On June 30, 2025 BerGenBio ASA (OSE: BGBIO) ("BerGenBio" or the "Company") and Oncoinvent ASA (OSE: ONCIN) ("Oncoinvent") reported that they have entered into a merger agreement (the "Agreement") to combine the two companies through a statutory merger (the "Merger"), where BerGenBio will be the acquiring entity (Press release, Oncoinvent, JUN 30, 2025, https://www.oncoinvent.com/press-release/bergenbio-and-oncoinvent-a-rising-innovator-in-radiopharmaceutical-cancer-therapies-announce-proposed-merger-and-a-fully-underwritten-rights-issue/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234654177]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Following the Merger, the combined company shall carry out a fully underwritten rights issue.

The Merger puts BerGenBio’s capital and listing to productive use by strengthening Oncoinvent’s ability to execute on its clinical strategy and advance potentially life-changing treatments for patients with cancer in the abdominal cavity (peritoneal carcinomatosis).
The exchange ratio in the Merger will be 25% to BerGenBio and 75% to Oncoinvent corresponding to 1.20268049 shares in BerGenBio per share in Oncoinvent and values BerGenBio prior to the Merger at NOK 65 million, which represents a significant premium to what would be available for distribution to BerGenBio’s shareholders in a solvent liquidation scenario, and a premium of 19% compared to the closing price on Monday 30 June 2025. The Merger values Oncoinvent at NOK 195.5 million, which corresponds to its valuation in connection with the listing on Euronext Growth in December 2024 and a premium of 8% compared to the closing price on Monday 30 June 2025.
The Merger will add approximately NOK 45 million in cash to fund Oncoinvent’s clinical development plan. Moreover, the combination will substantially broaden the shareholder base, improving liquidity in the share and enable an uplisting from Euronext Growth Oslo, subject to approval by the Oslo Stock Exchange.
Subject to approval by the extraordinary general meetings of BerGenBio and Oncoinvent, Euronext Oslo Børs’ approval of the continued listing and completion of the Merger, the merged company will carry out a fully underwritten rights issue of NOK 130 million (the "Rights Issue"). The proceeds from the Rights Issue is expected to provide the merged company with a cash runway into 2027, beyond the interim readout from Oncoinvent’s ongoing Phase 2 trial in ovarian cancer, expected H2 2026.
The Merger is supported by BerGenBio’s largest shareholder Meteva AS and Oncoinvent’s largest shareholders Hadean Capital I AS and HVentures Capital I AB (together "Hadean Ventures") and Linc AB, all of whom have entered into voting undertakings to vote in favour of the Merger and lock-up commitments for a period of six months following this announcement.
The Agreement follows from the strategic review that BerGenBio has conducted, in cooperation with DNB Carnegie, to optimise shareholder value following its decision to discontinue the BGBC016 study.

Anders Tullgren, chair of the board of BerGenBio, stated: "I am very pleased to be able to announce our joining forces with Oncoinvent. This Merger, which is backed by the boards of both companies, is the result of an extensive review that explored a range of strategic options for BerGenBio. The Merger gives BerGenBio shareholders a part of an exciting company leveraging Norwegian radiopharmaceutical technology, which has already seen encouraging preliminary efficacy data, without safety concerns. We are confident that this is the best option for current BerGenBio shareholders."

Øystein Soug, CEO of Oncoinvent and forthcoming CEO of the merged company, stated: "We are very excited for the time ahead and to continue the execution of our focused strategy to develop Radspherin in ovarian cancer. We are on track with our randomised phase 2 trial. Going forward with a strengthened balance sheet, we believe the company will be a transformative force in the radiopharmaceutical therapy field, improving the lives of patients with cancer in the peritoneal cavity."

