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 Ranok Therapeutics, a biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer and other serious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug application (IND) for RNK05047, a novel treatment for patients with advanced solid tumors and lymphomas (Press release, Ranok Therapeutics, JAN 24, 2022, View Source [SID1234606737]). Ranok expects to begin enrollment of the Phase 1/2 study entitled CHAMP-1 in the first half of 2022.

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RNK05047 is a first-in-class, small-molecule, BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMP (Chaperone-mediated Protein Degradation). This technology leverages the company’s expertise in protein homeostasis and the cellular chaperone network to degrade disease-associated proteins, and is designed to increase drug safety and efficacy through selective targeting of disease tissues.

"We are looking forward to initiating this clinical study of the first small-molecule therapy based on our CHAMP platform technology," said Weiwen Ying, Ph.D., Founder and Chief Executive Officer of Ranok Therapeutics. "The bromodomain transcription factor BRD4 is a master regulator of oncogenes involved in diverse cancer types. RNK05047 is designed to selectively degrade BRD4 protein in a tumor-targeted fashion, which differentiates it from other investigational therapies. We are optimistic that RNK05047 will provide a beneficial new therapeutic option for patients."

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 SeqOne Genomics, provider of next genomic analysis solutions for personalized medicine reported a Series A funding round of €20M (Press release, SeqOne, JAN 24, 2022, View Source [SID1234606738]).

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The round, led by Omnes, Merieux Equity Partners, together with the Software Club and existing investors, Elaia and IRDI Capital Investissement, will enable SeqOne Genomics to accelerate its international sales and the development of new collaborative genomic analysis tools to facilitate communications between different disciplines in the medical team, in order to improve patient outcomes in cancer and hereditary disease.

The company will intensify investments in the development of its genomic-aware data lake to improve the use of big data and machine learning approaches in genomic analysis with the aim of better addressing the fast-evolving needs of molecular biology labs that provide genomic analysis in clinical routine environments, as well as to biopharma companies developing new therapies.

SeqOne’s cloud-based solution manages the entire genomic analysis process from raw data to final report presented to clinicians. The solution’s end-to-end approach affords better analytic performance, high levels of traceability and improved operational efficiency and has already been adopted by a score of hospitals and central labs and biopharmas as well as spawning partnerships with leading manufacturers of genomics analysis hardware and reagents.

Nicolas Philippe, Ph.D., Co-founder and CEO of SeqOne Genomics stated "We are extremely happy to have closed this round with leading investors who bring extensive experience in deep-tech, healthcare and biotherapy and who share our vision of building SeqOne into a global leader in personalized medicine. The funding will give us the resources we need to enhance and commercialize our solution to make genomic analysis more accessible and affordable so that each patient can benefit from personalized medicine recommandations."

"The genomics analysis market is experiencing exponential growth driven by the needs of personalized medicine. With the rapid expansion in the available genomic-linked treatments, the complexity of treatment interactions, and the staggering volume of biological and medical data to be factored into each medical decision, biologists and doctors must have access to reliable and actionable analyses in real-time," stated Fabien Collangettes, Director at Omnes. "We were particularly impressed by SeqOne’s innovative technological approach that enables improved accuracy of genomic test while reducing turnaround time and cost, thus delivering a key competitive advantage in this fast-growing market."

With the closing of this round, SeqOne’s board of directors will be: Sacha Loiseau, Ph.D. independent board member and Chairman of the Board, Fabien Collangettes, Director at Omnes, Yoann Bonnamour, Investment Manager at Merieux Equity Partners, Marc Rougier, Partner at Elaia, Nicolas Philippe, co-founder and CEO of SeqOne Genomics and Jean-Marc Holder, Co-founder and Chief Strategy and Innovation officer of SeqOne Genomics.

This new funding round brings the total amount raised by SeqOne Genomics since its founding in 2017 to €23M.

The company currently employs over 40 staff, primarily experts in genomic medicine, data science, bioinformatics, software development and regulatory compliance / quality assurance. It plans to double its staff within the year to execute its ambitious plans.

On January 23, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported the presentation of interim clinical data from its Phase 1b combination therapy study of SBP-101, a proprietary polyamine analogue, with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Meeting that took place January 20-22, 2022 (Press release, Panbela Therapeutics, JAN 23, 2022, View Source [SID1234606716]).

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Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Panbela Therapeutics, commented, "We are excited to share interim data from cohort 4 and the expansion. A median overall survival (OS) of 12.0 months which is not yet final, and an objective response rate (ORR) of 48%, both exceeded historical rates reported for gemcitabine + nab paclitaxel and supports the continued development of SBP-101 as an addition to first-line treatment for advanced PDA and as neo-adjuvant treatment for patients with potentially resectable disease."

"The conclusion of the abstract is that SBP-101 may enhance first-line treatment with gemcitabine and nab-paclitaxel patients with metastatic PDA. We are encouraged by this conclusion even under sub-optimal conditions, including dose interruptions, which confounded results. Cohorts 2 and 3 did not have the dose interruptions that cohort 4 had, and cohort 2 had an objective response rate of 71%," continued Dr. Simpson. "We intend to continue development of SBP-101 and look forward to executing our global randomized phase 2 study in metastatic PDA."

At the Phase 1b dose and schedule (N=30), CA19-9 levels decreased 60-99% in 70% of evaluable patients, with 1/29 (3%) achieving a complete remission, 13/29 evaluable patients achieving partial responses (45%) and 10/29 achieving stable disease at 8 weeks (34%). PFS was 6.0 months. While PFS may be confounded by SBP-101 dosing holds implemented to investigate potential toxicity, the rates for 6-month PFS was 52% and for 12 month PFS was 10%. Nine subjects are in survival follow up as of the date the poster was presented at the ASCO (Free ASCO Whitepaper) GI meeting. Median OS is 12.0 months and is not final.

The safety population includes all subjects who received at least one dose of SBP-101 (N=50). The most common Grade ≥3 adverse events (AEs) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests in 14 subjects (5 attributed to SBP-101 and 9 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all subjects when SBP-101 administration was interrupted and dose-reduced or discontinued. Additionally, seven subjects experienced serious vision adverse events (4 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on PI assessment). All were considered by the sponsor to be possibly related to SBP-101; 5 had findings consistent with retinopathy.

The company has just begun a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, will begin a neoadjuvant pancreatic trial this quarter and will begin an Ovarian Cancer program mid-year.

Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source . After presenting at ASCO (Free ASCO Whitepaper) GI, the poster will be available on the company’s website on January 24, 2022.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .