On June 27, 2022 Dxcover Limited, a clinical stage diagnostics company developing spectroscopic liquid biopsy technology for early detection of multiple cancers, reported findings from a new study that shows how Dxcover’s infrared platform detects a solid and clear distinction between cancer and control samples when detecting early stage pancreatic cancer, suggesting a great potential for clinical implementation (Press release, Dxcover, JUN 27, 2022, View Source [SID1234616299]). The data has been published in Cancers. Pancreatic cancer is the seventh leading cause of cancer death and claims more than 460,000 lives per year. It is one of the hardest diseases to detect due to the lack of early symptomatic evidence and fast, simple, and non-invasive diagnostic tests. The carbohydrate antigen (CA) 19-9 test is the blood test used for pancreatic cancer’s detection, but its levels can be raised in symptomatic patients with other non-malignant diseases, or with other tumors in the surrounding area.

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Dxcover’s proof-of-concept study, investigating the use of attenuated total reflection Fourier-transform infrared (ATR-FTIR) spectroscopy on dried blood serum, focused on the discrimination of both cancer versus asymptomatic (healthy) control samples, and cancer versus symptomatic non-malignant control samples, as a novel liquid biopsy approach for pancreatic cancer diagnosis.

Machine learning algorithms were applied, achieving results of 92% sensitivity and 88% specificity when discriminating between cancers (n = 100) and asymptomatic (healthy) controls (n = 100). An area under the curve (AUC) of 0.95 was obtained through receiver operating characteristic (ROC) analysis. In addition, the test identified cancerous patients among a challenging symptomatic cohort to an AUC of 0.83.

"To our knowledge, this is the largest and most promising proof-of-concept study to date for clinical use of ATR-FTIR spectroscopy in the detection of early and advanced stages of pancreatic cancer. The use of our technology can save over $12 million in health care resources per 5000 cancers detected as well rapidly speed up the process for patients to get the required treatment sooner," said Dr. Matthew Baker, Chief Technology Officer and co-founder, Dxcover.

On June 27, 2022 Kovina Therapeutics Inc. reported receipt of a Fast-Track Small Business Technology Transfer (STTR) grant from the National Cancer Institute/NIH (Press release, Kovina Therapeutics, JUN 27, 2022, View Source [SID1234616298]). With successful achievement of its milestones, the award will transition to a Small Business Innovation Research (SBIR) award and will provide approximately $2,400,000 over three years.

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"We are excited to receive NCI funding to support Kovina’s development of therapeutic treatments for Human Papillomavirus (HPV) related cancers," said Kristin Sherman, CEO of Kovina Therapeutics. "HPV causes nearly all cervical and many oropharyngeal, anal, and genital cancers. Kovina is focused on developing expanded treatment options for patients afflicted with these malignancies."

"We are pleased Kovina’s research proposal successfully competed in NCI’s rigorous merit-based review process," said Dr. Elliot Androphy, CSO of Kovina Therapeutics. Kovina’s technology specifically targets a key HPV protein expressed in early, pre-malignant and cancerous pathologies. By inactivating this protein, Kovina’s compounds result in the selective death of HPV infected cells. "Our therapeutics are designed to stop HPV infections before cancer develops and to treat HPV related cancers after detection."

On June 27, 2022 BWX Technologies, Inc. (NYSE: BWXT) reported that subsidiary BWXT Medical Ltd. has executed a commercial agreement with Bayer AG (Bayer) to supply high-purity Actinium-225 (Ac-225) (Press release, Bayer, JUN 27, 2022, View Source [SID1234616297]).

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Today’s announcement follows the agreement reached by the two companies in September 2021. Under the terms of the commercial agreement, Bayer will purchase high-purity Ac-225 from BWXT Medical at pre-determined prices. The parties expect supply to commence later this year.

Ac-225 is a highly powerful radioisotope used in targeted alpha therapies (TATs). This emerging field combines Ac-225 with specific tumor-seeking targeting moieties, which deliver alpha radiation directly to tumors.

