of MCC in EU4 and the UK 8.6 Japan 8.6.1 Total Incident Cases of MCC in Japan 8.6.2 Gender-specific Incident Cases of MCC in Japan 8.6.3 Stage-specific Incident Cases of MCC in Japan 8.6.4 Etiology-specific Incident Cases of MCC in Japan 8.6.5 Total Metastatic Cases of MCC in Japan 9 Patient Journey 10 Marketed Therapies 10.1 Key Cross Competition 10.2 BAVENCIO (avelumab): Merck KGaA (EMD Serono) 10.2.1 Product Description 10.2.2 Regulatory Milestone 10.2.3 Other Developmental Activities 10.2.4 Clinical Trials Information 10.2.5 Safety and Efficacy 10.3 ZYNYZ (retifanlimab-dlwr): Incyte Corporation/MacroGenics 10.3.1 Product Description 10.3.2 Regulatory Milestone 10.3.3 Other Developmental Activities 10.3.4 Clinical Trials Information 10.3.5 Safety and Efficacy 10.4 KEYTRUDA (pembrolizumab): Merck 10.4.1 Product Description 10.4.2 Regulatory Milestone 10.4.3 Other Developmental Activities 10.4.4 Clinical Trials Information 10.4.5 Safety and Efficacy To be continued in the report... 11 Emerging Drug Profiles 11.1 Key Cross Competition of Emerging Drugs 11.2 IFx-2.0: TuHURA Biosciences 11.2.1 Drug Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analysts' View 11.3 NIDLEGY (L19-IL2/L19-TNF): Philogen 11.3.1 Drug Description 11.3.2 Other Developmental Activities 11.3.3 Clinical Trials Information 11.3.4 Analysts' View 11.4 ITI 3000: Immunomic Therapeutics 11.4.1 Drug Description 11.4.2 Other Developmental Activities 11.4.3 Clinical Trials Information 11.4.4 Safety and Efficacy 11.4.5 Analysts' View 11.5 PH 762: Phio Pharmaceuticals/AgonOx 11.5.1 Drug Description 11.5.2 Other Developmental Activities 11.5.3 Clinical Trials Information 11.5.4 Safety and Efficacy 11.5.5 Analysts' View 11.6 KT 253: Kymera Therapeutics 11.6.1 Drug Description 11.6.2 Other Developmental Activities 11.6.3 Clinical Trials Information 11.6.4 Safety and Efficacy 11.6.5 Analysts' View 11.7 MCLA 145: Merus N.V. 11.7.1 Drug Description 11.7.2 Other Developmental Activities 11.7.3 Clinical Trials Information 11.7.4 Safety and Efficacy 11.7.5 Analysts' View To be continued in the report... 12 MCC: Market Analysis 12.1 Key Findings 12.2 Key Market Forecast Assumptions 12.2.1 Cost Assumptions and Rebates 12.2.2 Pricing Trends 12.2.3 Analogue Assessment 12.2.4 Launch Year and Therapy Uptake 12.3 Market Outlook 12.4 Total Market Size of MCC in the 7MM 12.5 Market Size of MCC by Therapies in the 7MM 12.6 Market Size of MCC in the United States 12.6.1 Total Market of MCC 12.6.2 Market Size of MCC by Therapies in the United States 12.7 Market Size of MCC in EU4 and the UK 12.7.1 Total Market Size of MCC 12.7.2 Market Size of MCC by Therapies in EU4 and the UK 12.8 Market Size of MCC in Japan 12.8.1 Total Market Size of MCC 12.8.2 Market Size of MCC by Therapies in Japan 13 Key Opinion Leaders' Views 14 Unmet Needs 15 SWOT Analysis 16 Market Access and Reimbursement 16.1 The United States 16.1.1 Center for Medicare and Medicaid Services (CMS) 16.2 In EU4 and the UK 16.2.1 Germany 16.2.2 France 16.2.3 Italy 16.2.4 Spain 16.2.5 The United Kingdom 16.3 Japan 16.3.1 MHLW 17 Appendix 17.1 Acronyms and Abbreviations 17.2 Bibliography 17.3 Report Methodology 18 DelveInsight Capabilities 19 Disclaimer 20 About DelveInsight Related Reports Merkel Cell Carcinoma Epidemiology Forecast Merkel Cell Carcinoma Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Merkel cell carcinoma epidemiology trends. Merkel Cell Carcinoma Pipeline Merkel Cell Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Merkel cell carcinoma companies, including ImmunityBio, OncoSec Medical, Exelixis, 4SC, Kartos therapeutics, Incyte corporation, Amgen, BioInvent International AB, SOTIO Biotech, Xencor, Exicure, Checkmate Pharmaceuticals, Takeda, Genocea Biosciences, NeoImmuneTech, Sensei Biotherapeutics, among others. Metastatic Merkel Cell Carcinoma Market Metastatic Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic Merkel cell carcinoma companies, including Incyte Corporation, Merck, Pfizer, Millennium Pharmaceuticals Inc., Novartis, Exelixis, Bristol-Myers Squibb, EMD Serono, among others. Metastatic Merkel Cell Carcinoma Pipeline Metastatic Merkel Cell Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic Merkel cell carcinoma companies, including Incyte Corporation, Transgene, Ocellaris Pharma, Roche, Exelixis, Sensei Biotherapeutics, Checkmate Pharmaceuticals, SOTIO Biotech, among others. 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 UsShruti Thakurinfo@ + Logo: View original content: SOURCE DelveInsight Business Research, LLP
