Is life -threatening (i.e., the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it was more severe), 3. Requires in-patient hospitalization or prolongation of existing hospitalization excluding that for pain management, disease staging/re -staging procedures, or catheter placement unless associated with other serious events, 4. Results in persistent or significant disability/incapacity, or 5. Is a congenital anomaly/birth defect. Important medical events t hat may not result in death, be life-threatening, or require hospitalization may be considered serious adverse drug events when, based on appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervent ion to prevent one of the outcomes listed above. Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 43 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page Disease Progression, or death as a result of disease progression, are not considered to be SAEs . However, if the progression of the underlying disease is greater than what would normally be expected as part of the natural course of the disease under study for the patient, or if the Investigator considers that there was a causal relationship between treatment with study drug or protocol design/procedures and the disease progression, then it must be reported as an SAE. 8.1.2.5 Reference Safety Information The Reference Safety Information (RSI), in the current, approved Investigator's Brochure, is a list of expected Serious Adverse Reactions which are classified using Preferred Terms (PTs) according to the Medical Dicti onary for Regulatory Activities (MedDRA). The RSI section will be used for assessing the expectedness of the study medication. 8.1.2.6 Pregnancy Any pregnancy detected during the study, or that occurs within 30 days after stopping study medication, must be report ed immediately to the Investigator. Pregnancy, in and of itself, is not regarded as an adverse event, unless there is suspicion that study medication may have interfered with the effectiveness of a contraceptive medication. If the patient becomes pregnant while on-study, the study drug should be immediately discontinued. Pregnancy information about a female patient or a female partner of a male patient should be reported immediately from the time the Investigator first becomes aware of a pregnancy or its ou tcome. This will be performed by the Investigator per instructions from the Sponsor , or its designee. Any pregnancy complication, spontaneous abortion, elective termination of a pregnancy for medical reasons, outcome of stillbirth, congenital anomaly/birth defect, or serious adverse event in the mother will be recorded as an SAE and will be reported as des cribed in Section 8.1.2.7 . 8.1.2.7 Reporting of Serious Adverse Events Adverse events classified as serious require expeditious handling and reporting to Sponsor’s monitoring CRO to comply with regulatory requirements. In general, reporting of Serious Adverse Events (SAEs) will begin at the time of first dosing on Cycle Day 1 ; however, SAEs occurring prior to first dosing may be reported if directly attributable to a study procedure. For any serious adverse event (SAE) that occurs while a patient is on-study; within 30 days of the last study drug administration, regardless of any opinion as to the relationship of the SAE to the study drug; or if any SAE that the Investigator feels is related to the study drug occurs later than 30 days after the last study drug administration, the Sponsor or it’s designee must be notified immed iately ( within 24 hours of becoming aware of the event ). 8.1.2.8 Safety Data Review 8.1.2.8.1 Safety Review Committee A Safety Review Committee (SRC ) comprises of 3 members – one Investigator , a representative from Heat Biologics and the Medical Monitor will evaluate the data obtained at each dose level including a review of all adverse events (serious and non -serious adverse events) as they are reported by the study site. The SRC will recomme nd whether the dose should be escalated as per protocol, revised to a lower level or Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 44 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page intermediate level, halted altogether or more patients are required at the same dose level to evaluate safety. If a DLT is observed already with the first patient treated in Cohort 1 , the SRC may suggest and approve dose de-escalation with at least 50% reduction of HS -130 an d HS-110 (dose level -1), depending on the nature of the reaction . Ad-hoc SRC meetings may be called for by both the SRC and Sponsor any time during th e study if DLTs are observed and/or new safety data warrants immediate action to the conduct of the trial (including events defined by the Study Stopping Criteria in Section 5.5). The conclusion of the SRC meeting will be documented in meeting minutes. The outcome of the SRC meeting will be communicated to all Investigators. 