On June 30, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported it has been awarded a $1.5 million non-dilutive research grant from the Andy Hill Cancer Research Endowment (CARE) Fund under its Implementation and Outcomes Research program to support investigational new drug (IND)-enabling work for APVO451, Aptevo’s novel trispecific antibody-like immunotherapy candidate for solid tumors.

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Aptevo believes that obtaining this competitive award, reviewed by subject matter experts and awarded based on merit, provides external validation of APVO451’s tumor-directed trispecific design and supports Aptevo’s ongoing work around nectin-4-targeted therapies. Trispecific immunotherapies represent what Aptevo believes is the next generation of immuno-oncology therapies and are a strategic pipeline priority for Aptevo, with APVO451 advancing toward development candidate selection by year-end 2026 and initiation of IND-enabling studies in the first quarter of 2027. APVO451 is a strategic pipeline priority which reflects Aptevo’s broader effort to extend its controlled immune-activation platform into solid tumors.

"Solid tumors continue to present significant challenges for immunotherapy, particularly because the tumor microenvironment can limit effective immune activation," said Michelle Nelson, Ph.D., Senior Director at Aptevo and Principal Investigator of the study. "This award supports the generation of additional APVO451 preclinical data to further evaluate how its tumor-directed trispecific design may leverage CD40-mediated immune activation while bringing together T-cell engagement in a coordinated anti-tumor response and subsequently advancing it toward IND-enabling development."

CARE Fund grants promote cancer research led by public and private entities conducting cancer research in Washington State. Through research grants and strategic partnerships, CARE Fund improves health outcomes by advancing transformational research across the cancer research continuum. The grant will support IND-enabling activities for APVO451, including preclinical studies and development work intended to advance the program toward development candidate selection and future regulatory-enabling studies. The study will be led by Michelle Nelson, who brings deep scientific leadership and execution experience to the project with her background in immunobiology, solid tumor immunotherapy, and IND-enabling development.

"APVO451 reflects what we believe trispecific immunotherapies can uniquely do: bring complementary immune mechanisms together in a coordinated, tumor-directed way," said Mary Janatpour, Ph.D., Senior Vice President and Chief Scientific Officer of Aptevo Therapeutics. "By combining nectin-4-targeting with CD40 and CD3 engagement, APVO451 is designed to activate both antigen-presenting cells and T cells within the tumor microenvironment. We are grateful to the Andy Hill CARE Fund for supporting this program and for recognizing the promise of this approach as we work to advance new treatment options for patients with difficult-to-treat cancers."

About the APVO451 Program

APVO451 is designed to address a central challenge in solid tumor immunotherapy: the tumor microenvironment can suppress immune activity and limit the body’s ability to recognize and attack cancer cells. APVO451 brings together three functions in a single molecule: targeting nectin-4, a tumor-associated marker expressed in multiple solid tumors; activating CD40 on antigen-presenting cells to engage innate immunity in the tumor milieu; and engaging CD3 on T-cells to direct tumor-cell killing.

Together, these mechanisms are intended to concentrate immune activation within the tumor microenvironment, stimulate T-cell activity and broader immune engagement, and support an amplified attack against solid tumors. Unlike approaches that broadly activate the immune system, APVO451 is designed so that its CD3 and CD40 activity depend on binding to nectin-4, helping focus immune activation where it is needed and reduce the risk of systemic immune activation. APVO451 also incorporates Aptevo’s CRIS-7-derived CD3 binding domain, the same CD3 platform approach used in mipletamig, Aptevo’s lead clinical program. Aptevo’s CD3 strategy is designed to engage T cells while reducing the risk of excessive cytokine release, a key limitation that has historically challenged the development of T-cell-engaging therapies, particularly in solid tumors.

APVO451 is part of Aptevo’s broader pipeline of multispecific immunotherapies designed to control immune activation with precision. The program builds on Aptevo’s experience developing antibody-based candidates that seek to balance anti-tumor activity with tolerability while expanding the Company’s platform opportunity into next-generation trispecific approaches for solid tumors.

(Press release, Aptevo Therapeutics, JUN 30, 2026, View Source [SID1234669015])

On June 30,2026 Vect-Horus, a privately held biotechnology company that designs and develops molecular vectors facilitating the targeted delivery of therapeutic molecules and imaging agents, reported a research evaluation and exclusive license option agreement with Servier, an independent international pharmaceutical group governed by a foundation. This collaboration aims to develop targeted oligonucleotide therapeutics for the treatment of central nervous system (CNS) diseases.

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Under the agreement, Vect-Horus will leverage its proprietary VECTrans technology platform to facilitate the transport of Servier’s oligonucleotide therapeutics across biological barriers to the brain, addressing one of the key challenges in the treatment of neurological disorders.

"We are very pleased to enter into this collaboration with Servier, a global pharmaceutical company with a strong commitment to innovation and patient-focused research," said Alexandre Tokay, co-founder and CEO of Vect-Horus. "This agreement further validates the potential of our VECTrans platform to overcome delivery challenges in the CNS and expand therapeutic opportunities for patients suffering from serious neurological diseases."

Vect-Horus and Servier will conduct the research evaluation activities jointly during an initial option period. Following this evaluation phase, Servier will have the exclusive option to advance selected compounds into clinical development and commercialization.

"Progress in rare neurological disorders depends on bringing together complementary expertise and a shared sense of purpose," said Nitza Thomasson, Global Head of Neurology at Servier. "We are excited to work alongside Vect-Horus to unlock the potential of this technology and help advance transformative oligonucleotide therapies for patients."

Vect-Horus will receive research and exclusivity fees during the option period. Upon exercise of the option, Vect-Horus will be eligible to receive an upfront payment, as well as development, regulatory and commercial milestone payments. In addition, the company will be entitled to single-digit royalties on annual net product sales of any resulting commercialized products.

(Press release, Vect-Horus, JUN 30, 2026, View Source [SID1234669014])

On June 30, 2026 Ratio Therapeutics Inc. (Ratio), a clinical-stage pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment, reported that it has entered into a strategic supply agreement with PanTera, an innovative producer scaling the supply of vital medical radionuclides, supporting Ratio’s ongoing efforts to build a robust and scalable supply infrastructure for its radiopharmaceutical development programs.

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The agreement provides Ratio with access to dedicated Ac-225 supply and establishes a framework for future expansion as the company’s development needs evolve. The agreement will support Ratio’s clinical-stage radiotherapeutic programs while further strengthening Ratio’s manufacturing and supply chain foundation required to advance targeted alpha therapies.

"Building a resilient and diversified supply network is an important component of our long-term strategy as we advance our radiopharmaceutical pipeline," said Matthias Friebe, Chief Development Officerof Ratio Therapeutics. "PanTera has emerged as an important contributor to the global Actinium-225 ecosystem, and this agreement reflects our commitment to establishing the infrastructure needed to support ongoing clinical development of our radiotherapies."

"We are honored to partner with Ratio Therapeutics to support the advancement of their innovative radiopharmaceutical pipeline," said Christophe Malice, CBO of PanTera. "Ratio’s targeted approach to treating cancer exemplifies the kind of clinical progress enabled by reliable Ac-225 supply. By providing dependable Ac-225, produced in compliance with cGMP, we are proud to help ensure that programs such as Ratio’s can advance without the supply constraints that have long challenged the field. This collaboration reflects PanTera’s commitment to supporting the pharmaceutical industry as it works to bring next-generation targeted therapeutics to patients in need."

As demand for targeted alpha therapies continues to increase across the industry, reliable access to critical radioisotopes such as Ac-225 has become increasingly important. Through strategic collaborations with leading suppliers and manufacturing partners, Ratio continues to strengthen the supply chain necessary to support the development of its therapeutic candidates.

(Press release, Ratio Therapeutics, JUN 30, 2026, View Source [SID1234669013])

On June 30, 2026 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including the neurocutaneous manifestations of neurofibromatosis type 1 (NF1), reported updated interim safety and clinical activity data from its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, including patients who have failed prior BRAF/MEK inhibitor treatment (NCT06299839). The Company also announced details of its protocol amendment to extend dose escalation and initiate a pilot food effect assessment.

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Dr. Kartik Krishnan, Chief Medical Officer of Pasithea, said, "The literature reports that patients with BRAF mutated cancer who progress on BRAF/MEK combination therapy have a median progression-free survival of approximately 5 months with rechallenge with BRAF/MEK combination therapy. We have observed that a number of these patients who previously progressed on prior BRAF/MEK inhibitor treatment have demonstrated stable disease on PAS-004 for greater than six months, including two patients for over one year. We believe that this demonstrates that PAS-004 is an active agent. Importantly, we continue to be encouraged by the observed adverse event (AE) profile and the ability to maintain dosing in patients over a long period of time without discontinuations. Given that we have not reached the maximum tolerated dose (MTD) and the tolerability of the doses we have evaluated to date, we have decided to continue dose escalation in the study with the introduction of our tablet formulation, while also exploring the effect of food on the PK of PAS-004 to enhance our understanding about how best to maximize the benefit of PAS-004 in long-term chronic dosing."

Interim Phase 1 Results for PAS-004 through May 22, 2026:

34 patients have been enrolled and dosed
Heavily pre-treated population with a median of 3 prior lines of therapy (range 1 – 8)
Difficult to treat diagnoses (e.g., refractory pancreatic cancer and ovarian cancer), including 12 patients with BRAF V600E mutations, 10 of whom previously progressed on BRAFi and/or BRAFi/MEKi combinations

Well-tolerated safety profile with long-term, once daily dosing

No dose-limiting toxicities (DLTs), and no discontinuations due to TRAEs with 10 patients on study for >90 days, of which 6 patients >150 days, 4 patients >300 days, and 2 patients >365 days
All TRAEs were Grade 1 or Grade 2; Low cumulative rates of rash (12%) and diarrhea (6%) across all patients at all doses throughout the study, including no (0%) rash or diarrhea in the 4 patients on study >300 days and 2 patients >365 days
No events of retinal or cardiac toxicity
Disease stabilization in the refractory population (N=12)
Multiple patients demonstrating durable clinical benefit and tumor shrinkage, including several MEK/BRAF-pretreated patients who have remained on study for greater than six months and two patients on study for over one year – exceeding the approximately 5-month median PFS reported in the literature for BRAF/MEK rechallenge in this setting. The final PFS data will not be known until the end of the trial.
Pharmacokinetics support daily dosing and exploration of higher dose levels
Long half-life (approximately 60 hours)
Linear, dose proportional PK
Cmax/Cmin ratio <2, with both Cmax and Cmin above the IC50 (half-maximal inhibitory concentration) from our cellular assay at all dose cohorts
The Company plans to submit and present a more robust data set at a future scientific conference.

(Press release, Pasithea Therapeutics, JUN 30, 2026, View Source [SID1234669012])

On June 30, 2026 Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported the U.S. Food and Drug Administration (FDA) has approved TREGZI (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T, a precision-engineered cell therapy for use in matched-donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease (GVHD)-free survival (cGFS), in the treatment of adults with hematological malignancies.

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"For transplant physicians, one of our greatest challenges has long been preserving the vital graft-versus-leukemia effect while minimizing the risk of GVHD and infection," said Miguel-Angel Perales, M.D., medical oncologist and chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center. "The FDA approval of TREGZI signals a new era in transplant medicine. This precision-engineered cell therapy is built on the foundational principles established by our early CD34 cell selection work and can now be delivered at scale, equipping providers with a new option to reduce serious toxicities and improve treatment outcomes."

"We founded Orca Bio on the audacious goal to engineer living cells into curative medicines, rooted in the belief that single-cell precision could fundamentally rewrite patient outcomes," said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. "The FDA approval of TREGZI is a significant milestone that stands on the shoulders of decades of pioneering science. As we enter this next chapter, our focus turns to the immense responsibility of delivering TREGZI reliably, precisely and safely to the patients and families counting on us."

TREGZI is a personalized treatment manufactured for each individual patient using living cells from a matched donor. TREGZI uses hematopoietic stem and progenitor cells (HSPCs) to reconstitute the immune system, highly purified regulatory T cells (Tregs) to suppress GVHD and conventional T cells (Tcons) to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity.

"Developing this concept from early foundational research in our labs based upon the fundamental biology of regulatory T cells, to it now receiving the first FDA approval for a therapy that utilizes highly purified Tregs, is a defining moment for the transplant community," said Robert Negrin, M.D., professor of medicine, blood and marrow transplantation at Stanford Medicine. "The peer-reviewed findings demonstrated this precision-engineered cell therapy delivered improved GVHD-free survival alongside less toxicity, including fewer serious infections and lower non-relapse mortality."

The FDA approval of TREGZI is based on results from the randomized, multi-center Precision-T Phase 3 study of patients (n=187) with a median age of 43.6 years (range 19-65 years) with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). Results with TREGZI plus single-agent tacrolimus (TAC) compared with a conventional allogeneic hematopoietic stem cell transplant (alloHSCT) plus TAC/methotrexate (TAC/MTX) found the following at 12 months:

The primary endpoint of chronic cGFS was 78% with TREGZI compared to 38% with alloHSCT (HR 0.26; p<0.00001), an improvement driven by a reduction in chronic GVHD and fewer patient deaths.
The rate of chronic GVHD was 13% and 44% with TREGZI and alloHSCT, respectively (HR 0.19; p<0.00002).
Overall survival (OS) was 94% with TREGZI and 83% with alloHSCT.
GVHD-free and relapse-free survival (GRFS) was 63% and 31% with TREGZI and alloHSCT, respectively. 
Non-relapse mortality (NRM) was 3% for TREGZI compared with 13% for alloHSCT. 

