Biodesix to Present at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

On February 9, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present in a fireside chat at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference being held virtually February 15-17, 2022 (Press release, Biodesix, FEB 9, 2022, View Source [SID1234607921]).

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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

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BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Date: Wednesday, February 16, 2022
Time: 4:30 PM ET

Foundation Medicine Announces Global Collaboration With Lilly to Develop FoundationOne®CDx and FoundationOne®Liquid CDx as Companion Diagnostics for RETEVMO® and Loxo Oncology at Lilly’s Pipeline Programs

On February 9, 2022 Foundation Medicine, Inc. reported a collaboration with Eli Lilly and Company (Lilly) for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for RETEVMO and other therapies in Loxo Oncology at Lilly’s pipeline (Press release, Foundation Medicine, FEB 9, 2022, View Source [SID1234607920]). The partnership will initially explore the use of FoundationOneCDx for adult patients with metastatic rearranged transfection (RET) fusion across tumor types who may be eligible for Lilly’s RET inhibitor, RETEVMO in the United States and European Union.

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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

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"Foundation Medicine’s deep regulatory and genomics expertise makes us an essential partner for companies like Lilly who share our commitment to transforming cancer care," said Sanket Agrawal, MPH, MBA, chief biopharma business officer at Foundation Medicine. "This broad partnership will tap into our portfolio of end to end solutions to generate meaningful evidence and help optimize Lilly’s therapy development, and ultimately bring more targeted treatment options to cancer patients."

"We are pleased to collaborate with a widely-utilized and experienced laboratory like Foundation Medicine to ensure broad access to high quality, comprehensive genomic profiling for cancer patients who do not have access to such testing in their home institutions," said Anthony (Nino) Sireci, M.D., Vice President, Clinical Biomarkers and Diagnostics Development, Loxo Oncology at Lilly. "This global partnership offers this important patient population the opportunity to benefit from recent advances in precision oncology."

RETEVMO was approved by the Food and Drug Administration (FDA) in May 2020 as the first therapy specifically indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). RET fusions have been identified in approximately 2% of non-small cell lunger cancer (NSCLC) patients, 10% to 20% of papillary thyroid cancer patients, 60% of sporadic medullary thyroid cancer patients, over 90% of hereditary medullary thyroid cancer patients, and rarely in other cancers. i,ii,iii

Foundation Medicine has the most FDA-approved companion diagnostic claims on the market, across multiple cancer indications—FoundationOne CDx with 26 companion diagnostic claims and two group claims across 28 targeted therapies, and FoundationOne Liquid CDx with 9 companion diagnostic claims across 8 targeted therapies.

About FoundationOneCDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About FoundationOneLiquid CDx
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

ChemoCentryx to Participate in the 11th Annual SVB Leerink Global Healthcare Conference

On February 9, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 16th at 5:00 p.m. Eastern Time (Press release, ChemoCentryx, FEB 9, 2022, View Source [SID1234607919]).

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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

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A live webcast of the presentation can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. A replay of the webcast will be available on the Company’s website for two weeks following the live presentation.

Akebia Therapeutics to Report Fourth Quarter and Full-Year 2021 Financial Results and Discuss Recent Business Highlights

On February 9, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to release its financial results for the fourth quarter and full-year 2021 ended December 31, 2021, on Tuesday, March 1, 2022 (Press release, Akebia, FEB 9, 2022, View Source [SID1234607918]).

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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

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Akebia will not host a conference call due to the proximity to the anticipated March 29, 2022 Prescription Drug User Fee Act (PDUFA) target action date for vadadustat, which is under review by the U.S. Food and Drug Administration as a treatment for anemia due to chronic kidney disease.

Aptevo Therapeutics Earns $10 Million Non-Dilutive Milestone Payment on Sales of RUXIENCE, Provides Company Update

On February 9, 2022 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that the Company has earned a $10 million non-dilutive milestone payment related to 2021 sales of RUXIENCE (Press release, Aptevo Therapeutics, FEB 9, 2022, View Source [SID1234607917]). Additionally, based on RUXIENCE 2021 fourth quarter and full-year sales results, the Company is optimistic about the possibility of earning additional non-dilutive milestones totaling $22.5 million over the next two years. The Company also announced that its Phase 1b trial evaluating lead drug candidate APVO436 for the treatment of acute myeloid leukemia (AML) continues to enroll new clinical trial sites and that the first complete remission patient, announced in 2021, is proceeding to transplant.

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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

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RUXIENCE Milestones

Aptevo has earned a $10 million milestone payment related to sales of RUXIENCE under the terms of its royalty purchase agreement with HealthCare Royalty Management, LLC (HCR). The milestone will be used to pay down MidCap Financial debt, reducing outstanding principal on the debt to $5 million and strengthening the Company’s balance sheet. This, in combination with $46.3 million of cash-on-hand as of December 31, 2021, gives the Company cash runway through 1Q23, positioning Aptevo well to complete dosing in its ongoing APVO436 Phase 1b clinical trial and, in partnership with Alligator BioScience, to initiate a clinical trial for ALG.APV-527.

RUXIENCE, a Pfizer drug, is a biosimilar to RITUXAN. Pfizer reported 2021 revenue of $491 million from RUXIENCE, including $148 million in 4Q21, exceeding the $395 million threshold required for Aptevo to fully earn the 2021 $10 million milestone. Annualizing the $148 million Q4 revenue suggests 2022 full-year revenue could be approximately $592 million. Aptevo will earn $12.5 million of additional milestones in 2022 if revenue is at least $525 million. Similarly, an additional $10 million milestone can be earned in 2023 if revenue is at least $570 million. Given the above, Aptevo is optimistic about fully earning these additional future non-dilutive milestones totaling $22.5 million.

APVO436 Clinical Trial

The Company’s multi-site, multi-cohort Phase 1b clinical trial evaluating APVO436 for the treatment of acute myeloid leukemia (AML) continues to progress:

MD Anderson Cancer Center joins numerous other sites already enrolling and Aptevo plans to add additional sites this year
A patient with complete remission, announced in November 2021, is progressing to transplant
Initial data is expected mid-year 2022
"We are very pleased to announce meaningful progress in our clinical work and to reinforce the strength of our financial position, especially during such a challenging time in the market. From our inception, Aptevo has remained committed to a focused business strategy designed to deliver results that will ultimately benefit patients," said Marvin White, CEO. "On the clinical side, we are pleased to expand the number of trial sites as this increases the pool of patients potentially eligible to participate in the study. Further, we are happy to report that the patient we reported on in November, who achieved complete remission in the expansion trial, remains in remission and is proceeding to transplant. We wish them well."

"Adding to Marvin’s comments about a previously reported complete remission patient, it’s encouraging that they are proceeding to transplant after receiving a combination of chemotherapy plus APVO436. Complete remission and transplant in patients who have failed prior frontline therapy such as this one, are indicators that the patient is making positive clinical progress in fighting this difficult-to-treat disease." said Dirk Huebner, MD, Senior Medical Advisor.