On November 6, 2019 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three and nine months ended September 30, 2019 (Press release, Quanterix, NOV 6, 2019, View Source [SID1234550488]).

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!

"We are pleased with our execution and yet another record quarter with strong revenue growth, successful early launch of our new HD-X Analyzer and material progress accelerating global adoption of our ultra-sensitive Simoa technology," said Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix. "We are excited to have accelerated the HD-X Analyzer shipments a quarter early and also to have strengthened our balance sheet with a successful follow-on offering. We believe our growth trajectory and financial performance speak for themselves. We remain confident in our impressive opportunity for value creation as we pioneer disruption in healthcare. Our next major opportunity to advance our commercial momentum is by participating in the upcoming Powering Precision Health Summit in Barcelona, Spain on November 19, 2019 where over 40 top researchers are lined up to present on the disruptive potential of biomarker technology to transform drug development and enable a sea change advance in precision health."

Third Quarter 2019 Financial Highlights

Key financial results for the third quarter of 2019 are shown below:

·Q3 revenue was $14.9M versus prior year Q3 of $10.6M, an increase of 41%; Excluding $1.3M in revenue recognized in Q3 2018 in connection with the termination of a license agreement, non-GAAP year-over-year revenue growth was 62%;

·Q3 product revenue was $10.7M versus prior year Q3 of $6.0M, an increase of 80%;

·Q3 service and other revenue was $4.2M versus prior year Q3 of $3.0M, an increase of 39%; and

·Q3 GAAP gross margin was 47.1% versus prior year Q3 of 52.8%; Q3 non-GAAP gross margin was 51.8% versus prior year Q3 of 46.2%, an increase of 560 bps.

YTD 2019 Financial Highlights

Key financial results for 2019 YTD are shown below:

· YTD revenue was $40.8M versus prior year YTD of $26.8M, an increase of 53%. On a non-GAAP basis, year-over-year revenue growth was 61%;

· YTD product revenue was $29.1M versus prior year YTD of $15.9M, an increase of 83%;

·YTD service and other revenue was $11.8M versus prior year YTD of $8.7M, an increase of 35%; and

·YTD gross margin was 48.9% versus prior year YTD of 47.6%, YTD non-GAAP gross margin was 50.7% versus prior year YTD of 45.0%, an increase of 570 bps.

For additional information on the non-GAAP financial measures included in this press release, please see "Use Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below.

Third Quarter 2019 Business Highlights

·We began shipments of the HD-X Analyzer ahead of our Q4 expectation, following a successful Early Access Program. Trade-ins for the HD-1 instrument are outpacing expectations.

·Our Nf-L assay was highlighted in a record 50 publications at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, Sweden, continuing to demonstrate the growing momentum for clinical validity of this marker. Serum based Nf-L measurements were reported in major trials such as Novartis’ Phase III ASCLEPIOS trial, Roche’s results for Phase III OPERA I, II and ORATORIO trials, and Biogen’s data generated in collaboration with Siemens Healthineers using Quanterix/UmanDiagnostics Nf-L antibodies to adapt the Simoa assay onto a routine analyzer platform. We also hosted an extremely well-attended networking reception convening many leading opinion leaders in the field.

· We successfully raised $69M in gross proceeds through our follow-on offering, further strengthening our balance sheet with growth capital. Nearly $120M before expenses have been added to our balance sheet this year.

·We continued to strengthen our leadership team with a number of key hires. Dr. Tatiana Plavina joined us as vice president of Clinical BioMarker Strategy where she will focus on further advancing our industry by leading efforts on Nf-L and other biomarkers as clinically-meaningful tools for drug development and clinical care. Tatiana joins Quanterix after a successful 18-year career at Biogen, where she has been a biomarker leader, advancing clinical trials, developing a companion diagnostic test for Tysabri, and furthering the clinical relevance of serum Nf-L assay for drug development as a measure of neuronal health.

·Earlier this week, we entered into a licensing and supply arrangement with Siemens Healthineers for access to Quanterix’ proprietary Nf-L antibodies. We are pleased to have the opportunity to work with as formidable a partner as Siemens Healthineers to accelerate the availability of an Nf-L test for patients around the world.

