On August 23, 2022 Whiterabbit.ai, an AI-technology company dedicated to making late-stage diseases a rarity, reported it signed a national distribution agreement with Arterys, a San Francisco-based AI-powered software company and developer of the world’s first internet platform for medical imaging, to expand the reach of Whiterabbit’s AI-driven software program ACT, nationwide (Press release, Whiterabbit, AUG 23, 2022, View Source [SID1234618581]). The program is designed to increase mammography screening compliance and volume.

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Arterys’ broad customer base of healthcare systems, some of which use its Breast AI software to detect breast cancer, measure breast density and deliver personalized risk assessments, will be able to purchase and integrate ACT into their compliance screening programs. Increasing the number of women who schedule their annual mammograms is essential to detecting cancer earlier. The partnership has the potential to significantly reduce the backlog of preventive screenings that were missed and remain overdue as a result of the COVID-19 pandemic.

"Our strategic partnership with Arterys further anchors Whiterabbit’s mission to make late-stage diseases a rarity through increased accessibility, supported by innovative AI-powered software," said Whiterabbit.ai CEO Alexander Sardiña, MD. "We believe AI has the power to transform healthcare through compliance, accurate disease detection and a patient-centric approach at cost reduction."

"Arterys is extremely pleased to add Whiterabbit’s AI ACT solution to our current suite of breast AI applications," said Dan Arnoff, senior VP of commercialization at Arterys. "ACT drives the compliance of screening mammograms, which in turn potentially reduces interval cancers. ACT combined with our current Breast AI solution for tomosynthesis provides the end user a very unique platform in the fight against breast cancer. Arterys is committed to developing the best of class AI solutions, deployed from a single cloud interface to maximize the power of AI to breast centers across the globe."

According to leading organizations dedicated to breast cancer research and education, it is estimated more than 287,800 women will be diagnosed with invasive breast cancer and more than 43,000 will die from breast cancer in 2022 in the U.S. Whiterabbit and Arterys are dedicated to transforming healthcare through the intersection of human intelligence and artificial intelligence to improve clinical outcomes for patients.

Trained on millions of data points, Whiterabbit’s ACT is designed to facilitate compliance among women with mammography recommendations using a personalized notification system that does not require intensive one-on-one follow ups. Additionally, ACT evenly distributes a clinic’s increase in patient volume throughout the year. Tested in more than 300 breast cancer screening centers across the U.S., ACT has a proven track record of more than 20 percent growth year over year in breast cancer screening volume.

On August 23, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that the first patient dosing in Australia for its proprietary PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) in Phase I clinical trial for the treatment of patients with advanced solid tumors or lymphomas (Press release, Innovent Biologics, AUG 23, 2022, View Source [SID1234618582]). It is first candidate drug to conduct clinical trial in Australia in Innovent’s pipeline.

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The study (NCT05290597) is an open-label, multi-center Phase I study evaluating the safety, tolerability, and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma, and to determine the recommended Phase 2 dose (RP2D).

Interleukin 2 (IL-2), a cytokine secreted mainly by antigen-activated CD4 + T cells , is vital for maintaining CD4 + regulatory T cell (Treg) level, CD4 + T cell differentiation, and maintaining CD8 + T cell and natural killer cell activity. IL-2 was the first cytokine to be discovered and identified as playing a pivotal role in T-cell growth and expansion. Aldesleukin (IL-2) was approved by U.S. Food and Drug Administration for metastatic renal cell carcinoma and metastatic melanoma in the early 1990s, but it has not been widely used in clinic due to poor selectivity, narrow therapeutic window, and side effects.

IBI363, potential First-in-Class candidate drug, was independently developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 has both functions of simultaneously blocking PD-1/PD-L1 pathway and activating IL-2 pathway, allowing more precise and efficient targeting and activation of tumor specific T cells. IBI363 not only showed promising anti-tumor activity in a variety of tumor-bearing pharmacological models, but also exhibited prominent antitumor efficacy in PD-1 resistant and metastatic models; meanwhile, IBI363 demonstrated a good safety profile in preclinical in vivo models.

Dr. Morteza Aghmesheh, Southern Medical Day Care Centre Located in New South Wales, Australia, stated： "Wild type IL-2 is clinically validated as monotherapy, but limited by toxicity and low response rate due to poor selectivity. IBI363, a novel PD-1/IL-2 bispecific molecule, designed to selectively activates PD-1 positive T cells by cis-activating IL-2, but not PD-1 negative bystanders or naïve T cells, with the potential to significantly decrease toxicity related to IL-2 and potentially overcome immunotherapy resistance. We look forward to the positive results in the safety/tolerability and efficacy of IBI363 in the clinic."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Most patients will develop primary or secondary resistance after treatments of immune checkpoint inhibitors. At present, treatment options are limited upon progression after immunotherapy, and there is a huge unmet clinical needs. IBI363, developed by scientists at Innovent Academy, can enhance anti-tumor immune response by reversing T cell exhaustion, improving the efficacy of immune checkpoint inhibitors especially for patients with resistance to immunotherapy or "cold tumors", while minimizing IL -2 related side effects. We are pleased that the first patient dose of IBI363 has been completed in Australia. In parallel, the IND for IBI363 has been approved by NMPA in China. We are looking forward to the positive results of IBI363 in patients with advanced solid tumors or lymphoma. IBI363 is our first molecule to initiate clinical study in Australia, which marks a solid step of Innovent’s global innovation strategy. The company will also accelerate the development of more innovative molecules with high global potential, taking advantage of cross-regional R & D and clinical resources, adhering to the long-term development strategy of "driven by innovation, developed through globalization" with an aim to benefit cancer patients worldwide."

About IBI363

IBI363, potential First-in-Class candidate drug, was self-developed by Innovent. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein, which simultaneously blocks PD-1/PD-L1 pathway and activates IL-2 pathway to stimulate T cell activation and proliferation, thus killing tumor cells and inhibiting tumor growth. Currently, Phase 1 studies of IBI363 are conducted in China and Australia (NCT05460767, NCT05290597) to assess the safety, tolerability, and preliminary efficacy of IBI363 in subjects with advanced solid tumors or lymphoma, and to determine the recommended Phase 2 dose (RP2D).

On August 23, 2022 Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular disorders, reported it has entered into a global licensing agreement with Lee’s Pharmaceutical (HK) Limited, (Lee’s) and its affiliate Zhaoke Pharmaceutical (Hefei) Co. Ltd., (Zhaoke) for the development and commercialization of Windtree’s acute pulmonary pipeline treatments KL4 surfactant and drug/device combination, AEROSURF, for the treatment of preterm infants with respiratory distress syndrome (RDS) and other potential applications (Press release, Lee’s Pharmaceutical, AUG 23, 2022, View Source [SID1234618566]). RDS often occurs in preterm infants when the lung is not fully developed with natural lung surfactant and may require surfactant therapy to sustain life.

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"We are excited to announce this global licensing transaction for our KL4 surfactant platform given the value it can provide to the Company, its shareholders and critically ill patients," said Craig Fraser, President and Chief Executive Officer of Windtree. "The out-licensing of the KL4 platform supports our portfolio prioritization and increases non-dilutive resources to progressing istaroxime on the significant opportunity in the major markets of cardiogenic shock and heart failure where recent positive data has created what we believe could be a relatively fast and less expensive developmental pathway in cardiogenic shock. Given the clinical potential of KL4 surfactant and AEROSURF to help preterm infants with RDS, we desired a partner who was capable of fully assuming execution of the platform and could build value. Over the past few years, we have worked with the Lee’s and Zhaoke’s teams as they invested significantly in building manufacturing, analytical and clinical capabilities to move the KL4 platform into late-stage development. This transaction strengthens Windtree’s resources for its core programs and delivers significant potential value to its shareholders on assets we were no longer progressing ourselves."

Under terms of the global license agreement, Lee’s and Zhaoke will receive a global license to develop and commercialize Surfaxin, lyophilized lucinactant and AEROSURF for any potential indications and applications. Lee’s and Zhaoke will be responsible for funding all development, intellectual property, manufacturing, and commercialization activities and provide developmental, regulatory and eventual commercial sales milestones for Windtree of up to $78.9 million plus potential double-digit royalties. Windtree had previously granted a regional license to Lee’s and Zhaoke for KL4 and AEROSURF for the territory of Greater China for which Windtree received an upfront payment, and this new agreement expands that territory globally. With the execution of this agreement, Windtree will no longer have ongoing maintenance and operating costs for the KL4 platform.

About Lyophilized Lucinactant and AEROSURF
Lyophilized lucinactant is an investigational synthetic peptide (KL4 surfactant) containing drug product that is being developed to improve the management of RDS in premature infants who may not have fully developed natural lung surfactant and may require surfactant therapy to sustain life. AEROSURF (lucinactant for inhalation) is a drug/device combination designed to deliver aerosolized KL4 surfactant noninvasively using our proprietary ADS technology and potentially may meaningfully reduce the use of invasive endotracheal intubation and mechanical ventilation. We believe that AEROSURF, if approved, may meaningfully reduce the number of premature infants who are subjected to invasive surfactant administration, and potentially provide transformative clinical and pharmacoeconomic benefits. The FDA has granted Fast Track designation for AEROSURF to treat RDS and the program has Orphan Drug designation.

On August 23, 2022 Nanostics Inc., a precision health diagnostics company, reported that it has received the CE-IVD Mark for its ClarityDX Prostate test (Press release, Clarity Pharmaceuticals, AUG 23, 2022, View Source [SID1234618584]). This regulatory milestone allows Nanostics to market and sell ClarityDX Prostate in Europe, as well as other countries that require the CE Mark for market access.

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The ClarityDX Prostate test uses a proprietary machine-learning algorithm that combines data from biological and clinical biomarkers to generate a risk score for clinically significant prostate cancer, defined as Gleason grade group 2 or higher, on prostate biopsy. The ClarityDX Prostate test is intended to be used as a reflex test for men with elevated levels of PSA and is designed to help physicians and patients make a more informed decision on whether to proceed with a biopsy or not.

"We’re excited to reach this regulatory milestone for our ClarityDX Prostate test built on our robust biomarker and machine learning platform," said John Lewis, CEO of Nanostics. "Using ClarityDX Prostate as a reflex test for men with elevated PSA levels will help physicians, patients, and their families make more-informed decisions on how best to proceed with prostate cancer screening and result in better health outcomes for men with prostate cancer."

Recently, Nanostics announced positive results from its 1,500-patient clinical validation study of its ClarityDX Prostate test, showing 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant (grade group ≥2) prostate cancer. Implementation could eliminate up to 37% of unnecessary biopsies and significantly reduce the number of unnecessary treatments for prostate cancer.

Compliance with the relevant EU legislation and attainment of the CE-IVD mark represents Nanostics’ commitment to developing and marketing in vitro diagnostic medical devices that meet stringent regulatory requirements. Nanostics is committed to expanding its regulatory portfolio to allow for market access in different jurisdictions.

On August 23, 2022 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that initial results of the multi-regional clinical trial ("MRCT") of fruquintinib, FRESCO-2, will be presented at the upcoming European Society for Medical Oncology ("ESMO") Congress 2022, taking place on September 9-13, 2022 (Press release, Hutchison China MediTech, AUG 23, 2022, View Source [SID1234618567]). The meeting will be held at the Paris Expo Porte de Versailles, in Paris, France.

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Further details of the presentation are as follows:

Title: FRESCO-2: A global Phase 3 multi-regional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer
Presenter: Arvind Dasari, MD, MS, Associate Professor, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Session: Proffered Paper session 2: GI, lower digestive
Abstract No.: LBA25
Date & Time: Monday, September 12, 2022, 10:55 – 11:15 am Paris time
Location: 7.2.F – Fécamp Auditorium

Investor audio webcast and conference call is scheduled on Monday, September 12 at 2:00 pm Paris Time (1:00 pm London time, 8:00 am New York time, and 8:00 pm Hong Kong time).

Participating on the webcast will be members of the HUTCHMED management team as well as co-Principal Investigators from the study: Dr. Arvind Dasari and Professor Cathy Eng, MD, FACP, FASCO, David H. Johnson Endowed Chair in Surgical and Medical Oncology and Co-Leader, Gastrointestinal Cancer Research Program, at the Vanderbilt-Ingram Cancer Center.

Details of the conference call dial-in and the webcast link will be provided on the company website at www.hutch-med.com/event/. The presentation will be available for downloading before the conference call begins. A replay will also be available on the website shortly after the event.

About FRESCO-2
The FRESCO-2 study was a MRCT conducted in the U.S., Europe, Japan and Australia that investigated fruquintinib plus best supportive care ("BSC") vs placebo plus BSC in patients with advanced, refractory metastatic colorectal cancer ("CRC"). As previously disclosed, the study met its primary endpoint of overall survival ("OS") in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement in progression-free survival ("PFS"), a key secondary endpoint, was observed. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies.

About CRC
CRC is a cancer that starts in either the colon or rectum. CRC is the third most common cancer worldwide, estimated to have caused more than 915,000 deaths in 2020.[1] In the U.S., an estimated 151,000 people will have been diagnosed with CRC and 53,000 people will have died from CRC in 2022.[2] In Europe, CRC is the second most common cancer, with an estimated 507,000 new cases and 240,000 deaths in 2020.1 In Japan, CRC is the most common cancer, with an estimated 147,000 new cases and 59,000 deaths in 2020.1

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.

About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in late November 2018 under the brand name ELUNATE. It has been included in the China National Reimbursement Drug List (NRDL) since January 2020. ELUNATE is indicated for the treatment of patients with metastatic CRC who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study[3], a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

Gastric Cancer ("GC") in China: The FRUTIGA study is a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for the treatment of patients with advanced gastric or esophagogastric junction ("GEJ") adenocarcinoma who did not respond to first-line standard chemotherapy. Approximately 700 patients have received either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. The co-primary efficacy endpoints are OS and PFS (clinicaltrials.gov identifier: NCT03223376).

Immunotherapy combinations: HUTCHMED has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent Biologics, Inc. and marketed as TYVYT in China).

Metastatic breast, endometrial, and CRC in the U.S.: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase Ib/II study in the U.S. to investigate if the addition of fruquintinib can potentially induce activity to immune checkpoint inhibitor therapy in advanced, refractory triple negative breast cancer ("TNBC"), endometrial cancer, and CRC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04577963. Safety and preliminary efficacy of fruquintinib as a single agent were demonstrated in advanced solid tumors, including TNBC, in a Phase I study conducted in China (NCT01645215) and a Phase I/Ib study is ongoing in the U.S. (NCT03251378).
Gastric, colorectal and non-small cell lung cancers ("NSCLC") in China & Korea: BeiGene, Ltd. initiated this open-label, multi-center, Phase II study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic, unresectable GC, CRC or NSCLC. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04716634.
Endometrial cancer and other solid tumors in China: HUTCHMED initiated this open-label, multi-center, non-randomized, Phase II study to assess the safety and efficacy of fruquintinib in combination with sintilimab in patients with advanced cervical cancer, endometrial cancer, GC, hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma (RCC). Preliminary results of certain cohorts were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) and the Chinese Society of Clinical Oncology Annual Meeting (CSCO). Following encouraging data in the advanced endometrial cancer cohort, it has been expanded into a single-arm registrational Phase II study of over 130 patients. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT03903705.