On January 18, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that the U.S Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for KIN-3248, a next-generation pan-FGFR inhibitor being developed for intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC)(Press release, Kinnate Biopharma, JAN 18, 2022, View Source [SID1234605539]).

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"The IND clearance for KIN-3248 is another important validation of our Kinnate Discovery Engine and an exciting step forward in our mission to deliver new therapies to patients with difficult-to-treat, genomically-defined cancers," said Nima Farzan, Chief Executive Officer of Kinnate. "By targeting clinically relevant primary FGFR driver alterations and secondary resistance mutations, including FGFR2 and FGFR3 gatekeeper, molecular brake, and activation loop mutations, we believe that KIN-3248 is unique among FGFR inhibitors and has the potential to extend the clinical response of cancer patients with FGFR-altered tumors."

KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor that has been developed to address both primary FGFR2 and FGFR3 oncogenic alterations and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as ICC and other gastrointestinal cancers. In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance.

The Phase 1 trial is expected to initiate in the first half of 2022 and will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-cancer activity of KIN-3248 in FGFR inhibitor naïve and pretreated cancer patients with FGFR2 and/or FGFR3 gene alterations. The dose escalation portion (Part A) of the trial will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alterations. The dose expansion phase (Part B) of the trial will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC and other selected adult solid tumors.

Oncogenic FGFR (FGFR1, FGFR2, FGFR3, and FGFR4) gene alterations are observed in approximately 7% of all human cancers. FGFR2 gene fusions and FGFR3 activating alterations are predicted oncogenic drivers in approximately 10-20% of cholangiocarcinoma and 20-35% of urothelial cancers, respectively. While currently approved FGFR inhibitors and those in development provide clinical benefit in these cancer indications, disease progression typically occurs within 6-12 months of starting treatment and is often associated with the emergence of on-target resistance mutations within the FGFR kinase domain.

For more information about Kinnate’s pipeline of targeted oncology therapeutics, please visit: www.kinnate.com/science-and-pipeline.

On January 18, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its fourth quarter and full year 2021 financial results will be released on Tuesday, February 1, after the market closes (Press release, Gilead Sciences, 18 18, 2022, View Source [SID1234605596]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s fourth quarter and full year 2021 financial results and will provide a business update.

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A live webcast will be available on the investor relations page of View Source and will be archived on www.gilead.com for one year.

On January 18, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported the national launch of its new GeneStrat NGS genomic test, a blood-based tumor profiling test (Press release, Biodesix, JAN 18, 2022, View Source [SID1234605523]). The 52-gene panel includes guideline recommended mutations to help physicians treating advanced- stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

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The GeneStrat NGS test is paired with advanced variant interpretation technology connected to a powerful knowledge database developed by PierianDx. Physicians will now receive a streamlined report, including genomic insights for more precise patient care in an unprecedented 72-hour turnaround time.

The GeneStrat NGS test is paid by Medicare under the National Coverage Determination (NCD) for NGS Manual 90.2 section D by Novitas Solutions.

The Company also announced the launch of its new IQLung Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS and a broader view of each patient’s disease state. The testing strategy also includes blood-based proteomic and genomic testing workflows for both early and advanced stage lung cancer that can aid physicians in making treatment decisions. Biodesix plans to add additional tests in development to their IQLung portfolio.

"Initiating treatment as early as possible can help improve patient outcomes," said Scott Hutton, CEO, Biodesix. "Studies show the length of time to receive tests results impacts how quickly a patient goes on treatment. Current NGS tests can take anywhere from a week to a month to return results. This delay of diagnostic information contributes to patient anxiety and compliance, further delaying treatment when time is imperative in fighting lung cancer. It is our mission to change this paradigm, and we offer tests that provide important results in three days so patients can begin treatment as swiftly as possible."

On January 18, 2022 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported a collaboration and research agreement with The Danish Cancer Society Research Center (DCRC) to support clinical development of Lantern’s acylfulvene class drug candidates, LP-100 and LP-184, as well as the development of improved diagnostic methods to identify nucleotide excision repair (NER) deficient tumors (Press release, Lantern Pharma, JAN 18, 2022, View Source [SID1234605540]). LP-100 and LP-184 have both shown synthetically lethal impact in tumors that are lacking NER capabilities. The DCRC is a cancer research institute within the Danish Cancer Society. The Danish Cancer Society is Denmark’s largest non-government organization and dedicates more than 60% of its budget to research, with the remainder shared between prevention and patient support initiatives. Lantern expects the data, genomic signatures and biological models generated from this collaboration to add millions of data points to RADR and help accelerate the development of new indications for LP-100 and LP-184. This collaboration, together with the growing power of the RADR platform, can potentially uncover new drug combinations using LP-100 and LP-184 for cancer treatments at a fraction of the cost of traditional drug development.

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The overall aim of the collaboration is to determine the most promising patient populations for future LP-100 (irofulven) and LP-184 therapy. The collaboration will focus on developing improved diagnostic tools to detect NER deficiency patient profiles more accurately. The research study conducted as part of the collaboration will use expanded mutational signature-based analyses to achieve this objective. The study will include a comprehensive analysis of breast, ovarian, prostate, lung, kidney, bladder, stomach, pancreatic and esophageal cancer. This collaboration will help determine how many patients and which patients can benefit for targeting NER deficiency and also help assess the overall market size for both LP-100 and LP-184 across multiple solid tumors.

"Inherent DNA repair deficiencies characterize a subset of many of our common tumor types and are increasingly relevant as markers of therapeutic responses. The focus on defining NER deficiencies as a potential marker for irofulven use is in line with our strategies on drug repurposing as well as personalized oncology," says Mef Nilbert, medical oncologist and research director at the DCRC.

