On June 16, 2026 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig in combination with nivolumab and chemotherapy for the treatment of patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive. Givastomig is a novel CLDN18.2 x 4-1BB bispecific antibody.

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Phase 1b data demonstrated compelling efficacy and tolerability for givastomig in combination with immunochemotherapy, supporting its potential as a premier CLDN18.2-directed therapy for gastric cancer. Fast Track Designation is intended to accelerate development and review of therapies for serious conditions with unmet medical need.

"Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a broad patient population, with marked improvement relative to historical benchmarks for the standard of care. Fast Track Designation, combined with FDA’s prior confirmation of accelerated approval pathway eligibility, enables a more efficient path to a registrational Phase 3 trial, reflecting givastomig’s promise as a first-in-class and best-in-class CLDN18.2-directed therapy for gastric cancer. We look forward to ongoing dialog with the FDA to bring givastomig to patients as quickly as possible."

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of new therapies intended to treat serious or life-threatening conditions that demonstrate the potential to address an unmet medical need. Drugs receiving Fast Track Designation may benefit from more frequent interactions with the FDA throughout the development process. Programs receiving Fast Track Designation may also be eligible for Rolling Review of the regulatory submission, Priority Review, and Accelerated Approval, if relevant criteria are met.

About Givastomig

Givastomig (TJ033721 / ABL111) is a CLDN 18.2 X 4-1BB bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

(Press release, NovaBridge Biosciences, JUN 16, 2026, View Source [SID1234668756])

On June 15, 2026 CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that "tricks" the body’s immune system into fighting cancer, reported that the first ever biodistribution study of its complete novel lipid nanoparticle ("LNP") in mice was successful.

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The CancerVax platform is designed to harness the body’s existing immunity to detect, mark, and kill cancer cells with precision. At the core of the platform are customizable nanoparticles that use a novel two-step precision cancer targeting mechanism.

Detection: The nanoparticles first bind to surface proteins highly associated with the target cancer cells ("Marker1").
Activation: Once attached preferentially to the cancer cells via Marker1, the nanoparticles release proprietary "Smart mRNA" payloads that are activated in cancer cells that carry specific genetic signatures ("Marker2") but remain deactivated in healthy cells. These Smart mRNAs instruct the cancer cells to produce proteins associated with well-immunized diseases like measles. This effectively "tricks" the immune system into killing cancer cells as if they were common diseases.
Most conventional LNP therapies get trapped in the liver and cause liver toxicity. On March 31, 2026, the Company reported the successful biodistribution of a Marker1-LNP, which significantly reduced liver accumulation and suggests systemic circulation to other parts of the body.

This recent biodistribution study relates to the complete, first of a kind, Marker1+Marker2 LNP designed to precisely seek out cancer cells and avoid healthy cells. The specific goal of this study was to prove healthy cell de-targeting.

Based on these results, the study was a resounding success:

Marker1 showed signs of directing LNPs into specific cells with matching Marker1 surface proteins and delivered the Smart mRNA payload.
Once inside healthy cells, Marker2 was very effective in deactivating the Smart mRNA.
Marker1+Marker2 LNPs showed significantly lower liver stress markers (ALT/AST and total bilirubin) than conventional LNPs, consistent with the high cell selectivity of the construct.

"We have completed our technology development phase and are fully underway with our preclinical studies," said Dr. George Katibah, Chief Scientific Officer. "This early win continues to prove that we’re on the right track. These results are compelling because they showed where our LNPs went and that they didn’t activate where they’re not supposed to. The ALT/AST liver stress signals were striking because our Marker1+Marker2 LNPs have such high cell selectivity that they cause significantly lower liver stress than conventional LNPs. By successfully de-targeting healthy cells and avoiding healthy organs, we now have a clear picture of our therapeutic window — the dose range where we expect to achieve robust immune activation without triggering off-target liver burden. That gives us a very confident foundation as we advance toward efficacy studies."

Dr. Adam Grant, Principal Scientist, commented, "This milestone is the result of nearly two years of work. When we first envisioned a Marker1+Marker2 cancer-targeting nanoparticle, we had only computational data to guide us. But now, with lab data in hand, it’s exciting to see how successful Marker1+Marker2 LNPs are at de-targeting numerous off-target healthy tissues while intentionally maintaining spleen expression. The spleen is a key healthy organ we engage on purpose, because that is where the immune response is primed. Spleen uptake should maximize vaccine efficacy and strengthen the immune response. Seeing strong spleen signal and low healthy tissue signal was very satisfying. Through extensive effort, iteration, and teamwork, we have now validated a big part of our thesis in animals. Our novel particle is performing as intended, bringing us one step closer to a precise, universal cancer treatment platform."