Additional safety findings were consistent with previous studies. The cumulative incidence for Grade 3 or 4 acute GVHD at day +180 with TREGZI was 6% versus 10% with alloHSCT (HR 0.37; p=0.044). Grade ³3 infections were less common with TREGZI, with a one year estimated incidence of 44% for TREGZI and 51% for alloHSCT. 

"Historically, surviving a blood cancer has often meant navigating serious, long-term effects that can shape patients’ lives well beyond treatment," said Gwen Nichols, M.D., executive vice president and chief medical officer at Blood Cancer United. "As a researcher, physician and a patient advocate, it’s exciting that patients will have a new option that may change what life after transplant can look like, including the potential to support recovery and quality of life."

Hematological malignancies such as AML, ALL and MDS, commonly referred to as blood cancers, are cancers that can originate in the bone marrow and disrupt normal cell production. Despite therapeutic advances, these diseases, particularly in adult and high-risk populations, remain associated with poor outcomes, high relapse rates and significant treatment-related toxicities.

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

Graft Failure: Graft failure has occurred after TREGZI administration. Screen TREGZI recipients for antidonor antibodies that may prevent engraftment. Monitor patients closely for laboratory evidence of hematopoietic recovery.

Graft-Versus-Host Disease: Acute and chronic Graft-Versus-Host disease (GVHD), including life-threatening and fatal cases, occurred following treatment with TREGZI. Acute GVHD manifests as maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Chronic GVHD may include skin rash, mouth sores, dry eyes, liver inflammation, and development of scar tissue in the skin and joints and damage to the lungs. Treat patients with a single agent calcineurin inhibitor as prophylaxis to decrease the risk of GVHD. Monitor for signs and symptoms of GVHD, and treat if GVHD develops.

Infusion Reactions: Infusion reactions (IRs) may occur during or following treatment with TREGZI. Serious hypersensitivity reactions including anaphylaxis may occur to DMSO, human serum albumin (HSA), Dextran or murine protein present in TREGZI. IRs may begin within minutes of the start of TREGZI infusion, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of IRs during and after TREGZI administration. When a reaction occurs, pause the infusion and institute supportive care as needed. Premedicate patients with antipyretics and histamine antagonists prior to infusion to reduce the incidence and intensity of infusion reactions.

Secondary Malignancies and Malignancies of Donor Origin: Secondary malignancies and malignancies of donor origin may occur following treatment with TREGZI. Development of secondary malignancies, including posttransplantation lymphoproliferative disorder (PTLD) may occur many years after transplantation. PTLD manifests as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated. Serial monitoring of blood for EBV DNA may be warranted in patients with persistent cytopenias. No patient treated with TREGZI has developed PTLD. Monitor for malignancies of donor origin and secondary malignancies. Contact Orca Bio at 1-877-411-6722 if any patient is diagnosed with a secondary malignancy or a malignancy of donor origin.

Transmission of Infectious Agents: Transmission of serious infectious or communicable disease or agents may occur with TREGZI treatment as it is derived from human donor blood and manufactured using animal-derived reagents. Risks of transmission of infectious agents may occur despite screening or testing of donors. Risks of transmission of serious infections include, but are not limited to, human immunodeficiency virus, human T cell lymphotropic virus (HTLV)-1 and -2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, Trypanosoma cruzi, West Nile virus (WNV), cytomegalovirus, transmissible spongiform encephalopathy agents and vaccinia. Monitor patients for signs and symptoms of infections, perform tests for infectious agents and treat as clinically indicated.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 20%) were mucositis, diarrhea, rash, viral infections, infections pathogen unspecified, abdominal pain, vomiting, nausea, bacterial infections, hemorrhage, aGVHD, edema, and fungal infections.

The most common Grade 3-4 laboratory abnormalities (≥ 20%) are lymphocyte count decreased, platelet count decreased, leukocyte count decreased, neutrophil count decreased and hemoglobin decreased.

INDICATIONS AND USAGE

TREGZI is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies.

Please see accompanying full Prescribing Information.

About Precision-T
Precision-T (NCT05316701) is a randomized, open-label, multi-center study that evaluated the safety, efficacy and tolerability of TREGZI compared with conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Orca Bio received guidance from the U.S. Food and Drug Administration on the design of Precision-T, which evaluated TREGZI in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). There were 19 leading treatment centers participating in the trial, which enrolled 187 patients across the U.S. Results were published in Blood in December 2025.

(Press release, Orca Bio, JUN 30, 2026, View Source [SID1234669011])