On June 1, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it has held its pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") for surufatinib for the treatment of patients with advanced neuroendocrine tumors ("NET") (Press release, Hutchison China MediTech, JUN 1, 2020, View Source [SID1234558780]). Chi-Med has reached an agreement with the FDA that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a U.S. NDA submission.

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The FDA granted Fast Track Designation status to surufatinib for the non-pancreatic and pancreatic NET development programs in April 2020. Chi-Med has initiated preparatory work for the U.S. NDA and intends to utilize a rolling submission under Fast Track Designation Status. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. Filing acceptance of the NDA is subject to FDA review of the complete application. The planned start of the NDA submission is late 2020.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

Chi-Med currently retains all rights to surufatinib worldwide.

NET in the U.S., Europe and Japan: In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019. A U.S. FDA NDA submission is being prepared. Regulatory interactions in Europe and Japan are also underway to confirm the clinical development strategy and potential path to registration. All such interactions are based on the robust data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. that began in November 2015 (clinicaltrials.gov identifier: NCT02549937).

Non-pancreatic neuroendocrine tumors in China: In November 2019, a NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in patients with advanced non-pancreatic neuroendocrine tumors in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the Independent Data Monitoring Committee ("IDMC") to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress (clinicaltrials.gov identifier: NCT02588170).

Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission, following an interim analysis review conducted in January 2020 by the IDMC that recommended the registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821). Study results will be submitted for presentation at an upcoming scientific conference.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi (toripalimab) and Tyvyt (sintilimab), which are approved in China.

On June 1, 2020 Synlogic, Inc., (Nasdaq: SYBX) a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported the publication in Nature Communications of preclinical data supporting its first clinical immuno-oncology program, SYNB1891, which is being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors or lymphoma (Press release, Synlogic, JUN 1, 2020, View Source [SID1234558779]). Data described in the publication demonstrate that SYNB1891 treatment cleared tumors and stimulated antitumor immunity in preclinical models of cancer.

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"The targeted delivery and dual immune stimulatory activity of SYNB1891 offer distinct advantages over other approaches," said Aoife Brennan, M.B., Ch. B., Synlogic’s president and chief executive officer. "The preclinical data published today highlight the transformative potential of SYNB1891. Together with the early experience in the clinic demonstrating feasibility and tolerability in the initial cohorts of the clinical trial, these data provide support for the continued development of SYNB1891 as a potential therapeutic option to expand the benefits of immunotherapy to more patients with cancer."

The publication titled, "Immunotherapy with an engineered bacteria by targeting the STING pathway for anti-tumor immunity," details the engineering and characterization of SYNB1891. The work describes preclinical studies that demonstrate anti-tumor activity and generation of immunological memory by SYNB1891 in mouse models of cancer, as well as its robust activation of human antigen presenting cells (APCs) that are key to the generation of an anti-tumoral immune response.

SYNB1891 is an engineered strain of E. coli Nissle, that produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator of INterferon Genes) pathway. This mechanism can play a critical role in the initiation of an anti-tumor immune response via activation of APCs and presentation of tumor antigens. The bacterial chassis of SYNB1891 also stimulates the innate immune system by several other mechanisms, including via Toll-like receptors (TLRs), potentially adding to the magnitude of the overall immune response. A notable advantage of SYNB1891 is that the STING agonist is not released by the bacteria until they have been engulfed by the target cells (APCs) and so there is less risk of deleterious effects on other immune cells such as T-cells. Also, while SYNB1891 has been engineered with safety features that are designed to prevent its replication unless supplemented with specific nutrients, the bacteria remain active for several days within the injected tumor to stimulate a local immune response.

Intra-tumorally administered SYNB1891 is being evaluated as a monotherapy in an ongoing Phase 1 open-label, multicenter, dose escalation clinical trial (NCT04167137) in patients with advanced solid tumors or lymphoma. Synlogic expects to release data from the monotherapy arm of this study in late 2020. After establishing a maximum tolerated dose for SYNB1891 as monotherapy, Synlogic expects to initiate a second arm of the trial in which subjects will receive escalating dose levels of SYNB1891 in combination with a fixed dose of the checkpoint inhibitor, atezolizumab (Tecentriq), to establish a recommended dose for the combination regimen.

