On September 27, 2021 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Nader Pourhassan, Ph.D., President and Chief Executive Officer and Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development of CytoDyn will provide a comprehensive business update at the upcoming Emerging Growth Conference (Press release, CytoDyn, SEP 27, 2021, View Source [SID1234590334]). CytoDyn will present for 20 minutes, and 40 minutes will be dedicated to live questions and answers.

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Interested participants are encouraged to login early prior to the start of the event. This is a livestream presentation, and a link will also be posted on CytoDyn’s website approximately 48 hours after the presentation. The conference sponsor provides corporate visibility services to CytoDyn for a fee.

About Leronlimab

The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). Leronlimab has been studied in 16 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with HIV standard care in patients with multi-drug resistance to current available classes of HIV drugs).

Leronlimab, among various potential applications, is a viral-entry inhibitor in HIV/AIDS. It binds to CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV. Five clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies. Cancer research has shown CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control (for example, through angiogenesis). Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 97% in a murine xenograft model. As a result, CytoDyn is conducting two clinical trials, one, a Phase 2 in mTNBC, which was granted Fast Track designation by the FDA in 2019, and a second, a Phase 2, basket trial which encompasses 22 different solid tumor cancers.

The CCR5 receptor plays a central role in modulating immune cell trafficking to sites of inflammation. After completing two clinical trials with COVID-19 patients (a Phase 2 and a Phase 3), CytoDyn initiated a Phase 2 investigative trial for post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial evaluated the effect of leronlimab on clinical symptoms and laboratory biomarkers to further understand the pathophysiology of PASC. It is currently estimated that between 10-30% of those infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, sleep disorders, and shortness of breath. CytoDyn plans to pursue clinical trials to evaluate leronlimab’s effect on immunological dysregulation in other post-viral syndromes, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

CytoDyn is also conducting a Phase 2 clinical trial for NASH to evaluate the effect of leronlimab on liver steatosis and fibrosis. Pre-clinical studies revealed a significant reduction in NAFLD and a reduction in liver fibrosis using leronlimab. There are currently no FDA approved treatments for NASH, which is a leading cause of liver transplant. About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH. There have been no strong safety signals identified in patients administered leronlimab in multiple disease spectrums, including patients with HIV, COVID-19, and oncology.

On September 27, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported further results from a third test of biocompatibility of its CypCaps product candidate for pancreatic cancer (Press release, PharmaCyte Biotech, SEP 27, 2021, View Source [SID1234590330]). The tests results showed that the empty capsule material is not "mutagenic." A mutagen is a physical or chemical agent that permanently changes genetic material, usually DNA, in an organism and thus increases the frequency of mutations above the natural background level.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "As we continue to receive data from a myriad of tests that are currently in progress, we are generating exactly the data we expected to generate when we began addressing the U.S. Food and Drug Administration’s desire to see more data. These latest test results continue to support the safety of PharmaCyte’s product candidate, CypCaps. In line with data generated previously, we are confident that the encapsulation material used for CypCaps is biocompatible, safe and not toxic. Each of the tests that we’re conducting should continue to demonstrate this."

The study, which was performed by a third-party Contract Research Organization (CRO) in compliance with OECD Principles of Good Laboratory Practice [C(97)186/Final and ENV/MC/CHEM (98)17] and in accordance with four regulatory guidelines (OECD and ISO) was designed to determine if the device component of CypCaps (the empty capsule material) can cause mutations by altering DNA. The specific objective of the study was to evaluate whether two differently prepared extracts of empty capsule material can induce reverse mutations in specific genes in four indicator strains of bacteria Salmonella typhimurium and one indicator strain of Escherichia coli. The third-party CRO concluded from the data obtained that the empty capsule material is "non-mutagenic."

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 September 27, 2021 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported results of a secondary, post-hoc analysis of data from the prospective LOCATE and FALCON clinical trials that evaluated the impact of Axumin (fluciclovine F 18) PET/CT imaging on management of patients with recurrent prostate cancer (Press release, Blue Earth Diagnostics, SEP 27, 2021, View Source [SID1234590327]). This analysis characterized the impact of Axumin PET/CT on sites of disease recurrence and plans for androgen deprivation therapy (ADT) in patients with biochemical recurrence of prostate cancer. Of 146 patients who had a pre-scan plan for ADT, Axumin PET/CT detected lesions in 85 (58%) of patients. Detection rates in the prostate/bed, pelvic lymph nodes, extra-pelvic lymph nodes, soft tissue and bone were 30% (44/146), 25% (37/146), 13% (19/146), 2.1% (3/146) and 13% (19/146), respectively. Among the 146 patients with a pre-scan plan for ADT, 64% (93/146) had a change in their management plan following an Axumin scan. Of those whose management plan changed, 59% (55/93) avoided or delayed ADT. Of 60 patients originally planned for ADT monotherapy, only 25% (15) were still due to receive ADT monotherapy after Axumin PET/CT imaging. Axumin, a novel amino acid-based radiopharmaceutical, is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The secondary analysis is based on the Axumin LOCATE and FALCON trials, which have safety profiles consistent with that described in the approved U.S. Prescribing Information.

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"Prostate cancer will recur in up to 30% of patients after initial treatment," said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine. "The ability to determine the extent and location of recurrent prostate cancer, in conjunction with other available clinical information, can inform the management plan for men with recurrent disease. Informed decision-making can facilitate personalized patient management. ADT is commonly used to treat recurrent prostate cancer, but may produce undesirable side effects for many patients, and may also lose effectiveness over time. This analysis of data from the LOCATE and FALCON trials indicated that ADT was avoided in approximately 40% (55/146) of the men originally intended for ADT, based on the information provided by 18F-fluciclovine PET/CT imaging. Management plans were commonly amended to target salvage therapy to lesions identified with 18F-fluciclovine PET/CT, and consequently likely spared these patients the potential systemic morbidity often associated with ADT."

"As the recognized leader in diagnostic PET prostate cancer imaging, Blue Earth Diagnostics continues to advance scientific knowledge about the proven clinical utility of Axumin," said David Gauden, D.Phil., President and Chief Scientific Officer of Blue Earth Diagnostics. "Blue Earth’s independent, prospective FALCON and LOCATE studies demonstrated that Axumin PET/CT located recurrent disease in the majority of men in the study, which frequently resulted in significant changes to their management plans for biochemical disease recurrence. Notably, Emory University’s independent EMPIRE-1 study (NCT01666808), recently published in The Lancet, demonstrated that treatment informed by Axumin PET imaging significantly improved event-free-survival for men with recurrent prostate cancer at three and four years. These studies highlight the role that Axumin molecular imaging can have in guiding informed patient care."

Dr. Gauden continued, "In the United States, Axumin PET imaging has informed healthcare decisions for more than 125,000 men with recurrent prostate cancer across the country, where it is available at more than 1,300 imaging centers and widely reimbursed. Axumin availability and reimbursement continue to expand in Europe, with additional access anticipated this year. We are committed to helping patients through innovative diagnostic solutions that empower the evolution of care for men with recurrent prostate cancer, and we look forward to helping even more patients in the future."

Results from the secondary analysis were summarized in an oral presentation, "Impact of 18F-Fluciclovine PET/CT on Plans for ADT in Patients with Biochemical Recurrence of Prostate Cancer; Analysis from Two Prospective Clinical Trials," by Gerald L. Andriole, MD, Division of Urologic Surgery, Department of Surgery and the Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, Mo., at the Fifth Global Summit on Precision Diagnosis and Treatment of Prostate Cancer, on September 23, 2021.

About the LOCATE and FALCON Clinical Trials
The LOCATE trial (NCT02680041) was a prospective, multi-center, open-label study (NCT02680041) conducted at 15 sites in the United States. Its primary endpoint measured the percentage of men with biochemical recurrence of prostate cancer following initial prior therapy whose treatment plan was changed following an 18F-fluciclovine PET/CT scan. Results indicated that 59% (126/213) of patients had their clinical management changed when results of the 18F-fluciclovine PET/CT imaging were included in the diagnostic work-up. Of those changes, 78% (98/126) were classified as "major" (i.e., a change in treatment modality) and 22% (28/126) were classified as "other" (i.e., a change within a treatment modality).

