On June 10, 2026 Laverock Therapeutics (‘Laverock’), a biotechnology company developing disease-responsive advanced therapies through its unique, programmable gene control technology, reported key in-vivo functional milestones across its T-cell and macrophage oncology programmes for solid tumour indications. The data support lead programme selection and progression towards the clinic.

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Laverock’s platform technology enables programmable, tunable and multiplex gene control for both endogenous targets and for transgenically expressed payloads. In its T-cell programme (LVK201), the platform is designed to improve CAR-T cell anti-tumour activity without compromising safety. The latest data from ovarian cancer models, presented at the American Society of Cell and Gene Therapy (ASCGT) Annual Meeting in May, demonstrate that the Company’s technology can improve solid tumour control by targeting three distinct immunomodulatory pathways simultaneously. Previous studies have also shown that, because the technology harnesses T-cell activation dynamics to act only when needed, safety can be significantly improved compared with alternative approaches.

These findings inform development of Laverock’s lead programme whilst also providing broader validation of the platform, establishing a foundation for future tailored therapies across a range of solid tumour types. To realise this Laverock will apply AI and single-cell analytical approaches backed by recently announced grant funding.

In its macrophage programme (LVK301), Laverock’s platform technology is used to control macrophage cell phenotype and regulate the delivery of an immunomodulatory payload. The Company has shown that these engineered cells can both control tumour growth, and convert the ‘cold’, immunosuppressive solid tumour microenvironment to a ‘hot’ state, enabling the body’s immune system to attack the tumour. These findings provide strong validation of Laverock’s macrophage programme for oncology and open the way to applying myeloid biology to address additional disease classes.

Laverock is now engaged with a range of partner organisations, defining non-clinical and clinical strategy, to provide a de-risked route to early clinical validation.

David Venables, Laverock Therapeutics CEO, said: "These key data points from our oncology programmes highlight the capabilities and strength of our platform technology, and provide a clear route to lead programme selection and progression into non-clinical studies. Solid tumours remain an area of huge unmet need for cancer patients, and we look forward to moving our differentiated therapies towards the clinic."

(Press release, Laverock Therapeutics, JUN 10, 2026, View Source [SID1234666553])

On June 18, 2026 Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumor characterized by high mutation rates. The FDA has granted Priority Review and is expected to make a decision on the approval by October 9, 2026.

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"This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery."

"One in three patients with stage III colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options," said Michael Sapienza, CEO, Colorectal Cancer Alliance. "This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumor biology from the very beginning, giving them a better chance of preventing a recurrence."

The application is based on the landmark ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, determined by an immunohistochemistry test, such as the VENTANA MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with FOLFOX6 compared with 76% in the FOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and FOLFOX6.

Colon cancer remains one of the world’s most common and deadliest tumors. Over one million people are diagnosed globally each year, and despite surgery and chemotherapy, approximately 30% of stage III patients relapse within five years. Approximately 15% of colon cancer patients present with dMMR/MSI-H tumors, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.

The ATOMIC study was sponsored by the National Cancer Institute (NCI) and conducted by the Alliance for Clinical Trials in Oncology in partnership with Genentech and the Arbeitsgemeinschaft Internistische Onkologie (AIO) group in Germany. It highlights Genentech’s commitment to working alongside leading academic groups to tackle some of the most challenging cancers.

About the ATOMIC study
ATOMIC (A021502, NCT02912559) is a Phase III, randomized, open-label, multicenter study investigating the addition of Tecentriq (atezolizumab) to FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomized 1:1 to receive either FOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or FOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.

What are Tecentriq and Tecentriq Hybreza?

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription medicines used to treat:

Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your lung cancer:
to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery and you have received platinum-based chemotherapy, and
you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and
your cancer tests positive for "PD-L1".

Tecentriq or Tecentriq Hybreza may be used alone as your first treatment when your lung cancer:
has spread or grown, and
your cancer tests positive for "high PD-L1", and
your tumor does not have an abnormal "EGFR" or "ALK" gene.

Tecentriq or Tecentriq Hybreza may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC", and
your tumor does not have an abnormal "EGFR" or "ALK" gene.

Tecentriq or Tecentriq Hybreza may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC", and
your tumor does not have an abnormal "EGFR" or "ALK" gene.

Tecentriq or Tecentriq Hybreza may be used alone when your lung cancer:
has spread or grown, and
you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
If your tumor has an abnormal "EGFR" or "ALK" gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

Adults with a type of lung cancer called "extensive stage small cell lung cancer (SCLC)", which is SCLC that has spread or grown

Tecentriq or Tecentriq Hybreza may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
Tecentriq or Tecentriq Hybreza may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
has not progressed after first treatment with Tecentriq or Tecentriq Hybreza and the chemotherapy medicines carboplatin and etoposide.

Adults with a type of liver cancer called hepatocellular carcinoma (HCC). Tecentriq or Tecentriq Hybreza may be used with the medicine bevacizumab when your liver cancer:

has spread or cannot be removed by surgery, and
you have not received other medicines by mouth or injection through your vein (IV) to treat your cancer.

Adults with a type of skin cancer called melanoma. Tecentriq or Tecentriq Hybreza may be used with the medicines cobimetinib and vemurafenib when your melanoma:

has spread to other parts of the body or cannot be removed by surgery, and
has a certain type of abnormal "BRAF" gene. Your healthcare provider will perform a test to make sure this Tecentriq or Tecentriq Hybreza combination is right for you.

Adults and children (12 years of age and older), with a type of soft tissue tumor (cancer) called alveolar soft part sarcoma (ASPS). Tecentriq or Tecentriq Hybreza may be used when your sarcoma:

has spread to other parts of the body or cannot be removed by surgery.

Adults with a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body. Tecentriq or Tecentriq Hybreza may be used alone as a treatment for your bladder cancer:

to help prevent your bladder cancer from coming back after your bladder has been removed by surgery, and
small pieces of DNA from the tumor (called circulating tumor DNA [ctDNA]) were found in your blood, showing that cancer cells remain in the body (molecular residual disease). Your healthcare provider will perform a test to make sure that Tecentriq or Tecentriq Hybreza is right for you.

It is not known if Tecentriq Hybreza is safe and effective when used:

in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC.

It is not known if Tecentriq is safe and effective when used:

in children younger than 2 years of age for the treatment of ASPS.
in children for the treatment of NSCLC, SCLC, HCC, melanoma or MIBC.

Important Safety Information

Who should not receive Tecentriq Hybreza?

Do not receive Tecentriq Hybreza if you are allergic to hyaluronidase or any of the ingredients in Tecentriq Hybreza

What is the most important information about Tecentriq and Tecentriq Hybreza?

Tecentriq and Tecentriq Hybreza can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain

Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness

Liver problems

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal

Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite

Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in your mouth or your nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq or Tecentriq Hybreza. Call or see your healthcare provider right away for any new or worsening signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq or Tecentriq Hybreza. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq or Tecentriq Hybreza. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq or Tecentriq Hybreza if you have severe side effects.

Before you receive Tecentriq or Tecentriq Hybreza, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ or tissue transplant, including corneal transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq and Tecentriq Hybreza can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq or Tecentriq Hybreza. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq or Tecentriq Hybreza.
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.
are breastfeeding or plan to breastfeed. It is not known if Tecentriq or Tecentriq Hybreza passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq or Tecentriq Hybreza.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

feeling tired or weak
decreased appetite
nausea
cough
shortness of breath

The most common side effects of Tecentriq Hybreza when used alone include:

feeling tired or weak
muscle or bone pain
cough
shortness of breath
decreased appetite

The most common side effects of Tecentriq and Tecentriq Hybreza when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite

The most common side effects of Tecentriq and Tecentriq Hybreza when used in hepatocellular carcinoma (HCC) with bevacizumab include:

high blood pressure
feeling tired or weak
too much protein in the urine

The most common side effects of Tecentriq and Tecentriq Hybreza when used in melanoma with cobimetinib and vemurafenib include:

skin rash
joint, muscle, or bone pain
feeling tired or weak
liver injury
fever
nausea
itching
swelling of legs or arms
mouth swelling (sometimes with sores)
low thyroid hormone levels
sunburn or sun sensitivity

The most common side effect of Tecentriq and Tecentriq Hybreza when used alone in MIBC is:

urinary tract infection

Tecentriq and Tecentriq Hybreza may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq and Tecentriq Hybreza. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq and Tecentriq Hybreza.

You may report side effects to the FDA at 1-800-FDA-1088 or View Source You may also report side effects to Genentech at 1-888-835-2555.

