On August 10, 2022 Arbele, a clinical stage biopharmaceutical company, reported the successful dosing of the first patient in Australia in Phase I Study of ARB202, for the treatment of advanced gastrointestinal cancers patients (Press release, ARBELE, AUG 10, 2022, View Source [SID1234618073]). Globally, Arbele is the first company exploring the potential of CDH17xCD3 bispecific T-Cell engager antibody in cancer immunotherapy.

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"Dosing patients is a significant first step in targeting cadherin-17 on gastrointestinal cancers which globally affects so many lives, particularly in East Asia" said Dr. Dennis Wong, MD, Chief Medical Officer of Arbele.

The Phase I trial is a continuous multi-center, open-label, dose-escalation trial for both the ascending dose (Phase Ia) and dose ranging (Phase Ib/2a) phases (clinicaltrials.gov: NCT05411133), with aims to determine the tolerability and/or to be used dose of ARB202. The preliminary effects on biomarkers and clinical efficacy of ARB202 in GI cancer patients will be examined. Given tolerability potential expansion cohorts will further evaluate the safety and efficacy of ARB202 in specific indication(s) and in combination with other therapy. Arbele expects to report initial safety, tolerability, and PK/PD data in 2Q 2023.

About ARB202

ARB202 is a first-in-class bispecific antibody based on Abele’s patented CDH17 biomarker. The unique differential binding affinities of ARB202 toward CDH17 and CD3 allows it to have high specificity and cytotoxicity, while avoiding the "off-target" overactivation of T cells. Preclinical data showed that ARB202 can effectively increase interactions between T cells and target cancer cells that expresses CDH17. The trial is being led by Professor Paul de Souza of Western Sydney University Medical School and conjoint Professor, UNSW in Sydney, and Prof. Roland Leung of University of Hong Kong at Queen Mary Hospital. We also plan to expand the studies in the US and China, Japan, and Singapore.

On August 10, 2022 Peel Therapeutics, an evolutionary-inspired, clinical-stage biotech company developing medicines for cancer and inflammatory diseases reported that it has initiated a first-in-human clinical study of PEEL-224 in patients with advanced solid tumors (Press release, PEEL Therapeutics, AUG 10, 2022, View Source [SID1234618072]). This follows recent acceptance of the company’s Investigational New Drug (IND) Application by the U.S. Food and Drug Administration (FDA). PEEL-224 was developed from a medicine that originates from the leaves and stem of an ancient tree used for thousands of years in traditional Chinese medicine.

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The company is evaluating PEEL-224, a novel topoisomerase I inhibitor, in a Phase 1 dose escalation, repeat-dose, multi-center, open-label study in patients with advanced solid tumors. The trial will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PEEL-224.

"Building on millions of years of evolution, Peel Therapeutics’ scientists and collaborators have modified this plant compound to overcome chemotherapy cancer resistance," said Joshua Schiffman, M.D., CEO and Co-Founder of Peel Therapeutics. "We are very encouraged by the preclinical data seen in multiple solid tumor types. Our company looks forward to further evaluation of PEEL-224 in patients, bringing us closer to our goal of delivering safer and more effective cancer therapy."

Peel Therapeutics’ first clinical study comes on the heels of closing an $18M convertible note financing last year. The company has raised $30M overall since its start in oversubscribed note rounds and small business grants.

"At Peel Therapeutics, evolution is our platform and patients are our purpose. Our Peel scientists unlock evolutionary biology to treat cancer and inflammation," continued Dr. Schiffman. "With our additional programs also quickly advancing towards the clinic, we are optimistic about our progress. We are pleased to forge ahead with the support of our investors to introduce safer and more effective medicines for patients."

About PEEL-224
PEEL-224 is a small molecule nanoparticle for the treatment of cancer. The active molecule of PEEL-224 derives from camptothecin, a naturally occurring compound found in the Chinese Happy Tree (Camptotheca acuminata) thought to have evolved as a plant defense mechanism. Camptothecin and its derivatives inhibit topoisomerase 1 DNA repair, effectively killing dividing cells with mutations. By engineering the natural molecule and conjugating it with a synthetic polymer, Peel Therapeutics has designed PEEL-224 to improve efficacy while limiting toxicity.

On August 10, 2022 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, reported that it will report financial results for its first quarter of fiscal year 2023 on Tuesday, August 23, 2022 (Press release, Medtronic, AUG 10, 2022, View Source [SID1234618071]). A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s first quarter of fiscal year 2023, which ended on Friday, July 29, 2022.

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Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 23, 2022, to discuss results for its first quarter of fiscal year 2023. The webcast can be accessed at View Source

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source

Looking ahead, Medtronic plans to report its fiscal year 2023 second, third, and fourth quarter results on Tuesday, November 22, 2022, Tuesday, February 21, 2023, and Thursday, May 25, 2023, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

On August 10, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) (Press release, Everest Medicines, AUG 10, 2022, View Source [SID1234618070]).

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In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin).

"The acceptance of our New Drug Application for Xerava and our agreement with TTY are key steps towards bringing this important and novel therapy to Taiwan," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "With a robust organization that includes expert functions in regulatory, medical, marketing and sales, and a successful record of commercializing other important anti-infective products in the region, TTY was a clear partner of choice as we continue our work to expand the regional reach and access of this critical therapy for patients with complicated intra-abdominal infections and other potentially life-threatening infections."

"TTY Biopharm has been dedicated in the fields of cancer and critical care for many years. It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing. Through this partnership, TTY may provide more options and better solutions to both patients and medical professionals in the near future," said Sara Hou, Chief Executive Officer of TTY Biopharm.

Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.

Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals (a wholly owned subsidiary of La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Hong Kong region.

About Xerava (eravacycline)

Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK and Singapore and the medicine is currently under review for cIAI in Greater China. Everest is also developing Xerava for the treatment of community-acquired bacterial pneumonia (CABP). Xerava was licensed from Tetraphase Pharmaceuticals, a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit View Source

About Complicated Intra-Abdominal Infections

Complicated intra-abdominal infections (cIAI) is a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.

On August 10, 2022 Scientists at City of Hope reported that, one of the largest cancer research and treatment organizations in the United States, may have developed a novel blood test that can be used to detect early-onset colorectal cancer, which has been on the rise in younger adults in recent years (Press release, City of Hope, AUG 10, 2022, View Source [SID1234618069]).

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"More research is needed, but this finding could help fill a void in the cancer prevention and early detection field, which does not currently have a noninvasive and accurate way to detect the presence of nonhereditary colorectal cancer in people younger than 50 years old," said Ajay Goel, Ph.D., M.S., professor and chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope. "The study is significant because it is the first time a novel microRNA (miRNA) biomarker has been identified, developed and validated to detect early-onset colorectal cancer."

Colorectal cancer is the fourth most common cancer, according to the U.S. Centers for Disease Control and Prevention. The rate of colon or rectal cancers in people younger than 50 years old has been on the rise, an alarming trend, particularly because young people diagnosed with this nonhereditary form of colorectal cancer generally have more aggressive and advanced disease at diagnosis compared to late-onset colorectal cancer diagnosed in people 50 years or older. As a result, the recommendation to begin regular colorectal cancer screening has been moved to start five years earlier at age 45.

In the study, recently published in the journal Gastroenterology, researchers systematically conducted a genome-wide analysis to identify miRNA signatures by analyzing a large, publicly available dataset. They extrapolated the data of patients with either Stage 1 or 2 early-onset colorectal cancer (42) or patients with late-onset colorectal cancer (370). (MiRNAs regulate gene expression.) Scientists then validated the results using blood samples from 149 patients with early-onset colorectal cancer and compared the data with a control group of 110. While exciting, more research using larger patient cohorts must be performed before this novel liquid biopsy can be used in the clinic.

To enhance specificity and accuracy, the researchers eliminated all miRNA markers shared by people with early- and late-onset colorectal cancer to better identify patients with early-onset colorectal cancer. They were able to identify four miRNAs that, combined, create a signature biomarker which can be used to detect and diagnose the presence of early-onset colorectal cancer in younger adults.

"The goal would be to eventually be able to use this test as a part of an annual physical exam or every six months for people who are at high-risk for colorectal cancer due to the genes they inherited," Goel said. "Noninvasive fecal and blood tests that are currently available to people are not yet able to accurately detect early-onset colorectal cancer."

The study "A liquid biopsy signature for the detection of patients with early-onset colorectal cancer" was published in Gastroenterology. The research was supported by grants from the National Cancer Institute, National Institutes of Health (CA72851, CA181572, CA184792, CA202797 and CA227602) as well as from Fundación Mapfre Guanarterme.