The DOI for the paper is 10.1038/s41467-020-16602-0.

On June 1, 2020 AbbVie (NYSE:ABBV), a research-based global biopharmaceutical company, and Jacobio Pharmaceuticals, a clinical-stage pharmaceutical company, reported a global, strategic collaboration to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells (Press release, AbbVie, JUN 1, 2020, View Source [SID1234558778]).

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SHP2 is an important protein mediator of cellular signaling through RAS/MAP kinase pathway. Many tumors have genetic mutations, driving abnormal cancer cell growth which relies on SHP2 activity. SHP2 also plays a key role to control cytokine production and immune cell response. Therefore, inhibition of SHP2 is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities. Jacobio’s early clinical stage SHP2 assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity.

"Identifying promising new targeted approaches for solid tumor patients is a high priority for us," said Mohit Trikha, Ph.D., vice president and head, early development oncology and Bay Area site head, AbbVie. "Jacobio’s SHP2 program has the potential to treat cancer patients across many tumor types. By targeting a key node in both cancer and immune cell signaling pathways, SHP2 inhibition, both as a monotherapy and potentially in combination with other agents, may rapidly advance new treatment options for cancer patients."

"We are excited to expand our efforts in global development of delivering breakthrough innovation to not just Chinese, but global patients with cancer," said Yinxiang Wang, Ph.D., CEO and Chairman, Jacobio. "We look forward to a productive collaboration with AbbVie focused on rapidly advancing this novel SHP2 first-in-class therapy as a new approach for multiple cancer types. I am confident that this partnership will strengthen our R&D capabilities and ultimately bring benefits to cancer patients."

Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to conduct early global clinical trials of JAB-3068 and JAB-3312 with AbbVie covering R&D expenses. Upon completion, AbbVie will assume global development and commercialization responsibilities. Jacobio has an option, exercisable before the initiation of registrational trials, to exclusively develop and commercialize the SHP2 program in mainland China, Hong Kong, and Macau. Financial terms were not disclosed and the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

On June 1, 2020 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that patients in the OCEAN study stay on treatment longer than previously estimated (Press release, Oncopeptides, JUN 1, 2020, View Source [SID1234558777]). As a consequence, top-line results are estimated for H1 2021 instead of previously communicated Q4 2020. Patient recruitment in OCEAN will remain open to ensure that the 339 disease progression events needed to complete the study can be reached within a reasonable timeframe.

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OCEAN is a randomized, comparative study between melflufen and pomalidomide in patients with relapsed refractory multiple myeloma (RRMM). The patients enrolled in the study have previously been treated with at least an immunomodulator (IMiD) and a proteasome inhibitor (PI) and have all developed resistance to their last line of therapy and to lenalidomide (IMiD), the most commonly used drug for the treatment of multiple myeloma. The primary endpoint of the phase 3 study is Progression Free Survival (PFS). The results will be evaluated once 339 patients have progressed in their disease.

"A recent analysis indicates that patients enrolled in the OCEAN-study continue treatment for a longer period of time than originally estimated, which speaks to the potential benefit patients can have by participating in this trial", says Jakob Lindberg, CEO of Oncopeptides. "However, this most likely increases the time required to reach the number of disease progression events needed to complete the study. We will continue patient enrollment to enable an analysis of results within a reasonable timeframe."

Oncopeptides is preparing an application for accelerated approval in Q2 2020 based on the results from the ongoing pivotal phase 2 study HORIZON, evaluating melflufen in RRMM patients. Data from the pivotal phase 3 study OCEAN, will form the basis for a submission of a supplemental New Drug Application (sNDA) to the US FDA in H2 2021, followed by a submission of a Marketing Authorization Application (MAA) in Europe.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on June 1, 2020 at 08.00 (CET).

About melflufen
Melflufen (melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

On May 31, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the company presented four posters of the latest clinical data on three of its drug candidates, including the MDM2-p53 inhibitor APG-115, novel Bcl-2/Bcl-xL dual inhibitor palcitoclax or APG-1252, and IAP inhibitor APG-1387, at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO20) (Press release, Ascentage Pharma, MAY 31, 2020, View Source [SID1234558754]).

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As a globally focused biotech company, Ascentage Pharma showcased the research advances of its drug candidates at ASCO (Free ASCO Whitepaper) for the third consecutive year and attracted global attention.

