On August 8, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM, HKEX: 13) and AstraZeneca PLC ("AstraZeneca") (LON/STO/Nasdaq: AZN) reported that preliminary results from the SAVANNAH Phase II trial showed that TAGRISSO (osimertinib) plus savolitinib demonstrated an objective response rate ("ORR") of 49% (95% confidence interval ["CI"], 39-59%) in patients with epidermal growth factor receptor-mutated ("EGFRm") non-small cell lung cancer ("NSCLC") with high levels of mesenchymal epithelial transition ("MET") overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with TAGRISSO (Press release, Hutchison China MediTech, AUG 8, 2022, View Source [SID1234617739]).

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The highest ORR was observed in patients with high levels of MET who were not treated with prior chemotherapy (52% [95% CI, 41-63%]). In patients whose tumors did not show high levels of MET, the ORR was 9% (95% CI, 4-18%). These results are being shared at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), taking place on August 6-9, 2022 in Vienna, Austria.

Savolitinib, marketed in China under the brand name ORPATHYS, is an oral, potent and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed and commercialized by AstraZeneca and HUTCHMED.

While EGFR-targeted therapy can provide a durable survival benefit to patients with EGFRm NSCLC, most will eventually develop resistance to their treatment, with MET being the most common resistance biomarker.1 Among patients screened for enrolment in SAVANNAH, all of whom experienced disease progression on TAGRISSO, 62% had tumors with MET overexpression and/or amplification, and more than one-third (34%) met the defined high MET level cut-off.

Myung-Ju Ahn, MD, PhD, Professor of Hemato-Oncology at the Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and Principal Investigator in the SAVANNAH Phase II trial, said: "Acquired resistance to targeted therapy and disease progression are difficult realities for most patients with EGFR-mutated NSCLC. These preliminary SAVANNAH results potentially support a novel approach for identifying patients with MET overexpression and/or amplification who are most likely to benefit from a MET-directed therapy, like savolitinib. They also suggest that with the right biomarker testing strategy, MET may be a more prevalent target among resistant patients than previously understood, supporting further investigation of the osimertinib plus savolitinib regimen."

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca said: "The current standard of care for patients with EGFR-mutated lung cancer who progress on targeted treatment is chemotherapy. The results from SAVANNAH suggest savolitinib added to TAGRISSO at the time of disease progression could possibly provide these biomarker-selected patients with a potentially less toxic, more effective treatment option. We look forward to better understanding the potential of the TAGRISSO plus savolitinib regimen in this trial and in the SAFFRON Phase III trial."

Weiguo Su, Chief Executive Officer and Chief Scientific Officer, HUTCHMED, said: "It is encouraging to see the savolitinib and TAGRISSO combination regimen progress into a global Phase III study, SAFFRON, with a well-supported patient selection strategy that could benefit more patients than previously recognized. The preliminary results of the SAVANNAH study also affirm the role of molecular testing prior to initiating subsequent treatment for NSCLC patients who experience disease progression on an EGFR-targeted therapy. We are aligned in pursuing a selective, patient-centric approach in development efforts for savolitinib in this setting."

In this analysis, patients’ MET overexpression and/or amplification levels were determined by two tests: immunohistochemistry ("IHC"), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridization ("FISH"), which detects a specific DNA sequence from cancer cells. All patients in this analysis (n=193) had at least IHC50+ and/or FISH5+, and were treated with savolitinib 300mg once daily added to TAGRISSO 80mg once daily following disease progression on TAGRISSO alone.

The safety profile of TAGRISSO plus savolitinib was consistent with the known profiles of the combination and each treatment alone. No new safety signals were identified. Less than half (45%) of patients in this analysis experienced Grade 3 or higher adverse events ("AEs"), with those most frequently reported including pulmonary embolism, dyspnea, decreased neutrophil count and pneumonia. AEs attributable to savolitinib and leading to discontinuation occurred in 13% of patients.

The global SAFFRON Phase III trial will further assess the TAGRISSO plus savolitinib combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following TAGRISSO. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.3 The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease and approximately 10-15% of NSCLC patients in the U.S. and Europe and 30-40% of patients in Asia have EGFRm NSCLC.4,5,6,7

MET is a tyrosine kinase receptor that has an essential role in normal cell development.8 MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is the primary mechanism of acquired resistance to EGFR TKIs for metastatic EGFR-mutated NSCLC. 8,9 The prevalence of MET depends on the sample type, detection method and assay cut-off used.10

About SAVANNAH
SAVANNAH is an ongoing global, randomized, single-arm Phase II trial studying the efficacy of savolitinib added to TAGRISSO in patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression and/or amplification who progressed following treatment with TAGRISSO. Patients were treated with savolitinib 300 or 600 mg once-daily (QD) or 300 mg twice-daily, in combination with oral osimertinib 80 mg QD.

The trial has enrolled 294 patients to date in more than 80 centers globally, including centers in the U.S., Canada, Europe, South America and Asia. The primary endpoint is ORR. Key secondary endpoints include PFS, DoR and safety.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat approximately 575,000 patients across indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

In Phase III trials, TAGRISSO is being investigated in the neoadjuvant resectable setting (NeoADAURA), in the Stage IA2-IA3 adjuvant resectable setting (ADAURA2), in the Stage III locally advanced unresectable setting following chemoradiation therapy (LAURA), and in combination with chemotherapy in the advanced setting (FLAURA2). AstraZeneca is also researching ways to address tumor mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test TAGRISSO given concomitantly with savolitinib, an oral, potent and highly selective MET TKI, as well as other potential new medicines.

About Savolitinib
Savolitinib is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

Savolitinib is marketed in China under the brand name ORPATHYS for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney and gastric cancers, as a single treatment and in combination with other medicines.

About AstraZeneca and HUTCHMED collaboration
In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib. Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.

About AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and assessing innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations including TAGRISSO (osimertinib) and IRESSA (gefitinib); IMFINZI (durvalumab) and tremelimumab; ENHERTU (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; ORPATHYS (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

About AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On August 8, 2022 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Celldex Therapeutics, AUG 8, 2022, View Source [SID1234617774]).

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"In late June, Celldex reported positive interim data from our ongoing Phase 1b study of barzolvolimab in chronic spontaneous urticaria, where multiple doses demonstrated rapid, marked and durable responses, including in patients with prior omalizumab treatment," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We are very encouraged by these results which we believe demonstrate barzolvolimab’s potential to provide meaningful symptom relief to patients suffering from diseases driven by mast cells. These data, together with our previously reported positive results in chronic inducible urticaria, support the continued clinical development of barzolvolimab, including our recently initiated Phase 2 chronic urticaria studies."

Mr. Marucci continued, "We are pleased with our recent advances and expansion of the barzolvolimab program into later stage studies and additional indications, along with the continued development of our bispecific platform. We also recently made the decision to transition development of CDX-1140 to investigator-led studies, allowing us to focus our resources on the programs we believe hold the most value for patients and shareholders. We look forward to providing updates on progress across our programs, with additional significant key milestones expected in the upcoming quarters."

Recent Program Highlights

Barzolvolimab (also referred to as CDX-0159) – KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

On June 30, Celldex reported interim data from the barzolvolimab multiple dose Phase 1b study in Chronic Spontaneous Urticaria (CSU) which were presented as a late-breaking electronic poster presentation as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2022.

Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Barzolvolimab results in rapid, marked and durable responses in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment.
Mean reduction from baseline in urticaria activity (UAS7) of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the 3 mg/kg dose group (n=9) at week 8 (reflects only one dose), demonstrating clinically meaningful symptom improvements for patients.
Complete response (UAS7=0) of 57.1% in the 1.5 mg/kg dose group at week 12 and 44.4% at week 8 (reflects only one dose) in the 3 mg/kg dose group which is a key therapeutic goal.
75% well-controlled disease by Urticaria Control Test (UCT) in the 1.5 mg/kg dose group at week 12 and 83.3% in the 3 mg/kg dose group at week 8 (reflects only one dose).
Tryptase suppression paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.