·Quanterix was invited to present its disruptive approach to using minimally invasive biomarkers at a number of high-profile venues, including the SVB Leerink Healthcare CEO Summit, the Laguna Biotech CEO Forum, and the Healthcare CEO Summit in partnership with the Cleveland Clinic. We were also featured on "Nasdaq Spotlight" where we discussed our biomarker potential to enable precision health and participated in an interview with the author of the new book, "The First Cell: And the Human Cost of Pursuing Cancer to the Last," where we highlighted the potential of our newly released Simoa SP-X oncology technology in the battle against cancer. View Source

·Quanterix will be an exclusive Platinum Sponsor of the 2019 Powering Precision Health (PPH) Summit scheduled for November 19 in Barcelona, Spain, which continues to receive solid interest from opinion leaders and researchers from around the world. More than 40 speakers will be presenting their research across two full concurrent tracks in neurology and oncology.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 6 at 4:30 p.m. EST. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 5798993. A live webcast will also be available at: View Source and through the Investors section of the Company’s website,

On November 6, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2019 (Press release, Puma Biotechnology, NOV 6, 2019, View Source [SID1234550487]). Unless otherwise stated, all comparisons are for the third quarter 2019 compared to the third quarter 2018.

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!

Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the third quarter of 2019 was $53.5 million, compared to net NERLYNX revenue of $52.6 million in the third quarter of 2018. Net NERLYNX revenue in the first nine months of 2019 was $152.9 million, compared to net NERLYNX revenue of $139.4 million in the first nine months of 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $16.9 million, or $0.44 per share, for the third quarter of 2019, compared to a net loss of $14.2 million, or $0.37 per share, for the third quarter of 2018. Net loss for the first nine months of 2019 was $64.4 million, or $1.67 per share, compared to $82.9 million, or $2.19 per share, for the first nine months of 2018.

Non-GAAP adjusted net loss was $4.7 million, or $0.12 per share, for the third quarter of 2019, compared to non-GAAP adjusted net income of $6.6 million, or $0.17 per basic share and $0.16 per diluted share, for the third quarter of 2018. Non-GAAP adjusted net loss for the first nine months of 2019 was $18.6 million, or $0.48 per share, compared to non-GAAP adjusted net loss of $14.5 million, or $0.38 per share, for the first nine months of 2018. Non-GAAP adjusted net loss excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the third quarter of 2019 was $7.3 million, compared to $7.3 million in the third quarter of 2018. Net cash provided by operating activities for the first nine months of 2019 was $20.8 million, compared to net cash used in operating activities of $31.2 million for the first nine months of 2018. At September 30, 2019, Puma had cash, cash equivalents and marketable securities of $110.4 million, compared to $165.4 million at December 31, 2018.

"In the third quarter of 2019 we were pleased to report that our supplemental New Drug Application for neratinib for the treatment of third-line HER2-positive metastatic breast cancer was accepted by the U.S. Food and Drug Administration," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "The FDA also granted Orphan Drug Designation for neratinib for the treatment of breast cancer patients with brain metastases during the quarter. In addition, we were pleased to report that NERLYNX was approved by Health Canada and ANMAT in Canada and Argentina, respectively, during the quarter."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 to 18 months: (i) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; (ii) reporting Phase II data from the SUMMIT basket trial of neratinib in HER2 nonamplified (HER2 negative) breast cancer patients with a HER2 mutation in the fourth quarter of 2019; (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries; (iv) receiving a U.S. regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer in the second quarter of 2020; and (v) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in either the fourth quarter of 2020 or the first half of 2021."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the third quarter of 2019, total revenue was $56.4 million, of which $53.5 million was net product revenue, $2.8 million was license revenue received from Puma’s sub-licensees and $0.1 million was royalty revenue. This compares to total revenue of $62.6 million in the third quarter of 2018, of which $52.6 million was net product revenue and $10.0 million was license revenue received from one of Puma’s sub-licensees. For the first nine months of 2019, total revenue was $209.3 million, of which $152.9 million was net product revenue, $56.2 million was license revenue received from Puma’s sub-licensees and $0.2 million was royalty revenue. This compares to total revenue for the first nine months of 2018 of $179.9 million, of which $139.4 million was net product revenue and $40.5 million was license revenue.

Operating Costs and Expenses

Operating costs and expenses were $70.8 million for the third quarter of 2019, compared to $73.9 million for the third quarter of 2018. Operating costs and expenses for the first nine months of 2019 were $239.7 million, compared to $256.0 million for the first nine months of 2018.

