On January 24, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported the presentation of results from the INTRIGUE Phase 3 study of QINLOCK (ripretinib) in patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series Session (Press release, Deciphera Pharmaceuticals, JAN 24, 2022, View Source [SID1234606721]). The presentation, which follows the announcement in November 2021 of the top-line results, is titled "INTRIGUE: A phase III, randomized, open-label study to evaluate the efficacy and safety of ripretinib vs sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib" and is available on the Company’s website at www.deciphera.com/presentations-publications.

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ASCO will be hosting a livestream event on Tuesday, January 25, 2022 at 3:00 PM ET featuring presentation of the abstract by Michael Heinrich, M.D., FACP, Professor of Medicine at Oregon Health & Science University followed by a discussion of the abstract by George D. Demetri, M.D., FASCO, FACP, Dana-Farber Cancer Institute, as well as a panel discussion with Drs. Heinrich and Demetri and Vicki Keedy, M.D., MSCI, Vanderbilt University Medical Center. To participate in the free and open session participants may register and login at View Source

"Patients with GIST in the post-imatinib setting are in need of additional treatment options for their disease, and the results from INTRIGUE demonstrate that ripretinib is an active and well-tolerated agent. Although the INTRIGUE study did not meet its primary endpoint of superiority in progression-free survival versus sunitinib, the efficacy of ripretinib appears comparable to sunitinib in 2nd line patients. In addition, ripretinib had a more favorable safety profile than sunitinib with fewer Grade 3/4 adverse events and patients reported less deterioration in role functioning and several other key patient-reported outcome measures of tolerability," said Dr. Heinrich. "It is important to provide the detailed results of this study to the oncology community to help treating physicians make well-informed decisions on the best treatment options for their patients with advanced GIST."

In patients with GIST who progressed on or were intolerant to imatinib, the efficacy of QINLOCK and sunitinib were comparable, although progression-free survival (PFS) of QINLOCK as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST) did not meet the study’s primary endpoint of superiority compared to sunitinib. The statistical analysis plan included a hierarchical testing sequence that included evaluation of patients with a KIT exon 11 primary mutation (Exon 11) and then of the all patient (AP) population. Key highlights from the study presented today include the following:

An international, multicenter study conducted in 122 active sites across 22 countries, 453 patients were randomized to ripretinib (n = 226; Exon 11, n = 163) or sunitinib (n = 227; Exon 11, n = 164).
In patients with a KIT exon 11 primary mutation, ripretinib demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0 months for the sunitinib arm (Hazard Ratio [HR] 0.88, p=0.36). In the AP population (n=453), ripretinib demonstrated an mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR 1.05, nominal p value=0.72).
In patients with a KIT exon 11 primary mutation, ripretinib demonstrated an objective response rate (ORR) of 23.9% (n=39 of 163) compared to 14.6% (n=24 of 164) for sunitinib (nominal p value=0.03). In the AP population ripretinib demonstrated an ORR 21.7% (n=49 of 226) compared to 17.6% (n=40 of 227) for sunitinib (nominal p value=0.27).
Ripretinib was generally well tolerated. Fewer patients in the ripretinib arm experienced Grade 3-4 treatment-emergent adverse events compared to sunitinib (41.3% vs 65.6%).
Patients receiving sunitinib were three times more likely to develop Grade 3 hypertension compared to patients receiving ripretinib (26.7% vs. 8.5%) and patients receiving sunitinib were seven times more likely to develop Grade 3 palmar-plantar erythrodysesthesia compared to patients receiving ripretinib (10.0% vs. 1.3%).
Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving ripretinib compared to patients receiving sunitinib. Patients receiving ripretinib experienced less deterioration in their ability to engage in either work or leisure activities during treatment and fewer patients receiving ripretinib experienced moderate to extremely large impact on their lives due to skin toxicity across treatment cycles compared to patients receiving sunitinib.
QINLOCK is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. The new drug application (NDA) for QINLOCK was based on positive results from the Phase 3 INVICTUS trial in patients with fourth-line and fourth-line plus GIST1. QINLOCK is also approved for the treatment of fourth-line GIST in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, and the United Kingdom.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation2,3. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST2,3.

On January 24, 2022 AIkido Pharma Inc. (NASDAQ: AIKI ) ("AIkido" or the "Company"), a clinical and early-stage drug development company, reported that its board of directors (the "Board") has authorized a share repurchase program to repurchase up to $3 million of the Company’s outstanding common stock (Press release, Spherix, JAN 24, 2022, View Source [SID1234606720]). The share repurchase authorization is effective immediately.

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"The Board’s decision to establish this share repurchase program reflects the Company’s commitment to creating shareholder value, our strong balance sheet and the expectations we have for 2022." said Anthony Hayes, CEO of AIkido. "We will continue our efforts to create shareholder value by continuing to prioritize capital allocation that supports our growth strategies. Further, we anticipate several monetization events this year, from several of our recent investments, which we believe will further augment shareholder value."

The shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 10b-18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, including blackout period restrictions.

On January 24, 2022 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) reported that its Board of Directors has today authorized the Company’s management to implement a stock repurchase program for up to $5 million of the Company’s common shares at any time (Press release, Tiziana Life Sciences, JAN 24, 2022, View Source [SID1234606719]). The term of the board authorization is until December 31, 2022. The repurchase program may be suspended or discontinued at any time and will be funded using the Company’s working capital.

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Executive Chairman Gabriele Cerrone commented, "This announcement demonstrates our confidence in Tiziana’s business and the growth opportunities we see over the long term. We believe this is an attractive use of capital, and based on the strength of our balance sheet, we continue to see ample opportunity to invest and grow our business."

