On September 13, 2021 Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported an update on its ongoing Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1, in combination with nivolumab (Opdivo), a PD-1 inhibitor, in advanced cancer patients, with expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and in combination with nivolumab and nab-paclitaxel (Abraxane) in pancreatic cancer (Press release, Purple Biotech, SEP 13, 2021, View Source [SID1234587615]).

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In a Trials in Progress poster at the ESMO (Free ESMO Whitepaper) 2021 Congress, which will be held on September 16-21, 2021, Purple Biotech will present an overview and the design of the ongoing Phase 1b/2 study. The poster is titled, "A Phase 1b Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors, followed by a Phase 2a study of CM24 in Combination with Nivolumab in NSCLC, and in Combination with Nivolumab and nab-paclitaxel in Pancreatic Cancer."

Top-line data from the first dose cohort of CM24 10mg/kg included a partial response demonstrated in a patient with refractory advanced pancreatic cancer previously treated with two lines of therapy following two courses of treatment with CM24 in combination with nivolumab 480mg/kg. Additionally, there were no dose-limiting toxicities or serious adverse events observed in any of the three patients enrolled in the first cohort of the study.

"We are encouraged by the early data from the first cohort of this study, which showed combination agent safety, as well as a partial response in one patient," said Bertrand C. Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "The responsive patient showed a 40 percent reduction in tumor size following two courses of treatment with CM24 10mg/kg in combination with nivolumab. In addition, levels of CA19-9 tumor marker dropped by 56%, which was comparable to baseline levels. These results are especially compelling given that pancreatic tumors without high levels of microsatellite instability or deficient mismatch repair, such as the responsive patient, typically do not respond to immuno-oncology agents."

Enrollment in the second dose cohort (15mg/kg) has successfully concluded. Moreover, the Phase 1b/2 study is being expanded to additional sites in the U.S. and Israel.

"The top-line data from the first cohort of this study reinforce our confidence in the potential of CM24 to be a safe and effective treatment for advanced cancer patients. Moreover, we are pleased with the high level of interest in this study from some of the leading academic centers in the world and look forward to completing this dose-escalation study by year-end, as planned," said Isaac Israel, Chief Executive Officer of Purple Biotech.

The study is a Phase 1b/2 clinical trial with expansion cohorts in subjects with NSCLC and pancreatic cancer. CM24 is dose escalated (3+3 design) from 10mg/kg, in combination with nivolumab, 480mg q4w, in Phase 1b, in patients with NSCLC, pancreatic cancer, ovarian carcinoma, colorectal adenocarcinoma, melanoma, or thyroid carcinoma, with the primary objective of evaluating safety, PK and determining the recommended Phase 2 dose. In the Phase 2 component, patients with NSCLC will be treated with CM24 and nivolumab after first-line immuno-oncology failure, and patients with advanced/metastatic pancreatic adenocarcinoma will be treated with CM24, nivolumab, and nab-paclitaxel (Abraxane) after first-line therapy failure, with study endpoints being safety and preliminary efficacy. CEACAM1 level of expression, as well as a number of other immune, biochemical and adhesion-related molecules, will be evaluated as potential biomarkers in the study.

Additional information about the trial can be found at www.clinicaltrials.gov, NCT Identifier NCT04731467.

The trial is being conducted under a clinical collaboration and supply agreement with Bristol Myers Squibb. Purple Biotech is the sponsor of the trial.

Opdivo is a trademark of Bristol-Myers Squibb Company.

Abraxane is a trademark of Abraxis BioScience, LLC, a Bristol Myers Squibb company.

On September 13, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that interim data from the dose-escalation portion of its Phase 1/1b clinical trial evaluating SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress from September 16-21, 2021 (Press release, Silverback Therapeutics, SEP 13, 2021, View Source [SID1234587630]).

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The accepted abstract, with a data cut-off date of April 4, 2021, is now available on the ESMO (Free ESMO Whitepaper) website. The upcoming poster will include additional data with a cut-off date of August 1, 2021. Details of the poster are as follows:

Title: "Interim results of a Phase 1/1b study of SBT6050 monotherapy and pembrolizumab combination in patients with advanced HER2-expressing or amplified solid tumors"
Poster Number: 209P
Presenter: Samuel J. Klempner, MD
Session Date and Time: The poster will be released virtually on Thursday, September 16th at 8:30 AM Central European Summer Time / 2:30 AM Eastern Time

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call on Thursday, September 16, 2021, at 6:30 AM ET following the release of the poster at the ESMO (Free ESMO Whitepaper) 2021 Virtual Congress. A live webcast, including slides, can be accessed through the Events section of the Company’s website at View Source An archived replay will be available shortly after the conclusion of the event.

About SBT6050

SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-based therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.

On September 13, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported that the Company will virtually participate in ACCESS CHINA Biotech Forum (Press release, PharmAbcine, SEP 13, 2021, View Source [SID1234587645]). The event will take place from September 23 – September 30, 2021.

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ACCESS CHINA Biotech Forum is one of the largest corporate access events in China. It provides opportunities for business development, licensing deals, or commercial collaborations to global biopharmas. In the past event, more than 300 global companies that focus on oncology, cardiology, ophthalmology, orthopedics, pediatrics, and gastroenterology areas have participated to enter or expand their products in the Chinese market. For more information, please visit View Source

During the event, PharmAbcine’s pre-recorded presentation video will be made available to Chinese pharmas or biotechs that are looking to enrich their pipeline through in-licensing deals. In the presentation video, the Company will introduce its core technology and update the R&D progress of the main pipelines such as olinvacimab, PMC-403, and PMC-309.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. In early September 2021, PharmAbcine initiated a Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia. Also, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients at multiple sites in both US and Australia and two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

PMC-403 is a novel TIE2-activating fully human antibody designed to stabilize and repair damaged blood vessels in a variety of diseases. PMC-403 is currently in development for treating AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy) which are common abnormal vascular-related eye diseases. The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022.

PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody in development for the treatment of various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways activates T cells’ immune responses and leads to better anti-tumor effects. PMC-309 is expected to enter a global clinical trial in 2022.

On September 13, 2021, Moleculin Biotech, Inc. Presented the Corporate presentation (Press release, Moleculin, SEP 13, 2021, View Source [SID1234587664]).

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On September 13, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that the Center for Drug Evaluation of China’s National Medical Products Administration ("NMPA") has granted Breakthrough Therapy Designation ("BTD") to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma ("FL"), a subtype of non-Hodgkin’s lymphoma ("NHL") (Press release, Hutchison China MediTech, SEP 13, 2021, View Source [SID1234590538]).

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NMPA grants BTD to new drugs that treat life-threatening diseases or serious conditions for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies. Drug candidates with BTD may be considered for conditional approval and priority review when submitting a New Drug Application (NDA). This indicates that the development and review of amdizalisib for relapsed or refractory FL may be expedited, to address patients’ unmet needs more quickly.

Christian Hogg, CEO of HUTCHMED, said, "The granting of BTD to amdizalisib by the NMPA underscores the promising clinical value of this highly selective and potent PI3Kδ inhibitor. There is a clear need for new therapies in this treatment setting, particularly with regard to specific toxicities and suboptimal efficacy with existing treatments across different lymphoma subtypes. We look forward to important clinical data on amdizalisib being presented at the ESMO (Free ESMO Whitepaper) Congress next week and are continuing to accelerate global development of this novel therapy."

Updated preliminary results from the ongoing Phase Ib expansion study in China will be presented as a Proffered Paper at the 2021 ESMO (Free ESMO Whitepaper) (European Society for Medical Oncology) Congress on September 20, 2021. To date, amdizalisib has been shown to be well tolerated, exhibiting dose-proportional pharmacokinetics ("PK"), a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Additional details may be found at clinicaltrials.gov, using identifier NCT03128164.

HUTCHMED has initiated an extensive, globally-focused clinical development pathway for amdizalisib. In April 2021, HUTCHMED initiated a Phase II registration study in China for amdizalisib in approximately 100 patients with relapsed or refractory FL and approximately 80 patients with marginal zone lymphoma ("MZL"). The trial is being conducted in over 35 sites in China. Additional details may be found at clinicaltrials.gov, using identifier NCT04849351.

Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL (NCT03786926).

About PI3Kδ and NHL
PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is considered a promising target for drugs that aim to treat certain hematologic cancers.

FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively[i],[ii],[iii]. Patients with relapsed or refractory FL do not have curative treatment options and have a high unmet need for optimal therapeutic options.

About Amdizalisib
Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s PK properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.

HUTCHMED currently retains all rights to amdizalisib worldwide.