On 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 reported the completion of its previously announced merger with Kintara Therapeutics, Inc. (now TuHURA Biosciences, Inc.) (Press release, TuHURA Biosciences, OCT 17, 2024, View Source [SID1234647248]). 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 1st line Merkel Cell carcinoma under SPA agreement with FDA.

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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.

On October 17, 2024 Nusano, a physics company transforming the production of radioisotopes, and Starget Pharma, a clinical-stage biotechnology company developing precision peptide radioligand therapies focused on difficult to treat cancers, reported a supply agreement to advance the development of Starget’s Smart Targeted Radioligands (STRs) (Press release, Nusano, OCT 17, 2024, View Source [SID1234647247]). The supply agreement is expected to support Starget’s STR isotope needs from discovery through commercialization and will include both common radioisotopes as well as rare alpha particle-emitters such as Astatine-211, Lead-212, and Actinium-225.

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"We are excited to partner with Nusano, a leader in radioisotope production, to support the development of our novel pipeline of smart targeted radioligands," said Sigal Kalmanson Cusnir, CEO of Starget Pharma. "Our STR platform technology enables the rapid design and evaluation of radiotherapies in an isotope-agnostic manner, allowing us to optimize performance by tumor type. We are focused now on advancing our clinical pipeline, beginning with the planned initiation of a Phase 1b clinical trial in early 2025. The Nusano agreement will ensure that we have a reliable radioisotope supply chain, facilitating near and long term growth, with the ultimate goal of radically improving patient care and outcomes."

Starget’s STR platform is advancing the field of molecular radiation using its proprietary backbone cyclization technology to create innovative and diversified peptide radioligand candidates with enhanced properties. These STRs are designed to bind and deliver a payload of radiation specifically to biological targets that are overexpressed in cancer compared to normal cells. This highly focused radiation then damages the DNA in the cancer cells, leading to selective cell death and tumor shrinkage. Due to their unique molecular interaction with the target, STRs act with high sensitivity and precision, enabling effective radiation targeting tumors and metastasis.

Radioisotopes are essential components in the active pharmaceutical ingredients (API) used in new and emerging cancer therapies including molecular radiation. Existing supply chains for these treatment-enabling resources are often strained, posing a risk to patient care, clinical trials, and ongoing drug development.

Nusano is working to stabilize supply chains and enable innovation by bringing new sources of radioisotopes to medical and industrial markets. Opening in 2025 in West Valley City, Utah, the Nusano production platform will be capable of generating more than 25 radioisotopes applicable to medical and industrial uses. It is anchored by a proprietary ion source technology which accelerates heavy particles (alphas and deuterons) to generate high volume, high quality (cGMP-grade) radioisotopes with unparalleled efficiency using eco-friendly methods. The result is one of the first significant advancements in radioisotope production in decades.

Chris Lowe, CEO of Nusano commented, "The Nusano platform will make medical radioisotopes available in varieties and volumes needed to broaden and accelerate radiotherapeutics development. We share Starget’s enthusiasm for finding the right isotope to target specific tumor types and look forward to working with them to advance more isotopes into clinical development for the betterment of cancer patients around the world."

On October 17, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported preliminary revenue results for the third quarter of 2024, achieving $11.2 million, which included the recording of $10.0 million in U.S. revenue from the commercialization of HEPZATO KIT (Press release, Delcath Systems, OCT 17, 2024, View Source [SID1234647246]).

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The announcement of the recording of $10.0 million in U.S. quarterly revenue from the commercialization of HEPZATO KIT effectively triggers the exercise of Tranche B warrants issued in the previously announced March 29, 2023 Private Investment in Public Equity (the "PIPE"). Holders of the Tranche B warrants from the PIPE have 21 days from the date of this announcement to exercise their Tranche B warrants to purchase shares of common stock at an effective price of $6.00 per share of common stock for an aggregate exercise price of up to approximately $25 million.

"This revenue milestone is an important indicator of the strong demand for HEPZATO KIT, highlighting the unmet medical need it addresses in uveal melanoma patients with liver metastases and the rapid uptake by physicians," said Gerard Michel, Chief Executive Officer of Delcath. "The Company will utilize the additional $25 million of financing to support the ongoing commercial launch and invest in new clinical trials to expand indications which we plan to initiate in 2025."

Final financial results for the third quarter and a detailed business update will be provided during Delcath’s quarterly financial results release and investor call scheduled for November 8, 2024.

On October 17, 2024 Breakpoint Therapeutics GmbH ("Breakpoint"), a company dedicated to the discovery and development of drugs targeting the DNA Damage Response (DDR), reported that it will present preclinical data from its polymerase theta (Pol θ / POLQ) inhibitor programme in a poster at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, being held October 23-25, 2024 in Barcelona, Spain (ENA 2024) (Press release, Breakpoint Therapeutics, OCT 17, 2024, View Source [SID1234647244]).

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DNA polymerase theta is a DNA repair enzyme that is largely absent in normal cells but displays aberrant expression in multiple cancer types which often correlates with poor prognosis. Inhibition of Pol θ is a validated therapeutic modality in certain tumour-specific contexts.

Details of the presentation are as follows:

Abstract Title: Discovery and characterisation of DNA polymerase theta inhibitors for the treatment of cancer

Date: Friday, 25 October, 2024

Time: 9:00 a.m. – 3:00 p.m. CEST

Session Title: DNA Repair Modulation (e.g. PARP, CHK, ATR, ATM)

Abstract Number: 339

Poster Board Number: PB327

On October 17, 2024 Aura Biosciences, Inc. (NASDAQ: AURA), reported positive early data from an ongoing Phase 1 clinical trial of bel-sar (AU-011) in patients with NMIBC. To date, the trial includes 13 patients, with the primary endpoints of evaluating the safety and feasibility of local administration of bel-sar alone (n=5) and bel-sar with light activation (n=8) (Press release, Aura Biosciences, OCT 17, 2024, View Source [SID1234647243]). The secondary endpoints are to evaluate biological activity and immune mediated changes in the tumor microenvironment (TME). 10 of 13 study participants had low grade disease, approximating the 70% incidence of this patient population among all NMIBC patients. The other 3 study participants had high grade disease. In patients receiving bel-sar with light activation (n=8), 4 out of 5 patients with low grade disease demonstrated a clinical complete response with no tumor cells remaining on histopathological evaluation. 2 out of 3 patients with high grade disease demonstrated visual tumor shrinkage observed on cystoscopy. Aura will host a Virtual Urologic Oncology Investor Event at 4:30 pm ET today.

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"We are highly encouraged by this positive early data, which shows that bel-sar has the potential to be a transformative cancer treatment," said Sabine Brookman-May, MD, FEBU, Senior Vice President, Therapeutic Area Head Urologic Oncology of Aura Biosciences. "A potentially differentiating aspect of this novel treatment is the rapid tumor response accompanied by an immune oncology (IO) effect such as a marked CD8+ T-cell infiltration observed in just a matter of days with a single low dose. We believe this could have the potential to translate into a durable response. In parallel with expanding the ongoing Phase 1 trial, we are preparing for a Phase 2 trial to further evaluate bel-sar’s clinical activity and durability of response."

"Bel-sar has the potential to change the treatment paradigm for NMIBC," said Neal Shore, MD, FACS, Medical Director, Carolina Urologic Research Center, AUC Urology Specialists. "Based on this early data, bel-sar’s positive clinical activity and evidence of a bladder urothelial field effect with a single dose, may position bel-sar to be the first immune ablative treatment option for early-stage bladder cancer patients delivered with an in-office procedure."

Bel-sar is a virus-like drug conjugate, designed to have a dual mechanism of action, that induces direct tumor cell necrosis and elicits a robust and durable anti-tumor immune response.

Trial Design: The ongoing Phase 1 trial (NCT05483868) is a two-part, open-label clinical trial, designed to assess the safety and feasibility of bel-sar as a monotherapy. The study treatment is administered 7 to 12 days before the scheduled transurethral resection of bladder tumor (TURBT), the standard of care procedure. The participants are followed for safety monitoring over a 56-day period. The trial is also evaluating bel-sar’s biological activity with histopathological evaluation of tissue samples collected at the time of TURBT (regardless of tumor response) with evaluation of focal necrosis and immune changes in the tumor microenvironment. Part 1 (n=5) of the trial is complete, with patients receiving a single bel-sar dose without light activation. Part 2 (n=10) of the trial is ongoing. 8 patients with a confirmed tumor at time of treatment have received either 100ug or 200ug of bel-sar as a single dose. Of these 8 patients, 5 had low grade disease and 3 had high grade disease. 7 of these 8 patients had a history of recurrent bladder cancer and had undergone multiple TURBTs and adjuvant treatments such as Bacillus Calmette-Guerin (BCG), mitomycin, gemcitabine, cetrelimab and tamoxifen prior to trial enrollment. In the Phase 1 trial expansion, Aura plans to test additional doses and treatment regimens.

Safety Data: In the safety analysis as of the September 9, 2024 data cut-off date (n=12), bel-sar was well-tolerated, with less than 10% of patients reporting Grade 1 and no Grade 2 or higher drug-related adverse events reported. No serious adverse events have been reported. No significant differences between the light-activated and non-light activated cohorts have been observed.

Biological Activity: The data in these 8 patients receiving bel-sar with light activation showed clinical activity detectable as soon as 7 days after a single low dose of bel-sar with light activation. This was demonstrated by histopathological evidence of clinical complete response, necrosis, immune activation or visual tumor shrinkage observed on cystoscopy. For this analysis, "clinical complete response" was defined as the absence of tumor cells on histopathologic evaluation. Of the patients with low-grade disease, 4 out of 5 exhibited a clinical complete response (1 of 4 based on local pathology with central review ongoing), with no tumor cells detected in histopathological evaluation post-treatment in the target and in several non-target bladder tumors. 2 of 3 of the patients with high grade disease demonstrated visual tumor shrinkage observed on cystoscopy, while tumor cells were still present on histopathological evaluation. Immune activation was noted in all patients in both treated target and untreated non-target bladder tumors with infiltration of effector CD8+ and CD4+ T-cells (where immune staining was available). This data provides evidence of a bladder urothelial field effect with a single low dose of bel-sar with light activation, potentially indicating a broader immune response in the bladder beyond the target tumor in these patients.

Aura Virtual Urologic Oncology Investor Event

Aura will host a Virtual Urologic Oncology Investor Event featuring Max Kates, MD (Johns Hopkins), Joe Jacob, MD (Syracuse University), Neal Shore, MD (Carolina Urologic Research Center) and Gary Steinberg, MD (RUSH University) to discuss the early Phase 1 data on Thursday, October 17, 2024, at 4:30 pm Eastern Time. To register for the event, click here. A live question and answer session will follow the formal discussion.

The live webcast of Aura’s Virtual Urologic Oncology Investor Event will be available on the "Investors & Media" page under the "Events & Presentations" section of Aura’s website at View Source, where a replay of the webcast will be archived for 90 days following the presentation date.