On September 9, 2026 ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, reported the completion of treatment for all required patients enrolled in its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial carcinoma (LG-UTUC). Completion of treatment, along with a positive pre-NDA meeting held with the U.S. Food and Drug Administration (FDA) in April 2026, supports the Company’s planned reporting of topline data and anticipated NDA submission in 2027.

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"The completion of treatment for all required patients in the Phase 3 ENLIGHTED trial represents a major milestone towards our goal of delivering a next-generation treatment option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. "Preliminary clinical data to date show encouraging complete response rates, durability of response, and a consistent safety profile, further supporting Padeliporfin VTP’s potential to provide a minimally invasive, organ-sparing treatment option in LG-UTUC. This, alongside the existing dataset for Padeliporfin across solid tumor indications, gives us confidence in its potential to shift the treatment paradigm for these difficult-to-treat diseases and improve patient outcomes."

Following ImPact’s positive pre-NDA meeting in April 2026, "the FDA acknowledged the clinical considerations around the potential clinical meaningfulness of Padeliporfin-VTP as a treatment option for low-grade UTUC including the potential clinical value of durable CR in the treated area." The agency has confirmed the registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer for submission in LG-UTUC in 2027.

Additionally, the Company has engaged in discussions with the FDA regarding a potential expanded access program (EAP) for eligible patients with LG-UTUC in the US. The program would enable access to Padeliporfin VTP to qualifying patients prior to potential regulatory approval.

"With treatment now complete in the Phase 3 ENLIGHTED trial and following positive recent interactions with the FDA, our focus remains on bringing Padeliporfin VTP to patients as efficiently as possible," said Barak Palatchi, Chief Executive Officer of ImPact Biotech. "The FDA’s feedback further supports our confidence in the program and its path toward regulatory submission. Recognizing the significant unmet need among LG-UTUC patients, the potential for an expanded access program for Padeliporfin VTP underscores our commitment to expanding patient access and supporting treating physicians. We look forward to reporting topline results and advancing towards regulatory submission in 2027, while evaluating strategic commercialization opportunities to maximize patient reach."

ImPact plans to present interim data from the Phase 3 ENLIGHTED trial in LG-UTUC at the ESMO (Free ESMO Whitepaper) Congress taking place from October 23-27, 2026 in Madrid.

ePoster Title: Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC): ENLIGHTED Phase 3 Trial
Presenter: Asaf Shvero, M.D., Department of Urology, Sheba Medical Center
Poster Number: 4860eTiP
Category: Urothelial Cancer

About ENLIGHTED

The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact enrolled 91 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy was performed, via an ureteroscopy which applied a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) was achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

(Press release, ImPact Biotech, SEP 9, 2026, View Source [SID1234670710])

On September 9, 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 positive initial results from the RESTORE-PV Phase 2 trial of DISC-3405 in patients with polycythemia vera (PV). The data, presented in a poster session at the 2026 Society of Hematologic Oncology (SOHO) annual meeting in Houston, TX, demonstrated that treatment with DISC-3405 increased hepcidin and lowered serum iron, translating to reduction in phlebotomy, controlled hematocrit, and improved symptom burden in patients with PV. These data will be featured in an oral presentation at the SOHO conference tomorrow, September 10. Disc also presented an encore of the positive results from the Phase 2 RALLY-MF trial of selcodebart (DISC-0974) in patients with anemia of myelofibrosis (MF) and a new systematic literature review characterizing the humanistic burden of anemia associated with MF through patient reported outcomes.

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"This first look at data from the RESTORE-PV trial shows that the established pharmacodynamics of DISC-3405 are translating well on important clinical measures," said John Quisel, JD, PhD, President and Chief Executive Officer of Disc Medicine. "Iron restriction is proving to be a transformative treatment approach for a large population of patients with polycythemia vera, with the potential to address their crucial need for hematocrit control while managing symptom burden and reducing reliance on phlebotomy. Our goal for DISC-3405 is to deliver an optimal product presentation combining durable disease control with straightforward, controllable, and convenient dosing using a novel antibody approach. Between this update in PV and our earlier progress in MF this year, we have strengthened our commitment to hematologic oncology and now have two programs advancing toward potential pivotal development in myeloproliferative neoplasms."

