One hundred patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion. These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-5 days) for any delayed adverse events..

开始日期2021-06-10

申办/合作机构

TuHURA Biosciences, Inc. (Old)

NCT04160065 / Completed临床1期

Phase 1 Trial of Intralesional Immunotherapy With IFx-Hu2.0 Vaccine in Patients With Advanced Non-melanoma Skin Cancers

In this clinical phase I, non-randomized, open-label, uncontrolled, interventional, multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced non-melanoma skin cancers will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up to three lesions at up to three time points. Subjects will be observed for any acute adverse events (AEs) post injection and for any delayed AEs at Day 28, 35 and/or 42 ± 7 days, depending on the cohort (exposure escalation and expansion design).

开始日期2020-03-03

申办/合作机构

TuHURA Biosciences, Inc. (Old)

[+4]

NCT03655756 / Completed早期临床1期

Phase 1 Study Using a Plasmid DNA Coding for Emm55 Streptococcal Antigen in Patients With Unresectable Stage III or Stage IV Cutaneous Melanoma

Six patients will receive IFx-Hu2.0 on an outpatient basis at a single time point in a single lesion, two lesions, or three lesions, as a monotherapy (a maximum of three lesions could be injected). These patients will be assessed for any immediate adverse reactions and at Week 4 (Day 28+/-7 business days for any delayed adverse events.

开始日期2018-11-05

申办/合作机构

TuHURA Biosciences, Inc. (Old)

[+1]

100 项与 IFx-Hu2.0 相关的临床结果

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100 项与 IFx-Hu2.0 相关的转化医学

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100 项与 IFx-Hu2.0 相关的专利（医药）

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项与 IFx-Hu2.0 相关的文献（医药）

2024-08-01·Molecular cancer therapeutics

First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0

Article

作者: Pilon-Thomas, Shari ; Eroglu, Zeynep ; Chamizo, Alejandra ; Garcia, Edward T. ; Shamblott, Michael ; Markowitz, Joseph ; Khushalani, Nikhil I. ; Lawman, Patricia ; Tarhini, Ahmad A. ; Kim, Youngchul ; Dukes, Christopher W. ; Sondak, Vernon K. ; Bastawrous, Marina ; De Aquino, Deanryan B. ; Sarnaik, Amod A. ; Dehlawi, Ashraf ; Chen, Pei-Ling ; Brohl, Andrew S.

Abstract:

IFx-Hu2.0 was designed to encode part of the Emm55 protein contained within a plasmid in a formulation intended for transfection into mammalian cells. IFx-Hu2.0 promotes both adaptive and innate immune responses in animal studies. Furthermore, previous studies have demonstrated safety/efficacy in equine, canine, and murine species. We present the first-in-human study of IFx-Hu2.0, administered by intralesional injection into melanoma tumors of seven patients with stage III/IV unresectable melanoma. No dose-limiting toxicities attributable to IFx-Hu2.0 were observed. Grade 1/2 injection site reactions were observed in five of seven patients. IgG and IgM responses to Emm55 peptides and known melanoma antigens were seen in the peripheral blood, suggesting that IFx-Hu2.0 acts as an individualized “in situ vaccine.” Three of four patients previously refractory to anti-PD1 experienced clinical benefit upon subsequent anti-PD1–based treatment. Therefore, this approach is feasible, and clinical/correlative outcomes warrant further investigation for treating patients with metastatic melanoma with an immune priming agent.

1999-12-01·Expert opinion on investigational drugs2区 · 医学

DNA vaccines for cancer therapy

2区 · 医学

Article

作者: Mary K Wloch ; Suezanne E Parker ; Holly M Horton ; Jon A Norman

Vaccination with a tumour antigen-expressing plasmid DNA (pDNA) is a novel approach to human cancer immunotherapy. Initial results in preclinical rodent tumour models are promising, revealing that pDNA cancer vaccines can elicit both humoral, as well as cell-mediated immunity and, in some cases, protect against tumour growth. Compared to peptide, viral or dendritic cell vaccines, the delivery of tumour antigens using pDNA has the advantages of ease of manufacture, lack of toxicity and broad applicability to large populations. With advances in modern genomics strategies and the identification of an increasing number of tumour antigen genes, pDNA-based cancer vaccines may be used in the future to treat a wide variety of human cancers.

项与 IFx-Hu2.0 相关的新闻（医药）

2024-10-17

·BioSpace

TuHURA Biosciences Completes Merger Transaction with Kintara Therapeutics

Combined company will operate as TuHURA Biosciences, Inc. and advance pipeline of novel technologies to overcome resistance to cancer immunotherapy Lead program entering single Phase 3 accelerated approval registration trial in first half of 2025 for treatment of 1 st line Merkel Cell carcinoma under Special Protocol Assessment (SPA) agreement with FDA $31 million fully-funded financing in connection with the merger agreement expected to fund planned operations of the combined company into late 2025 Combined company to commence trading on The Nasdaq Capital Market under the ticker “HURA” on October 18, 2024 TAMPA, FL / ACCESSWIRE / October 17, 2024 / TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy today announced the completion of its previously announced merger with Kintara Therapeutics, Inc. (now TuHURA Biosciences, Inc.). The combined company will operate under the name “TuHURA Biosciences, Inc.” and will focus on advancing TuHURA’s innate immune response agonists and tumor microenvironment modulators, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The Company is preparing to initiate a single Phase 3 accelerated approval registration trial in the first half of 2025 for treatment of 1 st line Merkel Cell carcinoma under SPA agreement with FDA. The shares of the Company’s common stock, previously trading under the ticker symbol “KTRA,” will commence trading on a post-reverse split and post-business combination basis, on The Nasdaq Capital Market under the ticker symbol “HURA”, effective October 18, 2024. The Company’s common stock is now represented by a new CUSIP number, 898920103. As a result of the merger, post-merger Kintara equityholders collectively own approximately 2.85% (or approximately 5.45% after giving effect to the shares issued pursuant to the CVR Agreement if the milestones are achieved) of the common stock of the combined company on a pro forma fully diluted basis. TuHURA equityholders collectively own approximately 97.15% (or approximately 94.55% after giving effect to the shares issued pursuant to the CVR Agreement if the milestones are achieved) of the common stock of the combined company on a pro forma fully diluted basis. “This marks a transformational milestone for both companies and is a significant step in the evolution of TuHURA. As we look to the future, which I believe has never been brighter, we are working to solve a significant issue with current cancer immunotherapies,” commented Dr. James Bianco, President and Chief Executive Officer of TuHURA. “Our novel technologies are designed to overcome resistance to cancer immunotherapy, and we are planning to initiate a single Phase 3 accelerated approval registration trial in the first half of 2025 with our lead innate immune response agonist, IFx-2.0. If successful, not only does it provide the ability to target additional oncology indications but also unlocks tremendous value for all stakeholders.” Advancing Novel Technologies to Overcome Resistance to Cancer Immunotherapy TuHURA is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired resistance -- two major obstacles to cancer immunotherapy’s ability to treat and cure cancer. Immune Fx (IFx) Innate Immune Response Agonists : TuHURA’s IFx technology utilizes a proprietary plasmid DNA (“pDNA”) or messenger RNA (“mRNA”) which, when introduced into or targeted to a tumor cell, results in the expression of a highly immunogenic bacterial protein (Emm55) on the surface of the tumor cell. TuHURA’s lead innate immune response agonist candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single Phase 3 accelerated approval registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for advanced or metastatic Merkel Cell Carcinoma under a SPA agreement with the US FDA, in the first half of2025. Tumor Microenvironment Modulators: Leveraging its Delta receptor technology, TuHURA is developing bi-specific immune modulating Antibody (ADC) or Peptide (PDC) Drug 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. About the Transaction Under the terms of the merger agreement, Kayak Mergeco, Inc., Kintara’s wholly-owned subsidiary, will merge with and into the private-company TuHURA, with TuHURA surviving the merger and becoming the combined company’s direct, wholly-owned subsidiary effective at 12:03 AM Eastern Time on October 18, 2024. As previously announced, in connection with the merger and pursuant to the Contingent Value Rights Agreement (the “CVR Agreement”), the Company will issue CVRs to legacy Kintara stockholders (or in the case of warrants to purchase shares of Kintara common stock, each share of Kintara common stock for which such warrant to purchase shares of Kintara stock is exercisable), entitling such holders to an aggregate of approximately 1,539,918 shares of the combined company’s common stock on a post-split basis, upon the achievement of certain milestones as set forth in the CVR Agreement. The combined company will be led by James Bianco as President and Chief Executive Officer of TuHURA. In addition to Mr. Bianco, the TuHURA leadership team includes current members of management Dan Dearborn as Chief Financial Officer and Dennis Yamashita as Chief Scientific Officer. The Board of Directors of TuHURA will be composed of James Bianco, James Manuso, Alan List, George Ng and Robert Hoffman. Advisors Lucid Capital Markets, LLC acted as the exclusive financial advisor and Lowenstein Sandler LLP acted as legal counsel to Kintara. H.C. Wainwright & Co. acted as the exclusive financial advisor and Foley & Lardner LLP acted as legal counsel to TuHURA. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA’s lead innate immune response agonist candidate, 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) in first line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune response agonist candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-specific ADCs, and PDCs 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 tuhurabio.com and connect with TuHURA on Facebook , X , and LinkedIn . Forward-Looking Statements This news release contains forward-looking statements that are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. 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 Kintara’s or TuHURA’s management team’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the Proposed Transaction and the expected effects, perceived benefits or opportunities and related timing with respect thereto, expectations regarding clinical trials and research and development programs, in particular with respect to TuHURA’s IFx-Hu2.0 product candidate and its TME modulators development program, and any developments or results in connection therewith; the anticipated timing of the results from those studies and trials; expectations regarding the use of capital resources, including the net proceeds from the fully-funded financing; the time period over which the combined company’s capital resources will be sufficient to fund its anticipated operations; and the expected trading of the combined company’s stock on the Nasdaq Capital Market. 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 the “Risk Factors” section of Kintara’s Annual Report on Form 10-K for the fiscal year ended June 30, 2023 filed with the SEC and the proxy statement/prospectus dated August 19, 2024, as supplemented. Additional assumptions, risks and uncertainties 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 . You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and Kintara 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: Jenene Thomas JTC Team, LLC tuhura@jtcir.com SOURCE: TuHURA Biosciences, Inc. View the original press release on accesswire.com

免疫疗法临床3期高管变更细胞疗法并购

2024-10-16

·PRNewswire

Kintara Therapeutics Announces 1-for-35 Reverse Stock Split in Connection with the Proposed Merger with TuHURA Biosciences

SAN DIEGO, Oct. 16, 2024 /PRNewswire/ -- Kintara Therapeutics, Inc. ("Kintara") (NASDAQ: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that its Board of Directors (the "Board") has approved a reverse stock split of Kintara's common stock at a ratio of 1-for-35. Kintara's common stock is expected to begin trading on a post-reverse stock split basis on the Nasdaq Capital Market on October 17, 2024, under the new name TuHURA Biosciences, Inc. and under the new symbol "HURA" following the anticipated closing of the merger (the "Merger") with TuHURA Biosciences, Inc. ("TuHURA"), with a new CUSIP number 898920 103. The reverse stock split was approved by Kintara's stockholders at Kintara's special meeting of stockholders held on October 4, 2024, to be effected in the Board's discretion of not less than 1-for-20 and not more than 1-for-40. The final reverse stock split ratio of 1-for-35 was approved by the Board on October 4, 2024. As a result of the reverse stock split, every thirty-five pre-split shares of Kintara's common stock outstanding will become one share of common stock. The reverse stock split is expected to reduce the number of shares of Kintara's outstanding common stock from approximately 55.6 million shares to approximately 1.6 million shares. The par value of Kintara's common stock will remain unchanged at $0.001 per share after the reverse stock split. The reverse stock split will not change the authorized number of shares of Kintara's common stock. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder's percentage interest in Kintara's equity, except to the extent that the reverse stock split results in some stockholders owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Instead, in lieu of any fractional shares to which a stockholder of record would otherwise be entitled as a result of the reverse stock split, Kintara will issue to such stockholder such additional fraction of a share as is necessary to increase such resulting fractional share to a full share of common stock. The reverse stock split will also apply to common stock issuable upon the exercise of Kintara's outstanding warrants and stock options, with a proportionate adjustment to the exercise prices thereof, and under Kintara's equity incentive plans. Following the closing of the Merger, the combined company's total outstanding common stock is expected to be approximately 42.0 million shares. Equinity Trust Company, LLC is acting as the exchange agent and transfer agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions. About TuHURA Biosciences, Inc. TuHURA Biosciences is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA's lead personalized cancer vaccine candidate, 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) in first line treatment for advanced Merkel Cell Carcinoma. In addition, TuHURA is leveraging its Delta receptor technology to develop novel bi-functional antibody drug conjugates (ADCs), 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 tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. About Kintara Therapeutics, Inc. Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing therapeutics for clear unmet medical needs with reduced risk development programs. Kintara's lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC). Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications. Kintara Therapeutics, Inc. is headquartered in San Diego, California. For more information, please visit or follow us on X at @Kintara_Thera, Facebook and LinkedIn. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements based upon Kintara's and TuHURA's current expectations. This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology 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 Kintara's or TuHURA's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the proposed Merger and the expected effects, perceived benefits or opportunities and related timing with respect thereto, expectations regarding clinical trials and research and development programs, in particular with respect to TuHURA's IFx-Hu2.0 product candidate novel bifunctional ADCs, and any developments or results in connection therewith; the anticipated timing of the results from those studies and trials; expectations regarding the use of capital resources, including the net proceeds from the financing that closed in connection with the signing of the definitive agreement, and the time period over which the combined company's capital resources will be sufficient to fund its anticipated operations; and the expected trading of the combined company's stock on the Nasdaq Capital Market. These statements are only predictions. Kintara and TuHURA have based these forward-looking statements largely on their then-current expectations and projections about future events, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond each of Kintara's and TuHURA's control, and actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) the risk that the conditions to the closing or consummation of the proposed Merger are not satisfied; (ii) uncertainties as to the timing of the consummation of the proposed Merger and the ability of each of Kintara and TuHURA to consummate the transactions contemplated by the proposed Merger; (iii) risks related to Kintara's and TuHURA's ability to correctly estimate their respective operating expenses and expenses associated with the proposed Merger, as applicable, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the resulting combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company's cash resources; (iv) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the proposed Merger by either Kintara or TuHURA; (v) the effect of the announcement or pendency of the proposed Merger on Kintara's or TuHURA's business relationships, operating results and business generally; (vi) costs related to the proposed Merger; (vii) the outcome of any legal proceedings that may be instituted against Kintara, TuHURA, or any of their respective directors or officers related to the Merger Agreement or the transactions contemplated thereby; (vii) the ability of Kintara or TuHURA to protect their respective intellectual property rights; (viii) competitive responses to the proposed Merger; (ix) unexpected costs, charges or expenses resulting from the proposed Merger; (x) whether the combined business of TuHURA and Kintara will be successful; (xi) legislative, regulatory, political and economic developments; and (xii) additional risks described in the "Risk Factors" section of Kintara's Annual Report on Form 10-K for the fiscal year ended June 30, 2024, and the Registration Statement on Form S-4 related to the proposed Merger filed with the SEC. Additional assumptions, risks and uncertainties are described in detail in Kintara's registration statements, reports and other filings with the SEC, which are available on Kintara's website, and at . Accordingly, you should not rely upon forward-looking statements as predictions of future events. Neither Kintara nor TuHURA can assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Kintara and TuHURA undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Investors should not assume that any lack of update to a previously issued "forward-looking statement" constitutes a reaffirmation of that statement. INVESTOR INQUIRIES: Robert E. Hoffman Kintara Therapeutics [email protected] SOURCE Kintara Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期疫苗免疫疗法并购放射疗法

2024-10-15

·PRNewswire

Kintara Therapeutics Announces Correction to Prior Announcement Regarding CVR Issuance in Connection with the Proposed Merger with TuHURA Biosciences Expected to Close on October 18, 2024

SAN DIEGO, Oct. 15, 2024 /PRNewswire/ -- Kintara Therapeutics, Inc. ("Kintara") (NASDAQ: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced a correction to the press release previously issued by Kintara on October 14, 2024, regarding a record date for the issuance of the Contingent Value Rights ("CVRs") to stockholders of Kintara pursuant to the definitive merger agreement (the "Merger Agreement") with TuHURA Biosciences, Inc. ("TuHURA"). Kintara announced today that the CVRs will not be issued to stockholders of record of Kintara based on a record date of October 17, 2024, but rather will be issued stockholders of record of Kintara immediately prior to the planned reverse stock split that will be consummated immediately prior to the proposed Merger. Accordingly, the announcement of a record date for the CVRs made by Kintara on October 14, 2024 is hereby retracted. Kintara does not anticipate that this correction and retraction will affect the stockholders of record who will receive the CVRs or the number of CVRs to be received by them. As previously announced, Kintara's stockholders approved a reverse stock split of Kintara's common stock in a range of 1-for-20 to 1-for-40 at Kintara's special meeting of stockholders held on October 4, 2024. Kintara expects to effect a reverse stock split at a ratio of 1-for-35 immediately prior to the consummation of the proposed Merger. Also as previously announced, the proposed Merger is expected to close on October 18, 2024 (the "Closing Date"), subject to regulatory approval and the satisfaction of the remaining closing conditions under the Merger Agreement. In connection with the proposed Merger and pursuant to the Contingent Value Rights Agreement (the "CVR Agreement") to be entered into prior to the Closing Date, Kintara will issue a number of CVRs to Kintara stockholders entitling the holders thereof to an aggregate of 53,897,125 shares of Kintara's common stock, which number is subject to adjustment as a result of Kintara's proposed reverse stock split described above upon the achievement of certain milestones as set forth in the CVR Agreement. Kintara stockholders of record immediately prior to the reverse stock split will receive one CVR per share of Kintara common stock (or in the case of warrants to purchase shares of Kintara common stock, each share of Kintara common stock for which such warrant to purchase shares of Kintara stock is exercisable) each respectively owned. The CVRs will be issued immediately prior to the proposed reverse stock split and closing of the proposed Merger. Equiniti Trust Company, LLC is acting as the rights agent for CVRs. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the issuance of CVRs. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions. About TuHURA Biosciences, Inc. TuHURA Biosciences is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA's lead personalized cancer vaccine candidate, 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) in first line treatment for advanced Merkel Cell Carcinoma. In addition, TuHURA is leveraging its Delta receptor technology to develop novel bi-specific antibody drug or peptide drug conjugates (ADCs and PDCs), 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 tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. About Kintara Therapeutics, Inc. Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing therapeutics for clear unmet medical needs with reduced risk development programs. Kintara's lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC). Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications. Kintara Therapeutics, Inc. is headquartered in San Diego, California. For more information, please visit or follow us on X at @Kintara_Thera, Facebook and LinkedIn. FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements based upon Kintara's and TuHURA's current expectations. This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology 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 Kintara's or TuHURA's management team's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding the proposed Merger and the expected effects, perceived benefits or opportunities and related timing with respect thereto. These statements are only predictions. Kintara and TuHURA have based these forward-looking statements largely on their then-current expectations and projections about future events, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond each of Kintara's and TuHURA's control, and actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) the risk that the conditions to the closing or consummation of the proposed Merger are not satisfied; (ii) uncertainties as to the timing of the consummation of the proposed Merger and the ability of each of Kintara and TuHURA to consummate the transactions contemplated by the proposed Merger; (iii) risks related to Kintara's and TuHURA's ability to correctly estimate their respective operating expenses and expenses associated with the proposed Merger, as applicable, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the resulting combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company's cash resources; (iv) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the proposed Merger by either Kintara or TuHURA; (v) the effect of the announcement or pendency of the proposed Merger on Kintara's or TuHURA's business relationships, operating results and business generally; (vi) costs related to the proposed Merger; (vii) the outcome of any legal proceedings that may be instituted against Kintara, TuHURA, or any of their respective directors or officers related to the Merger Agreement or the transactions contemplated thereby; (vii) the ability of Kintara or TuHURA to protect their respective intellectual property rights; (viii) competitive responses to the proposed Merger; (ix) unexpected costs, charges or expenses resulting from the proposed Merger; (x) whether the combined business of TuHURA and Kintara will be successful; (xi) legislative, regulatory, political and economic developments; and (xii) additional risks described in the "Risk Factors" section of Kintara's Annual Report on Form 10-K for the fiscal year ended June 30, 2024, and the Registration Statement on Form S-4 related to the proposed Merger filed with the SEC. Additional assumptions, risks and uncertainties are described in detail in Kintara's registration statements, reports and other filings with the SEC, which are available on Kintara's website, and at . Accordingly, you should not rely upon forward-looking statements as predictions of future events. Neither Kintara nor TuHURA can assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Kintara and TuHURA undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Investors should not assume that any lack of update to a previously issued "forward-looking statement" constitutes a reaffirmation of that statement. INVESTOR INQUIRIES: Robert E. Hoffman Kintara Therapeutics [email protected] SOURCE Kintara Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床3期疫苗并购放射疗法

100 项与 IFx-Hu2.0 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
梅克尔细胞癌	临床3期	-	TuHURA Biosciences, Inc. (Old)	-
基底细胞癌	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2021-06-10
皮肤肿瘤	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2021-06-10
皮肤鳞状细胞癌	临床1期	美国	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2020-03-03
皮肤鳞状细胞癌	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2020-03-03
非皮肤黑色素瘤	临床1期	美国	H. Lee Moffitt Cancer Center & Research Institute, Inc.	2020-03-03
非皮肤黑色素瘤	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2020-03-03
皮肤黑色素瘤	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2018-11-05
转移性黑色素瘤	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2018-11-05
不可切除的黑色素瘤	临床1期	美国	TuHURA Biosciences, Inc. (Old)	2018-11-05

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04925713 (CTgov)	临床1期	基底细胞癌 \| 皮肤肿瘤 \| 皮肤鳞状细胞癌	5	IFx-Hu2.0	襯壓繭觸獵顧淵醖蓋齋(顧衊艱艱遞繭窪鏇範餘) = 窪糧製範選積鏇衊觸遞獵醖鑰網積襯醖蓋艱憲 (網築鏇糧蓋夢製選齋餘, 淵鹹簾糧積範襯衊網糧 ~ 選膚糧網齋膚齋顧廠範) 更多	-	2024-08-02
NCT04160065 (ASCO2024) 人工标引	临床1期	梅克尔细胞癌 \| 皮肤鳞状细胞癌	22	IFx-Hu2.0 (MCC)	繭衊鹽遞鬱鹹範鏇膚獵(壓鏇憲醖膚鬱齋鑰鬱餘) = 鏇顧範築衊壓艱壓積鏇顧遞夢壓築鹽衊鹹餘製 (憲醖鹹夢衊壓獵願窪廠 )	积极	2024-05-24
NCT04160065 (ASCO2024) 人工标引	临床1期	梅克尔细胞癌 \| 皮肤鳞状细胞癌	22	IFx-Hu2.0 (cSCC)	繭衊鹽遞鬱鹹範鏇膚獵(壓鏇憲醖膚鬱齋鑰鬱餘) = 獵簾淵範蓋網遞蓋遞製顧遞夢壓築鹽衊鹹餘製 (憲醖鹹夢衊壓獵願窪廠 )	积极	2024-05-24
NCT04160065 (ASCO2023) 人工标引	临床1期	梅克尔细胞癌 \| 皮肤鳞状细胞癌	9	IFx Hu2.0	醖觸壓淵簾網鹽顧衊顧(窪簾顧齋願簾遞夢選築) = 鹽鑰醖醖膚窪鬱繭餘鑰獵構憲膚鏇夢繭鏇蓋艱 (鬱觸醖鑰壓鏇齋憲艱構 ) 更多	积极	2023-05-26
NCT03655756 (CTgov)	早期临床1期	皮肤黑色素瘤 \| 转移性黑色素瘤 \| 不可切除的黑色素瘤	7	IFx-Hu2.0	壓蓋夢膚夢糧獵淵鑰鹽(淵範齋製顧窪蓋憲獵選) = 願淵鹹衊膚醖餘繭鑰衊願襯積鏇醖鏇簾襯範築 (範艱淵鑰窪構築憲襯網, 顧廠簾鹽獵積壓夢齋遞 ~ 構糧製餘積鹽齋簾鏇糧) 更多	-	2022-08-08
NCT03655756 (ASCO2022) 人工标引	临床1期	不可切除的黑色素瘤	6	IFx Hu2.0	鏇鏇鹽範壓膚壓觸淵餘(膚簾膚築網夢鹹鏇壓鏇) = 艱鏇觸餘範願築窪積襯範製願窪艱製窪窪鏇窪 (膚獵願遞艱襯製襯選製 ) 更多	积极	2022-06-02