Cost of Sales

Cost of sales was $9.4 million for the third quarter of 2019 and $26.7 million for the first nine months of 2019, compared to $9.0 million for the third quarter and $24.3 million for the first nine months of 2018.

Selling, General and Administrative Expenses

Selling, general and administrative expenses (SG&A) were $31.4 million for the third quarter of 2019, compared to $28.5 million for the third quarter of 2018. SG&A expenses for the first nine months of 2019 were $110.4 million, compared to $105.2 million for the first nine months of 2018. The $5.2 million year-to-date increase resulted primarily from increases of approximately $10.4 million for professional fees, such as legal fees and marketing and commercial support, and $0.6 million for office and banking expenses. These were partially offset by decreases of approximately $4.0 million in employee stock-based compensation expense, $0.9 million in payroll and payroll-related expenses, and $0.9 million in travel and meeting-related expenses.

Research and Development Expenses

Research and development (R&D) expenses were $30.0 million for the third quarter of 2019, compared to $36.4 million for the third quarter of 2018. R&D expenses for the first nine months of 2019 were $102.6 million, compared to $126.5 million for the first nine months of 2018. The $23.9 million year-to-date decrease resulted primarily from decreases of approximately $18.5 million in stock-based compensation expense, $4.4 million for internal R&D, primarily related to payroll and payroll-related expenses, $0.8 million in clinical trial expenses, and $0.2 million in consulting and contractor expenses related to clinical research and regulatory activities.

Total Other Income (Expenses)

Total other expenses were $2.5 million for the third quarter and $34.0 million for the first nine months of 2019, compared to total other expenses of $2.9 million for the third quarter and $6.8 million for the first nine months of 2018. The $27.2 million year-to-date increase includes approximately $16.4 million related to a March 2019 jury verdict against Puma, $8.1 million in loss on debt extinguishment related to fees paid in connection with our debt refinancing in the second quarter of 2019 and a $3.5 million increase in net interest expense. These amounts were offset by other immaterial fluctuations.

Conference Call

Puma Biotechnology will host a conference call to report its third quarter 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Wednesday, Nov. 6, 2019. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international) at least 10 minutes prior to the start of the call and referencing the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at www.pumabiotechnology.com. A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

On November 6, 2019 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported its financial results for the third quarter ended September 30, 2019, and provided a corporate update (Press release, Protagonist, NOV 6, 2019, View Source [SID1234550486]).

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 progress of our three clinical candidates shows the strength and versatility of the Protagonist peptide engineering platform," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "These maturing assets reflect our steady transition toward becoming a fully integrated company. In addition to the ongoing Phase 2 study in beta-thalassemia, we continue to explore the full potential of the hepcidin mimetic PTG-300 as one product with multiple clinical applications. We recently dosed the first patient in a Phase 2 open-label study for the potential treatment of polycythemia vera. We are on track to initiate a Phase 2 study with PTG-300 in hereditary hemochromatosis, and we expect an investigator sponsored study in myelodysplastic syndrome to begin in early 2020. In the portfolio of inflammatory bowel disease product candidates comprised of oral gut-restricted peptides, we plan to begin a Phase 2 study with the alpha-4-beta-7 integrin antagonist PN-943 in patients with ulcerative colitis in the second quarter of 2020, on the basis of a completed Phase 1 study. We also recently dosed the first patient in a Phase 2 study of oral interleukin-23 receptor antagonist PTG-200, partnered with Janssen Biotech, with results from this study expected in 2021. Finally, we continue to maintain a strong financial position, with available cash, investments and access to an established debt facility to support the development of pipeline assets through year-end 2021."

Product Development and Corporate Update:

PTG-300

·Preliminary Phase 2 results from the ongoing study of PTG-300 for the treatment of beta-thalassemia are expected in the fourth quarter of 2019.

·An abstract relating to pre-clinical studies of hepcidin mimetic PTG-300 has been accepted for presentation at the American Society for Hematology (ASH) (Free ASH Whitepaper) Annual meeting, taking place Dec. 7-10 in Orlando, Fla.

·The Company is planning to initiate a Phase 2 study in patients with hereditary hemochromatosis, a third indication of development for PTG-300, by early 2020.