The Phase 2 multi-center, open-label RESTORE-PV trial enrolled 40 adult participants with PV, including 20 participants in Cohort A and 20 participants in Cohort B. In the trial, following a 4- to 12-week observation, participants undergo a 12-week dose escalation, then receive DISC-3405 subcutaneously at 300 mg Q2 weeks (Cohort A) or Q4 weeks (Cohort B) for 20 weeks, followed by up to 20 additional weeks of treatment at these respective doses. At the time of the data cut, all 20 participants in Cohort A were dosed and n=13 patients completed 26 weeks of the study, and 18 of 20 participants in Cohort B were dosed. Efficacy data was presented for Cohort A and baseline and safety data were presented for Cohorts A and B. Across escalation and maintenance periods, results demonstrated:

Dose-proportional PK, elevation of hepcidin, reduction of serum iron, and increase in ferritin (Cohort A)
Control of hematocrit, with mean hematocrit maintained stably <45% through week 26 which led to initial improvement in symptom burden (Cohort A)
DISC-3405 significantly reduced phlebotomy events in Cohort A participants. For n=13 patients completing 26 weeks of study:
Mean total phlebotomy events significantly decreased from 4.0 in 26 weeks at baseline to 0.6 in 26 weeks post-Day 1 (p<0.0001)
61.5% of participants remained entirely phlebotomy-free post-baseline through 26 weeks
Of those who completed the first maintenance period (weeks 12-32, n=9), 77.8% of participants remained phlebotomy free during this period
DISC-3405 was generally well-tolerated with adverse events that are consistent with underlying disease and a low rate of injection site reactions which were mild and self-limited (Cohorts A and B)

Disc plans to provide an update on RESTORE-PV, as well as initial data from the Phase 1b trial of DISC-3405 in sickle cell disease, by the end of 2026.

With respect to selcodebart, the company also expects to share feedback from an end of phase 2 meeting with the U.S. Food and Drug Administration (FDA) and plans for pivotal development in anemia of MF by the end of the year.

About DISC-3405

DISC-3405 is an investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody designed to increase hepcidin production and suppress serum iron. Disc in-licensed DISC-3405 from Mabwell Therapeutics in January 2023. The therapeutic potential for hepcidin induction includes treatment of diseases associated with iron overload, diseases of excess red blood cell production, or diseases otherwise enabled by iron availability. Disc has established clinical proof-of-mechanism of DISC-3405 in a Phase 1 study in healthy volunteers and initiated a Phase 2 trial in patients with polycythemia vera and a Phase 1b trial in patients with sickle cell disease.

DISC-3405 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide.

About Polycythemia Vera

Polycythemia vera (PV) is a chronic and rare myeloproliferative neoplasm characterized by the abnormal proliferation of red blood cells. PV affects approximately 150,000 patients in the U.S. and has a similar prevalence in Europe. The overproduction of red blood cells alters the viscosity of blood, causing it to thicken and placing patients at an elevated risk of cardiovascular and thromboembolic events, such as heart attack and stroke. Patients also experience complications such as enlarged spleen and symptoms of their disease such as fatigue, pruritis, difficulty concentrating and others. Current therapy involves phlebotomy to physically remove blood and iron to limit erythropoiesis or treatment with cytoreductive agents, with the goal of reducing red blood cell count and managing symptoms.

(Press release, Disc Medicine, SEP 9, 2026, View Source [SID1234670709])

On September 9, 2026 SOTIO Biotech, a clinical-stage biopharmaceutical company owned by PPF Group, reported that the first participant has been dosed in its Phase 1/2 CADENCIA-01 clinical trial of SOT109 in colorectal cancer (CRC). SOT109 is a potentially best-in-class antibody-drug conjugate (ADC) exploiting the highly promising target of CDH17 for the treatment of CRC and other gastrointestinal cancers. As the only CDH17-targeting ADC that has been granted U.S. FDA Fast Track Designation, SOT109 is uniquely positioned within the emerging CDH17 landscape and has the potential to become a differentiated treatment option for patients with advanced gastrointestinal cancers.

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"Dosing the first patient marks an important step as we advance SOT109 into the clinic and begin generating initial clinical data," said Vivi Boura, M.D., chief medical officer of SOTIO. "Patients with advanced colorectal cancer continue to face limited treatment options after progression on standard therapies, highlighting the need for new targeted approaches. This study is designed to efficiently evaluate safety and early signs of anti-tumor activity in a well-defined population, with the goal of establishing a rapid path toward clinical proof of concept and supporting potential expansion into broader gastrointestinal indications."

SOT109 targets CDH17, an antigen homogeneously overexpressed in more than 90% of CRC cases and abundantly expressed in other GI cancers. SOT109 combines a proprietary, highly internalizing, fully human antibody with Lonza’s proven ADC technology platform incorporating the SYNtecan E linker-payload (DAR=4). In CRC, the SYNtecan E linker-payload is expected to deliver superior activity, reduced susceptibility to resistance, and an enhanced bystander effect driven by high cell permeability, differentiating SOT109 from earlier-generation ADC payloads.

Preclinical data show robust anti-tumor efficacy for SOT109, with significant and sustained tumor regressions observed across several challenging in vivo colorectal tumor models. Studies in non-human primates demonstrated a compelling pharmacokinetic and safety profile.

The multicenter international Phase 1/2 CADENCIA-01 trial (NCT07693751) is a dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of SOT109 in patients with advanced unresectable or metastatic CRC who have exhausted standard approved treatment options. The study focuses on CRC as an initial, well-defined population with high target expression, enabling efficient signal detection and supporting a potential path to broader gastrointestinal expansion. The study will enroll patients in Europe and the U.S. An Investigational New Drug (IND) application has recently been cleared by the U.S. Food and Drug Administration (FDA).

SOT109 represents the first of SOTIO’s two next-generation ADC programs entering the clinic in 2026, reflecting the company’s broader strategy to build a differentiated solid tumor ADC franchise.

(Press release, SOTIO, SEP 9, 2026, View Source [SID1234670708])

On September 9, 2026 Syncromune, Inc., a privately held clinical-stage biopharmaceutical company developing SYNC-T, an investigational in situ multi-target immunotherapy platform for solid tumors, reported that Stephen Kee, M.D., EVP, Clinical Medical & Business Operations, EMEA, presented the company’s investigational SYNC-T Therapy SV-102 approach at CIRSE 2026 in Copenhagen, Denmark.

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The presentation, titled "Cryolysis and Direct Immunotherapy Injection," reviewed the scientific and procedural rationale for combining image-guided partial tumor cryolysis with direct intratumoral immunotherapy, as well as previously reported Phase 1 clinical findings with SYNC-T Therapy SV-102 in metastatic prostate cancer.

Dr. Kee also reviewed previously reported preliminary results from Syncromune’s 15-patient Phase 1 study in metastatic prostate cancer. In this small, early-stage study, investigators reported a 100% disease control rate and an investigator-assessed overall response rate of 87%, including complete responses in 53% of patients. Independent radiological review reported an 87% overall response rate, including 40% complete responses and 47% partial responses. Study imaging showed complete resolution of bone metastases in seven of the 13 patients (54%) who had bone metastases at baseline. Across the study, 95% of reported treatment-emergent adverse events were Grade 1 or 2 with no Grade 4 or 5 reported. These preliminary results should be interpreted in light of the study’s small sample size and early-stage design. SYNC-T Therapy SV-102 remains investigational, and its safety and effectiveness have not been established. Results from this 15-patient study may not be predictive of results in larger or later-stage trials.

