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

On September 27, 2021 TYME Technologies, Inc. ("TYME" or the "Company") (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that the first patient has been dosed in the Phase II OASIS trial in patients with metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative ("HR+/HER2-") breast cancer who previously received a CDK4/6 inhibitor regimen being conducted by Georgetown University (NCT04720664) at several MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner (Press release, TYME, SEP 27, 2021, View Source;Breast-Cancer-After-Treatment-with-a-CDK46-Inhibitor [SID1234590323]).)

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"Metastatic breast cancer is still an incurable disease and represents the second-leading cause of cancer death in women.2 The sobering statistics speak to the urgent need to find novel effective therapies that address this difficult-to-treat cancer. As this important trial begins, we are encouraged by the results in breast cancer patients from our prior first-in-human study and compassionate use program, which showed broad anti-tumor activity, including complete responses. We believe the compelling data support our strategic decision to further evaluate oral SM-88 in this setting, and we are hopeful that we will repeat the promising early activity. If so, we believe an effective drug with SM-88’s demonstrated tolerability profile would offer patients an attractive treatment option, while maintaining quality of life," said Richie Cunningham, Chief Executive Officer of TYME.

"We are pleased to be collaborating with Georgetown University to work toward transforming the treatment landscape for these metastatic HR+/HER2- patients. Dosing the first patient is a critical milestone in advancing oral SM-88 as a potential treatment option prior to chemotherapy for this patient population. This is a significant opportunity for TYME, and we look forward to providing updates as the OASIS trial progresses," concluded Cunningham.

The Phase II OASIS Trial

The OASIS clinical trial is an investigator-initiated multicenter Phase II single-arm, prospective open-label study of oral SM-88 used with methoxsalen, phenytoin, and sirolimus ("MPS") in metastatic HR+/HER2- breast cancer who have received a prior CDK4/6 inhibtor regimen. The study is designed to determine efficacy, defined as the overall response rate ("ORR") of this investigational treatment. It is designed as a two-stage trial, initially enrolling 30 patients, with potential expansion up to a total of 50 patients without concurrent cancer therapies. The primary endpoint is RECIST v1.1 tumor response; collection of cell-free DNA from patients will also occur at several time points in their treatment. If anti-tumor activity or a signal is observed among the first 30 patients, the trial may be expanded to confirm the findings.

With this trial, the Company is also incorporating mechanism-of-action and biomarker research, both preclinically and clinically. Preclinically, the Company is working with a Georgetown laboratory on SM-88’s effect in breast cancer models, including models of CDK4/6 inhibitor resistance. Clinically, the Company is collecting cell-free DNA samples from patients at multiple timepoints in their treatment and through progression to possibly identify biomarkers that could further inform future development work.

CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma, with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease.

About Breast Cancer

According to the American Cancer Society, in 2021 in the United States, approximately 1 in 8 women will be diagnosed with invasive breast cancer in their lifetime, and 1 in 39 women will die from the disease. Breast cancer is the most commonly diagnosed cancer in women, with approximately 280,000 women diagnosed in the U.S. annually and more than 3.8 million breast cancer survivors in the United States today. In the United States, HR+/HER2- represents 73% of diagnoses and is the largest subtype of breast cancer.

On September 27, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported multiple updates on its R&D capabilities. Actinium recently completed expansion of its New York City based research facilities to focus on the development of targeted radiotherapies for solid tumors and blood cancers and to investigate novel radiotherapy combinations with checkpoint inhibitors (Press release, Actinium Pharmaceuticals, SEP 27, 2021, View Source [SID1234590317]). Actinium has more than doubled its laboratory footprint and expanded its R&D capabilities. In addition to infrastructure, Actinium has increased its R&D team to include scientists with expertise across cancer biology, immunology, radiation sciences and chemistry including the appointment of Helen Kotanides, Ph.D., as Vice President, Translational Research and Preclinical Development and Monideepa Roy, Ph.D., as Vice President, Corporate Development – R&D to its R&D leadership team.

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Sandesh Seth, Actinium’s Chairman and CEO, said, "I am delighted to announce the addition of Dr. Kotanides and Dr. Roy to the Actinium R&D leadership team. Targeted radiotherapy is rapidly being established as a differentiated therapeutic modality capable of producing results where other approaches have failed. We intend to continue to be at the forefront of innovation in the field, leveraging our deep understanding of radioconjugate behavior, AWE technology platform, clinical and supply chain experience, and most importantly our team of leading scientists and clinicians to achieve our objectives focused on solid tumor indications and novel targeted radiotherapy combinations. The addition of Dr. Kotanides and Dr. Roy in senior R&D leadership positions and the expansion of our R&D capabilities allows us to significantly accelerate these efforts. We look forward to showcasing our expanded R&D capabilities in the near future and highlight new initiatives and programs to complement our late-stage targeted radiotherapy clinical program led by Iomab-B, which we recently completed enrollment for the pivotal Phase 3 SIERRA trial."

Dr. Kotanides joins Actinium from Eli Lilly after a distinguished career with continued succession through multiple positions culminating as Senior Research Advisor, Cancer Immunobiology. Dr. Kotanides brings nearly 25 years of R&D experience from ImClone Systems and then Eli Lilly with a focus on the preclinical discovery and development of oncology biologic drugs. She has extensive first-hand knowledge and experience in cancer biology and immunotherapy, including target discovery and the testing, development, and advancement of biologics, immune checkpoint therapies, and targeted therapies. As a result, Dr. Kotanides has led several preclinical programs to successful IND filings. Dr. Kotanides received her Ph.D. in Molecular Biology and Biochemistry from the State University of New York at Stony Brook, her master’s degree in Biology from New York University and her bachelor’s degree in Biology from Clark University.

Dr. Roy is a scientist-entrepreneur whose experience includes tenure as CEO of an early-stage oncology drug development company and nearly a decade in academic experience that includes training and work experience at Harvard Medical School/Brigham and Women’s Hospital. Dr. Roy joins Actinium from Akamara Therapeutics, where she most recently served as Vice President, Corporate Development and Operations. As a founding member and interim CEO at Akamara, she played a critical role in recruiting an executive team, establishing the Company’s corporate and R&D strategy, operational execution and growing the global team from 4 to 40. During her tenure at Akamara, she contributed to partnership/collaboration efforts, developed portfolio strategies, evaluated technology platforms, oversaw research activities to support IND filings, led regulatory preparation and submissions, and worked to generate and secure intellectual property. Prior to Akamara, she was Director, Research and Development at Invictus Oncology Pvt. Ltd., a drug discovery company developing novel I/O and conjugated antibody therapies. Here she co-led the licensing of technology from Brigham and Women’s Hospital, raised Series A financing, established the Company’s strategy around a B-cell immunotherapy platform and established an international research capability to advance the Company’s technologies. Additionally, she established a network of KOLs and identified and evaluated supramolecular platform technologies. Prior to industry, Dr. Roy was a Lecturer at Harvard University, was a Leukemia and Lymphoma Society Special Fellow and Research Fellow, Dept. Of Pathology at Brigham and Women’s Hospital/Harvard Medical School. Dr. Roy received her Ph.D. in Molecular Biology from Jawaharlal Nehru University, her master’s degree in Biophysics and Molecular Biology from the University College of Science, Calcutta and her bachelor’s degree in Human Physiology from Presidency College, Calcutta.