A Phase 2 interventional study of AMB-05X in Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis (PVNS), sponsored by AmMax Bio, Inc.. Completed at 6 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by AmMax Bio, Inc. · Phase 2, Interventional, and Treatment
AMB-051-01 is a multicenter study with an adaptive design that will enroll subjects with Tenosynovial Giant Cell Tumor (TGCT) of the knee for 12 weeks of multiple-dose, open-label treatment with intra-articular AMB-05X.
AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R). Study
20 studies on the registry are indexed under Synovitis, Pigmented Villonodular; 2 are open to participants now.
This study's enrollment of 11 is below the median of 36 across 17 interventional studies indexed under Synovitis, Pigmented Villonodular.
Browse Synovitis, Pigmented Villonodular studies →AmMax Bio, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Compared within Synovitis, Pigmented Villonodular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Giant Cell Tumor of Tendon Sheath. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive an intra-articular injection of AMB-05X once every 2 weeks for 12 weeks (for 6 treatments total).
Biological: AMB-05X
AMB-05X is a fully human antibody antagonist (immunoglobulin G, type 2 \[IgG2\]) specific to the extracellular domain of human CSF1R
Number of Participants With Treatment-emergent Adverse Events
Frequency and severity of reported treatment-emergent adverse events
Time frame: 24 weeks
Tumor Response Based on RECIST Version 1.1
Proportion of subjects who achieve an overall tumor response (Objective Response or OR) per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 at week 12, Objective Response is defined as complete response \[CR\] and partial response \[PR\]) per RECIST v1.1 (Eisenhauer 2009) at Week 12. Complete response: disappearance of all target lesions; Partial Response: \>/=30% decrease in the sum of diameters of target lesions.
Time frame: Week 12
Tumor Response Based on Tumor Volume (TV)
Proportion of subjects with overall response based on tumor volume: Complete response (CR): lesion is completely gone; Partial response (PR): \>/=50% decrease in tumor volume relative to baseline; Progressive disease (PD): \>/=30% increase in tumor volume relative to the lowest volume during the study; Stable disease (SD): does not meet any of the other classifications. Tumor response based on tumor volume score ("TVS") is defined as CR or PR.
Time frame: Week 12
Mean Change From Baseline in Range of Motion (ROM): Flexion
ROM of the joint will be assessed by qualified assessors. Measurements will be recorded in degrees. At baseline, the plane of movement with the smallest (worst) relative value will be identified; only this plane will be used for evaluating change in ROM subsequently.
Time frame: Week 12
Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score
The PROMIS Physical Function Scale will be used to assess physical function. The scale incudes 10 questions, with scores that range from 1 to 5, where higher scores represent better outcomes. Five questions address the degree to which the subject's health limits certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("not at all"). Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("without any difficulty"). The score range for the PROMIS is 10 to 50, with higher scores indicated worse physical function.
Time frame: Week 12
Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score
The Worst Stiffness NRS is a 1-item, self-administered questionnaire assessing the "worst" stiffness within the last 24 hours. The NRS for this item ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).
Time frame: Week 12
Mean Change From Baseline in the Brief Pain Inventory (BPI) Pain Interference Index Score
Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10, where higher scores mean more pain interference. The reported score is the mean of the seven interference items.
Time frame: Week 12
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment
EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a widely used quality of life instrument that includes questions in each of 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by selecting the most appropriate statement in each of the five dimensions. Individual scores range from 1 to 5. The EQ-5D-5L scale score is the sum of the 5 individual EQ-5D-5L scores collected and ranges from 5 to 25. Lower scores represent a better quality of life.
Time frame: Week 12
Percentage of Subjects Who Respond With a Decrease of at Least 30% in Mean Brief Pain Inventory (BPI) Score
The BPI Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning.
Time frame: week 12
Serum Colony Stimulating Factor 1 (CSF1) Levels
Serum CSF1 levels will be analyzed as a biomarker.
Time frame: week 10
Serum AMB-05X Levels
Serum AMB-05X concentrations will be measured at Week 0 (pre-dose and 2 hours after the first dose), Week 2 (pre-dose \[trough\]), and Week 10 during steady state (including pre-dose \[trough\] and 2 hour after the last dose).
Time frame: week 10
Serum Anti-AMB-05X Antibody Levels
Anti-drug antibody (ADA) analysis will also be performed on select serum samples.
Time frame: week 10
Synovial Fluid CSF1
Measurement of CSF1 in synovial fluid (pharmacodynamic marker)
Time frame: Week 10
Synovial AMB-05X Levels
Synovial AMB-05X concentrations will be measured at Weeks 0, 2, 4, 6, 8, and 10 (all at pre-dose \[trough\]).
Time frame: Week 10
Synovial Anti-AMB-05X Antibody (ADA) Levels
Anti-drug antibody (ADA) analysis will also be performed on select synovial samples.
Time frame: Week 10
Proportions of Subjects Who Achieved Objective Response as Their Best Overall Tumor Response, Per Modified Response Evaluation Criteria in Solid Tumors (RECIST).
Objective response was measured using the modified Response Evaluation Criteria in Solid Tumors (RECIST), which requires \>/=30% reduction in the sum of short-axis diameters of 2 target lesions.
Time frame: 12 Weeks
| Milestone | AMB-05X High Dose | ABM-05X Low Dose |
|---|---|---|
| Started | 8 | 3 |
| Completed | 6 | 3 |
| Not completed | 2 | 0 |
Frequency and severity of reported treatment-emergent adverse events
| Participants | AMB-05X - High Dose | AMB-05X Low Dose |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events | 7 | 2 |
Proportion of subjects who achieve an overall tumor response (Objective Response or OR) per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 at week 12, Objective Response is defined as complete response \[CR\] and partial response \[PR\]) per RECIST v1.1 (Eisenhauer 2009) at Week 12. Complete response: disappearance of all target lesions; Partial Response: \>/=30% decrease in the sum of diameters of target lesions.
| Participants | AMB-05X High Dose | ABM-05X Low Dose |
|---|---|---|
| Tumor Response Based on RECIST Version 1.1 | 3 | 1 |
Proportion of subjects with overall response based on tumor volume: Complete response (CR): lesion is completely gone; Partial response (PR): \>/=50% decrease in tumor volume relative to baseline; Progressive disease (PD): \>/=30% increase in tumor volume relative to the lowest volume during the study; Stable disease (SD): does not meet any of the other classifications. Tumor response based on tumor volume score ("TVS") is defined as CR or PR.
| Participants | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Tumor Response Based on Tumor Volume (TV) | 2 | 1 |
ROM of the joint will be assessed by qualified assessors. Measurements will be recorded in degrees. At baseline, the plane of movement with the smallest (worst) relative value will be identified; only this plane will be used for evaluating change in ROM subsequently.
| degrees | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Mean Change From Baseline in Range of Motion (ROM): Flexion | 7.1 ± 16.3 | 3.3 ± 24.7 |
The PROMIS Physical Function Scale will be used to assess physical function. The scale incudes 10 questions, with scores that range from 1 to 5, where higher scores represent better outcomes. Five questions address the degree to which the subject's health limits certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("not at all"). Five additional questions address the degree to which the subject is able to perform certain physical activities, and subjects select a response to each question that ranges from 1 ("cannot do") to 5 ("without any difficulty"). The score range for the PROMIS is 10 to 50, with higher scores indicated worse physical function.
| score on a scale | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Mean Change From Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score | 6.7 ± 6.7 | 8.7 ± 5.0 |
The Worst Stiffness NRS is a 1-item, self-administered questionnaire assessing the "worst" stiffness within the last 24 hours. The NRS for this item ranges from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).
| score on a scale | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Mean Change From Baseline in Worst Stiffness Numeric Rating Scale (NRS) Score | -2.4 ± 4.4 | -2.3 ± 1.5 |
Brief Pain Inventory (BPI) Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. The subject is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a scale from 0 to 10, where higher scores mean more pain interference. The reported score is the mean of the seven interference items.
| score on a scale | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Mean Change From Baseline in the Brief Pain Inventory (BPI) Pain Interference Index Score | -2.8 ± 3.2 | -2.6 ± 1.8 |
EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a widely used quality of life instrument that includes questions in each of 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by selecting the most appropriate statement in each of the five dimensions. Individual scores range from 1 to 5. The EQ-5D-5L scale score is the sum of the 5 individual EQ-5D-5L scores collected and ranges from 5 to 25. Lower scores represent a better quality of life.