Prostate cancer remains difficult to treat with conventional systemic immunotherapies, underscoring the need for approaches designed to overcome local immune suppression. SYNC-T is designed to address this challenge through a localized, image-guided drug-device approach that integrates image-guided tumor intervention with direct intratumoral immunotherapy delivery. As presented at CIRSE, a portion of a target tumor undergoes partial cryolysis, disrupting tumor cells and releasing a heterogeneous population of patient-specific tumor antigens. The investigational fixed-dose, multi-target drug SV-102 is then infused directly into the treated area through the same device path.

SV-102 combines four immune modulators designed to inhibit immune-suppressive pathways while activating immune-stimulatory pathways. Combined with partial cryolysis, this approach is designed to synchronize tumor antigens, immunotherapy and immune cells within the tumor and locoregional tumor-draining lymphatics, with the goal of activating T cells capable of generating a systemic anti-tumor immune response while limiting systemic drug exposure.

"Interventional radiologists bring the imaging expertise and procedural capabilities needed to precisely access tumors throughout the body, creating an important opportunity to expand how image-guided intervention contributes to cancer treatment," said Dr. Kee, EVP, Clinical Medical & Business Operations, EMEA. "SYNC-T combines a minimally invasive local procedure with direct intratumoral immunotherapy delivery designed to generate an immune response beyond the treated tumor itself. We were pleased to share both the technical approach and our clinical experience with the CIRSE community as we continue to expand our clinical program and advance the role of interventional radiology in intratumoral immunotherapy."

"CIRSE represents an important opportunity to engage the interventional radiology community as we continue building the multidisciplinary clinical infrastructure to support SYNC-T," said Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune, and Adjunct Professor at the Lankenau Institute for Medical Research. "The encouraging preliminary findings generated in the Phase 1 study helped inform the development of LEGION-100, which is now advancing through Phase 2 dose optimization in the United States. At the same time, we are preparing to expand LEGION-100 into new regions outside the U.S."

Syncromune is currently evaluating SYNC-T Therapy SV-102 in LEGION-100 (NCT06533644), an ongoing multicenter Phase 2 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following standard-of-care treatment. Part 1 dose escalation has been completed, and Part 2 dose optimization is underway.

(Press release, Syncromune, SEP 9, 2026, View Source [SID1234670707])

On September 9, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported positive updated data as of the August 18, 2026 data cutoff date from its ongoing global Phase 1 monotherapy study evaluating micvotabart pelidotin (MICVO) in patients with second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

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The updated results represent a population (N=33 efficacy evaluable) dosed at 5.4 mg/kg intravenously once every three weeks with a dose equivalent to or below a dose cap. These data demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR). Median progression-free survival (mPFS) was 6.2 months, and the 12-month overall survival (OS) probability was 79% while median OS (mOS) has not yet been reached. Clinical activity was observed across key patient subgroups, including HPV status and prior treatment. No new safety signals were observed (N=35 safety evaluable), and dose capping reduced the frequency and severity of adverse events in high body weight patients.

MICVO, the company’s lead program, is a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix. MICVO’s differentiated, non-EGFR targeting mechanism of action positions it to potentially serve a significant patient population and address unmet need in 2L+ R/M HNSCC as the first-line treatment landscape continues to evolve.

"There remains significant need for effective treatment options for patients with recurrent or metastatic head and neck cancer who progress following first-line therapy, particularly as the front-line treatment landscape continues to evolve," said Alan L. Ho, M.D., Ph.D., Chief, Head and Neck Oncology Service and Attending Medical Oncologist, Memorial Sloan Kettering Cancer Center. "In this heavily pretreated population, these results demonstrated rapid and deep responses, along with progression-free survival and preliminary overall survival results that warrant further evaluation."