(Press release, CancerVax, JUN 15, 2026, View Source [SID1234668754])

On June 15, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported positive interim Phase 1 clinical data for its CLDN6 x CD3 T cell engaging bispecific antibody, CTIM-76, in advanced, late-line platinum-resistant ovarian cancer ("PROC"). The data are as of a May 29, 2026 data cutoff from the ongoing CTIM-76 Phase 1 study.

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"We are encouraged by the continued development of CTIM-76 as a potentially best-in-class CLDN6 T cell engager that may offer a much-needed new therapeutic approach for patients with platinum-resistant ovarian cancer," said Martin Lehr, Chief Executive Officer of Context. "In our first clinical presentation of dose-escalation data, weekly administration of CTIM-76 produced compelling anti-tumor activity and a well-tolerated safety profile in heavily pretreated patients, many of whom had extensive prior exposure to antibody-drug conjugates. Building on this encouraging data, we have advanced into the next phase of development, where we will evaluate CTIM-76 administered every three weeks ("Q3W"). These results are expected to inform subsequent Phase 1b dose expansion in 2027."

CTIM-76 Phase 1a Interim Data Summary:

21 patients with PROC (n=14), testicular (n=4), and endometrial (n=3) cancer were treated with CTIM-76 at doses ranging from 22.5µg to 560µg every week ("QW").
At the active doses of 140µg to 280µg, 13 patients were treated in total, 10 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff.
560µg exceeded target exposures with QW dosing and was not pursued further.
PROC Patient Characteristics:

Patients (n=9) received a median of 7 prior lines of therapy (range 5-16).
Prior patient treatments included ADC (89%), checkpoint inhibitor (55%), VEGF (100%), or DNA repair agent (78%).
44% of patients had liver metastases.
Efficacy Results:

As of the data cutoff, 7 PROC patients were efficacy-evaluable at doses of 140µg to 280µg.
Overall response rate (ORR): 29% of PROC patients (2/7) achieved confirmed partial RECIST v. 1.1 responses.
Disease control rate (DCR)1: 57% (4/7)
In early cohort patients who achieved confirmed stable disease or partial response, treatment durability was sustained for at least 6 months (n=3).
Safety Results:

At active dose levels, CTIM-76 produced a favorable safety profile that is consistent with the expected mechanism of action for a T cell engager and supports continued clinical development.
Adverse events generally occurred during the first or second dose and were predominantly low grade, with the majority of events reported as Grade 1 or Grade 2 and reversible with standard management.
CRS events were infrequent and limited to Grade 1 (11%, n=1/9) at active dose levels in PROC patients, which may be supportive of outpatient dosing in future trials.
Pharmacokinetic Results:

Approximately dose-dependent increases in CTIM-76 exposure with increasing dose level.
Preliminary PK supports exploration of Q3W dosing schedule.
Investor Webcast and Conference Call Information
The Company will host a conference call to discuss these data at 8:00 a.m. ET today, June 15, 2026. Participants may access the live webcast of the conference call from the "News & Events" page of the Company’s website at www.contexttherapeutics.com. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. The webcast will be available for replay for at least 90 days on the Company’s website.

About CTIM-76
CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on View Source

(Press release, Context Therapeutics, JUN 15, 2026, View Source [SID1234668753])

On June 15, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, reported first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (Abstract #LB5006).

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In the ongoing Phase 1 study, a single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. At the higher dose level (DL2), LB2501 achieved a 100% objective response rate (ORR) (6/6) and an 83.3% complete response rate (CR) (5/6), with all responses ongoing at the time of data cutoff. LB2501 also showed a favorable safety profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths reported.

"In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy. Backed by the commercial and scientific foundation we have built with CARVYKTI, we are well-positioned to advance this next generation of CAR-T delivery. These early data, with deep responses from a single infusion across patients, give us confidence in the path ahead."

LB2501 Demonstrates In Vivo CAR-T Generation and Early Clinical Activity

In an ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels, DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and 58.3% were refractory to their most recent treatment. The open-label, multi-center, dose-escalation study is evaluating safety, recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B-NHL. The study was conducted without lymphodepletion.

At DL2, LB2501 achieved a 100% ORR (6/6) and an 83.3% CR rate (5/6), with responses observed across patients with diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Across both dose levels, the ORR was 50.0% (6/12), and the CR rate was 41.7% (5/12). At the time of data cutoff, all responses at DL2 were ongoing.

LB2501 showed a favorable safety profile. No DLTs, SAEs, ICANS, or deaths were reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. Infusion-related reactions occurred in 75.0% (9/12) of patients overall, with a median onset of 1.4 hours after infusion and a median recovery time of 18.6 hours. CRS occurred in 66.7% (8/12) of patients overall, with a median onset at Day 11 and a median duration of 4.5 days. IRR and CRS were all Grade 1–2, no patients required glucocorticoids for CRS management. Four patients received tocilizumab.

Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in 100% (6/6) of patients at DL2 and 83% (5/6) of patients at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Viral copy number in peripheral blood peaked immediately after infusion and decreased to undetectable concentrations within 24 hours.

Additional translational analyses further characterized the in vivo profile of LB2501. No evidence of non-specific transduction was detected in NK cells or other non-T/B/NK lymphocyte populations. Vector integrations were highly polyclonal and diverse. These findings support proof-of-concept for in vivo T-cell engineering, with polyclonal vector integration and rapid vector clearance.

"These early clinical findings are encouraging in a heavily pretreated relapsed or refractory B-cell non-Hodgkin lymphoma population," said Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China. "The responses observed at the higher dose level achieved a 100% objective response rate, together with a favorable safety profile and the absence of lymphodepletion, support further investigation of LB2501 as a novel in vivo CAR-T approach. The additional pharmacokinetic and translational findings presented at EHA (Free EHA Whitepaper) further support the feasibility of generating CAR-T cells directly within the patient." ‡

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study (NCT07002112) in patients with relapsed/refractory B-cell malignanciesi to assess safety, tolerability, and preliminary efficacy.[i]

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.iii

While treatment advances have improved outcomes for some patients, those with relapsed or refractory B-cell NHL, particularly after multiple lines of therapy, often face limited options.

(Press release, Legend Biotech, JUN 15, 2026, View Source [SID1234668752])

On June 15, 2026 CERo Therapeutics Holdings, Inc. (OTCQB: CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company advancing engineered T cell therapeutics designed to engage phagocytic mechanisms, reported a clinical update from investigators participating in the ongoing Phase 1 CERTAIN-T clinical trial evaluating CER-1236 in hematologic malignancies.

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Patient five in the trial had multiple refractory acute myeloid leukemia (AML) and, according to the treating investigator, had not previously achieved disease control sufficient to enable allogeneic stem cell transplantation prior to enrollment in the study. Following treatment with CER-1236 at a total dose of 4 million cells/kg, bone marrow blast counts were reported at 14% on Days 14 and 28 and 7% on Day 42. The patient subsequently underwent allogeneic stem cell transplantation on Day 71 following infusion. Allogeneic stem cell transplantation is generally considered a potentially curative therapeutic option for eligible patients with refractory hematologic malignancies and remains a critical component of treatment for many patients with relapsed or treatment-resistant disease.

The patient’s transplant course and longer-term clinical outcome remain under evaluation. These observations are preliminary, based on a limited number of patients, and no definitive conclusions regarding safety or efficacy can be made at this stage of the trial.

Chris Ehrlich, CEO of CERo, commented, "We continue to observe encouraging findings from the ongoing trial, with investigators reporting clinical improvement in two patients treated across the first two cohorts. Although formal response assessments remain ongoing, investigators have reported findings suggestive of clinical benefit following treatment with CER-1236. We look forward to continuing dose escalation and further evaluating CER-1236 in the ongoing Phase 1 study."

The observed safety profile across all treated patients remains consistent with clinical data previously presented at the Tandem Meetings in February, which reported no cytokine release syndrome ("CRS"), immune effector cell-associated neurotoxicity syndrome ("ICANS"), DLTs, or treatment-related severe adverse events during the DLT assessment window.

The Company has now treated six patients in the ongoing Phase 1 trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities ("DLTs") observed during the DLT assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, and the Company continues to evaluate the pharmacokinetic and pharmacodynamic profile of CER-1236 as the study advances through dose escalation.

The Company has initiated the third planned cohort of the CERTAIN-T study, which is expected to evaluate the planned one billion cells/patient protocol and is currently screening patients for enrollment. The cohort is also expected to include patients with myelodysplastic syndromes ("MDS") and myelofibrosis ("MF"), reflecting the Company’s strategy to further evaluate CER-1236 in additional myeloid disease settings.

About the CERTAIN-T Trial

The first-in-human, multicenter, open-label Phase 1/1b CERTAIN-T study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of CER-1236 in patients with hematologic malignancies. The study initially enrolled patients with acute myeloid leukemia ("AML"), including relapsed/refractory AML, measurable residual disease AML, and newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent myelodysplastic syndromes ("TD-MDS"), high-risk myelodysplastic syndromes ("HR-MDS"), and post-JAK inhibitor myelofibrosis ("MF"). Primary endpoints include safety and tolerability. Secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate ("ORR"), complete response ("CR"), composite complete response ("cCR"), and measurable residual disease ("MRD").

(Press release, Cero Therapeutics, JUN 15, 2026, View Source [SID1234668751])