BWXT Medical is a global supplier of medical isotopes and radiopharmaceuticals. Bayer is a global enterprise with core competencies in the life science fields of healthcare and nutrition.

"We are very pleased to enter into this agreement with Bayer, one of the global leaders in the rapidly emerging field of targeted radionuclide therapies," said Martyn Coombs, president of BWXT Medical. "Targeted radionuclide therapies are developed to improve outcomes for patients with different types of cancers. We will leverage our nuclear medicine strengths to collaborate with Bayer over the long term."

On June 27, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported the Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer (Press release, Nuvation Bio, JUN 27, 2022, View Source [SID1234616296]). The Company’s Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose. Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the Company proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward. While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.

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"We are committed to patient safety across all of our studies and to working collaboratively with the FDA to develop, as efficiently as possible, new medicines where existing therapies are inadequate," said David Hung, M.D., founder, president and chief executive officer of Nuvation Bio. "Based upon the recent development of uveitis as a potential safety signal, we will conduct an overall risk/benefit analysis of the NUV-422 program. Our goal is always to ensure that we deploy our resources on programs that have the highest probability of success and of generating value for patients and our investors. With $737.7 million in cash as of March 31, 2022, we are well positioned to continue developing all of our internal product candidates.

The Company will provide updates on the direction of the NUV-422 program after it has completed its internal risk-benefit analysis which will factor in feedback from FDA.

On June 27, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, reported that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN: Ulenistamab), for the treatment of pancreatic cancer (Press release, Prestige BioPharma, JUN 27, 2022, View Source [SID1234616295]).

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The clinical trial will be conducted on patients with advanced/metastatic pancreatic cancer in the Massachusetts General Hospital and the Ronald Reagan UCLA Medical Center by Principal Investigators (PI) comprised of leading authorities at Harvard Medical School and UCLA School of Medicine. The study aims to identify an optimal dose of PBP1510 in combination with gemcitabine through Phase 1 study and continue on Phase 2a to investigate clinical efficacy.

Pancreatic cancer is a highly aggressive malignancy which contributes to high morbidity and mortality with an overall survival rate in the U.S. of around 11%1) at five years. Currently, the only curative options are surgical resection in combination with adjuvant chemotherapy. However, only 10 to 15%2) of patients are candidates as the diagnosis occurs in advanced or metastatic stages that are surgically inoperable. Limited efficacy of treatment modalities and rapid progression of pancreatic cancer can be partly explained by Pancreatic Adenocarcinoma Up-regulated Factor (PAUF) found in majority of pancreatic cancer patients. PAUF plays an important role in disease progression, but no targeted molecular therapy against PAUF currently exists. Prestige BioPharma’s anti-PAUF antibody PBP1510 is envisioned to provide significant benefit to all patients affected by PAUF-positive pancreatic cancer.

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Korean MFDS granted Orphan Drug Designation (ODD) to PBP1510 in 2020. ODD is granted to investigational drugs intended for the safe and effective treatment of rare diseases with an unmet medical need that affect few individuals but cause great suffering. This designation provides certain benefits and incentives including clinical protocol assistance, differentiated evaluation procedures for health technology assessments in certain countries, and if approved, marketing exclusivity in the EU for 10 years, in the U.S. for 7 years.

PBP1510 is also expected to be eligible for FDA’s accelerated approval program if certain conditions are met. This program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. The company believes that PBP1510 will be able to apply for the accelerated approval program with the validated surrogate endpoint from its Phase 2 study.

Lisa S. Park, CEO of Prestige BioPharma, commented: "We are very pleased to initiate the Phase 1/2a clinical trial of PBP1510 in the world-class medical institutions in the US," and "the company will accelerate the Phase 1/2a study of PBP1510 to demonstrate the solid evidence to provide better treatment for pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments".