On July 30, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Phase II clinical study of its core product Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line advanced biliary tract cancer (BTC) has completed enrollment of all 70 patients. In April 2026, the study successfully entered the expansion phase based on a favorable safety profile and robust efficacy that exceeded expectations, and rapidly completed full patient enrollment, fully demonstrating the efficient clinical advancement and continuously validated significant efficacy of Opamtistomig.

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Despite the recent adoption of PD-(L)1 immunotherapy combined with chemotherapy as a first-line standard of care for advanced BTC, clinical benefits remain limited. Current standard regimens, including pembrolizumab plus chemotherapy and durvalumab plus chemotherapy, have demonstrated objective response rates (ORR) below 30% and median overall survival (OS) of only approximately 12–13 months, leaving a substantial unmet medical need in this aggressive malignancy.

The potential of Opamtistomig as an IO 2.0 pan-tumor cornerstone therapy has been continuously validated across three dimensions: broad-spectrum anti-tumor activity, long-term survival benefit trends, and a safety profile comparable to PD-(L)1 monoclonal antibodies. Existing data show that, following extrapulmonary neuroendocrine carcinoma (EP-NEC) and small cell lung cancer (SCLC), Opamtistomig has once again demonstrated highly competitive efficacy in BTC, a typical immune-cold tumor, with the potential to elevate the efficacy of immunotherapy in BTC to new heights. Given that the predominant pathological type of BTC is adenocarcinoma, combined with the positive data previously observed in squamous cell carcinoma subtypes of major cancer types such as non-small cell lung cancer (NSCLC), Opamtistomig has shown clear efficacy in both adenocarcinoma and squamous cell carcinoma types, with its broad-spectrum anti-cancer potential being continuously validated.

The multicenter study is led by Academician Zhou Jian of Zhongshan Hospital, Fudan University and is being conducted across multiple hospitals in China. Results from safety run-in data showed that Opamtistomig in combination with chemotherapy demonstrated a favorable overall safety profile and good tolerability, with no new safety signals identified. Preliminary efficacy assessments showed an encouraging tumor shrinkage. Detailed clinical data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting to be held in Madrid, Spain from October 23 to 27, 2026.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The rapid progress of our Phase II BTC study reflects the strong confidence investigators and patients have placed in the encouraging efficacy signals generated by Opamtistomig to date. Immune-cold tumors remain among the greatest challenges in oncology and represent one of the most important frontiers for next generation immunotherapy. Across multiple immune-cold tumor types, Opamtistomig has consistently demonstrated promising clinical activity, further validating its potential as an IO 2.0 pan-tumor cornerstone therapy. We are committed to accelerating the clinical development of Opamtistomig in BTC and look forward to bringing a more effective and durable treatment option to patients with this devastating disease as early as possible."

About Biliary Tract Cancer
Biliary tract malignancies primarily include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly ‌adenocarcinomas‌ with high invasiveness, and most cases are diagnosed at advanced stages, leading to ‌poor prognosis‌ (5-year survival rate <5%)‌. Currently, global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries.

Although ‌PD-1/L1 inhibitors combined with chemotherapy‌ have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: ‌Modest improvement in median overall survival (OS)‌ (from ~11.5 to 12.8 months)‌ and ‌Low objective response rate (ORR)‌ (<30%)‌. These gaps highlight ‌unmet medical needs‌ for more effective therapies‌.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, JUL 30, 2026, View Source [SID1234669563])

On July 30, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported an update on the ongoing Phase 1 dose escalation ACESOT-1051 trial of its oral WEE1 inhibitor APR-1051.

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This latest corporate update builds on the positive progress in ACESOT-1051 to date in which APR-1051 demonstrated early signs of single-agent activity along with a favorable tolerability profile in patients with difficult-to-treat cancers.

Next Clinical Update and Accelerating Enrollment

Aprea expects to report the next clinical data update from ACESOT-1051 at a medical meeting in the fourth quarter of 2026. Enrollment is accelerating ahead of this anticipated clinical catalyst, with the number of active clinical sites expanding from three to ten. Aprea expects enrollment to reach 6 to 10 patients per month by Q4 of 2026, potentially increasing the pace of clinical data generation. The Company also plans to broaden the development by advancing APR-1051 into combination regimens, expanding the current study to include arms enrolling HPV-positive head and neck squamous cell carcinoma and colorectal cancer in combination with standard-of-care therapies.

"Expanding enrollment and adding combination regimens in HPV positive head and neck cancer and colorectal cancer will broaden the clinical dataset as we advance development of ACESOT-1051," said Gene Kennedy, M.D., Chief Medical Advisor of Aprea. "We look forward to sharing the next set of data from the trial at a medical meeting in the fourth quarter of this year,"

As previously announced, the Company is expanding enrollment to include at least 50 patients with uterine serous carcinoma or cyclin E-overexpressing, platinum-resistant ovarian cancer. Completion of dose escalation and backfill expansion is anticipated in the second quarter of 2027. This expansion is intended to further characterize the clinical activity of APR-1051 in biomarker-defined tumor populations with a mechanistic rationale for WEE1 inhibition.

Planned Combination Development

Aprea’s plans to evaluate APR-1051 in combination settings are supported by preclinical synergy observed in relevant disease models. In HPV-positive head and neck squamous cell carcinoma, the Company plans to combine APR-1051 with immune checkpoint therapy. In colorectal cancer, the Company plans to combine APR-1051 with standard-of-care chemotherapy.

The Company intends to advance dose levels that have already cleared safety review and shown single-agent activity into the planned combination regimens. This provides an appropriate starting point to establish the preliminary safety and preliminary efficacy of these regimens. In preclinical models, APR-1051 has demonstrated antitumor activity in combination with chemotherapy and with immuno-oncology agents, providing a rationale for the planned clinical combinations.

About ACESOT-1051 and Trial Design

ACESOT-1051 is a multi-center, open-label Phase 1 study evaluating oral, single-agent APR-1051 administered once daily in 28-day cycles. Part 1 is a dose escalation and dose backfill expansion of up to 100 patients, using accelerated titration at lower dose levels followed by a Bayesian optimal interval (BOIN) design. Part 2 is a dose selection optimization stage of up to 80 patients that will randomize patients 1:1 to two selected doses, to determine the recommended Phase 2 dose (RP2D).

Dose levels considered in the protocol range from 10 mg to 500 mg. Dose escalation is currently enrolling at the 300 mg cohort. Eligible patients are adults with advanced solid tumors harboring cancer-associated gene alterations, including uterine serous carcinoma regardless of biomarker status; cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC); tumors harboring CCNE1, CCNE2, FBXW7, or PPP2R1A alterations; HPV-positive oropharyngeal, cervical, vaginal, or vulvar carcinoma; and KRAS- and TP53-mutated colorectal cancer.

The primary objectives are safety, dose-limiting toxicity, maximum tolerated or maximum administered dose, and RP2D. Secondary objectives include pharmacokinetics and antitumor activity assessed by RECIST/PCWG3.

The most recent update from the ACESOT-1051 trial was presented at the ASCO (Free ASCO Whitepaper) 2026 annual meeting; a copy of the poster can be found on the Aprea corporate website here.

For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, JUL 30, 2026, View Source [SID1234669562])

On July 30, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 30 June 2026 (Q4 FY26).

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EFTILAGIMOD ALFA SYSTEMATIC EVALUATION

In May 2026, Immutep announced results from a systematic evaluation of five clinical trials of eftilagimod alfa (efti) in combination with standard-of-care (SOC) therapies in cancer patients, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting1.

The analysis included 592 patients across five independent studies (TACTI-mel, TACTI-002, TACTI-003, AIPAC, and AIPAC-003) spanning four cancer indications (NSCLC, HNSCC, metastatic breast cancer, and melanoma).

Treatment with 30 mg subcutaneous efti plus SOC in these trials resulted in a significant increase in circulating absolute lymphocyte count (ALC), a blood-based measure of immune activity, which was not seen with SOC alone.

Increased ALC was significantly associated with improved clinical outcomes, with ALC responders in the efti plus SOC group showing a clinically meaningful median overall survival (OS) improvement of 7.7 months compared to non-responders (p=0.0017). These effects were observed across tumour types and were independent of the combination partner.

The analysis did not include data from the TACTI-004 study, as immune data collection for that trial had not been completed at the time of the analysis.

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC

In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating efti in patients in 1st line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

In response to the IDMC’s recommendation, enrolment in TACTI-004 was halted and Immutep is continuing an orderly wind-down of the study, including appropriate patient follow-up and site close-out.

Immutep is also continuing its thorough review of available data to understand the factors behind the futility outcome, including manufacturing aspects. This root cause analysis is ongoing in Q3 CY 26, as it is dependent on data availability and logistics, and covers TACTI-004 database lock, statistical analysis, and laboratory data review.