| score on a scale | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| EuroQol 5 Dimension 5 Level (EQ-5D-5L) Health Assessment | -0.9 ± 1.5 | -0.7 ± 1.5 |
The BPI Short Form is a self-administered questionnaire used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning.
| Participants | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Percentage of Subjects Who Respond With a Decrease of at Least 30% in Mean Brief Pain Inventory (BPI) Score | 5 | 2 |
Serum CSF1 levels will be analyzed as a biomarker.
| pg/mL | AMB-05X - Low Dose | AMB-05X - High Dose |
|---|---|---|
| Serum Colony Stimulating Factor 1 (CSF1) Levels | 503 ± 725 | 1030 ± 301 |
Serum AMB-05X concentrations will be measured at Week 0 (pre-dose and 2 hours after the first dose), Week 2 (pre-dose \[trough\]), and Week 10 during steady state (including pre-dose \[trough\] and 2 hour after the last dose).
| ug/ml | AMB-05X - Low Dose | AMB-05X - High Dose |
|---|---|---|
| Serum AMB-05X Levels | 2.1 ± 3.2 | 33.0 ± 31.5 |
Anti-drug antibody (ADA) analysis will also be performed on select serum samples.
| Participants | AMB-05X - Low Dose | AMB-05X - High Dose |
|---|---|---|
| Pts ADA positive at any visit analyzed | 0 | 0 |
| Pts ADA negative at all visits analyzed | 3 | 8 |
Measurement of CSF1 in synovial fluid (pharmacodynamic marker)
| ng/ml | AMB-05X - Low Dose | AMB-05X - High Dose |
|---|---|---|
| Synovial Fluid CSF1 | 37.1 ± NA | 22.6 ± 3.1 |
Synovial AMB-05X concentrations will be measured at Weeks 0, 2, 4, 6, 8, and 10 (all at pre-dose \[trough\]).
| ug/ml | AMB-05X - Low Dose | AMB-05X - High Dose |
|---|---|---|
| Synovial AMB-05X Levels | 36.3 ± NA | 153 ± 138 |
Anti-drug antibody (ADA) analysis will also be performed on select synovial samples.
| participants | AMB-05X - Low Dose | AMB-05X - High Dose |
|---|---|---|
| Pts ADA positive at any visit analyzed | 1 | 0 |
| Pts ADA negative at all visits analyzed | 2 | 8 |
Objective response was measured using the modified Response Evaluation Criteria in Solid Tumors (RECIST), which requires \>/=30% reduction in the sum of short-axis diameters of 2 target lesions.
| Participants | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| Proportions of Subjects Who Achieved Objective Response as Their Best Overall Tumor Response, Per Modified Response Evaluation Criteria in Solid Tumors (RECIST). | 4 | 1 |
Collected over up to 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AMB-05X High Dose | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| AMB-05X Low Dose | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | AMB-05X High Dose | AMB-05X Low Dose |
|---|---|---|
| periorbital edemaEye disorders | 5/8 | 0/3 |
| FatigueGeneral disorders | 4/8 | 1/3 |
| Face EdemaGeneral disorders | 4/8 | 0/3 |
| arthralgiaMusculoskeletal and connective tissue disorders | 4/8 | 0/3 |
| rashSkin and subcutaneous tissue disorders | 4/8 | 0/3 |
| peripheral edemaGeneral disorders | 3/8 | 0/3 |
| pruritisSkin and subcutaneous tissue disorders | 2/8 | 1/3 |
| COVID-19Infections and infestations | 2/8 | 1/3 |
| hypertensionVascular disorders | 2/8 | 1/3 |
| localised edemaGeneral disorders | 2/8 | 0/3 |
Subjects with TGCT of the knee
| Age, Categorical(Participants) | AMB-05X Low Dose | AMB-05X High Dose | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 7 | 10 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | AMB-05X Low Dose | AMB-05X High Dose | Total |
|---|---|---|---|
| Female | 0 | 5 | 5 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | AMB-05X Low Dose | AMB-05X High Dose | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 2 | 3 |
| Unknown or Not Reported | 2 | 6 | 8 |
| Race (NIH/OMB)(Participants) | AMB-05X Low Dose | AMB-05X High Dose | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 6 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Anti-CSF1R Monoclonal Antibody AMB-05X
Synovitis, Pigmented Villonodular →
AmMax Bio, Inc.