The UK-based FALCON trial (NCT02578940) was a prospective, multi-center open-label multi-center study. Its primary endpoint evaluated the clinical impact of 18F-fluciclovine in affecting treatment decisions as assessed by comparing records of the patient’s treatment plan after an 18F-fluciclovine PET scan with the treatment plan prior to the scan. Results indicated that 64% (66/104) of patients had their clinical management plan changed when results of 18F-fluciclovine PET/CT imaging were added to the standard-of-care diagnostic work-up. Of those changes, 65% (43/66) were classified as "major," denoting a change in treatment modality.

Indication and Important Safety Information About Axumin

INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On September 27, 2021 Bio-Thera Solutions, Ltd. (688177.SH, "Bio-Thera") and Intract Pharma ("Intract") reported a global collaboration and licensing agreement that gives Bio-Thera access to Intract’s Soteria and Phloral drug delivery technologies to develop novel oral monoclonal antibody (mAb) treatments for chronic gastrointestinal (GI) inflammatory diseases (Press release, BioThera Solutions, SEP 27, 2021, View Source [SID1234590325]). Bio-Thera is a global pharmaceutical company developing innovative therapeutics and biosimilars for oncology, autoimmune diseases, cardiovascular diseases, and other serious unmet medical needs.

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Under the terms of the agreement, Intract has granted Bio-Thera a worldwide license to Intract’s oral biologics drug delivery platform for a single undisclosed mAb product. Intract will receive an undisclosed upfront payment, with potential development and commercial milestone payments along with royalties on product sales. Intract will lead preclinical research of the product and Bio-Thera will have the option to expand development of the product for multiple GI indications and will be responsible for manufacturing and commercialization of any approved products.

Intract’s oral biologics delivery platform includes Soteria a technology which protects proteins such as mAbs from degradation in the intestinal lumen. The platform also includes Phloral, a clinically- validated technology that utilizes both pH and the enzymes produced by colonic bacteria as a trigger mechanism to allow accurate release of payloads in the colon, a suitable site in the GI tract for targeting of biologics for local and systemic delivery.

"Developing oral biologics is the next step in advancing compliance and access to innovative monoclonal antibodies for chronic diseases," said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. "We believe that combining Bio-Thera’s antibody expertise with Intract’s oral delivery platform will lead to a great advance in the treatment of gastrointestinal disease."

"Intract Pharma is delighted to be partnering with Bio-Thera to address the significant challenge of delivering powerful biologics orally" said Dr Bill Lindsay, CEO of Intract. "We believe that our technologies will allow development of a more effective therapeutic for the treatment of IBD, while also increasing drug safety and reducing cost."

On September 27, 2021 AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, together with Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that interim clinical data from a Phase Ⅱ trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC) (Press release, AnHeart Therapeutics, SEP 27, 2021, View Source [SID1234590324]). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on September 25-29, 2021.

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The scientific presentation entitled: "Taletrectinib (AB-106): Preliminary results from TRUST, Phase Ⅱ trial of a new generation of potent ROS1/NTRK inhibitors in ROS1-positive non-small cell lung cancer (NSCLC)," summarized preliminary data from an ongoing Phase Ⅱ trial of taletrectinib (NCT04395677).

As of June 16, 2021, 21 crizotinib treatment-naïve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1 fusion-positive. The key results are as follows:

In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21).
In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16).
Among the crizotinib pre-treated patient group (n=16), ROS1 G2032R resistant mutations were identified in three patients and all three patients experienced tumor regression, 2 patients reported a partial response (PR), and 1 patient stable disease (SD).
In patients with assessable brain metastasis pre-enrollment, intracranial objective response rate (assessed by investigator) was 83.3% (5/6).
Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.
"We are pleased with the interim Phase Ⅱ data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer," said Dr. Caicun Zhou, Director of the Department of Oncology, Shanghai Pulmonary Hospital. "Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug."

"Our team is focused on completing patient enrollment for our Phase Ⅱ TRUST trial," said Bing Yan, MD, Co-founder and Chief Medical Officer at AnHeart Therapeutics. "The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs."

"We are glad to see the interim Phase Ⅱ data of taletrectinib presented at the CSCO meeting, one of the most authoritative clinical oncology conferences in China," said Dr. Hui Zhou, Senior Vice President of Innovent, "In China, ROS1-positive patients currently have limited treatment options. Novel therapies are urgently needed, and taletrectinib has good efficacy and safety results, which offers hope to patients with ROS1 fusion-positive NSCLC."

About Taletrectinib

Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at View Source