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Pasithea Therapeutics Announces Amendments to Clinical Study Protocol for Phase 1/1B NF1 Clinical Trial

On June 16, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported it has amended the clinical study protocol for the Phase 1/1b trial of PAS-004 in neurofibromatosis type 1 (NF1) patients with symptomatic inoperable, incompletely resected, or recurrent plexiform neurofibroma (PN). The amendments include an update to the dose escalation part of the study (Part A) to allow for the enrollment of additional participants at two additional higher dose levels (24mg and 32mg), the ability to backfill completed dose cohorts (4mg, 8mg, 12mg and 18mg) with up to two participants, and the evaluation of intermediate dose levels.

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In addition, the protocol amendments allow patients to remain on treatment for up to 18 months in Part A, and include additional MRI scans to comprehensively evaluate PN, as well as adding more detailed cutaneous neurofibroma (CN) measurements, including tumor height and volume.

Pasithea has completed enrollment and multi-cycle dosing of the initial 4mg, 8mg, 12mg and 18mg cohorts, and enrolled the 24mg cohort and an intermediate 15mg cohort.

"We believe increasing the breadth and depth of Part A of the NF1 study will help inform dose selection for Part B and our future registrational studies," said Dr. Kartik Krishnan, Chief Medical Officer, Pasithea. "I am pleased that we rapidly enrolled and dosed an additional 6 patients and that the amendments will allow us to provide more comprehensive data in 2026."

This multicenter, phase 1/1b, open-label study is divided into two parts: a dose-escalation phase (part A) and an expansion cohort phase (part B). To date, the dose-escalation phase has enrolled and dosed 18 patients with NF1.

About NF1- PN
Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, JUN 16, 2026, View Source [SID1234668758])

Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044

On June 16, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, reported that the United States Patent and Trademark Office ("USPTO") has issued a new patent broadly protecting the Company’s proprietary manufacturing process for pelareorep.

The newly issued patent covers key aspects of the methods used to manufacture pelareorep and is expected to provide intellectual property protection into 2044. The patent is designed to protect the Company’s ability to consistently produce pelareorep at commercial scale and represents a significant addition to Oncolytics’ growing intellectual property portfolio.

The Company also announced that a previously filed method-of-use patent application directed at pelareorep’s use as an immunotherapy remains under review and, if issued, is expected to provide protection into the year 2046. In addition, Oncolytics plans to file further patent applications this year that are designed to expand and strengthen the pelareorep intellectual property estate across additional therapeutic applications, treatment settings, and combination approaches.

"Building a strong intellectual property estate around pelareorep is an important part of our strategy as we advance the program toward potential registration and commercialization," said Jared Kelly, Chief Executive Officer of Oncolytics. "This newly issued patent strengthens our protection around the manufacturing of pelareorep and supports our ability to produce the product at commercial scale. Combined with our previously filed method-of-use patent application and additional planned filings, we continue to build a durable patent portfolio designed to support the long-term value of pelareorep. Checking this box represents another important milestone as we execute on our strategy and move pelareorep into its next phase of development."

The Company’s intellectual property strategy is focused on protecting pelareorep through a combination of manufacturing, method-of-use, formulation, and combination therapy patents designed to support the continued development and commercialization of pelareorep across multiple oncology indications.

(Press release, Oncolytics Biotech, JUN 16, 2026, View Source [SID1234668757])

NovaBridge Biosciences Receives FDA Fast Track Designation for Givastomig in First-Line HER2-Negative Metastatic Gastric Cancer

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.

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])

CancerVax Successfully Demonstrates Full Nanoparticle Delivery in Mouse Study

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.

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])

Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for CTIM-76

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.

"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])