On Janaury 24, 2023 VITRAC Therapeutics, reported LLC (VITRAC) initiated a Phase 1 Study of VIC-1911 as monotherapy and in combination with sotorasib for the treatment of KRAS G12C-mutant non-small cell lung cancer (NSCLC) (Press release, VITRAC Therapeutics, JAN 24, 2023, View Source [SID1234626517]). The study is being performed at Yale Cancer Center with Sarah Goldberg, MD, MPH, as Principal Investigator (PI) and Study Chair; New York University Perlmutter Cancer Center, Vamsidhar Velcheti, MD, PI; University of California Davis Comprehensive Cancer Center, Jonathan Riess, MD, PI; University of Maryland Cancer Center, Katherine Scilla, MD, PI; Emory University Winship Cancer Center, Jennifer Carlisle, MD, PI.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

VIC-1911 is a novel, highly selective, and orally active small molecular inhibitor of aurora kinase A (AURKA). AURKA gene amplification/overexpression is reported in multiple tumors, including NSCLC. AURKA inhibition with VIC-1911 demonstrated monotherapy activity in KRAS G12C-mutant human NSCLC cells with intrinsic and acquired resistance to the G12C inhibitor sotorasib. In addition, the combination of VIC-1911 and sotorasib showed synergy in the same cell lines. Interestingly, NSCLC cells with intrinsic resistance to sotorasib showed the most profound synergistic effects with the combination of VIC-1911 and sotorasib. These findings suggested that 1) AURKA activation led to both intrinsic and acquired resistance to sotorasib in KRAS G12C-mutant NSCLC and 2) the combination of VIC-1911 and sotorasib may be a potential therapeutic approach for KRAS G12C-mutant patients with intrinsic and acquired resistance to sotorasib. In vivo data suggests both sotorasib and adagrasib are synergistic in combination with VIC-1911 in human KRAS G12C-mutant NSCLC cell line xenograft models.

Additionally, in vivo studies demonstrated the synergy of VIC-1911 plus sotorasib compared with their respective monotherapies in KRAS G12C-mutant NSCLC xenograft models and a KRAS G12C-mutant PDX model. The combination of VIC-1911 plus sotorasib may be more active than sotorasib alone in KRAS G12C-mutant NSCLC that is naïve to G12C inhibitors.

"We now have two approved KRAS G12C inhibitors, sotorasib and adagrasib, available to treat our patients with KRAS G12C-mutated NSCLC," said Sarah Goldberg, MD, Study Chair. "Although response rates are considered good for patients naïve to KRAS G12C inhibitor therapy, more than 50% of patients have primary resistance and do not respond. In addition, many patients who do respond rapidly develop acquired resistance and relapse within months. With this new dual-targeted approach combining AURKA and KRAS G12C inhibitors, we hope to improve therapeutic outcomes for our patients with KRAS G12C-mutant NSCLC."

"VIC-1911 is a potent, selective AURKA inhibitor. Preclinical studies strongly support the combination of AURKA inhibition with VIC-1911 and KRAS G12C inhibitors in KRAS G12C-mutant NSCLC", said Thomas Myers, MD, Chief Medical Officer. "By utilizing this multi-targeted approach, we hope to provide a more effective therapeutic outcome for patients with KRAS G12C-mutant NSCLC."

On January 24, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported the closing of its underwritten public offering of 7,986,111 shares of its common stock (Press release, Deciphera Pharmaceuticals, JAN 24, 2023, View Source [SID1234626516]). The shares of common stock sold include 1,041,666 shares pursuant to the option granted by Deciphera to the underwriters, which option was exercised in full. The public offering price of each share of common stock was $18.00. The aggregate gross proceeds to Deciphera from this offering were approximately $143.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Deciphera intends to use the net proceeds from the offering to fund its planned Phase 3 INSIGHT study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18 only; to fund the development of vimseltinib, including completion of its Phase 3 MOTION study of vimseltinib in tenosynovial giant cell tumor patients, additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material and pre-commercial and medical affairs capabilities related to vimseltinib; to fund the development of DCC-3116, including multiple expansion cohorts in the ongoing Phase 1b combination dose escalation studies and potential Phase 2 expansion combination cohorts in multiple tumor types as well as clinical research outsourcing and manufacturing of clinical trial material; to fund the research and development of its pan-RAF program, as well as a potential new development candidate and other new research activities from its proprietary discovery engine of novel switch control inhibitors; and the remainder for working capital purposes, including general operating expenses.

J.P. Morgan, Jefferies, Cowen, and Guggenheim Securities acted as joint book-running managers for the offering.