8.2 Efficacy Assessments Patient ’s disease st atus will be monitored by clinical and radiological assessment (CT scans or MRI) as per RECIST 1.1 1 criteria (Section 8.2.1 ). Patient response per RECIST 1.11 will be evaluated as complete response, partial response, stable disease, or progressive disease . For the purpose of this study, patients will be evaluated after every 8 -weeks ± 1-week from C1D1. In the event objective response (PR or CR) is noted, changes in tumor measurements must be confirmed by repeat assessments that should be performed at least 4 weeks after the criteria for response are first met. For stable disease (SD), follow -up measurements must meet the SD criteria at least 6 weeks after study entry. Response to immune therapies may occur after conventional determination of disease progression based on RECIST 1.1 1; therefore , at the I nvestigator’s discretion patients may continue to receive the HS-130/HS - 110 combination t reatment after progressive disease is first observed. 8.2.1 RECIST 1.1 Criteria 8.2.1.1 Definitions Response and progression will be evaluated in this study using the international criteria (version 1.1) proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee1. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST 1.11 criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term “evaluable” in reference to measurability will not be used because it does not provide additional meaning or accuracy. 8.2.1.2 Measurable Disease Measurable disease is de fined by the presence of at least one measurable lesion. Measurable lesions are defined as those that can be accurately measured in at least one dimension [longest diameter ( LD) in the plane of measurement to be recorded] with a minimum size of: • 10 mm by CT scan (CT scan slice thickness no greater than 5 mm) • 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non -measurable) • 20 mm by chest x -ray Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 45 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node must be ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness no greater than 5 mm). 8.2.1.3 Non-measurable Disease All other lesions (or sites of disease), including small lesions (longest diameter < 10 mm or pathological lymph nodes with ≥ 10 to < 15 mm short axis) are considered non -measurable disease. Lesions considered truly non -measurable include: leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmoni s, inflammatory breast disease, abdominal masses/abdominal organomegaly identified by physical exam and not followed by CT or MRI. Bone lesions, cystic lesions and lesions previously treated with local therapy must be considered as follows: Bone lesions: • Bone scan, PET scan or plain films are not considered adequate imaging techniques to measure bone lesions. However, these techniques can be used to confirm the presence or disappearance of bone lesions. • Lytic bone lesions or mixed lytic -blastic lesions, with identifiable soft tissue components, that can be evaluated by cross sectional imaging techniques (i.e., CT or MRI) can be considered as measurable lesions if the soft tissue component meets the definition of measurability described above. • Blastic bone lesions are non -measurable. Cystic lesions: • Lesions that meet the criteria for radiographically defined simple cysts should not be considered malignant lesions (neither measurable nor non -measurable) since they are, by definition, simple cysts. • ‘Cystic lesions’ thought to represent cystic metastases can be considered measurable lesions, if they meet the definition of measurability described above. However, if non -cystic lesions are present in the same patient, these are preferred for selection as target lesions. Lesions with prior local treatment: • Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco - regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion. 8.2.1.4 Target Lesions All measurable lesions up to a maximum of two lesions per organ and five lesions in total, representative of all involved organs, should be identified as target lesions and recorded and measured at baseline. Target lesions shou ld be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target lesions will be calculated and reported as the baseline sum diameters. The baseline sum diameters will be used as reference by which to characterize the objective tumor response. Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 46 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page 8.2.1.5 Lymph Node Assessment For lymph nodes, measurements should be made of the short axis, which is defined as perpendicular to the LD of node assessed in the plane of measurement: • Target lesion if short axis ≥ 15 mm • Non -target lesion if short axis is ≥ 10 but < 15 mm • Normal if short axis < 10 mm For baseline, add the actual short axis measurement to the sum of LD of non -nodal lesions. 8.2.1.6 Non-target Lesions All other lesions (or sites of disease) including pathological lymph nodes should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required and these lesions should be followed as “present,” “absent,” or in rare cases “unequivocal progression.” In addition, it is possible to record multiple non -target lesions involving the same organ as a single item on the case report form (e.g., ‘multiple enlarged pelvic lymph nodes’ or ‘multiple liver met astases’). 