On July 22, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that three independent industry publications mention PharmaCyte and/or its past clinical trials and their contributions to prior and future work in the treatment of pancreatic cancer (Press release, PharmaCyte Biotech, JUL 22, 2021, View Source [SID1234585104]).

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PharmaCyte’s Chief Executive Officer (CEO), Kenneth L. Waggoner, commenting on the Company’s expected uplist to Nasdaq said, "As we head into the ninth day of a required 10 days of trading following a reverse stock split, we remain above the price requirement necessary to complete our list of criteria for the expected uplist. Our hope is that PharmaCyte will be trading on the highly respected platform and will become a Nasdaq listed company as early as next week."

Waggoner continued, "With a number of recent well-respected scientific review publications supporting the approach that our technology uses as a promising treatment for pancreatic cancer, it is a validation, of sorts, of our approach and technology against the disease by independent scientists."

Three recently published high profile international medical and scientific review articles have highlighted PharmaCyte’s pancreatic cancer treatment. The articles mention (i) the treatment’s use in clinical trials to develop a cellular microencapsulation technology to treat pancreatic cancer; (ii) the use of prodrugs in its treatment; and (iii) the treatment’s role in improving the pancreatic cancer treatment landscape.

First, the respected scientific journal, Drug Discovery Today, published an article by a Spanish academic group, known for their expertise in the field of cellular encapsulation titled, "Cell microencapsulation technologies for sustained drug delivery: Clinical trials and companies." This publication stresses that the Cell-in-a-Box technology has been tested for years at the preclinical level as well as in two previously successful human clinical trials.

The authors summarize the results of the trials, essentially stating that microencapsulated cells that overexpressed cytochrome P450 2B1 (CYP2B1), which metabolizes the chemotherapy prodrug ifosfamide, transformed it into its active metabolites. These microencapsulated cells were implanted in 27 patients with pancreatic cancer. By placing the microencapsulated cells close to the area to be treated, a more focused therapy is obtained and, thus, better results are expected with lower doses of the chemotherapy prodrug ifosfamide.

In the first Phase 1/2 clinical trial using a 1 g/m2/per day dose of ifosfamide, the median survival of patients was doubled and only one of the patients had treatment-related adverse effects. In a second Phase 2 clinical trial, the prodrug ifosfamide per day dose was increased to 2 g/m2/day. The results showed greater severe adverse effects, but the efficacy profile was similar to the results from the Phase 1/2 clinical trial. The publication notes that PharmaCyte is "continuing with these promising clinical trials and are currently conducting the tests required by the regulatory agencies to begin a Phase 2b clinical trial as soon as possible." (Lopez-Mendez et al., 2021, Drug Discovery Today 26, 852-861)

The sentiment expressed by Lopez-Mendez et al. is echoed in another recent review from the World Journal of Gastroenterology, "Room for improvement in the treatment of pancreatic cancer: Novel opportunities from gene targeted therapy," from the Department of Gastroenterology, Addenbrooke’s Hospital, Cambridge, U.K. This particular review specifically states, "The cytochrome P450/ifosfamide system proof of concept from pre-clinical studies has been used to conduct Phase 1 and Phase 2 clinical trials in pancreatic cancer patients with phenomenal success (improvement of 1-year survival by 3-fold and median survival doubled)." (Galanopoulos et al., 2021, World J Gastroenterol 27, 3568-3580)

The third publication supports the activity of PharmaCyte’s pancreatic cancer treatment titled, "Prodrugs and prodrug-activated systems in gene therapy." This publication that appeared in the high impact journal Molecular Therapy states, "At a dose of 1 g/m2, ifosfamide was well tolerated by all patients in the first part of the trial, with regression of tumors in four patients and stable disease in the other participants." (Sheikh et al., 2021, Molecular Therapy 29, 1716-1728)

PharmaCyte’s CEO added, "The positive assessments of our technology and its use in the treatment of pancreatic cancer by the authors of these key publications, underscore how important it is for us to receive the U.S. Food and Drug Administration’s approval to start our clinical trial in locally advanced and inoperable pancreatic cancer."

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On July 22, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that clinicians have treated the first patient in a Phase 1b/2 study evaluating the company’s lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML) (Press release, GlycoMimetics, JUL 22, 2021, View Source [SID1234585072]). The investigator-sponsored trial is being led by Tapan Kadia, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center.

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According to Eric Feldman, M.D., GlycoMimetics’ Chief Medical Officer, "Patients with treated secondary AML have an extremely poor prognosis. Despite new drug approvals in the field, subgroups of patients with limited options still exist, especially those whose disease has progressed following treatment with a hypomethylating agent. Our previous preclinical and clinical research supports the potential for these patients to benefit from the addition of uproleselan. If the new study demonstrates that targeting E-selectin with uproleselan could help to overcome resistance to other therapies, this would be a significant achievement that underscores the broad potential of our drug candidate."