"These updated data reinforce our conviction in MICVO’s potential to become an important treatment option for patients with cancer," said Tom Civik, Chief Executive Officer and Chairman of Pyxis Oncology. "We are particularly encouraged by the combination of rapid and deep responses, substantial survival outcomes and a manageable safety profile. The data also provide important validation of our dose capping strategy, which was intended to maintain clinical activity while mitigating the risk of safety events. Based on feedback from the FDA and EMA on the design of our pivotal Phase 3 study, Headliner, we believe MICVO is well positioned for success in a randomized trial, which we plan to initiate in mid-2027."

Updated MICVO Phase 1 Monotherapy Trial Results as of August 18, 2026

Demographics
Table 1: Patient Demographics and Disease Characteristics – 5.4 mg/kg Dose Cap Population (N=35)

Table 1: Patient Demographics and Disease Characteristics – 5.4 mg/kg Dose Cap Population (N=35)

Data as of 18-Aug-2026
1. cetuximab: Eli Lilly and Company & Merck KGaA; petosemtamab: Genmab A/S; ficerafusp alpha: Bicara Therapeutics
Abbreviations: HPV: human papillomavirus; SCC: squamous cell carcinoma; EGFR: epidermal growth factor receptor; IO: immuno-oncology; ECOG: Eastern Cooperative Oncology Group; BMI: body mass index; PR: partial response; N/n: number of patients.

Efficacy Data
Table 2: Efficacy Data Summary – 5.4 mg/kg Dose Cap Efficacy-Evaluable Population (N=33)

Efficacy Measure 5.4 mg/kg Dose Cap
(N=33)
Confirmed objective response rate (cORR), % (n/N) 36% (12/33)
Disease control rate (DCR), % (n/N) 94% (31/33)
Responders achieving response by the first scan at six weeks, % 75%
Responders achieving >50% tumor reduction from baseline*, % 83%
Median progression-free survival (mPFS), months, (95% CI) 6.2 (4.8-8.8)
12-month overall survival (OS) probability, %, (95% CI) 79% (58.1,90.3)
Median overall survival (OS), months NR (NR-NR)
Data as of 18-Aug-2026
*Per RECIST v1.1
Abbreviations: n/N: number of patients.

Table 3: Efficacy Data Across Key Patient Subgroups

Patient Subgroup N 5.4 mg/kg Dose Cap
Confirmed ORR, % 5.4 mg/kg Dose Cap
Median PFS, months
HPV Status
HPV+ oropharyngeal 17 35%
6.2
HPV-unrelated 16 38%
5.9
Prior EGFRi
Yes 18 28%
5.0
No 15 47%
8.8
Prior Novel EGFRi*
Yes 5 40%
5.8
Prior Taxane
Yes 23 35%
6.2
No 10 40%
4.9
Data as of 18-Aug-2026
*Prior novel EGFRi subgroup is a subset of patients with prior EGFRi treatment.
Abbreviations: HPV: human papillomavirus; ORR: objective response rate; EGFRi: EGFR inhibitor; n/N: number of patients.

Safety Data
No new safety signals were observed with MICVO. The tolerability data was consistent with that of other ADCs with auristatin payloads and was generally manageable. Adverse events of interest, including peripheral neuropathy, generally occurred after patients had received evidence of benefit, and after prolonged duration of treatment.

Table 4: Safety Data Summary – 5.4 mg/kg Dose Cap Population (N=35)

TRAEs 5.4 mg/kg with Dose Cap
(N=35)
Treatment duration – median days (range) 120 (21-470)
All TRAEs, n (%) 32 (91.4%)
TRAEs of CTCAE Grade ≥ 3, n (%) 19 (54.3%)
Non-Hematologic TRAEs of CTCAE Grade ≥ 3, n (%) 15 (42.9%)
Serious TRAEs, n (%) 5 (14.3%)
TRAEs leading to treatment discontinuation*, n (%) 5 (14.3%)
TRAEs leading to treatment discontinuation days, median (min-max) 162 (104-212)
TRAEs leading to dose reduction, n (%) 14 (40.0%)
Treatment related deaths (Grade 5) 0
ADC Payload TRAEs of Interest 5.4 mg/kg with Dose Cap
(N=35)

