On September 23, 2021 Akeso, Inc. (the Company, 9926.HK) reported that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world’s first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104) for the treatment of relapsed or metastatic cervical cancer, which has received priority review. Cadonilimab, independently developed and manufactured by the Company, is the first PD-1 based bi- specific antibody drug in the world to submit new drug application (Press release, Akeso Biopharma, SEP 23, 2021, View Source [SID1234590230]).

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Cadonilimab is the second innovative antibody drug of the Company to submit the new drug application and the fifth new drug application submitted by the Company in China and in the United States.

The clinical trial data has shown that Cadonilimab has favorable efficacy and safety profile for the treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy. Among the target indication population, Cadonilimab has shown better efficacy compared to the published data of PD-1 monoclonal antibody on the market. Relevant clinical data will be published in relevant international conferences and medical journals.

Director of Oncology and Gynecology, Fudan University Cancer Hospital, Prof. Wu Xiaohua said, "Although PD-1 monoclonal antibody for the treatment of cervical cancer indication has been approved for global market launch, but the clinical study results show that it only achieves an objective response rate of not more than 15% in second-line or more PD-L1 positive patients. The efficacy and safety data of Cadonilimab as monotherapy shown in the phase II pivotal clinical trial are encouraging. Not only does it achieve a high response rate among PD-L1 positive population, it also shows good effect in PD-L1 negative population, with a significant improvement in the median progression-free survival, offering better treatment for patients with advanced cervical cancer in China. 2030 is the critical year for both initiatives ”Global Strategy to Accelerate the Elimination of Cervical Cancer” and ”Healthy China 2030”. The Company believes that as the first self-developed bi-specific antibody drug in China, Cadonilimab will facilitate the smooth implementation of the global cervical cancer initiative and the health strategy of China as mentioned above."

Chairman-designate of Chinese Medical Association Gynecological Oncology Branch, Prof. Kong Beihua from the Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, said, "Cervical cancer has the highest incidence among gynecological malignancies in China, and patients with advanced recurrent metastatic cervical cancer are refractory to routine treatment. This represents one of the biggest challenges faced by gynecologic oncologists with significant clinical needs. The clinical efficacy of immune checkpoint inhibitors as monotherapy is not satisfactory. Despite the potential improvement in efficacy in combination with other treatments, its clinical application is greatly restricted due to severe toxic side effects. The clinical trials of Cadonilimab have demonstrated high efficacy, low susceptibility to toxic side effects as well as safe and controllable results to patients with advanced recurrent metastatic cervical cancer who have failed routine treatment. Cadonilimab has already entered the fast track designation process, this is good news for both doctors and patients, which will lead China’s oncotherapy to enter immunotherapy new era ahead of the world, as well as improve the prevention and treatment of cervical cancer in China, benefiting the patients and making good cause for celebration."

Founder, president & CEO of Akeso, Inc., Dr. Xia Yu said, "Cadonilimab is developed by scientists at Akeso with years of dedication. It is a bi-specific antibody new drug with global patent that targets simultaneously PD-1/CTLA-4 and also the first PD-1 based bi- specific antibody drug in the world to submit new drug application. We much appreciate the excellent efforts from the Akeso team, clinical research center, medical experts and departments of drug administration at all levels for this. The Company will dedicate its leading advantages in the field of bi-specific antibodies, accelerate the clinical research of Cadonilimab in other indications. We are looking forward to the advantages of Cadonilimab in the immuno-oncology therapy to benefit more oncology patients.

Milestones of Cadonilimab for treatment of cervical cancer:

July 2021, the phase III clinical trial of Cadonilimab in combination with chemotherapy for treatment of advanced cervical cancer officially initiated.

Feb 2021, the Food and Drug Administration of the United States (the FDA) granted orphan drug designation to Cadonilimab for treatment of cervical cancer.

Oct 2020, Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy was included in the list of "Breakthrough Therapy Designation" by the Center for Drug Evaluation (the CDE) under the NMPA.

July 2020, the FDA granted fast track designation to Cadonilimab for treatment of relapsed or metastatic cervical cancer patients after the failure of platinum-based chemotherapy.

Currently major indications of Cadonilimab include gastric cancer, lung cancer, liver cancer, esophageal squamous cancer, nasopharyngeal cancer, etc. Among which the phase III clinical trial for first-line treatment of gastric cancer has officially initiated.

About Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.

On September 23, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from an integrated safety analysis of UKONIQ (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory lymphoid malignancies in Blood Advances, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, TG Therapeutics, SEP 23, 2021, View Source [SID1234590247]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, "We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances. We believe these data further support the differentiated safety profile of UKONIQ, the first and only PI3k-delta and CK1-epsilon inhibitor, which is now commercially available to patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma. As we strive toward obtaining FDA approval of the investigational combination of UKONIQ and ublituximab, U2, in CLL by the PDUFA goal date of March 25, 2022, furthering our understanding of the safety and tolerability profile of UKONIQ remains paramount to us."

Matthew S. Davids, MD, MMSc, lead author of the integrated safety study and Director of Clinical Research in the Division of Lymphoma at Dana-Farber Cancer Institute stated, "Historically, the use of PI3K-delta inhibitors has been limited by high discontinuation rates. The integrated safety data analysis of umbralisib published [today/yesterday] is encouraging for patients, especially given the low rate of discontinuations due to adverse events observed. Our analysis further underscores the potential role of umbralisib in the treatment of relapsed or refractory marginal zone and follicular lymphoma and may support the future utilization of umbralisib in combination therapies for patients with lymphoid malignancies."

The manuscript includes integrated comprehensive toxicity data from 4 open-label phase 1 and 2 studies that included 371 adult patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients with follicular lymphoma (n=147), marginal zone lymphoma (n=81), diffuse large B-cell lymphoma/mantle cell lymphoma (n=74), chronic lymphocytic leukemia (n=43) and other (n=25). All patients were treated with umbralisib at 800mg or higher once daily. At data cutoff, median duration of umbralisib treatment was 5.9 months (range, 0.1-75.1), and 107 patients (28.8%) received umbralisib for ≥12 months.

Key highlights from this manuscript include:

The most common grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (11.3%), diarrhea (7.3%), and increase aminotransferases (5.7%).
AEs of special interest were limited and included pneumonia in 29 patients (7.8%), noninfectious colitis in 9 patients (2.4%), and pneumonitis in 4 patients (1.1%).
Treatment-emergent serious AEs occurred in 95/371 patients (25.6%).
AEs led to discontinuation of umbralisib in 51 patients (13.7%).
No cumulative toxicity over time was observed.

These data are described further in the manuscript entitled, "Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies," which was published online in Blood Advances. The online version of the article can be accessed at View Source

On September 23, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported multiple senior leadership appointments including Arun Swaminathan, Ph.D., as Chief Business and Commercial Officer, Paul Diamond, Ph.D., as Vice President, Patent and Legal Counsel and Avinash Desai, M.D., who previously served as Executive Vice President, Clinical Development, Operations and Medical Affairs, to the position of Chief Medical Officer, effective immediately (Press release, Actinium Pharmaceuticals, SEP 23, 2021, View Source [SID1234590214]). These senior leadership additions add over 50 years of experience in key areas aligned with Actinium’s growth strategy.

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Sandesh Seth, Actinium’s Chairman and CEO, said, "I am thrilled to welcome Arun and Paul to the Actinium team. Arun brings a unique blend of experiences across commercial-focused roles at global biopharmaceutical companies, as well as an entrepreneurial mindset and track record of value creation in smaller organizations. His scientific training, experience and business acumen make him ideal to lead our commercial planning for Iomab-B, following the recent completion of the Phase 3 SIERRA trial and to lead our business development activities focused on our clinical assets and AWE technology platform to further expand our leadership in target radiotherapies."

Sandesh Seth, continued, "Equally exciting is Paul’s appointment, which coincides with our expansion in R&D, leveraging our AWE technology platform, which is expected to yield new programs in the coming months. Paul is a highly experienced and proven patent attorney who brings a strong scientific pedigree. He will be imbedded in the R&D activity at Actinium to ensure our patent portfolio is architected in line with our development objectives through value-added patent development and prosecution. With our clinical progress led by Iomab-B, novel clinical pipeline of actinium-225 targeted radiotherapies and enhanced R&D capabilities overlaid with our strong balance sheet, we are excited with the caliber of talent being attracted to and joining Actinium."

"I am excited to announce Dr. Desai’s promotion to Chief Medical Officer, in place of Dr. Berger, who will be leaving the Company effective September 24th. I have been impressed with Dr. Desai’s execution since he joined Actinium last November. In this short time, he has taken the lead on clinical operations for Iomab-B and implemented strategies that led to the completion of our Phase 3 SIERRA trial, with the last 25 percent of patients being enrolled faster than any previous cohort, despite the challenging environment from the ongoing COVID pandemic. Additionally, he has assumed leadership of our CMC operations and further strengthened its integration with our clinical team. With SIERRA enrollment complete, Dr. Desai will leverage his extensive drug development experience to execute the BLA filing strategy he has led. Finally, with his extensive medical affairs experience in oncology, he will be invaluable in our Iomab-B commercial planning. With Dr. Desai and Dr. Swaminathan onboard, I am confident in our team’s capabilities and look forward to working with them in executing our strategic vision to create value for patients and shareholders."

Dr. Swaminathan stated, "I am excited to join the Actinium team just as enrollment is completed for the pivotal Phase 3 SIERRA trial of Iomab-B. This is an exciting time in the Company’s evolution, as it sets the stage for us to further leverage the SIERRA study to expand our pipeline of target radiotherapies across hematologic and solid tumor indications, leveraging our AWE technology platform. With the growing interest in targeted radiotherapy, Actinium’s capabilities, clinical development experience, intellectual property and supply chain set us apart. Through the development of Iomab-B and Actimab-A, Actinium has gained tremendous insights into the development of targeted radiotherapies across multiple isotopes, targeting agents and indications, which I look forward to leveraging in my business development efforts. Additionally, through the Phase 3 SIERRA and Phase 1/2 Actimab-A trials, Actinium has developed a supply chain that can bring targeted radiotherapies to the point of care in many of the leading comprehensive cancer centers across the United States and Canada, where a significant number of patients with advanced cancers are treated. As we begin our commercial planning, first for Iomab-B, I am struck by the concentrated nature of the bone marrow transplant market and the opportunity to leverage a conditioning-focused commercial organization across transplant, cell, and gene therapies for potential future indications beyond acute myeloid leukemia. We believe there is a significant opportunity across several of these indications, which are expected to build upon the growing awareness of Iomab-B among transplant centers and physicians."

Dr. Avinash Desai, added, "I am honored and excited to be promoted to the role of Chief Medical Officer at Actinium. I have a deep passion and energy for oncology drug development that I will continue to apply to the advancement of Actinium’s pipeline of novel and differentiated targeted radiotherapies together with my amazing clinical development, clinical operations, and CMC colleagues at Actinium. Across our pipeline, I believe we have the opportunity to transform patient outcomes, particularly in indications not adequately addressed by traditional therapeutics. Iomab-B is a prime example, as the older, relapsed/refractory AML patients with active disease are not considered eligible for transplant with traditional cytotoxic conditioning regimens, yet in the SIERRA trial, 100% of patients receiving Iomab-B have accessed transplant and engrafted without delay. After completing SIERRA enrollment with strong momentum, we look forward to preparing for a BLA filing and with Arun’s joining, beginning commercial planning for Iomab-B. Beyond Iomab-B, our Iomab-ACT initiative for cell and gene therapy conditioning and actinium-225 alpha therapy and combination trials in relapsed/refractory hematology indications have the same paradigm-shifting potential as Iomab-B. Finally, I am excited to leverage our clinical experience and capabilities with our AWE technology platform to unveil new targeted radiotherapies to further bolster Actinium’s pipeline."

Arun Swaminathan, Ph.D., Chief Business and Commercial Officer

Dr. Swaminathan is a highly accomplished executive with over 20 years of experience in the global biopharmaceutical industry, which has included increasing positions of responsibility across commercial, business development, and clinical roles. He has a proven track record of converting great science into successful business opportunities. Prior to joining Actinium, Dr. Swaminathan was the Chief Business Officer and Senior Vice President at Alteogen Inc. a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics. In this role, his negotiations with partners led to deals totaling over $6 billion in potential value, including agreements with two of the top ten global pharmaceutical companies. During his tenure at Alteogen, the Company’s market value increased from approximately $400 million to over $4 billion. Dr. Swaminathan joined Alteogen after they entered into an agreement with Lynkogen Inc. and gained full rights to develop the assets. As CEO and co-founder of Lynkogen, he raised capital, in-licensed potentially transformative drug candidates to address complex metabolic diseases and advanced Lynkogen from concept to a pre-clinical stage company with a lead drug candidate ready for IND enabling studies that he successfully negotiated for out-licensing. Previously, Dr. Swaminathan held commercial and business development roles at Bristol Myers Squibb over 12 years during two tenures, most recently as Worldwide Brand Director, where he managed products with over $2 billion in annual sales across the top 10 global markets. Earlier at BMS, Dr. Swaminathan advanced from principal scientist to associate director, working on approved products including Nulojix, Orencia and Eliquis. Between his tenures at BMS, he spent nearly four years at Covance (now Labcorp Drug Development), where he rose to Marketing Head, in charge of a $1 billion clinical business. Dr. Swaminathan received his Ph.D., Pharmaceutical Sciences at the University of Pittsburgh, and is a graduate of the Marketing Management Program at Wharton, University of Pennsylvania.

Avinash Desai, M.D., Chief Medical Officer

Dr. Desai is a hematologist/oncologist with nearly 25 years of drug development industry experience. Over the course of his career, Dr. Desai has successfully designed and implemented clinical development, U.S. and global medical affairs, and life cycle management plans for a variety of pharmaceutical products. This has included participation in multiple INDs, NDAs, and sNDA submissions and efficiently managing the product Scientific Advisory Boards (SAB) and Data and Safety Monitoring Boards (DSMB) for hematology, oncology, and therapeutic candidates. Most recently, Dr. Desai, served as Vice President, Head of U.S. Medical Affairs – Oncology at Glaxo Smith Kline (GSK). At GSK, he established the U.S. medical affairs oncology team that oversaw the launch readiness plans for three novel oncology products—Blenrep in multiple myeloma, Zejula in ovarian cancer, and dostarlimab in endometrial cancer. Prior to GSK, Dr. Desai has overseen the clinical development, implementation, and delivery of oncology life cycle management plans for various oncology therapies at several leading global pharmaceutical companies, including Eli Lilly & Company (Lilly), Janssen Pharmaceuticals, Inc. and Takeda, Inc. Prior to GSK, he was the VP of Global Medical Affairs at Lilly, during which time he oversaw the global medical affairs team for Lilly’s GI Oncology portfolio. Earlier in his career, Dr. Desai contributed to the approval of Janssen’s myeloma drug Darzalex (daratumumab) and leading and strategically executing medical affairs activities globally for Velcade (bortezomib). Prior to Janssen, Dr. Desai was responsible for the international development of oncology products in solid tumors and hematological malignancies at Sanofi, where he successfully executed pivotal trials that led to NDA submission for Jevtana (cabazitaxel).

Paul Diamond, Ph.D., Esq., Vice President, Patent and Legal Counsel

Dr. Diamond joins Actinium with over 20 years of experience in patent law, developing and executing IP strategy within the biotechnology industry. He joins Actinium from Enzo Biochem, Inc., where he was Senior Counsel, Patents and Business Development. As Enzo’s sole patent attorney and senior-most counsel, he reported to the CEO and led all IP related and essential in-house legal functions. During his time at Enzo, Dr. Diamond obtained critical, high-value patent coverage for key products and technologies and managed high-profile litigations and settlement negotiations that resulted in a number of sizeable settlements. Prior to Enzo, Dr. Diamond first practiced IP law at global law firm White & Case LLP before opening his own practice, Diamond Law Office, LLC, where he was of counsel to the firms Lucas & Mercanti, LLP and Zuber, Lawler & Del Duca, LLP. Paul received his law degree from Fordham University School of Law. He also has a strong scientific background, receiving a B.A. in Biology from The Johns Hopkins University and a Ph.D. in Molecular and Cellular Biology from Harvard University.

On September 23, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present at the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference on Wednesday, September 29, 2021 at 2:40pm ET. Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D (Press release, Fusion Pharmaceuticals, SEP 23, 2021, View Source [SID1234590231]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On September 23, 2021 GlycoMimetics reported that Efficacy and safety data from a Phase 1/2 clinical study of uproleselan, GlycoMimetics’ lead investigational drug, were published online September 16, 2021 in the journal BLOOD (Press release, GlycoMimetics, SEP 23, 2021, View Source [SID1234590215]). In the manuscript, scientists highlight an analysis of minimal residual disease (MRD) and report an MRD negative rate of 69 percent in trial participants with relapsed/refractory acute myeloid leukemia (AML), indicating an enhanced depth of response following addition of uproleselan to salvage therapy. The paper also confirms that uproleselan can be safely combined with an intensive salvage chemotherapy regimen without adding toxicity in both relapsed/refractory and in newly diagnosed older AML patients and builds upon results first reported at the 2018 ASH (Free ASH Whitepaper) Meeting. The paper’s lead author, Daniel J. DeAngelo, M.D., Ph.D., of the Dana Farber Cancer Institute in Boston, noted that "the combination of uproleselan with a standard salvage regimen of mitoxantrone, etoposide and cytarabine (MEC) demonstrated a substantial improvement in both response rate and survival in relapsed/refractory AML patients compared to previously reported results with chemotherapy alone."

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"The results of this Phase 1/2 study demonstrate the safety and tolerability of uproleselan in combination with an intensive salvage chemotherapeutic regimen. The reported response rates and survival outcomes are superior to what has been seen with chemotherapy alone in similar relapsed/refractory AML patient populations," noted Eric J. Feldman, M.D., GlycoMimetics’ Chief Medical Officer. "In particular, the MRD negative rate of 69 percent in the relapsed/refractory cohort is unprecedented in producing a high proportion of patients who underwent a successful transplant. We are confident that our ongoing Phase 3 randomized trial will confirm the efficacy seen in the Phase 1/2 study and will help to establish uproleselan in combination with intensive chemotherapy as the new standard of care in relapsed/refractory AML."

According to Dr. DeAngelo, principal investigator of the company’s ongoing Phase 3 registrational trial, "We believe that uproleselan is clearly a novel and potent inhibitor of E-selectin that has been shown in the clinic to overcome chemotherapy resistance. Should the ongoing registrational trial prove positive, we will have created a foundational paradigm shift that has the potential to significantly impact outcomes for AML patients worldwide."

Key Data

MRD was assessed by multi-parametric flow cytometry in the relapsed/refractory cohort. Of the 16 evaluable patients, 11 patients (69%) were MRD negative at the end of induction. Following treatment with MEC plus the recommended Phase 2 dose (RP2D) of uproleselan, 31% of patients (17/54) underwent allogeneic hematopoietic stem cell transplant. Of the 22 patients achieving CR/CRi, 11 (50%) underwent transplant.
Median overall survival at the RP2D of 10 mg/kg in relapsed/refractory and newly diagnosed AML patients was 8.8 and 12.6 months, respectively.
The addition of uproleselan was associated with low rates of oral mucositis.
E-selectin-mediated drug resistance contributes to poor outcomes in patients with AML.
E‑selectin ligand expression on leukemic blasts was higher in patients with relapsed versus primary refractory AML, and with high-risk cytogenetics and secondary AML in newly diagnosed older patients. In the Relapsed/Refractory cohort, E‑selectin expression above 10% was associated with a higher response rate and improved survival.
About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.