Dr. Reddy’s Laboratories Ltd. ("Dr. Reddy’s"), a licensing partner for efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis.

Subsequent to quarter end, Immutep provided an update on aspects of the root cause analysis. In the interim futility analysis (N=173), the objective response rate was 42.9% in the efti arm compared with 55.1% in the control arm, with no superiority observed in any PD-L1 subgroup. Pending final analysis, no new safety signals have been observed. Preliminary immune-monitoring data indicated that patients treated with efti in TACTI-004 showed a different immune-activation profile, with lower circulating lymphocyte and monocyte counts, compared with prior efti studies. While no conclusive causal factor has been established to date, the ongoing analysis is expected to provide further insights, with additional results anticipated in Q3 CY26.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

Patients in the investigator-initiated INSIGHT-003 Phase I trial, in which dosing is now complete, continue to be followed up.

In this study, the combination of efti with KEYTRUDA and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels2.

Subsequent to the end of the quarter, Immutep announced mature overall survival (OS) results from INSIGHT-003 (data cut-off 27 March 2026). Median OS was 30.9 months in the overall population (N=51) and in patients with PD-L1 TPS <50% (N=47). Approximately 92% of patients had no or low PD-L1 expression (PD-L1 TPS <1 or PD-L1 TPS 1-49).

These single-arm Phase I results compare favourably with historical benchmarks.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

The investigator-initiated EFTISARC-NEO Phase II trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary objective, with patients showing strong immune system activation in line with efti’s mode of action, including statistically significant increases in the expression of key cytokines and chemokines in peripheral blood. Patients are continuing to be followed up for disease-free survival.

In April 2026, Immutep announced that it had been granted orphan drug designation for efti in this setting from the FDA.

An abstract containing health-related quality of life (HRQoL) data from the EFTISARC-NEO trial has been accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in October 2026. Consistent with the congress’ embargo policy, the data will be made available by the investigator at the time of presentation.

BREAST CANCER

AIPAC-003 – Phase II Trial in Metastatic Breast Cancer

The AIPAC-003 Phase II trial, evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2 negative/low metastatic breast cancer that is resistant to endocrine-based therapy, as well as in metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy, has been completed. The last patient follow-up visit occurred during the quarter and the trial was accordingly closed effective 30 June 2026.

Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

As previously announced, a proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer remains on hold pending completion of the root cause analysis related to TACTI-004.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In June 2026, Immutep presented positive interim data from its placebo-controlled, double-blind, randomized, first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody, at the EULAR 2026 Congress in London.

The single ascending dose part of the study met its primary endpoint, demonstrating favourable safety and tolerability in healthy volunteers, with IMP761 well tolerated across all dose levels tested.

The data also showed statistically significant pharmacodynamic activity, including reduced local inflammatory responses and attenuated T-cell activity compared to placebo, with the 7 mg/kg dose achieving a statistically significant inhibition in skin blood perfusion (p = 0.029).

The pharmacokinetic profile supports once-every-four-weeks dosing. These encouraging results support further clinical evaluation of IMP761 in autoimmune diseases driven by T-cell-mediated inflammation, such as rheumatoid arthritis, with additional trial updates expected in H2 CY26.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted seven patents.

Four patents were granted directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody. The patents were granted in China, Hong Kong, South Korea, and Canada. A new patent was also granted in Indonesia directed to IMP761.

New patents were also granted during the quarter in the United States and Israel directed to LAG525 (ieramilimab), jointly owned by Immutep S.A.S. and Novartis AG. Subsequent to quarter end, Novartis gave notice terminating the out-license agreement relating to ieramilimab after years of clinical inactivity, effective 9 August 2026. The license is not generating revenue for Immutep and no further milestone or royalty payments are anticipated. Under the terms of the agreement, following termination Novartis is required to assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S.

LEGAL PROCEEDINGS

Following the announcement on 13 March 2026 regarding the discontinuation of the TACTI-004 Phase III trial, one putative securities class action was filed in the United States but not served. After the Company sent a Rule 11 letter to the plaintiff, the suit was dismissed voluntarily.

FINANCIAL SUMMARY

During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.

The Company is well funded with cash and cash equivalents, and term deposit balance as at 30 June 2026 of approximately A$68.87 million, which is A$29.2 million greater than the FY2026 budget.

The total balance consists of 1) a cash and cash equivalent balance of A$63.67 million and 2) bank term deposits totaling A$5.20 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q4 FY26, cash receipts from customers were A$13K, which is mainly due to research material sales. For the very first time the Company also received A$218K (EUR 133K) under Germany’s R&D tax incentive program (Forschungszulage) in relation to eligible R&D activities undertaken in FY22. The Forschungszulage is Germany’s statutory research tax incentive under the Forschungszulagengesetz (FZulG). Under the current regime, eligible companies may claim a tax credit of up to 35% (25% before 28 March 2024) of qualifying internal R&D personnel costs. The timing of receipt of Forschungszulage payments may differ significantly from the period in which the related R&D expenditure is incurred due to the statutory application, assessment and review process. The FY2022 claim was the Company’s first claim under the program and was subject to a detailed review. The allowance is a non-dilutive source of funding for the Company’s German R&D operations (conducted through Immutep GmbH).

The net cash used in G&A activities in the quarter was A$1.5 million compared to A$0.9 million in Q3 FY26. In respect of the US$20 million upfront eftilagimod license fee received from Dr. Reddy’s in January 2026, US$2.7 million (A$4.1 million3) was recognised as revenue and US$17.3 million (A$25.8 million4) as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following discontinuation of TACTI-004, Immutep repaid US$10 million to Dr. Reddy’s in June 2026, reducing unearned revenue accordingly, with the remaining US$7.3 million fully recognised as revenue for the financial year ended 30 June 2026. As previously disclosed, Dr. Reddy’s holds exclusive rights to develop and commercialise efti in the licensed territories, while Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan. Immutep also remains eligible for up to US$349.5 million in potential milestones along with royalties on commercial sales, and retains global manufacturing rights.

Net cash used in R&D activities was A$22.0 million for the quarter, compared with A$11.8 million in Q3 FY26, with the increase primarily reflecting higher payments relating to TACTI-004. Although the Company took immediate action following the discontinuation of TACTI-004 in March 2026, trial activity only began to slow from May 2026, with close-out and root cause analysis activities continuing through the quarter. As invoices are generally payable approximately one month after issue, TACTI-004 payments in Q4 FY26 were approximately A$8 million higher than in Q3 FY26. These payments are expected to decline significantly in subsequent quarters.

Payment for staff costs was A$2.5 million in the quarter, compared to A$2.6 million in Q3 FY26. Total net cash outflows used in operating activities in the quarter were A$38.9 million compared to net cash inflow from operating activities of A$13.5 million in Q3 FY26.

Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$336K.

Total net cash inflow received in investing activities for the quarter was A$21.1 million, which is mainly due to the net decrease of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the Company transferred back A$21.1 million from short-term investments that had matured to cash at bank.

After the TACTI-004 Phase III futility outcome, the Company has initiated cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions, most of which will become effective following the end of FY26. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend well into H1 of CY28.

(Press release, Immutep, JUL 30, 2026, View Source [SID1234669561])

On July 30, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the second quarter ended June 30, 2026, and provided a review of recent program and corporate developments.

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"The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Completed Type A meeting with the FDA to discuss the CRL for bitopertin in erythropoietic protoporphyria (EPP) and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response and could potentially support a traditional approval
Presented updated data from the HELIOS open-label extension trial of bitopertin in EPP at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, demonstrating sustained reductions in protoporphyrin IX (PPIX), significant improvement in light tolerance measures, and favorable longer-term safety
Launched an Expanded Access Program (EAP) for bitopertin in the US and select other geographies, providing eligible patients with EPP and XLP access to treatment prior to a regulatory decision
On track to report APOLLO topline results in Q4 2026 and expect to submit CRL response and receive an FDA decision by mid-2027
APOLLO completed enrollment in March 2026 and enrolled ahead of schedule with a final N of 183

Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Shared updated data from RALLY-MF trial of selcodebart in anemia of myelofibrosis (MF) in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings, solidifying selcodebart’s differentiated emerging profile in MF. Data showed:
Major anemia response rate of 56% and overall anemia response rate of 72% across evaluable patients
Similar, strong response rates across transfusion cohorts and with or without background JAK inhibitor therapy
Additional data from RALLY-MF anticipated in Q4 2026, with an end-of-Phase 2 meeting with the FDA expected to occur by year-end
Received EU Orphan Drug Designation for selcodebart for the treatment of myelofibrosis
Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027

DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Completed enrollment for RESTORE-PV Phase 2 study in patients with polycythemia vera with initial data expected in Q3 2026
Progressing Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026

Second Quarter 2026 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $717.7 million as of June 30, 2026, which are expected to fund operational plans into 2029.

