On August 18, 2020 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that it will provide funding for a 30-day survival study in mice in collaboration with University of Kentucky related to the anticancer drug designated G4-1, a novel proteasome inhibitor (Press release, AIkido Pharma, AUG 18, 2020, View Source [SID1234563806]). In exchange, Aikido has been granted an exclusive option to license the drug ("Option") pending the results of the study.

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The Option includes two issued patents, United States Patent Nos. 9,493,439 and 9,586,946, each having expiration dates in the mid-2030’s. AIkido was previously granted an option to license these patents, which it did not exercise in favor of performing this further research.

Mr. Anthony Hayes, CEO of AIkido stated, "The published mouse data on G4-1 shows exciting promise for the treatment of solid tumors compared to already approved drugs. Given those encouraging preliminary results, we agreed to fund a survival study to determine whether G4-1 can also increase survival over the marketed drugs. This transaction represents another low-risk initiative to bolster our portfolio. We optimistically anticipate the results of this study and hope they support adding G4-1 to our oncology products."

Dr. Chang-Guo Zhan, Professor, College of Pharmacy at the University of Kentucky, added, "Proteasome inhibitors in current clinical use are all peptides with very low in vivo stability. G4–1 is a non-peptide proteasome inhibitor with the desirably high in vivo stability required for the treatment of solid tumors. We are excited about the opportunity to further evaluate the therapeutic potential of G4-1 with funding supporting from AIkido."

On August 18, 2020 MaxCyte, Inc., a global cell-based therapies and life sciences company, reported the expansion of subsidiary CARMA Cell Therapies’ ongoing Phase I intraperitoneal delivery and dose-escalation trial of MCY-M11, its lead anti-mesothelin CAR-PBMC cell therapy candidate (Press release, MaxCyte, AUG 18, 2020, View Source [SID1234563802]). The expansion will involve a new parallel cohort of patients and the initiation of two additional clinical sites.

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The new parallel Phase I cohort will evaluate intraperitoneal delivery of MCY-M11 at escalating doses in additional patients with relapsed/refractory ovarian cancer and malignant peritoneal mesothelioma, with the addition of a preconditioning regimen of cyclophosphamide prior to MCY-M11 infusion. This parallel Phase I cohort with preconditioning will progress independently from the ongoing evaluation of MCY-M11 in the existing no-preconditioning Phase I cohort. The MCY-M11 Phase I trial will also allow for multiple treatment cycles where indicated for both future preconditioning and no-preconditioning patients.

New clinical sites for the study at Massachusetts General Hospital/Harvard Medical School and Hackensack University Medical Center are joining existing sites at the National Cancer Institute at the National Institutes of Health and Washington University in St. Louis.

In May, encouraging preliminary results for MCY-M11, which support this study expansion and the pursuit of new strategies with the therapy, such as the addition of a preconditioning regimen and delivering multiple cycles of treatment to further enhance efficacy, were presented at the virtual ASCO (Free ASCO Whitepaper) meeting. Results to date also support the continued validation of MaxCyte’s proprietary CARMA autologous cell therapy platform.

For the ASCO (Free ASCO Whitepaper) abstract, please visit: View Source

Following the expansion of the Phase I trial, preliminary clinical data for the existing no-preconditioning MCY-M11 trial are anticipated in H2 2020.

"We are very pleased with the progress of this first-in-human trial to date, and have great hopes that we are moving closer towards bringing a more effective immunotherapeutic option for patients with solid tumors," said Claudio Dansky Ullmann, MD, Chief Medical Officer of MaxCyte.

About MCY-M11

MCY-M11 is a non-viral, mRNA-based anti-mesothelin CAR-PBMC cell therapy manufactured using un-manipulated peripheral blood mononuclear cells (PBMC). It is being evaluated in the clinic as treatment for high mesothelin expressing solid tumors. It is under ongoing development in a first-in human multi-center, non-randomized, open label, dose-escalation Phase I clinical trial evaluating the safety and preliminary efficacy of intraperitoneal infusions of MCY-M11 in individuals with platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube, or individuals with advanced peritoneal mesothelioma, with recurrence after prior chemotherapy. MaxCyte anticipates 27 study participants will be enrolled across the existing and the new parallel cohort. Interim results presented at the ASCO (Free ASCO Whitepaper) 2020 meeting show that intraperitoneal infusion of MCY-M11 is feasible, safe, and well tolerated. There have been no dose-limiting toxicities and no treatment related discontinuations or deaths and most reported treatment related adverse events have been Grades 1-2 per NCI CTCAE in three completed dose levels as a single agent in the existing cohort. Enrollment in the fourth dose level of the existing cohort is in progress and will run alongside with enrollment in the new parallel cohort that includes a preconditioning regimen. Multiple cycles of treatment will be allowed in both the fourth dose level of the existing cohort and at all dose levels in the new parallel preconditioning cohort. We currently anticipate preliminary clinical data in H2 2020. More information about the study can be found at ClinicalTrials.gov (Identifier: NCT03608618).