8.2.1.7 Guidelines for Evaluation of Measurable Disease All measurements should be taken and recorded in metric notation using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of the treatment. Target lesions located in a previously irradiated areas should if possible be avoided, but such lesions may be designated as target lesions if clearly progressing (by RECIST 1.1 1 definition) at the latest evaluation prior to screening. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow -up. Imaging- based evaluation is preferred to evaluation by clinical examination when both methods have been used to assess the antitumor effect of a treatment. Clinical lesions. Clinical lesions will only be considered measurable when they are superficial and ≥ 10 mm diameter as assessed using calipers (e.g., skin nodules). In the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended. W hen lesions can be evaluated by both clinical exam and imaging, imaging evaluation should be undertaken since it is more objective and may be reviewed at the end of the study. Chest x -ray. Chest CT is preferred over chest x -ray, particularly when progress ion is an important endpoint. Lesions on chest x-ray may be considered measurable if they are clearly defined and surrounded by aerated lung. Conventional CT and MRI. This guideline has defined measurability of lesions on CT scan based on the assumptio n that CT slice thickness is 5 mm or less. When CT scans have slice thickness > 5 mm, the minimum size for a measurable lesion should be twice the slice thickness. MRI is acceptable in certain situations (e.g., for body scans). Ultrasound (US). US should not be used to measure tumor lesions. US examinations cannot be reproduced in their entirety for independent review at a later date because they are operator dependent. If new Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 47 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page lesions are identified by US, confirmation by CT or MRI is advised. If there i s concern about radiation exposure at CT, MRI may be used instead of CT. 8.2.1.8 Response Criteria 8.2.1.8.1 Evaluation of Target Lesions Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non -target) must have red uction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolut e increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. 8.2.1.8.2 Assessment of Target Lymph Nodes Lymph nodes identified as target lesions should always have the actual short axis measurement recorded (measured in the same anatomical plane as the baseline exam), even if the nodes regress to bel ow 10 mm on study. In order to qualify for CR, each node must achieve a short axis < 10 mm. For PR, SD and PD, the actual short axis measurement of the nodes is to be included in the sum of target lesions. 8.2.1.8.3 Target Lesions that Become “too small to measure ” All lesions (nodal and non -nodal) recorded at baseline should have their actual measurements recorded at each subsequent evaluation, even when very small (e.g., 2 mm). If it is the opinion of the radiologist that the lesion has disappeared, the measurement should be recorded as 0 mm. If the lesion is believed to be present and is faintly seen but too small to measure, a default value of 5 mm should be assigned. 8.2.1.8.4 Lesions that Split or Coalesce on Treatment When non -nodal lesions fragment, the longest diameters of the fragmented portions should be added together to calculate the target lesion sum. Similarly, as lesions coalesce, a plane between them may be maintained that would aid in obtaining diameter measurements of each individual lesion. If the lesions have truly coalesced such that they are no longer separable, the vector of the longest diameter should be the maximal longest diameter for the ‘coalesced lesion.’ Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 48 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page 8.2.1.8.5 Evaluation of Non-target Lesions Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non -pathological in size (< 10 mm short axis). Non -CR/Non -PD: Persistence of one or more non -target lesion(s) and/or maintenance of tumor marker level above the normal li mits. Progressive Disease (PD): Unequivocal progression of existing non -target lesions. (The appearance of one or more new lesions is also considered progression.) To achieve ‘unequivocal progression’ on the basis of the non -target disease, there must be an overall level of substantial worsening in non - target disease such that, even in the presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation. 