On May 6, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has awarded a Commissioner’s National Priority Voucher (CNPV) pilot program voucher for BIZENGRI (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. PTx submitted a supplemental Biologics License Application (sBLA) to the FDA for this indication based on data from the Phase 2 eNRGy trial. BIZENGRI previously received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for NRG1+ cholangiocarcinoma.

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"We are honored to receive this Commissioner’s National Priority Voucher, which reflects the FDA’s recognition of the profound unmet need facing patients with NRG1+ cholangiocarcinoma, an ultra-rare cancer for which no approved targeted therapy currently exists," said Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics. "Receiving this voucher highlights the urgent need for new treatment options in NRG1 fusion-positive cholangiocarcinoma. Based on the encouraging data from the eNRGy trial, including meaningful tumor responses, durable benefit and a favorable tolerability profile, we believe BIZENGRI has the potential to address a critical gap in care for these patients. We look forward to working closely with the FDA through this accelerated review process."

The FDA’s Commissioner’s National Priority Voucher pilot program, announced in June 2025, is designed to reduce drug and biologic review times from the standard 10–12 months to as little as 1–2 months for products that align with one or more U.S. national health priorities. These priorities focus on advancing innovative breakthrough therapies that introduce novel mechanisms and meaningfully improve how diseases are treated, while also addressing significant unmet medical needs where current treatment options fall short for patients. The program employs a multidisciplinary, tumor board-style review process involving the primary FDA review team and senior agency leadership. BIZENGRI, as a first-in-class bispecific antibody targeting a rare and actionable oncogenic driver with no approved targeted therapy, aligns directly with national priorities.

"For patients facing cholangiocarcinoma, innovation and timely diagnosis can make a profound difference. The FDA’s recognition of this potential treatment underscores both the unmet need in this rare biomarker-defined population and the importance of expanding access to comprehensive biomarker testing so patients can be matched to the most appropriate therapies as early as possible," said Stacie Lindsey, CEO of the Cholangiocarcinoma Foundation.

Data from the cohort of patients with NRG1+ cholangiocarcinoma in the Phase 2 eNRGy trial were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting in October 2025, highlighting clinical outcomes in this rare cancer.1 "Patients with NRG1 fusion–positive cholangiocarcinoma face a significant unmet need, with limited effective treatment options available today," said Alison Schram, MD, Gynecologic Medical Oncologist at Memorial Sloan Kettering Cancer Center (MSK) and Principal Investigator of the eNRGy trial. "The FDA’s recognition through the Commissioner’s National Priority Voucher program emphasizes the urgency of advancing therapies for this population. In the eNRGy study, zenocutuzumab demonstrated clinically meaningful activity, with objective responses in more than one-third of evaluable patients and a median progression-free survival of over nine months. These data also highlight the critical role of comprehensive molecular testing, particularly RNA-based comprehensive molecular profiling, in identifying patients who may benefit from emerging targeted approaches."

About NRG1+ Cholangiocarcinoma
Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with an all-stage 5-year overall survival of less than 15%. NRG1 gene fusions occur in fewer than 1% of cholangiocarcinoma cases. NRG1 fusions are largely mutually exclusive with other actionable oncogenic drivers, leaving affected patients—many of whom are younger adults —without approved targeted therapy. Standard cytotoxic regimens carry substantial toxicity, and second-line options such as FOLFOX produce objective responses in only approximately 5% of patients.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

About NRG1 Gene Fusions
NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS
BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions
BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis
BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.

In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.

Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction
BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity
Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, MAY 6, 2026, View Source [SID1234665220])

On May 6, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI (taletrectinib) in both TKI-naïve and TKI-pretreated advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) with a target action date of January 4, 2027.

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The submission, which fulfills an FDA post-marketing commitment and is intended to update the efficacy information provided in the IBTROZI label, includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, further validating the overall clinical profile with long-term follow-up. As of this data cutoff, IBTROZI demonstrated median duration of response (mDOR) of 49.7 months and median progression-free survival (mPFS) of 49.6 months in TKI-naïve patients in TRUST-I, reflecting more than four years of sustained clinical benefit, and mDOR of 19.4 months in TKI-pretreated patients in TRUST-II. In the TRUST-II study, the mDOR had not yet been reached in TKI-naïve patients at the time of the data cutoff and is subject to change as the data mature. Importantly, the safety profile remained consistent with prior reports, and no new signals were identified. Many patients remained on therapy for extended periods and without disease progression—some for multiple years—highlighting the long-term tolerability of IBTROZI and reinforcing its importance as a treatment option. These data were recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

"These longer-term data for IBTROZI—which show an impressive median duration of response of more than four years in TKI-naïve patients, mirrored by the progression-free survival results and supported by a consistent safety profile—reinforce our belief that IBTROZI is becoming the new standard of care in advanced ROS1+ NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "The breadth and maturity of these data give both patients and providers even greater confidence when selecting IBTROZI."

The U.S. FDA granted full approval to IBTROZI in June 2025 for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, followed by a successful launch. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON. Additionally, the Company, along with its partner, Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency for full approval consideration with a standard review timeline.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, following Priority Review and Breakthrough Therapy Designations for both first- and second-line or later, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.