On August 18, 2020 ImmPACT Bio USA Inc., a company founded in the FutuRx incubator located in Ness Ziona, Israel, developing novel cell therapies for treating cancer, reported the closing of a US$ 18 million equity financing round (Press release, ImmPACT-Bio, AUG 18, 2020, View Source [SID1234563800]). The financing included OrbiMed, Johnson & Johnson Innovation – JJDC, Inc., Takeda Ventures, Inc., RM Global Partners (RMGP) BioPharma Investment Fund, Novartis Venture Fund, Bukwang Pharmaceutical, Hayan Health Networks, Inc., and JVC Investment Partners.

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ImmPACT Bio USA Inc. is developing a novel set of engineered T-cell therapeutics that target loss of genes in solid tumors. The company was founded based on the insights of Prof. Gideon Gross (Migal Research Institute), who collaborated with Prof. Zelig Eshhar to design the first Chimeric Antigen Receptor technologies for T-cells (CAR T). While CAR-T drugs have provided meaningful breakthroughs for the treatment of some hematologic malignancies, little progress has been made in applying the technology to solid tumors. Such diseases are rarely characterized by the over-expression of tumor-selective antigens, but genomic analyses have revealed many mechanisms for loss of expression.

Founder Prof. Gideon Gross explains ImmPACT’s origins by observing, "Engineered cells have progressed tremendously in lymphomas and leukemias, in large part because lymphocytes have very selective targets. We will need new targeting strategies to tackle solid tumors, as few selective targets have been discovered, and antigens are almost always shared by indispensable tissues." Prof. Gross ultimately realized that, "Many solid tumors demonstrate genetic losses due to abnormal chromosomal maintenance – a fact that can be utilized to design new types of cellular immuno-oncology drugs."

"We have built a world-class team and a promising pipeline to realize Prof. Gross’ vision of targeting loss-of-gene features of solid tumors. We look forward to working with our investors to advance this pipeline and make the company a success," said Rick Kendall, Ph.D., CEO of ImmPACT Bio USA Inc.

On August 18, 2020 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients, reported that it has been granted US Patent number: 10,745,749, entitled METHODS FOR DETECTING NUCLEIC ACID SEQUENCE VARIANTS (Press release, Biocept, AUG 18, 2020, View Source [SID1234563799]). The patent provides intellectual property protection for Primer-Switch technology, which is useful for the detection of rare cell mutations using circulating tumor DNA (ctDNA) analysis through real-time PCR and associated analysis methods, including next-generation sequencing (NGS).

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The issuance of this patent expands Biocept’s intellectual property protection for the detection of rare mutations, including cancer biomarkers found in tissue, blood and cerebrospinal fluid. This is the second issued patent for the Primer-Switch technology, and is another step in Biocept’s pursuit of worldwide patent protection for this technology. The Primer-Switch technology provides another method for specifically enriching patient specimens for oncogene mutations of interest. Additionally, the Primer-Switch technology can be used to enhance the performance and specificity of the PCR method, which is the most widely used amplification approach used in diagnostic assays.

"Our Primer-Switch methodology has the potential to find rare mutations in PCR reactions, especially where the detection of rare genetic events is needed, or in cases where more precise PCR amplification reactions are desired or required," said Michael Nall, Biocept’s President and CEO. "This technology builds upon our ability to detect rare genetic events in addition to our Switch-Blocker technology, which we routinely use in our ctDNA Target Selector assays. This is another tool in our toolkit for methods to inform on biomarkers found in tissue, blood and cerebrospinal fluid to aid physician decision making in the treatment of their patients with cancer."

On August 18, 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 its interim results for the six months ended June 30, 2020 (Press release, Ascentage Pharma, AUG 18, 2020, View Source [SID1234563798]). During the reporting period, Ascentage Pharma made significant strides in clinical development, external partnerships, and the building of its intellectual property portfolio, with the New Drug Application (NDA) submitted in June this year marking a key milestone for the company.

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Increasing investment in innovation and further strengthening product pipeline

The company’s research and development expenses for the first half of 2020 amounted to RMB240 million, as Ascentage Pharma continued to increase investment in research and development. As of June 30, 2020, Ascentage Pharma has built a robust pipeline of eight clinical-stage small molecule drug candidates, with over 40 Phase I or II clinical studies being conducted in China, Australia, and the US. The company’s pipeline consists of inhibitors that target key proteins in the apoptotic pathways, including Bcl-2, IAP, and MDM2-p53, to restore normal apoptotic functions; and next-generation tyrosine kinase inhibitors (TKIs) that target mutant kinases in cancers.

Besides the eight drug candidates in clinical development, Ascentage Pharma is further expanding its preclinical pipeline including Mcl-1 inhibitor candidate AS00491 and APG-3526, EED inhibitor APG-5918, as well as the fourth-generation BCR-ABL inhibitor AS1266 that is currently in discovery.

Advancing global clinical development and submitting the company’s first New Drug Application

During the reporting period, Ascentage Pharma achieved major progress with the global clinical development of its drug candidates and submitted the company’s first NDA.