Gr1/2 Gr3
Cutaneous, n (%) 17 (48.6%) 2 (5.7%)
Peripheral Neuropathy, n (%) 14 (40.0%) 6 (17.1%)
Peripheral Neuropathy days to onset, median (min-max) 82 (3-151) 166 (85-197)
Ocular, n (%) 10 (28.6%) 2 (5.7%)
Pneumonitis, n (%) 4 (11.4%) 0
Data as of 18-Aug-2026
*TRAEs leading to discontinuation, N=1 Ocular, N=1 Muscle Weakness, N=3 Peripheral Neuropathy
Abbreviations: ADC: antibody-drug conjugate; TRAE: treatment-related adverse event; CTCAE: Common Terminology Criteria for Adverse Events; Gr: grade; N: number of patients.

MICVO Next Steps

Monotherapy
Pyxis Oncology is advancing the clinical development of MICVO through Project Optimus, a U.S. Food and Drug Administration (FDA) initiative focused on dose optimization and dose selection in oncology drug development. An End of Phase 2 meeting with the FDA to align on dose selection is anticipated in the first quarter of 2027. Updated overall survival data from the MICVO monotherapy study are expected in the first half of 2027.

The Company has aligned with the feedback from the FDA and the European Medicines Agency (EMA) on the design of the planned pivotal Phase 3 monotherapy study of MICVO in patients with second- or third-line R/M HNSCC who have progressed following treatment with both a platinum-based therapy and an anti-PD-1 therapy. The randomized, open-label, 2-arm study will enroll approximately 500 patients who will be randomized 1:1 to receive MICVO or investigators’ choice of cetuximab, docetaxel, or methotrexate. The co-primary endpoints of the study will be overall response rate and overall survival. Pyxis Oncology plans to initiate the study in mid-2027 following alignment with the FDA on dose selection.

Combination with KEYTRUDA (pembrolizumab)
Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in the fourth quarter of 2026. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025. Additional data evaluating initial durability and selection of the recommended Phase 3 dose (RP3D) for the 1L combination are expected in the second half of 2027.

Webcast Information
Pyxis Oncology will host a live webcast today at 7:30 a.m. Eastern Time. To participate in the live event, please register using this link. The event and accompanying slides can be accessed by visiting the investor relations section of the Company’s website at View Source An archived webcast will be available on the Company’s website following the event.

About the MICVO Phase 1 Monotherapy Trial
The ongoing Phase 1 monotherapy study of MICVO is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2 is a dose expansion study in 2L+ R/M HNSCC. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025.

The dose expansion portion of the study includes two arms: post-platinum and anti-PD-(L)1 patients (Arm 1) and post-EGFR inhibitor and anti-PD-(L)1 patients (Arm 2). Target enrollment for each arm was approximately 20 patients, and the Company completed target enrollment in the Phase 1 Part 2 monotherapy dose expansion study in the first quarter of 2026.

In December 2025, a dose cap was implemented for high body weight patients. Based on internal pharmacokinetic (PK) simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation. The updated results reported today focus on patients treated at 5.4 mg/kg Q3W with a dose cap.

About Micvotabart Pelidotin (MICVO)
Micvotabart pelidotin (MICVO, formerly PYX-201) is an antibody-drug conjugate (ADC) that uniquely targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix. MICVO is designed to generate a multi-pronged attack on difficult-to-treat cancers by directly killing cancer cells, reducing extra-cellular matrix density, inhibiting tumor angiogenesis and mobilizing an anti-tumor immune response.

MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)-1 therapy.

(Press release, Pyxis Oncology, SEP 9, 2026, View Source [SID1234670706])