On January 24, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of new data that suggest the company’s Percepta Genomic Sequencing Classifier (GSC) can accelerate delivery of curative therapy for patients with high-risk lung nodules and inconclusive bronchoscopy results (Press release, Veracyte, JAN 24, 2022, View Source [SID1234606715]). The findings, from a prospective, randomized decision impact study published in BMC Pulmonary Medicine, also show that the test can increase physician confidence in clinical decision-making and decrease unnecessary diagnostic procedures.

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While many physicians use bronchoscopy to evaluate potentially cancerous lung nodules, results from the non-surgical procedure are often inconclusive, which can lead to diagnostic uncertainty and treatment delays. Veracyte developed the Percepta GSC to aid in the diagnosis of patients who have suspicious lung nodules and inconclusive bronchoscopy results. Clinical guidelines and data suggest patients with nodules identified as high-risk for lung cancer should be considered for immediate curative therapy (ablative therapy and/or surgery); however, studies have shown that physicians frequently opt for conservative management such as further surveillance or additional diagnostic procedures in these patients.

"Determining how to manage high-risk lung nodule patients who’ve had a non-diagnostic bronchoscopy is clinically challenging," said Sonali Sethi, M.D., FCCP, Interventional Pulmonology, Cleveland Clinic, and lead author of the paper. "The findings from our study suggest that, by accurately up-classifying patients’ risk of malignancy from ‘high’ to ‘very high,’ this tool can help provide objective data that inform a more aggressive treatment approach in appropriate cases and increase physician confidence in their decision-making."

The Percepta GSC stratifies the risk of primary lung cancer to guide patient management when bronchoscopy is inconclusive. In the current, prospective, randomized decision-impact study, researchers evaluated whether a Percepta GSC result that up-classified a nodule’s pre-bronchoscopy risk of malignancy (ROM) from "high" (>60%) to "very high" (>90%) led to an increase in the rate of referral for surgical or ablative therapy without additional intervening procedures and to an increase in physician confidence in patient management.

Using patient cases from the Percepta GSC validation cohort, researchers selected 37 cases that had a high ROM pre-bronchoscopy, a non-diagnostic bronchoscopy, and a Percepta GSC result that up-classified ROM from "high" to "very high." They presented these cases to 101 U.S.-based pulmonologists in three formats: a pre-post cohort where each case was presented without and then with a Percepta GSC result, and two independent cohorts where each case was presented either with or without a GSC result. Researchers then surveyed the physicians regarding subsequent patient management steps and confidence in their clinical decision.

The study found that Percepta GSC test results significantly increased the rate of recommendation for curative therapy (in alignment with current guideline recommendations) without additional, intervening procedures. Physicians who received the Percepta GSC result recommended surgical resection or ablative therapy more than twice as often as those who did not receive the test result (45% vs. 17%, respectively, p<0.001). Among the pre-post cohort, the rate of recommendation increased from 17% to 56% (p<0.001) following review of the Percepta GSC result. Additionally, pulmonologists’ confidence in decision-making following a non-diagnostic bronchoscopy increased with the Percepta GSC up-classification. Prior to receiving the Percepta GSC result, 70% of physicians reported confidence level in their decision was at a 6 or 7 on a 7-point scale. This increased to 76% of physicians upon receipt of the Percepta GSC "very high" result, with a statistically significant increase at the highest possible level of 7 (from 21% to 31%; p=0.0017).

"Both pulmonologists and patients are often confronted by a great deal of uncertainty when faced with a non-diagnostic bronchoscopy," said Giulia Kennedy, Veracyte’s global chief scientific officer and chief medical officer. "These findings reinforce the clinical value and benefits of Veracyte’s Percepta GSC, suggesting that the test could help improve outcomes for early-stage lung cancer patients by supporting recommended treatment approaches, reducing diagnostic delays and preventing unnecessary procedures."

About the Percepta Genomic Sequencing Classifier (GSC)

The Percepta GSC is an RNA sequencing-based risk-stratification test designed to aid patient management in cases where a lung nodule is present and bronchoscopy results are unclear. The Percepta GSC is based on novel "field of injury" science, which identifies genomic changes that correlate with lung cancer risk in current or former smokers using a brushing to collect cells from the patient’s main lung airway during a standard bronchoscopy, without the need to sample the lesion directly. Previous analyses demonstrated the test’s accuracy in "down-classifying" patients at low risk of lung cancer and in "up-classifying" patients at high risk of the disease.1

About Lung Cancer

Lung cancer kills more than 1.8 million people worldwide each year.2 Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to 6 percent when it is found at a later stage.3 Lung nodules are typically the first sign of lung cancer, but most lung nodules are benign. Each year in the U.S., an estimated 1.6 million lung nodules are found incidentally on CT scans and, with recently expanded recommendations from the U.S. Preventive Services Task Force, an estimated 15 million Americans are eligible for annual lung cancer CT screening.

On January 24, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported it has been named to the 2022 OTCQX Best 50, a ranking of top performing companies traded on the OTCQX Best Market last year (Press release, Nuvo Pharmaceuticals, JAN 24, 2022, View Source [SID1234606714]).

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The OTCQX Best 50 is an annual ranking of the top 50 U.S. and international companies traded on the OTCQX market. The ranking is calculated based on an equal weighting of one-year total return and average daily dollar volume growth in the previous calendar year. Companies in the 2022 OTCQX Best 50 were ranked based on their performance in 2021.

"We are very pleased to be included in the 2022 OTCQX Best 50 at #39," said Jesse Ledger, Miravo’s President and CEO. "This achievement comes as a result of the dedication and hard work Miravo employees have made during 2021, as we continued to execute on our strategic plan."

For the complete 2022 OTCQX Best 50 ranking, visit

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The OTCQX Best Market offers transparent and efficient trading of established, investor-focused U.S. and global companies. To qualify for the OTCQX market, companies must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with applicable securities laws.