Ascentage Pharma’s core drug candidate, the third-generation BCR-ABL/KIT inhibitor HQP1351, has reached multiple milestones during the reporting period. In June 2020, Ascentage Pharma submitted an NDA to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for HQP1351 in patients with T315I-mutant chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML). This is the company’s first ever NDA since its inception and it will likely lead to the market authorization for the first third-generation BCR-ABL inhibitor in China. A third pivotal study of HQP1351 in patients resistant/intolerant to first- or second-generation TKIs is currently ongoing and has begun patient enrollment. While advancing the global development of HQP1351 during the reporting period, HQP1351 was granted an Orphan Drug Designation and a Fast Track Designation by the US Food and Drug Administration (FDA).

The novel, orally administered Bcl-2 inhibitor APG-2575, is a key drug candidate in Ascentage Pharma’s pipeline focusing on apoptosis and the first China-developed Bcl-2 inhibitor entering clinical development. Since March 2020, several Phase Ib/II studies of APG-2575 have been approved in China and the US, further accelerating the development of APG-2575 in multiple hematologic malignancies. In the US, upon receiving clearances for two clinical studies of APG-2575, Ascentage Pharma is poised to commence two global Phase Ib/II trials of APG-2575 including one of APG-2575 as a single agent or in combinations for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL); and the other for the treatment of Waldenström macroglobulinemia (WM). Of those two studies, the study in r/r CLL/SLL has dosed the first patients in the US shortly after receiving the clearance. Following the recent approval from the CDE of NMPA in China, Ascentage Pharma will soon initiate a Phase Ib study of APG-2575 as a single agent or in combination for the treatment of relapsed/refractory acute myeloid leukemia (AML), and a Phase Ib/II study of APG-2575 as a single agent or in combinations for the treatment of r/r CLL/SLL. Furthermore, the US FDA has granted APG-2575 an Orphan Drug Designation for the treatment of WM in July 2020.

Moreover, Ascentage Pharma has made significant progress with other assets in its pipeline, including APG-1252, a Bcl-2/Bcl-xL dual inhibitor; APG-115, a MDM2-p53 inhibitor; and APG-1387, an IAP antagonist. A number of datasets of those drug candidates were accepted by this year’s American Society of Oncology (ASCO) (Free ASCO Whitepaper) and American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meetings, further signifying the global recognition of the company.

Expanding global strategic collaborations and actively exploring potential for combination therapies

While building a strong internal research and development team, Ascentage Pharma has effectively developed and maintained partnerships with multinational pharmaceutical companies, biotech companies, and academic institutions. During the reporting period, the company entered multiple global collaboration agreements to explore combination therapies in a range of indications.

In June, the company entered a global clinical collaboration with Acerta Pharma, the hematology research and development center of excellence of AstraZeneca to evaluate the combination of APG-2575 with the BTK inhibitor CALQUENCE (acalabrutinib) in patients with r/r CLL/SLL.

In July, the Ascentage Pharma entered a clinical collaboration with MSD to evaluate the combination of APG-115 and KEYTRUDA (pembrolizumab) for the treatment of patients with advanced solid tumors.

In addition, the company signed a strategic cooperation agreement with China National Clinical Research Center for Hematologic Diseases in July on the joint construction of the "National Clinical Research Center for Hematologic Diseases Ascentage Research Institute" to promote the research and clinical development in the hematology field.

The continued expansion of the company’s global collaboration network further elevates the company’s global recognition and brand awareness, provides the company with access to leading drugs and candidates.

Building a global IP portfolio and solidifying leadership position in the industry

Intellectual property rights are of vital importance to Ascentage Pharma, a China-based innovative biopharmaceutical company with a global footprint. Utilizing its robust R&D capabilities, Ascentage Pharma has strategically developed a global intellectual property portfolio with exclusive licenses to issued patents or patent applications worldwide with respect to the company’s product candidates. As of June 30, 2020, the company has 96 issued patents and more than 300 patent applications globally, among of which, 80 patents are issued overseas.

"In midst of the COVID19 pandemic that rampaged the world in the first half of 2020, we have overcome numerous challenges and achieved breakthroughs on many fronts. The submission of the first NDA since the company’s inception marked a major milestone ushering Ascentage Pharma’s transition from clinical-stage to commercialization. Our continued effort to advance global clinical development of APG-2575 and other assets in the apoptosis-focused pipeline has delivered marked progress, with clinical data of these products making frequent appearances at major scientific congresses, signifying the company’s growing scientific influence globally. We have advanced global development and partnerships, and have entered into collaboration agreements with multinational pharmaceutical companies and academic institutions including MSD, AstraZeneca, and China National Clinical Research Center for Hematological Diseases," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Moving forward, we will continue to enhance our research and development capabilities, strengthen our global IP portfolio, and solidify our leadership position in the industry. We aim to accelerate the global clinical development of our pipeline assets and expedite the commercialization of HQP1351, in fulfilling our mission of ‘addressing unmet clinical needs in China and around the world’. In the meantime, we will remain vigilant of our financial health to safeguard the interest of our investors."