IASO Receives NMPA Acceptance of its First Indication IND Application for CT120, a Fully Human CD19/CD22 Dual-Targeting CAR-T Therapy

On June 3, 2021 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases, reported that its investigational new drug (IND) application for CT120, a fully human CD19/CD22 dual-targeting chimeric antigen receptor (CAR)-T cell therapy, has been accepted by the China National Medical Products Administration (NMPA) (acceptance number CXSL2101070) for treatment of relapsed/refractory B-acute lymphoblastic leukemia (B-ALL) (Press release, IASO BioMed, JUN 3, 2021, View Source [SID1234583478]). CT120 is the second clinical stage CAR-T therapies developed by IASO Bio, which signifies the company’s solid step in the development of next-generation CAR-T therapies.

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B-ALL is the most common of all Acute lymphoblastic leukemia (ALL). The emergence of CAR-T therapy and its application in ALL diseases in recent years have brought revolutionary changes to B-ALL treatment. However, the risk for poor prognosis and loss of lives remains high with a significant number of relapsed/refractory patients. Tumor recurrence and drug resistance are often attributed to the loss of target antigen expression. Therefore, next-generation CAR-T therapy such as dual targeting with multiple antigens is important to overcome the relapse challenge.

About CT120

CT120 is an autologous dual-antigen specific CAR-T therapy. Its extracellular domain contains two fully-human scFv sequences that can specifically recognize CD19 and CD22. Dual-antigen specific CAR-T cells have the potential to persistent in vivo longer than mono-specific CAR-T cells, and also enhance therapeutic effects by reducing relapse resulted from antigen escape.

CT120 proves to be significantly effective in an ongoing investigator-initiated trial (IIT) in China. The results show that CT120 not only has a durable response on CAR-T treatment-naive relapsed/refractory B-ALL patients, but also has a curative effect on relapsed patients who have previously received mono-specific CAR-T treatment. CT120 can reduce the risk of antigen escape and tumor relapse as a result of lower/loss of CD19 or CD22 expression following mono-specific CAR-T treatment, which will bring better therapeutic outcome and longer survival benefit for patients.

About B-ALL

Acute B-Lymphoblastic Leukemia (B-ALL) is a rapidly progressing cancer of the blood and bone marrow that occurs in both adults and children. About 75% of cases in adult patients occur in B cell lineage. Based on 2014-2018 cases and deaths, new cases of ALL were 1.8 per 100,000 men and women per year with the death rate at 0.4 per 100,000 men and women per year in the United States. In 2016 alone, there were 6,590 new ALL cases, and 1,400 deaths. Globally, ALL affected around 837,000 people and resulted in 110,000 deaths in 2015. The relapse rate for children afflicted by ALL is nearly 10% and for adults is as high as 50%. B-ALL is one of the most common forms of cancer in children between ages two and five and adults over age 50. (National Cancer Institute)

Dr. David Klimstra joins Paige as Chief Medical Officer

On June 3, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported that leading pathologist and Paige co-founder David Klimstra, M.D. has joined as Chief Medical Officer effective August 2021 (Press release, Paige AI, JUN 3, 2021, View Source [SID1234583477]). Dr. Klimstra is an internationally recognized leader in cancer pathology whose career spans more than three decades. In this new role, Dr. Klimstra will lead the clinical implementation and evidence generation for Paige’s technology and will shape product strategy for the most compelling use cases, helping pathologists realize the benefits of the enhanced clinical workflows enabled by Paige’s technology.

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"We are thrilled to welcome Dr. Klimstra into his new role as we launch digital pathology products into clinics worldwide while ramping up development programs for new tissue types," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "As a leading pioneer in pathology and digital pathology, Dr. Klimstra has a deep understanding of how AI-based technology can help pathologists overcome the challenges they face in their daily practice and has the first-hand experience to guide hospital groups and labs who are going digital."

Dr. Klimstra is currently Chair of the Department of Pathology at Memorial Sloan Kettering Cancer Center (MSK) and holds the James Ewing Alumni Chair of Pathology. As Chair, Dr. Klimstra has led the evaluation and implementation of digital pathology workflows at MSK and built an academic computational pathology program. During his 10 years leading the Department, he doubled the number of pathology faculty and broadened the department’s scope by recruiting a range of experts, including in bioinformatics, engineering, spectrometry and mathematics. His leadership has emphasized the introduction of new technology into the practice of pathology, with digital and computational pathology as key examples.

"As a co-founder of Paige and through my clinical practice, I have seen that digital pathology is the future of our discipline, and the application of AI to digital pathology is the pathway to drive adoption," said Dr. Klimstra. "I am extremely impressed with the progress Paige has made in a short time and am eager to formally join this endeavor and work with the team to deliver on the promise of computational pathology for widespread clinical use."