The collaboration research will be led by Dr. Zoltan Szallasi, MD as principal investigator at DCRC. Dr. Szallasi serves joint appointments as Group Leader of the Translational Cancer Genomics department at DCRC and as Faculty, Computational Health Informatics Program (CHIP) and Assistant Professor of Pediatrics at Boston Children’s Hospital affiliated with Harvard Medical School.

"Through our breakthrough approach of collaborating with internationally recognized research centers such as DCRC, we are able to leverage and grow our proprietary RADR A.I. platform with millions of additional data points to further our ability to rapidly discover biomarker signatures aimed at helping identify patients more likely to respond to cancer therapies, which we believe will significantly reduce development timelines and cost of treatment," commented Panna Sharma, CEO and President of Lantern Pharma Inc. "We are assembling a growing body of data supporting LP-184 and LP-100’s synthetic lethality to tumor cells with either NER or HR deficiency, and our collaboration with DCRC will further accelerate our path to clinical trials as well as provide opportunities for new trials and additional targeted indications."

LP-184 is a DNA-damaging small molecule drug candidate currently in preclinical development for certain genomically defined solid tumors, including pancreatic cancer and glioblastoma. As a next-generation acylfulvene class agent that preferentially damages DNA in cancer cells overexpressing certain biomarkers, LP-184 has the potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs. LP-184 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of malignant gliomas, as well as pancreatic cancer.

LP-100 exploits cancer cells’ deficiency in DNA repair mechanisms. LP-100 has the potential to be an important compound — either as monotherapy or in combination — for several challenging cancers that are impacting patients globally. LP-100 is in an existing genomic-signature guided phase 2 clinical trial in Denmark for patients with metastatic castration resistant prostate cancer (mCRPC). 9 patients (out of a targeted enrollment of 27) have been treated in the trial. The median overall survival (OS) for the initial group of 9 patients has been approximately 12.5 months, which is an improvement over other similar fourth-line treatment regimens for mCRPC.

On January 18, 2022 Exact Sciences reported performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy (Press release, Exact Sciences, JAN 18, 2022, View Source [SID1234605599]). Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 at ASCO (Free ASCO Whitepaper) GI in a poster titled, "Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions."

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Cologuard is the first and only FDA-approved, non-invasive stool DNA test used to screen average-risk people for CRC. Exact Sciences is developing a second-generation Cologuard to improve the specificity and precancer sensitivity of the test, decreasing the false positive rate and increasing the detection rate of precancerous lesions. The study shows the potential of a highly discriminate panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting. If approved, the second-generation Cologuard test could help increase screening rates while sending fewer people to follow-up colonoscopies unnecessarily and identifying more advanced precancers before they progress to cancer, helping prevent the disease.

"The Exact Sciences team is constantly innovating to help make earlier cancer detection a routine part of medical care," said Kevin Conroy, chairman and CEO. "These data demonstrate our commitment to patients and the power of our research and development teams, scientific platform, and expertise in colorectal cancer screening."

The study was carefully designed to simulate a true screening population and better predict real-world, prospective performance of the marker panel. It included non-advanced precancers, samples collected prospectively across all precancer types and sizes, and colorectal cancer samples weighted heavily towards early stages. The study consisted of 777 stool samples collected in the United States and Canada across 134 sites, including 112 cancers – 78% in stages I and II, 98 prospectively collected advanced precancerous lesions, 176 non-advanced precancerous lesions, and 391 negative controls.

"Exact Sciences and Mayo Clinic scientists worked together to discover these new methylation markers, which demonstrate improved performance over first-generation Cologuard markers," said Paul Limburg, MD, MPH, AGAF, Chief Medical Officer for Screening at Exact Sciences. "In particular, the observed increased specificity suggests that false positive screening results can be reduced, which has important implications for clinical practice and decision-making."

Colorectal cancer is the second deadliest cancer impacting both men and women in the United States. It’s also treatable if caught in early stages.1 Despite the benefits of CRC screening, approximately 45 million average-risk people in the United States remain unscreened.2 A multi-center pivotal trial evaluating second-generation Cologuard markers is ongoing, and results are expected late 2022 or early 2023. Exact Sciences plans to use results of the ongoing trial to support an FDA submission and approval and make the enhanced Cologuard test available broadly.

Conference call and webcast details

Exact Sciences management and Mayo Clinic will host a conference call and webcast on Wednesday, Jan. 19, 2022, at 11 a.m. ET to discuss results of the second-generation Cologuard study. The webcast will be available at www.exactsciences.com. Domestic callers should dial (833) 952-1519 and international callers should dial +1 236-714-2125. The access code for both domestic and international callers is 3972189.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 3972189. The webcast, conference call, and replay are open to all interested parties.

Additional data presented at 2022 ASCO (Free ASCO Whitepaper) GI Cancers Symposium

Four additional Exact Sciences abstracts were accepted and will be shared at ASCO (Free ASCO Whitepaper) GI. Details for each are included below and all abstracts can be found on the conference website.

Cologuard abstracts

Title: Patterns of Colorectal Cancer (CRC) Screening Rates Among the Average Risk US Population
Authors: Fisher, D., et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Title: Preferences for Colorectal Cancer Screening of Physicians and Individuals at Average Risk in the United States: A Discrete Choice Experiment
Authors: Heidenreich, et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Oncoguard Liver abstracts

Title: A Prospective Trial to Evaluate the Performance of the Multi-Target Hepatocellular Carcinoma Blood Test (mt-HBT) for Screening At-Risk Patients: The ALTUS Study
Authors: John, B., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

Title: Multi-Target Blood Test Can Improve the Performance of Hepatocellular Carcinoma Surveillance Programs: A Modeling-Based Virtual Trial
Authors: Chhatwal, J., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

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