8.2.1.8.6 New Lesions The finding of a new lesion should be unequivocal (i.e., not attributed to differences in scanning technique, change in imaging modality, or findings thought to represent something other than tumor, such as a ‘new’ healing bone lesion). A lesion identified on a follow -up study in an anatomica l location that was not scanned at baseline is considered a new lesion and will indicate disease progression. If a new lesion is equivocal, continued therapy and follow -up evaluation will clarify if it represents truly new disease. If repeat scans confir m this is definitely a new lesion, then progression should be declared using the date of the initial scan. 8.2.1.9 Evaluation of Best Overall Response The best overall response is the best response recorded from the start of the treatment until disease progressio n/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient’s best overall response assignment will depend on findings of both target and non -target disease and will also take into consideration the appearance of new lesions. Furthermore, depending on the nature of the study, it may also require confirmatory measurement. Specifically, in non-randomized trials where response is the primary endpoint, confirmation of PR or CR is needed to deem either one the “best overall response.” It is assumed that at each protocol -specified time point, a response assessment occurs ( Table 4) provides a summary of the overall response status calculation at each time point for patients who have measurable disease at baseline. When patient s have non -measurable disease, ( Table 5) should be used. Table 4: Time point response: Patients with target (+/ - non- target) disease Target Lesions Non -target Lesions New Lesions Overall Response CR CR No CR CR Non -CR / non-PD No PR CR Not evaluated No PR PR Non -PD or not all evaluated No PR SD Non -PD or not all evaluated No SD Not all evaluated Non -PD No NE Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 49 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page PD Any Yes or No PD Any PD Yes or No PD Any Any Yes PD CR=complete response, PR=partial response, SD=stable disease PD=progressive disease, NE=inevaluable Table 5: Time point response: Patients with non -target disease only Non -target Lesions New Lesions Overall Response CR No CR Non -CR / non -PD No Non -CR / non -PD* Not all evaluated No NE Unequivocal PD Yes or No PD Any Yes PD CR=complete response; PD=progressive disease; NE=inevaluable * Non -CR/non -PD is preferred over SD for non -target disease Best response determination for studies where confirmation of CR or PR is required: Complete or partial responses may be claimed only if the criteria for each are confirmed by a repeat assessment at least 4 -weeks later . In this circumstance, the best overall res ponse can be interpreted as in (Table 6). Table 6: Best overall response when confirmation of CR and PR required Overall response First time point Overall response Subsequent time point BEST overall response CR CR CR CR PR SD, PD or PR* CR SD SD provided minimum criteria for SD duration met, otherwise PD CR PD SD provided minimum criteria for SD duration met, otherwise PD CR NE SD provided minimum criteria for SD duration met, otherwise NE PR CR PR PR PR PR PR SD SD PR PD SD provided minimum criteria for SD duration met, otherwise PD PR NE SD provided minimum criteria for SD duration met, otherwise NE NE NE NE CR=complete response; PR=partial response; SD=stable disease; PD=progressive disease; NE=inevaluable * If CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR). Best response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed when subsequent scans suggest small lesions were likely still present and in the fact patient had PR, not CR, at the first time point. Under these circumstances, the original CR should be changed to PR and the best response is PR. Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 50 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page 8.2.1.10 Confirmatory Measurement/Duration of Response 8.2.1.10.1 Confirmation To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed at least 4 weeks after the criteria for response are first met . In the case of SD, follow -up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-week s. 8.2.1.10.2 Duration of Overall Response The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented. 8.2.1.10.3 Duration of Stable Disease Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started. 8.3 Best Overall Response The best overall response is the best response (CR, PR, SD) recorded from the start of the study treatment until disease progression/recurrence , taking into account any requirement for confirmation . 8.4 Overall Survival (OS) OS will be calculated as the duration of survival from the date of first HS- 130/ HS-110 combination treatment until the date of death from any cause. If the date of death is not available, OS will be censored at the date the patient was last known to be alive. 8.5 Progression-f ree Survival (PFS) Progression -free survival (PFS) is defined for each patient as the time from date of first HS-130/ HS-110 combination treatment to the date of the first documented tumor progression (per RECIST 1.1 1) or death due to any cause. Patients who die without a reported prior progression will be considered to have progressed on the date of their death. Patients who did not progress or die will be censored on the date of their last evaluable tumor assessment. Patients who started any subsequent anticancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to the initiation of the subsequent anticancer therapy. 8.6 Analysis of Immune Response Approximately 23 mL of blood will be collected on Day 1 ( prior to administration of HS130/HS110) and Day 8 of Cycle 1 and Cycle 2, and at 30 -day safety follow-up visit for the following immune response assessments. Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 51 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page 8.6.1 Analysis of Immunological Effect Immune-phenotyping of patient’s peripheral b lood sample will be performed by flow cytometry , which may include but is not limited to surface and intracellular markers that define naïve T cells (CD4 and CD8), central memory T cells (CD4 and CD8), effector T cells (CD4 and CD8) , memory T cells (CD4 and CD8), senescent T cells (cytotoxic and helper ), terminal differentiated senescent T cells ( cytotoxic and helper), natural killer ( NK) cells, natural ki ller T cells ( NKT) , T regulatory cells, proliferative T regulatory cells, activated T cells (helper and cytotoxic), proliferative T cells (helper and cytotoxic), T cell markers of exhaustion (helper and cytotoxic; CTLA -4, PD -1, TIGIT, TIM3). Immune pheno type profiling to determine proportions of NK and T cell subsets for levels of activation, memory and exhaustion will be performed from blood samples collected on Day 1 ( prior to administration of HS130/HS110) and Day 8 for Cycle 1 and Cycle 2 , and at 30-day safety follow-up visit . The goal of this analysis will be to establish an immunologically active clinical dose for the combination of HS-130 and HS - 110. 8.6.2 Immune Reactivation Response Immune reactivation response to CTA expressed in HS -110 will be e valuated by determining antigen - induced secretion of cytokines IFNγ, granzyme B (gzB) from patients PBMCs via ELISPOT from blood samples collected Day 1 ( pre-dose) and Day 8 for Cycle 1 and Cycle 2 and at 30 -day safety follow-up visit . Number of cells resp onding over the course of treatment after subtraction of appropriate patient controls will be calculated. 8.7 Analysis of Pro -inflammatory Cytokines and Chemokines Approximately 3 mL of b lood samples will be collected at the following time-points during Day 1 of C ycle 1 and C ycle 2 for determination of serum cytokines and chemokines using an extensive panel of markers that may include but is not limited to, G -CSF, GM -CSF, IFN -gamma, IFN-alpha, IL -1alpha, IL -1beta, IL -2, IL - 3, IL-4, IL -5, IL-6, IL -7, IL -8, IL-9, IL -10, IL -12p40, IL-13, IL-15/15R, IL -17A, IL-18, IL -22, IL-23, IL- 27, IL-28, IL- 31, IP -10/CXCL10, LIF, MCP-3/CCL7, M -CSF, MIP -1alpha/CCL3, MIP-1beta/CCL4, MIP-2/CXCL2, RANTES/CCL5, TNFalpha, ENA78/CXCL5, and Eotaxin -1/CCL11 . • Day 1: Prior to administration of HS130/HS110 • Day 1: 2hr ± 10 minutes after completion of HS130/HS110 treatment For Cycle 3 and beyond cytokine/chemokine testing will only be performed if the patient is symptomatic (i.e. flu-like symptoms, fever, or allergic reactions) . 8.8 Bioinformatics Analysis of CTAs and Shared Antigen Expression Archival tissue from patients will be sent for bioinformatics analysis (e.g. RNA sequencing) of overexpressed CTAs and to study shared antigen expression with HS -110. 8.9 Exploratory Biomarkers Biopsy samples will be collected from patients during screening/baseline and within 5 -14 days after patients have completed second dose of treatment with the HS- 130/HS -110 combination drug product. Archival tissue may be substituted for fresh biopsy during screening/baseline, if collecte d less than 6 - Heat Biologics Protocol No. HS130 -001 A Phase I Study of HS -130 in combination with HS-110 in patients with solid tumors HS130- 001 52 of 60 Version 2.0 - 11 Feb 2020 Confidential - Entire Page months prior to Cycle 1 D ay 1 and the local pathologist confirms that an adequate amount of tissue/tumor cells exist to allow completion of all testing as outlined in the Tumor Biopsy Collection Manual . Biopsies should only be collected from lesions considered safely accessible, either image -guided or palpable cutaneous or sub -cutaneous lesions. For patients on continuous anticoagulant therapy, study - specific biopsies should not be done unless local guidelines to mitigate the risk of hemorrhage are followed and the procedure can be done with minimal risk for the patient . Genomic , immunohistochemistry and proteomic analyses of the collected tumor tissue may be performed to identify biomar kers predictive of response or resistance to HS-110/HS -130, for example by multiplex immunohistochemistry ( mIHC). Immunohistochemistry analysis using multiplexed immune markers on the collected on-treatment biopsy and could be compared to baseline biopsy to study effect of HS -110/HS - 130 combination treatment on patient tumors and could be correlated with clinical response . This exploratory analysis could change in line with scientific understanding and technical development as the clinical study progresses.