(Press release, Genentech, JUN 10, 2026, View Source [SID1234666538])

On June 10, 2026 BostonGene, leading developer of AI models for tumor and immune biology, reported its participation at the 22nd Annual Industry/Academia Precision Oncology & RadMed Symposium. At this premier event, global leaders in life sciences will explore the latest innovations in AI, immuno-oncology, molecular imaging, and targeted therapies. The symposium will be held on Thursday, June 11, 2026, at The Alexandria at Torrey Pines Conference Center in San Diego, California.

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Presentation details:

Title: Beyond Multiomics: Leveraging AI Foundation Models to Decode the Tumor-Immune Interface
Date & time: Thursday, June 11 | 1:25 PM PST
Speaker: Michael F. Goldberg, PhD, VP of R&D, BostonGene
The presentation will showcase how BostonGene utilizes advanced AI architecture and foundation models to integrate multimodal oncology and immunology data spanning molecular, tissue, cellular, and patient levels to deliver deep biological insights and accelerate drug development. Trained on extensive data points across multiple indications, this model generates high-dimensional embeddings that significantly improve the prediction of immunotherapy response and toxicity profiles.

Dr. Goldberg will highlight how AI-based analysis of minimally invasive peripheral blood immune profiling can support clinical development. The presentation will include key findings from a large-scale clinical collaborative study, demonstrating how the platform predicts patient response and toxicity, mitigates overfitting, and unlocks rare biological signals to guide patient stratification.

To learn more or to schedule a meeting with BostonGene during the event, please contact Hannah Oman at [email protected]. For additional details, visit the 22nd Annual Industry/Academia Precision Oncology & RadMed Symposium website.

(Press release, BostonGene, JUN 10, 2026, View Source [SID1234666554])

On June 10, 2026 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported data demonstrating the clinical benefits of CASGEVY (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, from pivotal studies in children ages 5–11, show that the efficacy and safety outcomes in this age group are consistent with the transformative profile established in adult and adolescent patients. These data were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress and simultaneously published in the New England Journal of Medicine (NEJM).

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"The data presented at EHA (Free EHA Whitepaper) and published in NEJM underscore the consistent, durable and transformative benefits CASGEVY can provide to people living with sickle cell disease or transfusion-dependent beta thalassemia from early in life," said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.

"Despite optimized supportive therapy, children living with sickle cell disease and transfusion‑dependent beta thalassemia carry a significant disease burden from a very young age, with progressive complications leading to the irreversible and life-shortening consequences of these diseases," said Franco Locatelli, M.D., Ph.D., Professor of Pediatrics at the Catholic University of the Sacred Heart of Rome, Director of the Department of Pediatric Hematology and Oncology at Bambino Gesù Children’s Hospital, Chair of Vertex’s TDT Program Steering Committee, and presenting author of the 5–11 years old CASGEVY data at EHA (Free EHA Whitepaper). "These data represent a profoundly important step forward, and I look forward to the possibility of providing earlier intervention to prevent complications in children and for families who have had limited potentially curative options to date."

CASGEVY clinical data for children ages 5–11 presented at EHA (Free EHA Whitepaper) and published in NEJM

Data from an interim analysis of the CLIMB-151 and CLIMB-141 studies highlight the transformative potential CASGEVY can provide to children ages 5–11 and are consistent with the durable clinical profile established in adult and adolescent patients. Collectively, these findings highlight the potential benefits of addressing vaso-occlusive crises (VOCs) and transfusion burden earlier in life, which can begin in childhood and are associated with cumulative, long-term complications in SCD and TDT including organ damage.

In the Phase 3 CLIMB-151 clinical study of children with severe SCD, all 11 patients dosed are free from VOCs and all 8 out of 8 (100%) patients with sufficient follow-up achieved the primary endpoint of being free from VOCs for at least 12 consecutive months (VF12). Of children achieving VF12, the mean (min, max) duration VOC-free was 19.0 (13.2, 30.1) months.
In the Phase 3 CLIMB-141 clinical study of children with TDT, 15 patients have been dosed with CASGEVY, and all 8 out of 8 (100%) patients with sufficient follow-up achieved the primary endpoint of transfusion independence for at least 12 consecutive months while maintaining a weighted average hemoglobin of at least 9 g/dL (TI12). All children who achieved TI12 remained so throughout the follow-up; the mean (min, max) duration transfusion independence was 23.4 (13.3, 28.5) months.
The safety profile of CASGEVY in younger patients is consistent with myeloablative conditioning and autologous transplant, as established in clinical studies in older patients with SCD and TDT.
As previously disclosed, there was one death, not related to CASGEVY, in a child with TDT who developed severe veno-occlusive disease from busulfan conditioning.
Consistent with studies in older patients, children with severe SCD and TDT treated with CASGEVY have durable and clinically relevant increases in fetal hemoglobin (HbF) and stable allelic editing.
Global regulatory submissions to expand use of CASGEVY