"In this Phase Ib study, the novel IAP antagonist APG-1387 was combined safely with pembrolizumab with a manageable adverse event profile. This represents an important milestone in the continued development of APG-1387," said Drew W. Rasco, MD, Associate Director of Clinical Research at the START Center for Cancer Care in San Antonio. "Furthermore, we observed some encouraging signs of clinical activity, which warrants further evaluation in specific patient populations, including microsatellite-stable colorectal cancer [CRC] and non-small-cell lung cancer [NSCLC]."

"Palcitoclax [APG-1252] is a novel and potent inhibitor of the Bcl-2 family of proteins and induces apoptosis in tumor cells. In the first-in-human Phase I trial in the U.S., palcitoclax has demonstrated safety and tolerability as well as preliminary evidence of efficacy in patients with solid tumors," said Nehal Lakhani, MD, PhD, START Center for Cancer Care（START Midwest）. "It also demonstrates predictable pharmacokinetics ideal for a new molecular entity. Given the promising evidence of safety and efficacy in the Phase I trial, further evaluation of efficacy in select solid tumors is warranted."

"Advanced liposarcoma is a common histological type of malignant soft-tissue sarcoma with poor prognosis and high recurrence rate, and there is lack of effective treatment options currently. APG-115 is a highly potent MDM2-p53 inhibitor, and our data on liposarcoma presented in last year’s ASCO (Free ASCO Whitepaper) report were promising," said Prof. Xing Zhang, Chief Physician of Melanoma and Sarcoma Medical Oncology Unit of Sun Yat-sen University Cancer Center. "In the updated data, a safety expansion at the 100-mg dose level was performed, and the recommended phase II dose [RP2D] was determined as 100 mg. These results support our previous findings that wild-type TP53 is a predictive biomarker of response to APG-115, and liposarcoma may be one of its potential target tumor types. We also look forward to more clinical studies and molecular biological evidence of APG-115."

"Through the showcase at ASCO (Free ASCO Whitepaper), Ascentage Pharma is demonstrating its capabilities of global clinical development in apoptosis. The initial data with our drug candidates, including MDM2-p53 inhibitor APG-115, novel Bcl-2/Bcl-xL dual inhibitor palcitoclax or APG-1252, and IAP inhibitor APG-1387, support further study with great potential in combination therapies," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We will accelerate our clinical development programs, hoping to offer more treatment options for cancer patients with unmet medical needs."

Phase Ib study of a novel, small-molecule MDM2 inhibitor
APG-115 combined with pembrolizumab in U.S. patients with metastatic solid tumors
Abstract：#3512

APG-115-US-002 is an open-label, multi-center, Phase Ib/II study in U.S. , which was designed to assess safety, toxicity, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of APG-115 in combination with pembrolizumab in patients with advanced solid tumors. The Phase Ib dose-escalation study has been completed, and the Phase II is ongoing. The poster only reports the Phase Ib results.
As of April 1, 2020, in the Phase Ib study, 19 patients were treated with
APG-115 in 4 alternate-day (QOD) dose cohorts (50 mg, 100 mg, 150 mg, and 200 mg) in combination with pembrolizumab. No dose-limiting toxicities (DLTs) were observed. The maximum tolerated dose (MTD) was not reached, and the recommended Phase II dose (RP2D) of APG-115 combined with pembrolizumab was determined as 150 mg QOD according to safety data.
APG-115 in combination with pembrolizumab was generally tolerated. The most common treatment related adverse events (TRAEs) (>10%) included: nausea, fatigue, platelet count decreased, appetite decreased, vomiting, neutrophil count decreased, diarrhea, hypothyroidism, etc.
Antitumor effects were observed among 18 efficacy evaluable patients, including one patient with a confirmed complete response (CR) lasting for 20 months (still ongoing). Two patients had confirmed partial response (PR) for 8 to 9 months: of these, one patient with NSCLC failed 3 months, nivolumab therapy and the other had immunotherapy-naïve appendix cancer; seven patients had stable disease (SD) for 1.5 to 7 months. The objective response rate (ORR) was 16.7%, and the disease control rate (DCR) was 55.5%. Details of the patient with CR follows:
White female, age 55 years, diagnosed with stage IIIc serous-cell ovarian carcinoma in 2014, which recurred (as stage IV) within 6 months after surgery and platinum-containing adjuvant chemotherapy and then progressed on doxorubicin, topotecan + bevacizumab, and XMT1536 (ADC targeting NaPi2b) multiple lines of antitumor therapy, but still progressed. However, the patient had a PR after receiving APG-115 and pembrolizumab for 4 cycles, CR after 8 cycles, then maintain CR, now in 25th cycle of treatment. This patient has a family history of malignancy, with blood genetic tests showing wild-type TP53, ATM germline mutation.
PK analyses showed that AUC and Cmax generally increased dose proportionally over the dose range of 50 to 200 mg. Combining APG-115 with pembrolizumab did not appear to affect the PK of APG-115. PD analyses showed an increase in serum MIC-1 (biomarker of TP53 activation) that was dose dependent within the APG-115 dose ranges (50-200 mg).
Conclusion: Safety and efficacy data from this Phase Ib study demonstrated that APG-115 in combination with pembrolizumab is promising. The Phase II study is ongoing in the cancer patients with specific biomarker profiling.