The securities described above were offered by Deciphera pursuant to a shelf registration statement on Form S-3 (No. 333-266523) that was declared effective by the Securities and Exchange Commission (SEC) on August 10, 2022. A copy of the final prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone: +1 (833) 297-2926, or via email: [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, New York 10017, by telephone at 212-518-9544 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On January 24, 2023 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported it submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its noninvasive, stool-based, at-home screening test to detect colorectal cancer (CRC) and advanced adenomas (AA) in average-risk individuals (Press release, Geneoscopy, JAN 24, 2023, View Source [SID1234626515]). The FDA designated the test as a Breakthrough Device in January 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over 50 million Americans between the ages of 45 and 85 are eligible to be screened for CRC.1,2 Unfortunately, despite CRC being the second leading cause of cancer death in the U.S., millions of eligible Americans do not get screened – many due to a lack of knowledge of the importance of screening, lack of access to screening and concerns about the invasive nature of options like colonoscopy," said Dr. Erica Barnell, Chief Science Officer and Geneoscopy’s co-founder. "We are committed to closing this gap for patients who require screening and look forward to working with the FDA to bring a convenient and reliable screening option to patients that may allow for earlier detection and treatment – and potentially save lives."

The PMA submission is based on the favorable results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated 94% sensitivity for CRC and 45% sensitivity for advanced adenomas, representing the highest sensitivity profile reported to date for any noninvasive CRC screening test in a prospective clinical study.

Additionally, in the 45-49 age population, Geneoscopy’s test demonstrated 100% sensitivity for cancer and 44% sensitivity for advanced adenomas, at an 89% specificity. CRC-PREVENT is the first prospective study of a stool-based test to report CRC sensitivity in patients ages 45-49, an age group most recently added to the recommended screening population by the United States Preventive Services Task Force and the American Cancer Society. The robust sensitivity profile for CRC and advanced adenomas will offer significant value to this patient population.

"The completion of our PMA submission is a major milestone – Geneoscopy’s first regulatory approval application," said Andrew Barnell, Chief Executive Officer and Geneoscopy’s co-founder. "This product and the years of effort from our team that have brought us here exemplify the dedication to our mission to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The impact this test can have on patient health is beyond exciting, as is the validation of our stool RNA platform. We believe this platform will yield additional tests, including increasingly more precise CRC screening and high-value diagnostic testing for other gastrointestinal indications."

About CRC-PREVENT

CRC-PREVENT was a Phase 3 prospective, single-arm study designed to evaluate the efficacy of Geneoscopy’s noninvasive, stool-based, at-home screening test to detect colorectal cancer and advanced adenomas in average-risk individuals. Using a collection kit, participants submitted self-collected stool samples via express delivery and underwent an optical colonoscopy examination. All significant lesions discovered during the colonoscopy were biopsied or removed and sent for histopathology. A comparative analysis was conducted to determine sensitivities and specificities for colorectal cancer, advanced adenomas, non-advanced adenomas, hyperplastic polyps, and colonoscopies with no findings.

About Colorectal Cancer & Screening

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. Yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and potential time away from work. Currently available noninvasive screening methods demonstrate lower sensitivity to detect early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are estimated to be a precursor in 95 percent of CRC cases.3

On January 24, 2023 Geneseeq Technology Inc. reported that Geneseeq’s multi-cancer minimal residual disease detection (MRD) and multi-cancer early detection (MCED) kits were both CE Marked for liquid biopsy use in solid tumor patients (Press release, Geneseeq, JAN 24, 2023, View Source [SID1234626514]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The markings will enable Geneseeq to expand its global business operations and establish new partnerships in the European market.

The MRD detection kit (Shielding) employs ultra-deep sequencing technology ATG-SEQ to detect low amounts of circulating tumor DNA (ctDNA) in the peripheral blood post-surgical intervention.

For early cancer detection, the in vitro diagnostic kit uses highly sensitive next-generation sequencing-based technology MERCURY to assess multi-omics features of circulating free DNA (cfDNA) and detect tumorigenesis in health population.

In 2022, the council of the European Union has decided to improve cancer screening and strengthening cancer prevention through early detection1.

"Obtaining the CE marks for both our MRD and MCED kits is an important milestone for Geneseeq to bring personalized liquid biopsy tests to patients worldwide," said Dr. Xue Wu, Geneseeq Technology CEO.

On January 24, 2023 Biomica Ltd., a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported its CEO and VP R&D will both be participating in 7th Annual Microbiome Movement Drug Development Europe, taking place in London, UK, between January 31 and February 2, 2023 (Press release, Biomica, JAN 24, 2023, View Source [SID1234626513]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The 7th Microbiome Movement – Drug Development Summit Europe aims to unite Europe’s leading drug developers and microbiome experts to share their latest discoveries on microbiome functionality, translation, clinical development, biomarker discovery and manufacturing scale-up. In attendance from Biomica will be CEO Dr. Elran Haber and VP R&D Dr. Shiri Meshner.

Dr. Haber will take part in two industry panel discussions. These are entitled, "How to Turn Outstanding Microbiome Science into Effective & Efficient Products", taking place on February 1, 2023, at 9:30am GMT and "Working with Microbiome Investors", scheduled to take place later that day at 4:30pm GMT.

Dr. Meshner will be presenting on February 1, 2023, at 2:55pm, and the presentation is entitled, "Rationally Designed LBPs – From Computational & Pre-clinical Data to Clinical Studies."

Dr. Haber and Dr. Meshner will both be available for one-on-one meetings at the conference, and those interested should be in touch with the investor or public relations team.