CASGEVY is currently approved for eligible people 12 years and older with SCD with recurrent VOCs or TDT in several countries around the world. In the United States the regulatory review is underway with the FDA to expand the use of CASGEVY to younger children after Vertex was awarded the Commissioner’s National Priority Voucher. Vertex has also recently completed regulatory submissions in the Kingdom of Saudi Arabia and United Kingdom to expand the use of CASGEVY to younger children. Upon availability, there is an established network of activated authorized treatment centers in these countries prepared to support patients.

The use of CASGEVY in children ages 5–11 years is investigational.

About Sickle Cell Disease (SCD)

Sickle Cell Disease (SCD) is a rare serious, inherited blood disease that is progressive and life‑shortening. The disease causes red blood cells to become rigid and misshapen, restricting blood flow and oxygen delivery to vital organs. Recurrent vaso‑occlusive crises (VOCs), unpredictable episodes of severe pain caused by blocked blood vessels, are a defining feature of SCD and frequently require hospitalization. Many patients experience these complications early in life, and over time, repeated VOCs and chronic anemia lead to progressive and irreversible organ damage, including damage to the brain, lungs, kidneys and heart. SCD places a substantial burden on patients and their families, who must manage frequent medical visits, hospitalizations, school and work disruptions, and the emotional toll of chronic pain and life‑threatening complications. Despite lifelong treatment, people with SCD and recurrent VOCs in Europe face shortened life expectancy, with a mean age of death of around 40 years, and report quality‑of‑life outcomes far below the general population.

About Transfusion‑Dependent Beta Thalassemia (TDT)

Transfusion‑dependent beta thalassemia (TDT) is a rare serious, inherited blood disease that is progressive and life‑shortening. The disease impairs the body’s ability to produce sufficient hemoglobin, limiting oxygen delivery to tissues and organs. People with TDT do not have enough functional hemoglobin in their red blood cells and require regular, lifelong blood transfusions, often beginning early in childhood, along with ongoing iron chelation therapy. While transfusions are necessary for survival, many of the long‑term complications of TDT are exacerbated by chronic transfusion therapy and iron overload and cumulative damage to the heart, liver and endocrine system, as well as bone abnormalities and delayed growth and puberty. TDT places a significant and ongoing burden on patients and their families, requiring frequent medical visits and complex lifelong treatment. Despite lifelong treatment, people with TDT face shortened life expectancy, with a mean age of death of approximately 50–55 years in Europe, reduced quality of life and productivity, and significant use of health care resources.

About CASGEVY (exagamglogene autotemcel)

CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene through a precise double-strand break. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown in clinical trials to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT.

About the CLIMB Studies

The completed Phase 1/2/3 open-label studies, CLIMB-111 and CLIMB-121, were designed to assess the safety and efficacy of a single dose of CASGEVY in patients ages 12–35 years with TDT or with SCD and recurrent VOCs. Patients were followed for approximately two years after CASGEVY infusion in these studies. CLIMB-141 and CLIMB-151 are ongoing Phase 3 open-label studies, designed to assess the safety and efficacy of a single dose of exagamglogene autotemcel in patients ages 2–11 years with TDT or with SCD and recurrent VOCs. Enrollment and dosing are complete for the 5–11-year-old cohort in both studies.

Each patient in these studies is asked to participate in the ongoing long-term, open-label study, CLIMB-131. CLIMB-131 is designed to evaluate the long-term safety and efficacy of CASGEVY in patients with up to 15 years of follow-up after CASGEVY infusion.

U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR CASGEVY

WHAT IS CASGEVY?