Additionally, Dr. Klimstra has also authored more than 450 peer-reviewed publications related to his research on the pathology of pancreatic, hepatic, and gastrointestinal tumors. He has served as an editor of the World Health Organization’s standard classification series for tumors of the gastrointestinal tract and endocrine organs and he has authored four books and numerous book chapters. He is widely sought for his diagnostic expertise and has lectured extensively around the world.

"Dr. Klimstra’s arrival comes at a pivotal moment as we define the trajectory for clinical implementation of our products," said Thomas J. Fuchs, Dr.Sc., co-founder and Chief Scientist of Paige. "He knows the value of novel diagnostic technologies in pathology, having built one of the most technologically advanced pathology departments through the implementation of digital pathology, next-generation sequencing and many other sophisticated diagnostic modalities. I am tremendously excited about working closely with David to propel Paige’s vision and scientific leadership forward to serve the pathology community and its patients."

Guided Therapeutics Replaces Convertible Note Facility and Significantly Reduces Dilution

On June 3, 2021 Guided Therapeutics, Inc. or the "Company" (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, reported that it has raised an additional US $1.13 million under the terms of a 3-year convertible debenture (Press release, Guided Therapeutics, JUN 3, 2021, View Source [SID1234583476]). The proceeds are intended to pay off an existing convertible note that matures at the end of 2021. The convertible note that is being repaid included a highly dilutive discounted variable conversion mechanism based on the trading price of our common stock over the term of the note. In contrast, the new debenture has a fixed conversion price of $0.50. As a result, if converted, the new debenture will result in significantly less dilution than that produced by the retired note. Aspen Capital and Fieldhouse Capital Management advised the company for this financing.

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Additionally, the new debenture will automatically convert into the securities issued in a subsequent financing if that financing is undertaken in connection with an uplisting to Nasdaq.

"Over the past two years, we have made considerable progress in reducing our liabilities and increasing our assets. We believe that these efforts put us in a strong position to obtain a Nasdaq listing for our common stock this year" said Gene Cartwright, CEO of Guided Therapeutics. "Additionally, we are pleased with recent progress toward regulatory approvals of our products in the US and China that continue to improve the Company’s future prospects".

City of Hope Physicians and Scientists Present New Immunotherapy Research at ASCO Virtual Conference

On June 3, 2021 City of Hope physicians and scientists reported that it will present updated research on a potential immunotherapy for multiple myeloma, a study on chimeric antigen receptor (CAR) T cell therapy for brain tumors and an investigational drug for advanced urothelial carcinoma, among other studies on leading-edge cancer treatments, during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, City of Hope, JUN 3, 2021, View Source [SID1234583475]). The meeting takes place virtually June 4 to 8.

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"City of Hope’s commitment to investigating and delivering the most effective cancer therapies to our patients is bolstered by scientific learnings and discussions that take place each year at the ASCO (Free ASCO Whitepaper) conference," said Steven T. Rosen, M.D., City of Hope’s chief scientific officer. "Our faculty look forward to sharing their findings and engaging with the diverse audiences at ASCO (Free ASCO Whitepaper), as well as learning about the latest research on cancer prevention, detection and treatment that could ultimately improve outcomes for patients."

New immunotherapy drug effective against relapsed/recurrent multiple myeloma

A new type of therapy – bispecific antibody T-cell engagers – are being studied at City of Hope and are showing promising results against multiple myeloma, a blood cancer that is diagnosed in almost 35,000 Americans each year.

Teclistamab targets the BCMA protein on multiple myeloma cells and also directs CD3+ T cells against BCMA-expressing cancerous cells.

"Bispecific antibody therapy engages the patient’s own immune system to fight cancer, and directly targets the myeloma cell, providing a double dose of powerful action against multiple myeloma cells," said Amrita Krishnan, M.D., City of Hope director, Judy and Bernard Briskin Center for Multiple Myeloma Research and the lead investigator of the immunotherapy study.

Krishnan will present updated results of patients treated with the recommended Phase 2 dose in the first-in-human Phase 1 study of teclistamab.

Approximately 160 patients received the therapy. The overall response rate in 40 patients treated with the Phase 2 dose was 65%. Fifty-eight percent of patients achieved a "very good" partial response or better, and 40% achieved a complete response or stringent complete response, which is a deeper response category used for multiple myeloma patients.

Side effects included mild cytokine release syndrome and neutropenia. There were no dose-limiting toxicities at the Phase 2 dose level.

Krishnan concluded that the therapy at the recommended Phase 2 dose level was well-tolerated and showed encouraging efficacy. Patients’ responses appear durable and deepened over time.

"Our research supports further investigation of teclistamab as a therapy on its own and in combination with other therapies," Krishnan added.

Updated data on abstract no. 8007 will be presented during an oral presentation at the ASCO (Free ASCO Whitepaper) conference on Tuesday, June 8, 8 to 11 a.m. EDT.

Predicting how CAR T cell therapy may work against brain tumors

A team of City of Hope scientists and researchers conducted a study using artificial intelligence to predict treatment response and survival in brain tumor patients.