Associated Press
10-03-2025
- Business
- Associated Press
TuHURA Biosciences, Inc. to Present at the 37th Annual ROTH Conference
Live webcast fireside chat on Tuesday, March 18th at 8:30 AM PT TAMPA, FL / ACCESS Newswire / March 10, 2025 / TuHURA Biosciences, Inc. (NASDAQ:HURA) ('TuHURA'), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that James A. Bianco, M.D., President and Chief Executive Officer of TuHURA, will participate in a fireside chat on Tuesday, March 18, 2025 at 8:30 AM PT at the 37th Annual ROTH Conference being held in Dana Point, CA. In addition to the presentation, management will be available to participate in one-on-one in-person meetings with qualified members of the investor community who are registered to attend the conference. For more information about the event, please visit the conference website. live webcast of the fireside chat will be available on the Events page of the Investors section of the Company's website ( About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA's lead innate immune agonist drug candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate in second quarter 2025, a single randomized placebo-controlled Phase 3 registration=directed trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® and placebo in first=line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist candidates, following the closing of the previously announced proposed merger with Kineta, TuHURA plans to advance its VISTA inhibiting antibody into a phase two trial in combination with a menin inhibitor in NPM1 mutated relapsed or refractory AML. Leveraging its discovery of the central role the Delta Opioid Receptor plays in modulating the immunosuppressive effects of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages on the tumor microenvironment (TME), the Company is also developing non-tumor targeting ADCs and APCs to convert the TME to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies. Investor Contact: JTC Team, LLC Jenene Thomas
Globe and Mail
07-03-2025
- Health
- Globe and Mail
Merkel Cell Carcinoma Market is Expected to Advance at a CAGR of 8.7% During the Study Period (2020-2034)
The Merkel Cell Carcinoma Market is expected to grow significantly in the 7MM, driven by the rising awareness among healthcare professionals contributing to earlier diagnosis, increasing chronic UV exposure, and the emergence of innovative therapies such as IFx-2.0 (TuHURA Biosciences), NIDLEGY (Philogen), MCLA 145 (Merus N.V.), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals / AgonOx), KT 253 (Kymera Therapeutics) and others. DelveInsight's latest report, ' Merkel Cell Carcinoma Market Insight, Epidemiology, and Market Forecast,' combines robust epidemiological data with market trends, competitive landscape analysis, and patient journey assessments. The report forecasts that the Merkel Cell Carcinoma (MCC) market in the 7MM which includes the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan is expected to grow at a CAGR of 8.7% from USD 411 million between 2023 to 2034 Among the 7MM, the US market represented 44% of the total market size in 2023. Other major markets, EU4 and the UK, accounted for approximately 54%. Among the EU4 and the UK, Germany held the largest Merkel Cell Carcinoma market share, followed by France. Download the report to understand which factors are driving the Merkel Cell Carcinoma therapeutic market @ Merkel Cell Carcinoma Market Trends. The report also provides an in-depth epidemiological analysis and forecasts until 2034, segmented by Total Merkel Cell Carcinoma Incident Cases, Gender-specific Incident Cases, Stage-specific Incident Cases, Etiology-specific Incident Cases of Merkel Cell Carcinoma, and Total Metastatic Merkel Cell Carcinoma Cases in the 7MM. According to DelveInsight's analysis, there were approximately 9000 