· An investigator-sponsored study of PTG-300 in patients with myelodysplastic syndromes, which represents a fourth potential indication for PTG-300, is expected to begin in early 2020.

PTG-943

· Protagonist announced results from the multiple ascending dose (MAD) part of the Phase 1 study of PN-943 with two weeks of daily administration, demonstrating sustained target engagement and additional confirmation of superior target engagement as compared with the first generation oral alpha-4-beta-7 integrin antagonist PTG-100.

· Clinical data from the Phase 1 study of oral alpha-4-beta-7 integrin antagonist PN-943 were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting.

·The Company plans to initiate a Phase 2 study of PN-943 for the treatment of ulcerative colitis in the second quarter of 2020.

PTG-200 (JNJ-67864238)

·Data from the Phase 1 study of PTG-200, an oral peptide IL-23 receptor antagonist partnered with Janssen Biotech, were recently presented at the United European Gastroenterology Week conference and the American College of Gastroenterology (ACG) Annual Scientific Meeting.

·The first patient has been dosed in a Phase 2 study of PTG-200 (also referenced as JNJ-67864238) in patients with moderate to severe Crohn’s disease. Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 through completion of Phase 2 clinical proof of concept in the treatment of Crohn’s disease.

Financing

·During the third quarter of 2019, the Company issued 1.9 million shares through its at-the-market (ATM) program and raised $23.9 million, at an average price of $12.44 per share.

·The Company recently announced it has entered into a four-year debt facility with MidCap Financial and Silicon Valley Bank providing access to an aggregate principal amount up to $50 million to support the ongoing Protagonist clinical development programs and related general corporate purposes.

Financial Results

Protagonist reported a net loss of $16.4 million and $59.7 million, respectively, for the third quarter and first nine months of 2019, as compared to a net loss of $8.7 million and $25.1 million, respectively, for the same periods of 2018. The increase in net loss for the third quarter of 2019 as compared to the prior year period was driven primarily by increased research and development (R&D) costs related to advancing its products in various clinical trials. The increase in net loss for the first nine months of 2019 as compared to the prior year period was driven primarily by the previously reported application of revenue accounting principles following the May 2019 Amendment to the Janssen collaboration agreement where the Company re-assessed overall timelines as well as re-estimated completed and remaining services, including a cumulative one-time adjustment of $9.4 million reported in the second quarter of 2019, and an increase in R&D costs related to advancing its products is various clinical trials. The net loss for the third quarter and first nine months of 2019 includes non-cash stock-based compensation of $2.2 million and $6.2 million, respectively, as compared to $2.0 million and $4.8 million, respectively, for the same periods of 2018.

R&D expenses for the third quarter and first nine months of 2019 were $17.3 million and $49.1 million, respectively, as compared to $12.1 million and $45.2 million, respectively, for the same periods of 2018. The increases in R&D expenses were primarily due to increased clinical development costs related to PTG-300 and PN-943, offset by lower cost related to pre-clinical and discovery expenses and other clinical development expenses.

General and administrative (G&A) expenses for the third quarter and first nine months of 2019 were $4.0 million and $11.6 million, respectively, as compared to $3.4 million and $10.2 million, respectively, for the same periods of 2018. The increases in G&A expenses were primarily due to increases in salaries and employee-related expenses driven by an increase in headcount and professional services expenses to support growth in operations.

Protagonist ended the third quarter with $137.7 million in cash, cash equivalents and marketable securities, and $10 million of the debt facility was funded at closing in October 2019. The Company expects cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its planned operating and capital expenditures through year-end 2021.

On November 6, 2019 Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS platform, reported that initial results from the ongoing Phase 1/2a trial of its lead investigational off-the-shelf (allogeneic) chimeric antigen receptor (CAR) T cell therapy candidate, PBCAR0191, will be presented during the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, Florida, December 7-10, 2019 (Press release, Precision Biosciences, NOV 6, 2019, View Source [SID1234550485]).

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!

PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials and targets the well characterized cancer cell surface protein CD19. It is being developed in collaboration with Servier, an international pharmaceutical company. The Phase 1/2a trial includes adult patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL). The abstract outlining initial data from patients treated with PBCAR0191 at Dose Level 1 is available on the ASH (Free ASH Whitepaper) conference website (View Source). This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be presented at the ASH (Free ASH Whitepaper) Annual Meeting on December 9, 2019 starting at 6:00 p.m. ET.