Phase Ib study of a novel bivalent IAP antagonist APG-1387 in combination of pembrolizumab for patients with advanced solid tumors
Abstract：#3508

APG-1387-US-001 is an open-label, two-part, Phase I (APG-1387 monotherapy) and Phase Ib (APG-1387 in combination with pembrolizumab) study in U.S. Previous Phase I study showed that the MTD of APG-1387 single agent was 45 mg IV once weekly, and DLTs included elevated lipase and facial nerve disorder. This poster reports only Phase Ib results, including the safety, tolerability and preliminary efficacy of APG-1387 + pembrolizumab in patients with advanced solid tumors.
Through April 1, 2020, 41 patients with various advanced solid tumors had been treated with APG-1387 in combination with pembrolizumab, including 10 patients in dose escalation: 20 mg (n=4), 30 mg (n=3), and 45 mg (n=3); and 31 patients in MTD dose expansion. No DLT was observed during dose escalation, and the MTD of APG-1387 was determined as 45 mg.
APG-1387 was generally well tolerated with manageable adverse events when used in combination with pembrolizumab. Most common TRAEs (≥10%) included fatigue, headache, nausea, and maculopapular rash. Facial nerve disorder was seen in 2 patients (4.9%), which was not higher than in the single-agent study.
Antitumor effects: among 37 efficacy evaluable patients, 4 patients had PR (2 NSCLC, 1 CRC, and 1 breast cancer) and 12 patients had SD; the overall ORR was 10.8%, and the DCR was 43.2%. The NSCLC cohort achieved 50% ORR and 100% DCR. The CRC cohort achieved 50% DCR with 1 PR and 3 durable SD.
Preliminary PK data of APG-1387 showed dose proportionality in exposure (Cmax and AUC) over the dose range of 20 to 45 mg.
APG-1387 treatment induced rapid and significant cIAP-1/XIAP suppression, suggesting a potential PD effect.
Conclusion：The efficacy and safety data demonstrated that APG-1387 in combination with pembrolizumab is a promising approach and deserves further study in patients with advanced NSCLC and CRC.

First-in-human study of palcitoclax (APG-1252), a novel dual Bcl-2/Bcl-xL inhibitor, demonstrated advantages in platelet safety while maintaining anticancer effect in U.S. patients with metastatic solid tumors
Abstract：#3509