About the Phase 1b/2 Clinical Trial

The Phase 1b/2 single-arm trial is enrolling patients 18 years or older, with a diagnosis of ts-AML who have not received therapy for their AML. Considered a distinct high-risk subset of AML with an adverse prognosis, ts-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm). Clinicians plan to enroll approximately 25 patients in the trial.

GlycoMimetics is providing uproleselan for the investigator-sponsored trial. The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML. Among the trial’s secondary objectives are efficacy assessments including overall response rate, complete response, complete response without blood count recovery, and other measures. The rate of minimal residual disease negativity will also be evaluated by flow cytometry at response. Exploratory endpoints include examination of biomarkers of response and resistance and the correlation of the expression of E-selectin ligand-forming glycosylation genes of leukemic blasts with clinical outcome.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist 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. Food and Drug Administration and the Chinese Health authority 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.

On July 22, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation cancer immunotherapies, reported thar it will host its second quarter 2021 financial results and corporate update conference call and live audio webcast on Thursday, July 29th at 8:30 a.m. E.T (Press release, Genocea Biosciences, JUL 22, 2021, View Source [SID1234585088]).

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Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6789021. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source

A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On July 22, 2021 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported that as part of its growing pipeline of investigational therapies, it has identified several proprietary drug candidates, including TC220 and TC221 (Press release, TAE Life Sciences, JUL 22, 2021, View Source [SID1234585105]).

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"TLS is the only company developing comprehensive, in-house target drugs as well as a neutron technology system called Alphabeam to enable the next-generation in biologically targeted radiation therapy. Today’s news brings us closer to our goal of providing new hope to patients with the most difficult to treat cancers," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "Historically, brain, head and neck, and melanoma cancers have been treated with BNCT and studies have shown improvements in survival compared to other cancer therapies. New boron drugs expand the potential to treat other indications including breast, lung and liver cancers."

Most BNCT clinical studies to date have been carried out using boronophenylalanine (BPA) as the boron target drug. When neutron radiation is applied, the boron atoms react to generate alpha particles that destroy cancer cells. Healthy cells without the boron are spared, resulting in less normal tissue damage. This is a key difference compared to conventional radiation therapy. While historical BNCT clinical outcomes have been encouraging, the availability of better boron-10 drugs and access to an in-hospital neutron system will now provide more opportunities for clinical research and potential improved efficacy of this new cancer therapy.

TC220 and TC221 have similar targeting as BPA, but have several more favorable properties, including:

Delivers more boron selectively to tumor cells compared to BPA in pre-clinical studies.
Much greater solubility than BPA, potentially allowing for of easier administration and delivery of far more boron to tumor tissue. This could be key for improving clinical outcomes.
In pre-clinical studies, TC220 is retained longer in the tumor compared to BPA, making it possible to attain a greater tumor to normal tissue ratio for boron than possible with BPA. This should provide greater flexibility in treatment planning.
As demonstrated by early preclinical data, TC220 and TC221 have shown consistent superior delivery of boron in multiple human tumor xenografts compared with BPA, expanding their potential clinical application.
"It is very exciting to add these two new compounds to our rich pipeline of boron containing drugs and to nominate them as product candidates so quickly," said Kendall Morrison, PhD, Chief Scientific Officer of TAE Life Sciences. "Our early pre-clinical data has shown TC220 and TC221 to have excellent boron delivery properties. The next step will be to identify a contract manufacturer and evaluate the two compounds in stability, pharmacokinetic, toxicokinetic and pre-clinical efficacy studies."

About Biologically Targeted Radiation Therapy (BNCT)

BNCT is a non-invasive, biologically targeted particle therapy that combines a non-toxic compound containing boron-10 and a low-energy, epithermal neutron beam. This combination generates a therapeutic dose at the cellular level that destroys tumor cells while sparing healthy tissues surrounding the tumor. This results in less toxicity for the patient and the potential to escalate the therapeutic dose to the cancer cells. BNCT has the potential to treat undetected metastases in the local region of the tumor in the same treatment session, which is difficult to impossible for conventional radiotherapy because of the logistical patient treatment setup barriers and the amount of radiation that would be delivered to healthy cells. In addition, BNCT may be utilized for several cancers which are resistant to many, if not all, current cancer therapies available, such as glioblastoma multiforme.

On July 22, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that it will host a conference call and webcast on Friday, August 6, 2021, at 8:00 a.m. ET to discuss a corporate update and financial results for the second quarter 2021 (Press release, Oncolytics Biotech, JUL 22, 2021, View Source [SID1234585073]).

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Conference Call & Webcast

A webcast of the call will also be available on the Investor Relations page of Oncolytics’ website, available by clicking here, and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using reference code: 148-191#.