CASGEVY is a one-time therapy used to treat people ages 12 years and older with:

• sickle cell disease (SCD) who have frequent vaso-occlusive crises or VOCs

• beta thalassemia (β-thalassemia) who need regular blood transfusions

CASGEVY is made specifically for each patient, using the patient’s own edited blood stem cells, and increases the production of a special type of hemoglobin called hemoglobin F (fetal hemoglobin or HbF). Having more HbF increases overall hemoglobin levels and has been shown to improve the production and function of red blood cells. This can eliminate VOCs in people with sickle cell disease and eliminate the need for regular blood transfusions in people with beta thalassemia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CASGEVY?

After treatment with CASGEVY, you will have fewer blood cells for a while until CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of platelets (cells that usually help the blood to clot) and white blood cells (cells that usually fight infections). Your doctor will monitor this and give you treatment as required. The doctor will tell you when blood cell levels return to safe levels.

Tell your healthcare provider right away if you experience any of the following, which could be signs of low levels of platelet cells:
severe headache
abnormal bruising
prolonged bleeding
bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood
Tell your healthcare provider right away if you experience any of the following, which could be signs of low levels of white blood cells:
fever
chills
infections
You may experience side effects associated with other medicines administered as part of the treatment regimen for CASGEVY. Talk to your physician regarding those possible side effects. Your healthcare provider may give you other medicines to treat your side effects.

How will I receive CASGEVY?

Your healthcare provider will give you other medicines, including a conditioning medicine, as part of your treatment with CASGEVY. It’s important to talk to your healthcare provider about the risks and benefits of all medicines involved in your treatment.

After receiving the conditioning medicine, it may not be possible for you to become pregnant or father a child. You should discuss options for fertility preservation with your healthcare provider before treatment.

STEP 1: Before CASGEVY treatment, a doctor will give you mobilization medicine(s). This medicine moves blood stem cells from your bone marrow into the blood stream. The blood stem cells are then collected in a machine that separates the different blood cells (this is called apheresis). This entire process may happen more than once. Each time, it can take up to one week.

During this step rescue cells are also collected and stored at the hospital. These are your existing blood stem cells and are kept untreated just in case there is a problem in the treatment process. If CASGEVY cannot be given after the conditioning medicine, or if the modified blood stem cells do not take hold (engraft) in the body, these rescue cells will be given back to you. If you are given rescue cells, you will not have any treatment benefit from CASGEVY.

STEP 2: After they are collected, your blood stem cells will be sent to the manufacturing site where they are used to make CASGEVY. It may take up to 6 months from the time your cells are collected to manufacture and test CASGEVY before it is sent back to your healthcare provider.

STEP 3: Shortly before your stem cell transplant, your healthcare provider will give you a conditioning medicine for a few days in hospital. This will prepare you for treatment by clearing cells from the bone marrow, so they can be replaced with the modified cells in CASGEVY. After you are given this medicine, your blood cell levels will fall to very low levels. You will stay in the hospital for this step and remain in the hospital until after the infusion with CASGEVY.

STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous infusion) over a short period of time.

After the CASGEVY infusion, you will stay in hospital so that your healthcare provider can closely monitor your recovery. This can take 4-6 weeks, but times can vary. Your healthcare provider will decide when you can go home.

What should I avoid after receiving CASGEVY?

Do not donate blood, organs, tissues, or cells at any time in the future
What are the possible or reasonably likely side effects of CASGEVY?

The most common side effects of CASGEVY include:

Low levels of platelet cells, which may reduce the ability of blood to clot and may cause bleeding
Low levels of white blood cells, which may make you more susceptible to infection
Your healthcare provider will test your blood to check for low levels of blood cells (including platelets and white blood cells). Tell your healthcare provider right away if you get any of the following symptoms:

fever
chills
infections
severe headache
abnormal bruising
prolonged bleeding
bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood
These are not all the possible side effects of CASGEVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of CASGEVY

Talk to your healthcare provider about any health concerns.

(Press release, Vertex Pharmaceuticals, JUN 10, 2026, View Source [SID1234666539])

On June 10, 2026 VERAXA Biotech AG, an emerging leader in designing novel cancer therapies, reported that its previously announced business combination ("Business Combination") with Voyager Acquisition Corp. (NASDAQ: VACH, "Voyager"), a special purpose acquisition company sponsored by Cantor Fitzgerald & Co., Voyager Acquisition Sponsor Holdco LLC, and Odeon Capital Group LLC, was closed successfully (the "Closing"). Pursuant to the Closing, VERAXA Biotech AG and Voyager merged with and into VERAXA Biotech Holding AG, which will change its name to VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"). The shareholders of Voyager approved the transaction on March 12, 2026. The transaction had been previously approved by VERAXA’s shareholders on February 27, 2026. Tomorrow, on June 11, 2026, VERAXA will commence trading its shares under the symbol "VRXA" and its warrants under the symbol "VRXAW" on the Nasdaq Capital Market.

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VERAXA is developing a new generation of bispecific TCEs and ADCs aimed at increasing patient benefit through enlarging the therapeutic window and maximizing safety and efficacy. Central to VERAXA’s strategy is the use of its proprietary technology platform BiTAC (Bi-targeted Tumor-Associated Cytotoxicity), which enables the creation of conditionally activated, AND-gated therapeutic strategies that precisely target cancer cells while leaving healthy cells intact. This highly specific dual-antigen approach targets tumor cells with precision and makes it possible to target solid tumors with non-exclusive cancer markers. VERAXA is currently advancing a pipeline of development programs with a focus on solid tumors, which are predominantly sourced from its BiTAC platform. VERAXA’s BiTAC platform also enables the company to contribute value to developments in complementary therapeutic sectors such as radioimmunoconjugates (RICs) and antibody-oligonucleotide conjugates (AOCs).

Initial data from VERAXA’s most advanced BiTAC program were presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, CA, USA. VERAXA’s BiTAC-TCE candidate performed as intended in vitro and in vivo, attacking cancer cells featuring both target molecules while sparing cells expressing just one of these targets. Data demonstrated a superior safety profile and matching efficacy compared to a more traditional TCE, pointing to the possibility of a significantly improved therapeutic index. The Company’s posters are available on the VERAXA website at www.veraxa.com.

Proceeds from the financings will provide VERAXA with the ability to advance its pipeline of BiTAC-TCE and BiTAC-ADC programs toward clinical development and through initial value inflection points. The financings are comprised of a senior secured note in the principal amount of $27.5 million and a securities purchase agreement of up to $50 million.

"Entering this next chapter as a public company with significant momentum is a transformational milestone for VERAXA," said Christoph Antz, Ph.D. Chief Executive Officer of VERAXA. "We are grateful for the support received to date from current and new shareholders as the completion of our business combination better positions us to deliver meaningful value to patients with cancer. From here, we look to fully unlocking the transformative therapeutic potential of our BiTAC-TCE and BiTAC-ADC programs and establish our BiTAC platform as a launch pad for a multitude of innovative cancer therapies."

"VERAXA combines strong technology, excellent science, and an experienced management team – the ideal foundation for sustainable success on an international scale," added Oliver R. Baumann, Chairman of the VERAXA Board and CEO of Xlife Sciences AG. "Bringing our first portfolio company onto the NASDAQ market and setting VERAXA up for the accelerated growth of its pipeline and organization is a significant milestone for VERAXA and for Xlife Sciences at the same time."

"New technologies are poised to unlock significant value in two of the most vibrant subsectors in cancer medicine in recent years – bispecific T-cell engagers and ADCs," said Warren Hosseinion, M.D., Chairman of the Voyager Board of Directors prior to the Closing of the Business Combination and a current member of the VERAXA Board of Directors. "In VERAXA, we have found a unique opportunity to fulfill Voyager’s mission of scaling a transformational approach in the healthcare industry toward clinical readiness and market approval."

About the Business Combination

On April 22, 2025, VERAXA entered into a definitive business combination agreement (the "Business Combination Agreement") with Voyager Acquisition Corp., a Cayman Islands exempted company and special purpose acquisition company targeting the healthcare sector (NASDAQ: VACH, "Voyager"). Upon closing of the Business Combination, the combined company is expected to become a publicly traded company listed on NASDAQ trading under the symbol "VRXA".

The description of the Business Combination contained herein is only a high-level summary and is qualified in its entirety by reference to the underlying documents filed with the Securities and Exchange Commission (the "SEC"). A more detailed description of the terms of the transaction has been provided in a proxy statement/prospectus filed with the SEC by Voyager on February 19, 2026.

(Press release, Veraxa Biotech, JUN 10, 2026, View Source [SID1234666555])