incident cases of MCC in the 7MM. Among them, the United States accounted for nearly 37% of the cases in 2023. Furthermore, in the EU4 and the UK, approximately 80% of the total reported cases are associated with MCPyV, while 20% are linked to UV damage, indicating that MCPyV is the primary causative factor. Discover evolving trends in Merkel Cell Carcinoma patient pool forecasts @ Merkel Cell Carcinoma Epidemiology Analysis The Delveinsight report also discusses current diagnosis and treatment strategies for Merkel Cell Carcinoma. Existing drugs for MCC treatment include KEYTRUDA (Merck), ZYNYZ (Incyte Corporation/MacroGenics), and BAVENCIO (Merck KGaA). The treatment depends on the disease stage and individual factors, primarily involving surgery as the first-line therapy, often combined with radiation or chemotherapy. Chemotherapy, once a key treatment for advanced Merkel Cell Carcinoma, now plays a reduced role due to limited long-term effectiveness. Cytotoxic chemotherapy, while it has been effective for metastatic MCC, often leads to significant side effects by affecting normal cells. DelveInsight's analysis reveals that several companies are launching clinical trials to investigate new MCC treatment options or to improve existing ones. The Merkel Cell Carcinoma clinical development pipeline includes drugs such as IFx-2.0 (TuHURA Biosciences), NIDLEGY (Philogen), MCLA 145 (Merus N.V.), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), and KT 253 (Kymera Therapeutics), among others. Unlock which emerging Merkel Cell Carcinoma drug is expected to capture the largest market share in 7MM by 2034. Visit the Merkel Cell Carcinoma Market Insights. In January 2025, 225Ac-SSO110, a somatostatin receptor 2 (SST2) antagonist for targeted radionuclide cancer treatments of MCC developed by Ariceum Therapeutics, received clearance for a Phase 1/2 trial (SANTANA-225) and is expected to begin enrolling patients in the first quarter of 2025. Another pipeline drug, IFx-2.0 (developed by TuHURA Biosciences), is also set for phase III trial with KEYTRUDA for advanced MCC in 2025. These developments highlight the momentum in the MCC treatment landscape. MCC presents significant challenges, especially in diagnosis, due to its rarity, unclear origin, and similarity to other skin lesions. DelveInsight's leading oncology consultant commented, 'As MCCs are frequently misdiagnosed, biomarkers are needed to improve their detection to prompt biopsy to confirm diagnosis by histology and immunohistochemistry, respectively.' This highlights the potential of more precise and sensitive emerging diagnostic methods to revolutionize Merkel Cell Carcinoma treatment, driving market growth. Table of Contents 1. Key Insights 2. Report Introduction 3. Merkel Cell Carcinoma Market Overview at a Glance 4. Executive Summary 5. Key Events 6. Disease Background and Overview 7. Epidemiology and Market Methodology 8. Epidemiology and Patient Population 9. Patient Journey 10. Merkel Cell Carcinoma Marketed Therapies 11. Merkel Cell Carcinoma Emerging Drug Profiles 12. MCC: Market Analysis 13. Key Opinion Leaders' Views 14. Unmet Needs 15. SWOT Analysis 16. Market Access and Reimbursement 17. Appendix 18. DelveInsight Capabilities 19. Disclaimer 20. About DelveInsight Merkel Cell Carcinoma Pipeline Insight Merkel Cell Carcinoma Pipeline Insight provides comprehensive insights about the Merkel Cell Carcinoma pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Merkel Cell Carcinoma companies, including ImmunityBio, OncoSec Medical, Exelixis, 4SC, Kartos therapeutics, Incyte corporation, Amgen, BioInvent International AB, SOTIO Biotech, Xencor, Exicure, Checkmate Pharmaceuticals, Takeda, Genocea Biosciences, NeoImmuneTech, and Sensei Biotherapeutics, among others. About DelveInsight DelveInsight is a leading business Healthcare consultancy and market research firm specializing in life sciences. It assists pharmaceutical companies by offering comprehensive, end-to-end solutions to improve their performance. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Arpit Anand Email: Send Email Phone: +14699457679 Address: 304 S. 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