In June and July 2022, Celldex announced that the first patients have been dosed in the Phase 2 clinical studies of barzolvolimab for the treatment of CSU and the two most common forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD). These randomized, double-blind, placebo-controlled, parallel group Phase 2 studies are evaluating the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategies.

Celldex continues to enroll patients in the barzolvolimab Phase 1b open label study in chronic inducible urticaria in a third cohort (single dose, 3 mg/kg) in cholinergic urticaria and a fourth cohort at a lower dose (single dose, 1.5 mg/kg) in cold urticaria.

Celldex continues to enroll patients in the barzolvolimab Phase 1b multi-center, randomized, double-blind, placebo-controlled study in patients with prurigo nodularis (PN), a chronic skin disease characterized by the development of hard, intensely itchy (pruritic) nodules on the skin.

Celldex remains on track with the development of barzolvolimab in eosinophilic esophagitis (EoE), the most common type of eosinophilic gastrointestinal disease, and plans to initiate a Phase 2 trial in the fourth quarter of 2022.
CDX-527 – Bispecific Antibody Program

CDX-527 is the first candidate developed by Celldex from its bispecific platform which utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.

In the Phase 1 dose-escalation study of CDX-527 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy, enrollment to the dose escalation portion of the study has been completed and an expansion cohort in ovarian cancer is currently enrolling patients.
CDX-1140 – CD40 Agonist Program

CDX-1140 is a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

Recently, Celldex reviewed updated data from the CDX-1140 Phase 1 expansion cohorts in combination with KEYTRUDA (pembrolizumab) in patients with squamous cell head and neck cancer (SCCHN) and non-small cell lung cancer who had progressed on checkpoint therapy. Evidence of clinical benefit was most evident in patients with SCCHN, all of whom had progressive disease on prior anti-PD-1/L1 based therapies. Despite evidence of clinical benefit, questions remain to be answered about CDX-1140, and the broader CD40 agonist class, regarding the best clinical settings, regimens, and possible combinations before advancing into additional Celldex sponsored studies. Given our pipeline priorities and resource requirements, Celldex will not progress further Company-sponsored studies at this time and is exploring alternative means of answering these questions, including through investigator sponsored studies.
Recent Operational Highlights

In June 2022, Cheryl L. Cohen and Dr. Garry Neil were appointed to the Celldex Board of Directors. Ms. Cohen currently serves as President of CLC Consulting, a pharmaceutical and biotechnology consulting firm that specializes in new product start-ups and commercialization. Dr. Neil currently serves as Chief Executive Officer at Avalo Therapeutics (formerly Cerecor, Inc.), a publicly held biotechnology company.

In July 2022, Celldex executed a settlement agreement with Shareholder Representative Services (SRS), the representative of the former stockholders of Kolltan Pharmaceuticals, Inc. Celldex believes this is a favorable financial outcome for the Company and its shareholders and it achieves certainty and avoids the distraction and further cost of litigation. Total potential contingent milestones (payable in cash or stock at Celldex’s discretion) from the merger agreement were reduced from $172.5 million to $80.0 million of which $15.0 million was paid in July.
Second Quarter 2022 Financial Highlights and 2022 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2022 were $356.8 million compared to $380.5 million as of March 31, 2022. The decrease was primarily driven by second quarter cash used in operating activities of $22.2 million. At June 30, 2022, Celldex had 46.8 million shares outstanding.

Revenues: Total revenue was $0.2 million in the second quarter of 2022 and $0.3 million for the six months ended June 30, 2022, compared to $3.5 million and $4.2 million for the comparable periods in 2021. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University and Gilead Sciences.

R&D Expenses: Research and development (R&D) expenses were $20.7 million in the second quarter of 2022 and $37.8 million for the six months ended June 30, 2022, compared to $12.4 million and $25.1 million for the comparable periods in 2021. The increase in R&D expenses was primarily due to an increase in clinical trial and personnel expenses.

G&A Expenses: General and administrative (G&A) expenses were $7.2 million in the second quarter of 2022 and $14.1 million for the six months ended June 30, 2022, compared to $4.3 million and $8.4 million for the comparable periods in 2021. The increase in G&A expenses was primarily due to higher legal costs related to reaching a binding settlement term sheet ("the Term Sheet") with SRS, commercial planning and stock-based compensation expenses.

Changes in Fair Value Remeasurement of Contingent Consideration: The gain on fair value remeasurement of contingent consideration was $6.3 million for the second quarter of 2022 and $6.9 million for the six months ended June 30, 2022, primarily due to the Company’s decision to deprioritize the CDX-1140 program.

Litigation Settlement Related Loss: The Company recorded a one-time loss of $15.0 million in the second quarter of 2022 related to the initial payment due under the Term Sheet entered with SRS.

Net Loss: Net loss was $36.0 million, or ($0.77) per share, for the second quarter of 2022, and $59.1 million, or ($1.26) per share, for the six months ended June 30, 2022, compared to a net loss of $13.4 million, or ($0.34) per share, for the second quarter of 2021 and $29.9 million, or ($0.76) per share, for the six months ended June 30, 2021. The litigation settlement related loss had a ($0.32) impact on net loss per share in the three and six months ended June 30, 2022. The gain on fair value remeasurement of contingent consideration had a $0.14 and $0.15 impact on net loss per share in the three and six months ended June 30, 2022, respectively.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2022 are sufficient to meet estimated working capital requirements and fund planned operations through 2025.

On August 8, 2022 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and a strong emerging pipeline, reported financial results for the second quarter of 2022 and provided an update on recent corporate highlights (Press release, Inhibrx, AUG 8, 2022, View Source [SID1234617790]).

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Recent Corporate Highlights

On May 16, 2022, Inhibrx announced topline results from its Phase 1 clinical trial in INBRX-101 showing a favorable safety profile in patients with alpha-1 antitrypsin deficiency, or AATD, and demonstrating the potential to achieve normal functional alpha-1 antritrypsin levels with monthly dosing. The data shows the treatment was well tolerated with no severe or serious adverse events related to the study drug.
On June 30, 2022, Inhibrx announced completion of its Phase 1 dose escalation of INBRX-105 in combination with Keytruda and the initiation of Part 4 of the Phase 1 clinical trial.
On June 30, 2022, Inhibrx announced the receipt of $60.0 million in gross proceeds under its Loan and Security Agreement with Oxford Finance LLC.
Financial Results

Cash and Cash Equivalents. As of June 30, 2022, Inhibrx had cash and cash equivalents of $176.4 million, compared to $131.3 million as of December 31, 2021.
R&D Expense. Research and development expenses were $29.9 million during the second quarter of 2022, compared to $17.9 million during the second quarter of 2021. During the period, Inhibrx’s clinical trial expenses increased, both for its Phase 1 trials as they continue to progress, including the purchase of Keytruda as used in combination studies in its INBRX-105 trial, as well as its continued expenses related to the INBRX-109 potentially registration-enabling Phase 2 trial which was initiated during the second quarter of 2021. The organization also incurred increased contract manufacturing expenses due to greater production run costs at its contract development and manufacturing organization partners, including drug substance batch manufacturing in preparation for a Phase 2 trial supply and pilot batch production for one of its preclinical candidates. Personnel-related costs also increased during the period, which is attributable to an increase in headcount as Inhibrx continues to expand its clinical operations and technical operations teams.
G&A Expense. General and administrative expenses were $5.4 million during the second quarter of 2022, compared to $2.9 million during the second quarter of 2021. This overall increase was primarily driven by an increase in additional personnel-related costs due to an increase in headcount as the organization builds out its commercial strategy team. In addition, Inhibrx incurred market research expenses related to its continued pre-commercialization efforts for INBRX-101 and INBRX-109.
Net Loss. Net loss was $37.7 million during the second quarter of 2022, or $0.97 per share, compared to $20.7 million during the second quarter of 2021, or $0.55 per share.
About the Inhibrx sdAb Platform
Inhibrx utilizes diverse methods of protein engineering in the construction of therapeutic candidates that can address the specific requirements of complex target and disease biology. A key tool for this effort is the Inhibrx proprietary single-domain antibody, or sdAb, platform, which enables the development of therapeutic candidates with attributes superior to other monoclonal antibody and fusion protein approaches. This platform allows the combination of multiple binding units in a single molecule, enabling the creation of therapeutic candidates with defined valency or multiple specificities that can achieve enhanced cell signaling or conditional activation. An additional benefit of this platform is that these optimized, multi-functional entities can be manufactured using the established processes that are commonly used to produce therapeutic proteins.