The study of palcitoclax (APG-1252) is a Phase I trial to characterize the safety, tolerability, PK, PD and preliminary anti-tumor effects of palcitoclax, and to determine the MTD/RP2D as well. Palcitoclax is intravenously administered twice per week (BIW) or once per week (QW) to patients with small-cell lung cancer (SCLC) and other solid tumors in a 28-day cycle, the standard "3+3" design was applied to dose-escalation stage. More patients will be included in the MTD expansion cohort after MTD/RP2D is determined.
As of December 21, 2019, 42 patients (31 on BIW and 11 on QW) with metastatic solid tumors had received APG-1252 treatment ranging from 10 to 400 mg in a 28-day cycle.
Four DLTs (Grade 4 thrombocytopenia) were judged by investigators at 400 mg and 320 mg. APG-1252 was well tolerated up to 240mg. MTD/RP2D was determined as 240mg QW.
Most adverse events (AEs) were G1 or G2, and 26.2% patients had ≥ G3 TRAEs. The most common TRAEs were platelet count decreased (14.3%), aspartate aminotransferase increased (9.5%), and alanine aminotransferase increased (7.1%).
Of 36 efficacy-evaluable patients, 3 patients with PR had relapsed SCLC, poorly differentiated neuroendocrine tumor of the prostate, or high-grade serous ovarian cancer. The patient with SCLC had PR that lasted for >18 cycles (dose level: 40 mg BIW). A total of 7 patients achieved SD, including 2 patients with SD lasting ≥ 6 cycles and 3 lasting ≥4 cycles. Another 26 patients had progressive disease at their first tumor assessment. The overall DCR was 27.8%.
APG-1252 displayed linear PK, which were approximately dose proportional over the dose range of 10 to 400 mg.
Conclusion: A sustainable antitumor effect was observed in this first-in-human study, which supports further development of palcitoclax (APG-1252) in combination with other therapies for solid tumors and hematological malignancies.

Phase I study results of APG-115, a MDM2-p53 antagonist, in Chinese patients with advanced liposarcoma and other solid tumors
Abstract：#11542

As of January 9, 2020, 21 eligible patients with advanced solid tumors were treated with APG-115 at 3 dose levels: 100 mg, 150 mg, and 200 mg. Liposarcoma comprised two-thirds of all tumors. Most of the 21 patients had completed ≥ 2 cycles of APG-115 treatment, and 1 patient had completed 6 cycles.
Efficacy assessment was performed in 19 patients (4 patients were still on treatment), including 13 with liposarcoma. Among these patients, 1 had a PR, and 12 had SD. The ORR was 5.3%, and the DCR was 68.4%. In patients with LPS and wild-type TP53 (n=9), the ORR was higher, reaching 11.1%, with a DCR of 77.8%.
Common treatment-emergent adverse events (TEAEs) included anemia and decreases in leukocyte and platelet counts. However, most AEs were G1 or G2, and the incidence of TEAEs was much lower at the 100-mg dose level.
This study found that, using a 21 day-on/7 day-off dosing schedule, APG-115 was generally safe and well tolerated especially at the 100-mg dose level. The RP2D was determined as 100 mg QOD.
Conclusion:

Evidence of single-agent clinical efficacy of APG-115 was observed in patients with LPS, as well as in patients with expression of wild-type TP53. Updated results of this study continue to support our previous interpretation that wild-type TP53 is a predictive biomarker of response to APG-115 in patients with LPS and other cancers.
The over 10 months’ duration of response observed in a patient with PR after treatment discontinuation suggests host immunomodulatory effects of APG-115 and also provides impetus for further evaluation of APG-115 as monotherapy or in combination with immunotherapy.
About APG-115
APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 protein-protein interaction (PPI). APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the U.S., including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma or advanced solid tumors, and a Phase I/II study as single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as single agent and a Phase Ib study as single agent or in combination with chemotherapy for treatment of AML (acute myelogenous leukemia) or MDS (myelodysplastic syndromes) are ongoing in China.

About APG-1387
APG-1387 is a novel small molecule inhibitor of apoptosis protein (IAP) antagonist that was discovered and is being developed by Ascentage Pharma. Ascentage is developing APG-1387 globally and has completed dose-escalation Phase I trials in solid tumors in China and Australia, and a Phase Ib/II clinical trial of APG-1387 and pembrolizumab combination is currently ongoing in the U.S. In addition, APG-1387 is being investigated in a Phase Ib trial for treatment of patients with CHB in China. In February 2020, APG-1387 was approved for a Phase Ib/II clinical trial in combination with chemotherapy for treatment of advanced pancreatic cancer.

About Palcitoclax or APG-1252
APG-1252 is a novel, highly potent, small-molecule drug that was discovered and is being developed by Ascentage Pharma. APG-1252 is designed to treat SCLC, NSCLC, lymphoma, and other solid tumors by selectively blocking Bcl-2 and Bcl-xL to restore the apoptosis process. Two Phase I dose-escalation trials in patients with advanced cancers are currently ongoing in the U.S. and Australia, and a Phase I dose-escalation/expansion trial as monotherapy in patients with SCLC is ongoing in China.