"We are excited to share initial clinical data from Precision’s PBCAR0191 program at ASH (Free ASH Whitepaper), which we believe demonstrate the potential of our differentiated approach to the development of allogeneic CAR T therapies," said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. "These data bring the reality of a true off-the-shelf CAR T therapy a step closer for patients in need of new and improved treatment options. We remain committed to the wider goal of improving access to cellular therapies for patients with advanced NHL and ALL, and we are optimistic, based on these initial findings, that we may be able to help meet this need. While preliminary and from a limited number of patients, the safety profile, in vivo cell expansion and early evidence of clinical activity we have demonstrated at our lowest dose level with PBCAR0191 in the absence of biologic lymphodepletion is very encouraging. We look forward to sharing updated results from patients treated at Dose Levels 1 and 2 at ASH (Free ASH Whitepaper)."

Investigator Update & Webcast Information
Precision will host a live webcast of an investigator update event during the ASH (Free ASH Whitepaper) Annual Meeting to discuss the presented data, beginning at 8:15 p.m. ET on Monday, December 9, 2019. To access the webcast, please visit the "Events & Presentations" page within the Investors & Media section of the Precision BioSciences website at View Source A replay of the webcast will be available on the Precision website for 30 days following the call.

First Clinical Data from Precision’s PBCAR0191 Program
Title: Initial findings of the Phase 1 trial of PBCAR0191
Presenter: Bijal Shah, MD, Moffitt Cancer Center
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Retrospective/Observational Studies
Poster/Presentation Number: Poster III
Date and Time: December 9, 2019, 6:00-8:00 p.m. ET
Location: Orange County Convention Center, Hall B

PBCAR0191 is Precision’s first allogeneic CAR T therapy candidate in clinical trials. This presentation will include initial data from the Phase 1 portion of the ongoing Phase 1/2a trial of PBCAR0191, which is designed to assess safety, identify an optimal dose of PBCAR0191 and evaluate preliminary clinical activity in patients with R/R NHL and B-ALL. The trial is a 3+3 dose escalation study (at dose levels of 3×105, 1×106, and 3×106 CAR T+ cells/kg); in each of the three dose levels up to six patients may be enrolled in each of the two cohorts (NHL and B-ALL). Lymphodepletion is achieved using fludarabine 30mg/m2/day and cyclophosphamide 500mg/m2/day.

Data in the abstract include results as of the data cutoff date of August 1, 2019 for three patients with advanced NHL treated at Dose Level 1, one with mantle cell lymphoma (MCL) and two with diffuse large B cell lymphoma (DLBCL). No significant toxicity was observed, including no serious adverse events and no dose-limiting toxicities. All patients had a minimum follow-up of 28 days (median 60 days).

Findings indicate preliminary evidence of cell-mediated anti-tumor activity, which will be evaluated more fully at subsequent dose levels. Two of the three patients experienced an objective tumor response by Lugano criteria, at day 14 and day 28, respectively. Both patients progressed due to new lesions (on day 28 and day 60, respectively). The third patient, who had previously progressed following treatment with axicabtagene ciloleucel (Yescarta), an approved anti-CD19 autologous CAR T therapy, had not met the definition of response, but had shown evidence of central necrosis, decreased tumor size, and decreased PET-avidity at day 28, in the context of post-infusion tumor site pain and mild CRS symptoms.

Peripheral blood analysis for CAR T cell expansion has identified preliminary evidence of cell expansion.

This trial is ongoing and updated results, including from patients treated at Dose Level 2, will be shared at the ASH (Free ASH Whitepaper) conference.

Precision’s Off-The-Shelf CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy by improving access to care through a well-tolerated lymphodepletion regimen. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

On November 6, 2019 Pfenex Inc. (NYSE American: PFNX) reported that Eef Schimmelpennink, President and Chief Executive Officer, will be presenting at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20th, taking place at the Waldorf Hilton in London (Press release, Pfenex, NOV 6, 2019, View Source [SID1234550484]).

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!

Conference: Jefferies 2019 London Healthcare Conference

Date: Wednesday, November 20, 2019

Time: 4:00 p.m. GMT (8:00 a.m. PST)

Webcast: Interested parties can access the live audio webcast and archive from the Investors Section of Pfenex’s website at www.pfenex.com