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).

Humanigen to Present at the 2021 LD Micro Invitational XI

On June 3, 2021 Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported it will present at the 2021 LD Micro Invitational XI, held virtually from June 8- 10, 2021 (Press release, Humanigen, JUN 3, 2021, View Source [SID1234583473]).

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LD Micro is host to some of the most influential conferences in the small-cap world. Humanigen has been selected to participate in the first day of the conference, during the "Hall of Fame" session, which highlights some of the top performers since the LD Micro conference began in 2008.

Management will discuss its lead product, lenzilumab, which has been submitted for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration, in addition to providing an update on the Company’s launch preparation efforts for lenzilumab, and an overview of the Company’s other development programs.

Details for the upcoming event are below:

2021 LD Micro Invitational XI

Date: Tuesday, June 8, 2021
Time: 12:00 PM ET
Link: View Source

Nucleix Establishes Collaborative Research and License Agreement with MD Anderson to Develop Methylation Assays to Assess Lung Cancer Patients

On June 3, 2021 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that it has entered into a collaborative research and license agreement with The University of Texas MD Anderson Cancer Center to evaluate and develop methylation assays focused on lung cancer, using Nucleix’s highly sensitive EpiCheck platform (Press release, Nucleix, JUN 3, 2021, View Source [SID1234583472]).

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The collaboration will focus initially on evaluating methylation markers believed to be important for the characterization of lung cancer subtypes. Selected markers will be evaluated using EpiCheck – Nucleix’s proprietary platform, which can be run using both PCR and next-generation sequencing technologies, and has shown best-in-class analytical sensitivity.

For those markers that demonstrate efficacy in helping with this characterization, Nucleix will lead the development of new assays. MD Anderson will work to validate assays using in vitro and in vivo cell lines, preclinical models and clinical samples.

"As described in a recent publication in the European Respiratory Journal, our Lung EpiCheck test is highly sensitive and has the potential to assist in the early detection of lung cancer for high-risk individuals, but we know there is also a significant need for patients who have already been diagnosed and are undergoing treatment," said Chris Hibberd, chief executive officer of Nucleix. "By collaborating with MD Anderson, we aim to expand the methylation tools available for the assessment and care of this patient population."

Nucleix’s Lung EpiCheck test analyzes changes in methylation patterns for early detection of lung cancer. The company is focused on advancing the test for the roughly 15 million high-risk smokers who are eligible for annual screening. In a recently published study, the test detected 85% of early stage lung cancers among individuals at high risk for developing the disease based on their history of smoking.

"Blood-based methylation assays are minimally invasive and have the potential to provide key information about a patient’s lung cancer that cannot be provided by standard genomic profiling of DNA mutations, helping physicians to better identify disease subtypes and emerging biomarkers in the clinic," said John V. Heymach, M.D., Ph.D., chair of Thoracic/Head and Neck Medical Oncology at MD Anderson. "We look forward to collaborating with Nucleix to advance methylation measurement tools with the goal of enabling physicians to provide more personalized, biomarker-driven treatment approaches for our patients."

About EpiCheck

EpiCheck is an ultra-sensitive technology for the detection of methylation changes and is compatible with both next-generation sequencing (NGS) and polymerase chain reaction (PCR) platforms. Nucleix is applying the NGS application of EpiCheck for deep discovery, to reveal new biomarkers that may be used in the early detection and monitoring of cancer. In turn, these discoveries can be advanced as highly sensitive tests using the PCR application of EpiCheck, with the potential to run cost-effectively in both centralized and local laboratories.