(Press release, Nuvation Bio, MAY 6, 2026, View Source [SID1234665219])

On May 6, 2026 AbbVie (NYSE: ABBV) reported it will participate in the Bank of America Securities Healthcare Conference on Wednesday, May 13, 2026. Management will participate in a fireside chat at 1:20 p.m. Central Time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

(Press release, AbbVie, MAY 6, 2026, View Source [SID1234665218])

On May 6, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021, the Company’s first-in-class, patient-derived double-loaded dendritic cell investigational therapy, for the treatment of unresectable or metastatic cutaneous melanoma.

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Unresectable or metastatic cutaneous melanoma represents an advanced form of skin cancer in which the disease cannot be removed surgically or has spread to distant organs. While advances in targeted therapies and immune checkpoint inhibitors have improved outcomes for some patients, many individuals experience disease progression, limited durability of response, or treatment‑related toxicity, underscoring the continued need for novel therapeutic approaches that can generate durable anti‑tumor immune responses.

"Receiving Fast Track designation underscores the FDA’s recognition of the significant unmet need that remains for patients with advanced melanoma and the potential of DOC1021 to address this challenge," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "This designation supports our ongoing clinical development efforts and reflects the promise of DOC1021’s novel approach, which leverages a patient’s full complement of tumor antigens to drive meaningful anti-tumor immune responses."

Building on this regulatory milestone, Diakonos plans to advance DOC1021 through ongoing and upcoming clinical studies, including the Phase 1/2 trial in refractory melanoma, which is now recruiting. The Company remains focused on generating robust clinical data to further validate its platform and expand treatment options for patients with advanced cancers.

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.

The unique double-loading approach, a physiologic mimic of viral infection, unlocks a synergistic and exponentially more powerful tumor killing response that permits complete targeting of the total cancer antigen pool. Moreover, the approach does not require any molecular modification or genetic engineering of the patient’s immune cells and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 is designed for outpatient administration and broad access via community cancer centers.

Diakonos currently has three actively enrolling clinical trials evaluating DOC1021, including a Phase 1 pancreatic cancer study (NCT04157127), a Phase 2 glioblastoma (GBM) study (NCT06805305) and a Phase 1/2 study in refractory melanoma (NCT07288112) supported by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and unresectable or metastatic cutaneous melanoma, reflecting the significant unmet medical need across these indications. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.

(Press release, Diakonos Oncology, MAY 6, 2026, View Source [SID1234665217])

On May 6, 2026 BioOra Limited, a New Zealand-based company pioneering automated, cost-effective CAR T-cell manufacturing, reported the signing of a binding Heads of Terms agreement with Wellington Zhaotai Therapies Limited (Wellington Zhaotai) under which BioOra secures global rights to develop and commercialise Wellington Zhaotai’s novel third-generation anti-CD19 CAR T-cell therapy for the treatment of multiple conditions (WZTL-002), including haematological malignancies and auto-immune diseases.

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BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.
BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.
This milestone agreement builds on BioOra’s existing partnership with the Malaghan Institute of Medical Research through which BioOra already holds exclusive rights for commercialisation of WZTL-002 in New Zealand and Australia. The agreement with Wellington Zhaotai will provide BioOra the exclusive rights to commercialise the therapy in all markets outside of China and India, including USA, Europe and the UK.

BioOra have combined the unique CAR-T asset developed by Wellington Zhaotai, with BioOra’s manufacturing and commercialisation expertise to deliver Atla-cel, an autologous CAR T-cell product incorporating patented co-stimulatory domains designed to deliver robust efficacy with a favourable safety profile, including low rates of neurotoxicity. The clinical value of the third-generation design has been demonstrated through New Zealand’s first CAR T-cell clinical trial, sponsored by Malaghan Institute and conducted in collaboration with Wellington Zhaotai (ENABLE-1, NCT04049513). This study also confirmed BioOra’s capabilities in automated manufacturing in a clinical setting. Results from 30 patients showed a complete response rate and fewer serious toxicities than those observed in similar clinical trials of first- and second-generation CAR T-cell therapies1.

Through their partnership, BioOra and the Malaghan Institute are now confirming the safety and efficacy of Atla-cel in patients with relapsed/refractory large B-cell lymphoma in a pivotal Phase 2 study designed to enable registration in New Zealand and Australia (ENABLE-2, NCT06486051)

BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.

John Robson, CEO of BioOra Limited said, "This agreement positions BioOra to expand Atla-cel into high-value global markets and marks an important commercial milestone for the company. At its heart is the opportunity to bring CAR-T to more patients in more markets. Too many people around the world still have limited access to these personalised cell therapies, largely because of cost. Combining Wellington Zhaotai’s innovative science with BioOra’s automated manufacturing expertise creates the pathway to change that. To date, Atla-cel has demonstrated remarkable safety outcomes, which are central to its clinical and commercial potential."

Dr Peter Crabree, Chairman of BioOra Limited said, "CAR T-cell therapy represents one of the most consequential advances in oncology of the past decade, yet access remains profoundly unequal. This agreement with Wellington Zhaotai is a concrete step toward changing that, bringing technology developed through world-class international collaboration, and further advanced here in New Zealand, to patients across the globe. For BioOra, this is about more than commercial expansion; it is about ensuring that patients with blood cancers and B-cell mediated diseases have access to therapies that can genuinely alter the course of their disease".

(Press release, BioOra, MAY 6, 2026, View Source [SID1234665216])