On August 18, 2022 CG Pharmaceuticals, Inc. reported the first patient dosed with the ivaltinostat and capecitabine combination therapy for the Phase 1b/2 pancreatic adenocarcinoma (PDAC) maintenance study (Press release, CG Therapeutics, AUG 18, 2022, View Source [SID1234618496]).

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Commencement of treatment for the first patient began on Aug 15, 2022, and the study will continue to recruit patients in approximately 25 institutions throughout the US.

The Phase 1b study will investigate the safety and tolerability of ivaltinostat in 3 different dose cohorts with locally advanced or metastatic PDAC who have completed at least one prior therapy. In the Phase 2 study, metastatic PDAC patients who show no evidence of disease progression after treatment with FOLFIRINOX will receive either the ivaltinostat/capecitabine combination therapy or capecitabine monotherapy after randomization. The primary endpoint is to evaluate ivaltinostat’s effect on improving progression free survival (PFS), while key secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).

Dr. Joong Myung Cho, CEO of CG Pharmaceuticals and CrystalGenomics, stated "Dosing of the first patient is a significant milestone for ivaltinostat as there is a great unmet medical need for the PDAC patients. We are very excited about the start of this trial as ivaltinostat has demonstrated promising signs of efficacy from previous preclinical and clinical studies."

About Ivaltinostat

Ivaltinostat is a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase (HDAC). Ivaltinostat has been evaluated for anticancer effect for metastatic PDAC and myelodysplastic syndrome (MDS). The results of the Phase 2 study with unresectable or metastatic PDAC patients who have not had prior treatment were 93.8%, 25%, and 10.8 months, respectively for DCR, ORR and median OS. These results were published in the June 2022 publication of "International Journal of Cancer".

On August 18, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the Company has dosed the first patient in a Phase I/II clinical study of STP705, the Company’s leading siRNA (small interfering RNA) drug candidate, for the treatment of patients with facial squamous cell skin cancer in situ (isSCC) (Press release, Sirnaomics, AUG 18, 2022, View Source [SID1234618495]).

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The open label, dose escalation study is designed to evaluate the safety, tolerability, and efficacy of various doses of STP705 administered by intralesional injection and to determine the recommended dose. The study will also analyze biomarkers common to isSCC formation pathways, including TGF-β1 and COX-2. The primary endpoint is to determine the number of patients with histological clearance (HC) of facial isSCC lesions at the end of treatment with STP705. HC is defined as the absence of detectable evidence of the isSCC tumor cell nests as determined by central pathology review. A total of 30 patients, divided into three cohorts of 10 patients each, will receive a given dose once per week for six weeks. Cohort A will receive a 30 μg dose, Cohort B a 60 μg dose, and Cohort C a 90 μg dose.

"We expect that the study of STP705 as a treatment for facial isSCC to yield positive results given previous studies of STP705 that have shown to be safe and effective as a cancer treatment," said Dr. Patrick Lu, founder, Chairman of the Board, Executive Director, President and CEO of Sirnaomics. "Our drug has the potential to offer millions of patients with these non-melanoma facial lesions a non-surgical, non-invasive alternative to traditional lesion removal."

"With surgical removal being the only available treatment for isSCC currently, patients have normally found the results to be painful and aesthetically unpleasing on the face. By dosing our first patient in this Phase I/II study, we can begin to evaluate the safety and effectiveness of STP705 in eradicating these cancerous lesions," said Michael Molyneaux M.D., Executive Director and Chief Medical Officer of Sirnaomics. "Formulating this clinical trial as a dose escalation study also gives us the opportunity to determine which dose is the best suited in removing the cancer without adverse events."

The study started in the United States in August 2022, and is expected to be completed in Q1 2023. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT05421013.

About STP705
Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX2 gene expression. The product candidate has received multiple IND approvals from both the U.S. Food and Drug Administration (FDA) and the Chinese National Medical Products Administration (NMPA), including treatments of cholangiocarcinoma, non-melanoma skin cancer and hypertrophic scar. STP705 has also received Orphan Drug Designation for treatment of cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC). STP705 is currently in seven clinical trials for different indications: a Phase IIb for squamous cell carcinoma in situ (isSCC), a Phase II for basal cell carcinoma (BCC), a Phase I/II for keloid scarring, a Phase I/II for hypertrophic scar (HTS), a Phase I/II for facial isSCC, a Phase I for liver cancer (basket), and a Phase I for medical cosmetology treatment.

On August 18, 2022 The board of directors of Medtronic plc (NYSE:MDT) reported that approved the fiscal year 2023 second quarter cash dividend of $0.68 per ordinary share, representing an 8% increase over the prior year (Press release, Medtronic, AUG 18, 2022, View Source [SID1234618494]). This quarterly declaration is consistent with the dividend announcement made by the company in May 2022. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 45 consecutive years. The dividend is payable on October 14, 2022, to shareholders of record at the close of business on September 23, 2022.

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On August 18, 2022 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT), a new modality that uses emissions generated from the cancer itself to direct radiotherapy, reported a three-system contract with Select Healthcare, a developer of affiliated cancer facilities throughout the United States (Press release, RefleXion Medical, AUG 18, 2022, View Source [SID1234618493]). The multi-year, multi-site contract will create new free-standing treatment centers that showcase the dual modality of the RefleXion X1 platform for treating all stages of cancer with external beam radiotherapy (EBRT).

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"The creation of these initial three new free-standing radiotherapy centers will bring RefleXion’s novel BgRT to local communities so that patients with solid tumor cancers can receive state-of-the-art cancer care near their home," said Matthew Cutler, CEO, president and founder of Select Healthcare Solutions. "The X1 is the only system to offer breakthrough motion management for moving tumors using biological guidance and anatomic guidance for earlier stage cancers. We envision that this future capability will be attractive to our physician partners because it brings radiotherapy as a new treatment option to patients with late-stage cancer."

The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy to one or two tumors. Instead, it will one day allow radiotherapy to reach more tumors during the same treatment session, even those tumors that move due to patient motion, such as breathing or digestion.

"We applaud the Select Healthcare vision of bringing advanced cancer care to patients being treated at the community level through the establishment of these new centers," said Todd Powell, president and CEO of RefleXion. "As we move forward commercializing the X1 and our future release of BgRT, we are proud to count Select Healthcare among our early customers."

BgRT uses emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope, known as a PET tracer, to guide EBRT. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine design integrates PET arcs with a linear accelerator to detect these emissions and then direct radiotherapy to each tumor.

On August 18, 2022 Celltrion Healthcare reported that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer (Press release, Celltrion, AUG 18, 2022, View Source [SID1234618492]).

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"The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price," said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. "With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year."

The EC approval of Vegzelma follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.

Today’s approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.2

Vegzelma (CT-P16) is Celltrion’s third oncology biosimilar approved for use in the EU, following the approval of Truxima (biosimilar rituximab) and Herzuma (biosimilar trastuzumab). Vegzelma was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA) in September 2021. Approval is expected during the third quarter of 2022.