On June 30, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that updated results from the Phase 1/2 FRAME study conducted by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust were published online in Nature Medicine (Press release, Verastem, JUN 30, 2025, View Source [SID1234654176]). The full manuscript, titled "Defactinib with avutometinib in patients with solid tumors: the phase 1 FRAME trial," was the first-in-human study to evaluate the safety, tolerability, and efficacy of avutometinib in combination with defactinib in patients with low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC), and other solid tumor types.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The FRAME study was the early foundation for the recent FDA approval of avutometinib plus defactinib in KRAS-mutated recurrent low-grade serous ovarian cancer and we are pleased to see that the mature data set continues to show the safety and tolerability of this combination therapy," said Dan Paterson, president and chief executive officer of Verastem Oncology. "This supports our ongoing commitment to advancing our research into the combination for use in other solid tumors, including RAMP 205 in first-line metastatic pancreatic cancer."

The FRAME study enrolled patients, across dose escalation and dose expansion cohorts, with RAS-MAPK-driven solid tumors including LGSOC, NSCLC, colorectal, pancreatic and endometrial cancers. The updated data include an extended follow-up period and more detailed analyses from the FRAME study, featuring efficacy and safety data that demonstrated the novel combination of avutometinib and defactinib continues to be well-tolerated and shows encouraging responses in patients with LGSOC, consistent with previous findings.

"This was the first clinical study to show significant clinical activity of the combination of avutometinib, a RAF/MEK clamp, with defactinib, a FAK inhibitor. The FRAME study demonstrated an important potential advancement in the treatment of solid tumor diseases like low-grade serous ovarian cancer where seventy percent of these tumors are driven by the RAS/MAPK pathway and with thirty percent of these patients carrying a KRAS mutation," said Professor Udai Banerji, co-Director of the Drug Development Unit, The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust, London. "We are pleased to have contributed to the development of avutometinib and defactinib. With FRAME’s encouraging efficacy signal, the recommended Phase 2 dose was selected and the intermittent dosing schedule evaluated, which is the dose and schedule recently FDA approved in the U.S. and being used in the global confirmatory Phase 3 RAMP 301 trial."

In 26 patients with LGSOC who were evaluable for efficacy, the overall response rate (ORR) was 42.3% (11/26) and median progression-free survival (mPFS) was 20.1 months. In the 24 patients whose samples could be sequenced for KRAS mutations, ORR and mPFS were 58.3% (7/12) and 30.8 months in the 12 patients with KRAS mutations, and 33.3% (4/12) and 8.9 months in the 12 patients without KRAS mutations. In 11 patients who had previously received a MEK inhibitor, the ORR was 27.3% (3/11). Additionally, in two patients with LGSOC who had brain metastases prior to enrolling, MRI imaging at 30 months post-treatment with the combination showed the metastases had shrunk in both patients.

In 27 patients with LGSOC who were evaluable for safety, only one (4%) discontinued treatment due to Grade 3 skin toxicity. The five most common adverse events (AEs) (all grades, grade ≥3) were: rash (90%, 8%), elevated blood levels of creatine phosphokinase (56%, 9%), AST elevation (43%, 1%), hyperbilirubinemia (38%, 2%), and diarrhea (38%, 1%). The tolerability profile of avutometinib plus defactinib was comparable to the tolerability of each agent as monotherapy.

About the Phase 1/2 FRAME Study

The FRAME study is an open-label, investigator-initiated study that is designed to assess safety, dose response, and preliminary efficacy of the VS-6766/defactinib combination in patients with KRAS mutant solid tumors, including low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The FRAME study is being led by Professor Udai Banerji, MBBS, MD, DNB, PhD, FRCP, Deputy Director of the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, and is being conducted in the United Kingdom. In this study, VS-6766 was administered using a twice-weekly dose escalation schedule and was administered three out of every four weeks. Defactinib was administered using a twice-daily dose escalation schedule, also three out of every four weeks. Dose levels were assessed in three cohorts: cohort 1 (avutometinib 3.2mg, defactinib 200mg); cohort 2a (avutometinib 4mg, defactinib 200mg); and cohort 2b (avutometinib 3.2mg, defactinib 400mg). The recommended Phase 2 dose was determined to be cohort 1 (avutometinib 3.2mg, defactinib 200mg).

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a rare ovarian cancer that is insidious and persistent. LGSOC is distinct and different from high-grade serous ovarian cancer (HGSOC) and requires different treatment. LGSOC is highly recurrent and less sensitive to chemotherapy compared to HGSOC. Approximately 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease. LGSOC affects younger women with bimodal peaks of diagnosis at ages between 20-30 and 50-60 and has a median survival of approximately ten years. Approximately 70 percent of LGSOC shows RAS pathway-associated mutations, and 30 percent of people with LGSOC have a KRAS mutation. The majority of patients report a negative impact of LGSOC on their mental and physical health, fertility, and long-term quality of life.

About AVMAPKI and FAKZYNJA Combination Therapy

AVMAPKI (avutometinib) inhibits MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway. Blocking RAF and/or MEK activates FAK, a key mediator of drug resistance. FAKZYNJA (defactinib) is a FAK inhibitor and together, the avutometinib and defactinib combination was designed to provide a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.

The U.S. Food and Drug Administration (FDA) approved AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent LGSOC who have received prior systemic therapy on May 8, 2025. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Verastem is conducting RAMP 301 (GOG-3097/ENGOT-ov81/GTG-UK) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC) with and without a KRAS mutation. Verastem is also evaluating avutometinib in combination with defactinib and other agents as a potential treatment for patients with advanced pancreatic cancer (RAMP 205; NCT05669482) and advanced KRAS G12C mutant non-small cell lung cancer (RAMP 203; NCT05074810). Avutometinib and defactinib are not approved by the FDA or any other regulatory authority, either in combination or with other therapies, for any of these investigative uses. Neither avutometinib nor defactinib are approved by the FDA or any other regulatory authority on a stand-alone basis for any use.

AVMAPKI FAKZYNJA CO-PACK U.S. Indication

Indication
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Ocular Toxicities: Ocular toxicities, including visual impairment and vitreoretinal disorders, occurred. Perform comprehensive ophthalmic evaluation at baseline, prior to cycle 2, every three cycles thereafter, and as clinically indicated. Withhold AVMAPKI FAKZYNJA CO-PACK for ocular toxicities until improvement at the same or reduced dose. Permanently discontinue AVMAPKI FAKZYNJA CO-PACK for any grade 4 toxicity.
Serious Skin Toxicities: Skin toxicities, including photosensitivity and severe cutaneous adverse reactions (SCARSs) occurred. Adhere to concomitant medications. Monitor for skin toxicities and interrupt, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity, tolerability and duration.
Hepatotoxicity: Monitor liver function tests prior to each cycle, on day 15 of the first 4 cycles, and as clinically indicated. Withhold, reduce or discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and persistence of abnormality.
Rhabdomyolysis: Monitor creatine phosphokinase prior to the start of each cycle, on day 15 of the first four cycles, and as clinically indicated. If increased CPK occurs, evaluate patients for rhabdomyolysis or other causes. Withhold, reduce or permanently discontinue AVMAPKI FAKZYNJA CO-PACK based on severity and duration of the adverse reaction.
Embryo-Fetal Toxicity: AVMAPKI FAKZYNJA CO-PACK can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.
Adverse Reactions
The most common (≥ 25%) adverse reactions, including laboratory abnormalities, were increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.

Drug Interactions

Strong and moderate CYP3A4 inhibitors: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Strong and moderate CYP3A4 inducers: Avoid concomitant use with AVMAPKI FAKZYNJA CO-PACK.
Warfarin: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with warfarin and use an alternative to warfarin.
Gastric acid reducing agents: Avoid concomitant use of AVMAPKI FAKZYNJA CO-PACK with proton pump inhibitors (PPIs) or H2 receptor antagonists. If use of an acid-reducing agent cannot be avoided, administer FAKZYNJA 2 hours before or 2 hours after the administration of a locally acting antacid.
Use in Specific Populations

Lactation: Advise not to breastfeed.
Fertility: May impair fertility in males and females.

On June 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported the initiation of the ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM) (Press release, Plus Therapeutics, JUN 30, 2025, View Source [SID1234654175]). The dose optimization trial follows encouraging results from the Company’s single-dose escalation trial and is designed to evaluate multiple-dose regimens of REYOBIQ administered at defined intervals via intraventricular catheter (Ommaya reservoir).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"A safe and effective therapeutic to address the epidemic of CNS metastases and specifically leptomeningeal metastases is urgently needed," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We expect that optimizing the dosing regimen for REYOBIQ in this trial will provide data needed to design and support a follow-on registrational trial."

ReSPECT-LM Dose Optimization Trial Design
The study design is consistent with the FDA’s Project Optimus, and aims to optimize treatment dosing for maximum efficacy and safety. The primary objectives of the trial include determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals in patients with LM from any primary solid tumor cancer and to identify both the maximum tolerated dose and minimum effective dose.

Key additional elements of the trial design include:

Enrollment of up to 24 patients, evaluating REYOBIQ administered at the recommended Phase 2 dose or R2PD of 44.1 mCi, fractionated across three dosing intervals, with up to six patients per cohort interval:
Cohort 1: 56 days
Cohort 2: 28 days
Cohort 3a: 14 days
Cohort 3b: 14 days (6 doses)
The trial will evaluate both safety, pharmacokinetics/dosimetry, and select efficacy-related endpoints such as objective response rate (ORR), neurologic progression-free survival (PFS), overall survival (OS), changes in neurologic status
Furthermore, the trial will analyze cerebrospinal fluid (CSF) tumor cell counts via Plus’ CNSide CSF assay platform, other pharmacodynamic markers, and compare these to standard CSF cytology
Because of the anticipated pace of enrollment, the trial is being limited initially to only two prestigious and high enrolling cancer centers, both in Texas—the University of Texas Health Science Center at San Antonio (UTHSCSA) and the University of Texas Southwestern Medical Center (UTSW) but may expand to more sites if needed.

The dose optimization study builds on promising results from the Company’s single-dose escalation trial. Key highlights include:

Cohort 4 dose (44.1 mCi) was determined to be the RP2D
Pharmacodynamic and pharmacokinetic data showed that a single dose of REYOBIQ remained in the CSF for at least 7 days, and delivered up to an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5
Neuroimaging results showed a clinical benefit rate1 of 76%, with 5 of 17 patients (29%) achieving partial responses and 8 (47%) maintaining stable disease through Day 112
Clinical examination showed a clinical benefit rate in 87% of evaluable patients, with 13 of 15 patients showing a partial response or stable disease based on physician assessment
No dose-limiting toxicities (DLTs) were observed in the first four cohorts; one Grade 4 DLT (thrombocytopenia) occurred in each of Cohorts 5 and 6
Biologic signals of early apoptosis, innate immune activation, and increased T-cell activity by Day 28, as observed through RNA sequencing of LM cells
5 of 7 patients with over 80% reduction of LM tumor cells in CSF survived at least one year after initial treatment
The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial.

The ReSPECT-LM dose optimization trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), the second largest public funding source for cancer research in the world.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

On June 30, 2025 Tyra Biosciences, Inc. (Tyra or the Company) reported the first patient has been dosed in the SURF302 Phase 2 clinical study of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) (Press release, Tyra Biosciences, JUN 30, 2025, View Source [SID1234654174]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival, progression free survival, safety and tolerability. The Company expects to report initial three-month CR data in the first half of 2026.

TYRA-300 will also be evaluated in pediatric achondroplasia in the BEACH301 Phase 2 study, which is open for enrollment and for which the Company now expects first child dosing in the second half of 2025.

On June 30, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported the successful completion of the acquisition of Kineta, Inc. (OTCPK:KANT) ("Kineta"), the maker of the novel VISTA inhibiting mAb formerly known as KVA1213, now renamed as TBS-2025 (Press release, TuHURA Biosciences, JUN 30, 2025, View Source [SID1234654173]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While TuHURA’s IFx-2.0 is being investigated for its potential to overcome primary resistance to checkpoint inhibitors in Merkel cell carcinoma, the acquisition of VISTA expands TuHURA’s pipeline with a Phase 2 ready drug candidate, TBS-2025, which TuHURA believes has the potential to overcome acquired resistance to cancer immunotherapy," stated James Bianco, M.D., President and Chief Executive Officer of TuHURA. "The acquisition provides for synergies across both TuHURA’s therapeutic focus as well as with TuHURA’s antibody drug conjugate (ADC) technology. Not only can TBS-2025 be administered as the intact mAb alone or in combination with other therapeutics, we are also investigating the possibility of it being conjugated to a Delta Opioid Receptor inhibitor(s) resulting in a potential immunomodulatory, bi-functional, and bi-specific ADC targeting myeloid derived suppressor cells (MDSCs) in the tumor microenvironment (TME)."

"We are currently planning on investigating TBS-2025 (formerly known as KVA12123) in a Phase 2 trial in combination with a menin inhibitor in NPM1 mutated AML. Unlike other checkpoints, which are mostly present on activated T cells, VISTA is predominately expressed on myeloid cells, notably MDSCs, and on quiescent T cells. Research has demonstrated that when mutated, NPM1 and DNM3TA, two of the most common mutations in AML and typically co-mutated in myelodysplasia (MDS), result in high expression of VISTA on the surface of leukemic blasts. The presence of VISTA on these cells is believed to be the primary mechanism by which leukemic cells escape immune recognition and attack, resulting in a low treatment response rate and a high level of relapse in AML. We believe, in a relatively inexpensive, small Phase 2 study, we can determine if TBS-2025, our VISTA inhibiting antibody, can augment the response rates seen with menin inhibitors and decrease the rate of relapse in patients with NMP1 mutated relapsed or refractory AML where menin inhibitors are the current standard of care."

About the Transaction
Pursuant to the terms and conditions of the merger agreement between TuHURA and Kineta, each share of Kineta common stock, par value $0.001 per share (each, a "Share"), issued and outstanding immediately prior to the merger, was converted into the right to receive at the closing of the merger 0.185298 shares of TuHURA common stock, par value $0.001 per share ("TuHURA Common Stock"), for an aggregate of 2,868,169 shares of TuHURA Common Stock. Also pursuant to the terms and conditions of the merger agreement, each Share is also entitled to its pro rata portion of an aggregate of 1,129,885 additional shares of TuHURA Common Stock to be issued after 6 months following the closing, which aggregate number of shares is subject to adjustment for losses incurred or accrued during the six month period from the closing of the merger, and (ii) the right to its pro rata share of cash consideration received by Kineta pursuant to disposed asset payments related to legacy Kineta assets. Such payments of cash consideration, if any, will be made at a later date and in accordance with the terms of the merger agreement. In each case, in lieu of the issuance of a fractional share of TuHURA Common Stock to former holders of Kineta common stock, TuHURA will pay an amount equal to the product of (A) such fractional share and (B) $5.7528.

Leerink Partners acted as the exclusive financial advisor to TuHURA on the transaction.

About TBS-2025 (f/k/a KVA12123)
VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint highly expressed on myeloid cells. VISTA is a strong driver of immunosuppression in the tumor microenvironment (TME). VISTA expression is found on infiltrating immune cells, with the highest levels on myeloid lineage cells, including MDSCs. It suppresses T cell function, and high levels of VISTA expression in the human TME have been correlated in most studies with decreased overall survival (OS).

TBS-2025 VISTA-blocking immunotherapy is administered intravenously every 2 weeks (Iadonato et al. Front Immunol 2023). It is an engineered IgG1 mAb with an extended half-life that binds to a unique epitope at both acidic and neutral pH.

TBS-2025 was investigated in a dose escalation Phase 1/2 trial, both as a monotherapy and in combination with pembrolizumab, in patients with relapsed and/or treatment-refractory advanced solid tumors. TBS-2025 was well tolerated at doses up to 1,000mg both in the monotherapy arm (n=24) or in the pembrolizumab combination therapy arm (n=16). Pharmacokinetic and pharmacodynamic data demonstrated greater than 90% receptor occupancy across the every two- week dosing interval. Immunocytokine analysis was consistent with the mechanism of action for VISTA inhibition on immune cells.