The team evaluated the data from 60 patients with high-grade glioma who participated in a Phase 1 City of Hope clinical trial in which they underwent surgical resection and CAR T cell therapy. The team developed an explainable machine learning model that used clinical, molecular and radiomic data to predict overall survival in patients treated with CAR T cell therapy. (Radiomic data is a type of imaging.)

They also used such features as age, gender, race, ethnicity, histology, tumor grade, the expression of the IL-13 receptor alpha 2 (IL-13Rα2), a protein found on brain tumor cells, tumor location and other factors in the model.

The team was able to predict how a patient would respond to CAR T cell therapy. They found that patients with a larger tumor surface area and volume, as well as older age, had reduced survival, while patients with more IL-13Rα2 and tumor sphericity had increased survival.

The model also allowed researchers to place patients in two groups: those who had a higher risk of the cancer progressing and those who had a lower risk.

"Our model can potentially be used to optimize clinical trial enrollment through more precise patient screening and treatment planning," said Chi Wah "Alec" Wong, Ph.D., lead data scientist and the abstract’s lead author.

"Our long-term goal is continued optimization of the model for validation and application in a more diverse population," said Ammar Chaudhry, M.D., City of Hope assistant clinical professor, Department of Diagnostic Radiology and the lead investigator for the glioblastoma CAR T imaging biomarker study. "Once validated, this model has the potential to be applied across different tumor types treated with CAR T and other cell therapies."

Behnam Badie, M.D., City of Hope neurosurgeon and The Heritage Provider Network Professor in Gene Therapy, and Christine Brown, Ph.D., City of Hope deputy director, T Cell Therapeutics Research Laboratory, and The Heritage Provider Network Professor in Immunotherapy, also contributed to the research.

Updated data on abstract no. 104 will be presented in a clinical science symposium during the ASCO (Free ASCO Whitepaper) conference on Sunday, June 6, 11:30 a.m. to 12:45 p.m. EDT.

ATR inhibitor not effective when combined with standard chemotherapy for patients with advanced urothelial carcinoma

The standard frontline chemotherapy regimen for patients with metastatic urothelial cancer is cisplatin and gemcitabine but could those therapies, combined with an ATR inhibitor, produce better clinical outcomes?

Led by City of Hope’s Sumanta K. Pal, M.D., an open-label, randomized Phase 2 study was conducted in 23 centers nationwide to test whether the combination of cisplatin with gemcitabine and berzosertib, a selective ATR inhibitor, could improve clinical outcomes. The ATR inhibitor is a first-in-class therapy that prevents repair of DNA strands damaged within cancer cells. The trial was conducted through Experimental Therapeutics Clinical Trials Network.

A total of 87 patients (median age 67) took part in the trial. Forty-one patients received cisplatin/gemcitabine alone and 46 received the chemotherapies with berzosertib.

Median progression free survival was 8.0 months for both groups. The response rate was 54% in the chemotherapy/berzosertib arm and 63% in patients who only received chemotherapy. Median overall survival was shorter with chemotherapy/berzosertib as compared to patients who only received chemotherapy (14.4 months versus 19.8 months). There were higher rates of thrombocytopenia and neutropenia in the chemotherapy/berzosertib group compared to chemotherapy alone.

Pal concluded that there was no improvement in progression-free survival with the addition of berzosertib to the chemotherapy, and a trend toward inferior survival was observed. These results suggest caution in reducing the starting dose of cytotoxic therapy to accommodate addition of a myelosuppressive agent.

"Cisplatin and gemcitabine remain the standard of care for metastatic urothelial carcinoma," said Pal, City of Hope clinical professor, Department of Medical Oncology & Therapeutics Research, and co-director, Kidney Cancer Program.

Reducing the dose of the chemotherapy regimen to accommodate for hematological toxicities that could be caused by berzosertib may have reduced the therapeutic combination’s effectiveness, Pal added.

Final data on abstract no. 4507 will be presented in an oral presentation during the ASCO (Free ASCO Whitepaper) conference on Monday, June 7, 8 to 11 a.m. EDT.

Guangzhou Bio-Gene Announces Oral Presentation at the 2021 ASCO Annual Meeting

On June 3, 2021 Guangzhou Bio-Gene, a clinical-stage biopharmaceutical company developing a pipeline of innovative oncology therapies, reported the company will present at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting taking place June 4-8th, 2021 (Press release, Guangzhou Bio-gene, JUN 3, 2021, View Source [SID1234583474]).

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The presentation, entitled "The efficacy and safety of anti-CLL1 based CAR-T cells in children with relapsed or refractory acute myeloid leukemia: a multi-center interim analysis" will highlight Phase I clinical data demonstrating the safety and efficacy of BG1805, a potent anti-CLL1 CAR-T therapy, in R/R AML pediatric patients. An abstract of the presentation is currently available on ASCO (Free ASCO Whitepaper) website (View Source).