On August 8, 2022 Guardant Health Inc. (Nasdaq: GH), a leading precision oncology company, and Blueprint Medicines Corporation (Nasdaq: BPMC) reported they are presenting new data demonstrating that the EGFR C797X mutation is the most common resistance mechanism to osimertinib therapy for patients with advanced non-small cell lung cancer (NSCLC) (Press release, Guardant Health, AUG 8, 2022, View Source [SID1234617805]). The results are being reported today at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer in Vienna.

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"This real-world study improves our understanding of how resistance mutations to osimertinib emerge over time, with new insights on when EGFR C797X mutations overtake MET amplifications as the most commonly acquired resistance mechanism," said Suresh Ramalingam, M.D., FACP, FASCO, executive director of Winship Cancer Institute of Emory University, who served as the principal investigator for the study. "The analysis characterizes the increased frequency of EGFR C797X mutations as patients are treated with first-line osimertinib for longer durations, reinforcing the need for next-generation EGFR inhibitors to address C797X-driven resistance."

A collaborative effort between Guardant Health, Blueprint Medicines and Winship Cancer Institute, the study analyzed de-identified clinical and genomic data using the GuardantINFORM real-world evidence platform, which includes more than 65,000 adults with advanced NSCLC. The analysis evaluated genomics data from the Guardant360 circulating tumor DNA (ctDNA) test for more than 2,000 patients who had any EGFR mutation and treatment with osimertinib, a third-generation EGFR TKI (tyrosine kinase inhibitor) and the current standard of care for patients with advanced-stage NSCLC with common EGFR mutations. The study incorporated ctDNA results up to five years after patients initiated osimertinib therapy.

Cumulatively, the analysis indicated that EGFR C797X mutations were 1.25 times more common than MET amplification when osimertinib was used as first-line therapy and 2.4 times more common when it was used as second-line therapy. In patients likely to experience disease progression after first-line treatment with osimertinib, the cumulative incidence of EGFR C797X mutations was 12.5 percent. MET amplifications were the most common resistance mutation in the first year of osimertinib treatment, and EGFR C797X mutations exceeded the rate of MET amplifications in years two through five.

"This study is an excellent example of how real-world data from the GuardantINFORM platform can be used to shed new light on resistance mechanisms in lung cancer therapy," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The analysis provided critical insights about resistance mutations that can contribute to the development of more effective therapies for lung cancer."

"We are committed to developing transformative precision therapies that prevent or overcome treatment resistance, which represents an important medical need for patients with EGFR-mutant, non-small cell lung cancer," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "Our collaboration with Guardant Health advances our efforts to characterize dynamic treatment resistance patterns in lung cancer, helping inform therapeutic strategies, including novel combinations, that may prolong patient benefit."

Blueprint_Logo_RGB_full-color (1).jpg Guardant Health

About GuardantINFORM
The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 225,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon and prostate.

On August 8, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported the closing of its previously announced underwritten public offering of 23,000,000 shares of its common stock at a public offering price of $3.50 per share, including 3,000,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Poseida Therapeutics, AUG 8, 2022, View Source [SID1234617821]). All of the shares were sold by Poseida. Including the option exercise, the aggregate gross proceeds to Poseida from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $80.5 million.

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Piper Sandler and William Blair & Company, L.L.C. acted as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BTIG, LLC also acted as book-running managers for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3, including a base prospectus, previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). The offering was made only by means of a written prospectus and prospectus supplement that formed a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall 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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.