Research and Development Expenses: R&D expenses were $46.9 million for the three months ended June 30, 2026, as compared to $46.3 million for the three months ended June 30, 2025. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including the advancement of the selcodebart (DISC-0974) and DISC-3405 clinical studies and drug manufacturing, as well as increased headcount. These increases were partially offset by a decrease in manufacturing costs related to bitopertin and a $10.0 million milestone payment incurred upon initiation of the APOLLO study during the comparative period.

Selling, General and Administrative Expenses: SG&A expenses were $18.1 million for the three months ended June 30, 2026, as compared to $15.1 million for the three months ended June 30, 2025. The increase in SG&A expenses was primarily due to increased headcount.

Net Loss: Net loss was $59.5 million for the three months ended June 30, 2026, as compared to $55.2 million for the three months ended June 30, 2025. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, JUL 30, 2026, View Source [SID1234669560])

On July 30, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the first patients have been dosed in DOC-RM, its Phase 1/2 clinical study evaluating DOC1021 (dubodencel) in patients with refractory melanoma, at City of Hope in Duarte, California, and the University of Alabama at Birmingham (UAB).

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This milestone follows the presentation of DOC-RM as a trial-in-progress abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and represents the transition of the program into active clinical evaluation.

"Roughly half of melanoma patients progress after checkpoint inhibition, and the options that follow are defined as much by their toxicity and cost as by their benefit," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "We are encouraged that the first patients have received DOC1021 treatment with no significant acute adverse events, consistent with our glioblastoma and pancreatic trials. We look forward to reporting initial preliminary results from DOC-RM by the end of the year."

DOC-RM is a multicenter Phase 1/2 study (NCT07288112) evaluating safety, immune activity, and preliminary clinical efficacy of DOC1021 in patients with unresectable or metastatic melanoma who have progressed after prior therapies, including anti-PD-1 treatment. Patients receive two courses of DOC1021 in combination with pegylated interferon and an optional booster dose approximately six months later. Primary and secondary endpoints include safety, objective response, circulating tumor DNA (ctDNA), and immune biomarkers measured in tumor and peripheral blood.

"Patients whose melanoma progresses following anti-PD-1 therapy continue to face limited treatment options, highlighting the need for new immunotherapeutic strategies," said Yan Xing, MD, PhD, Associate Professor in the Department of Medical Oncology & Therapeutics Research and Principal Investigator at City of Hope. "DOC1021 is designed to utilize each patient’s own tumor antigens to generate an individualized immune response. We’re excited to evaluate this investigational approach and contribute to the clinical development of DOC1021."

"The design of this trial offers the opportunity to study an investigational dendritic cell immunotherapy without the need for preconditioning chemotherapy or high-dose IL-2," said John Dubay, MD, Assistant Professor in the Department of Medicine, Division of Hematology and Oncology, and Principal Investigator at the University of Alabama at Birmingham. "The ability to administer DOC1021 in an outpatient setting may also help streamline treatment delivery and broaden patient access. We’re pleased to begin treating patients and participating in this important study."

DOC-RM is currently enrolling patients at City of Hope, the University of Alabama at Birmingham, Massachusetts General Hospital, Banner MD Anderson Cancer Center, UT Southwestern, HonorHealth Research Institute, University of North Carolina, and Atlantic Health. The trial is supported by Diakonos Oncology and a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

The study builds on preclinical data demonstrating antitumor activity across multiple tumor models, including B16F10 melanoma. DOC1021 received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma in May 2026.

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy designed to generate a broad, personalized anti-tumor immune response. The therapy combines tumor lysate and amplified tumor-derived mRNA prepared from each patient’s tumor with autologous dendritic cells, enabling presentation of the full spectrum of tumor antigens.

The proprietary double-loading approach mimics the natural immune activation that occurs during viral infection, unlocking a synergistic and robust multi-antigen immune response while targeting the complete repertoire of the cancer antigen pool. Unlike many cell therapies, DOC1021 does not require any molecular modification or genetic engineering of immune cells, lymphodepleting chemotherapy, or high-dose IL-2 for administration, allowing for outpatient administration and broad access through community cancer centers.

Diakonos is currently evaluating DOC1021 in three actively enrolling clinical trials: a Phase 1 pancreatic cancer (NCT04157127), a Phase 2 in glioblastoma (GBM) (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. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.

(Press release, Diakonos Oncology, JUL 30, 2026, View Source [SID1234669559])