On May 14, 2020 Foundation Medicine, Inc. reported that new data supporting the clinical use of its portfolio of tissue and liquid comprehensive genomic profiling (CGP) tests will be presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, which will be held from May 29 to May 31 (Press release, Foundation Medicine, MAY 14, 2020, View Source [SID1234558072]). The company and its collaborators will present a total of 22 studies, including two clinical symposia presentations and one poster discussion. The data highlight insights into the utility of liquid biopsy CGP testing to help inform treatment selection across a variety of advanced cancers and the predictive role of tumor mutational burden (TMB) as a genomic signature to optimize precision medicine approaches.

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Highlights of these presentations include:

new data demonstrating the use of liquid biopsy CGP to identify predictive and prognostic biomarkers to improve clinical outcomes for patients with advanced cancer, including metastatic breast cancer, non-small lung cancer (NSCLC) and prostate cancer;
additional evidence of the role of complex biomarkers and genomic signatures such as TMB may have in patient response to targeted therapies and immunotherapies; and
the clinical value of liquid biopsy as a tool for oncologists in various treatment settings, including the ability to identify resistance mechanisms across primary and metastatic tumors and enable precision medicine.
"At this meeting, we’ll share new data demonstrating the use of clinically relevant insights from our tissue and liquid comprehensive genomic profiling tests to inform treatment decision-making and improve patient outcomes through methods such as identifying resistance mechanisms," said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. "We’re at an important juncture in personalized medicine where pan-tumor complex signatures such as TMB and MSI are growing in their clinical importance, and our data show the unique ability of CGP to investigate these nuanced biomarkers of response and advance precision treatment approaches."

Clinical Validity of Liquid Biopsy Comprehensive Genomic Profiling

In a study conducted in collaboration with the Dana Farber Cancer Institute, researchers characterizing NSCLC cases found MET exon 14 skipping alterations present in 2.3 percent of tumor DNA samples, representing six major subtypes. The analysis of paired tumor and liquid biopsy samples identified potential acquired resistance mechanisms that may be critical to predicting response to MET inhibitors and identifying matched targeted therapy options, which have recently shown clinical efficacy for this subset of patients, demonstrating the importance of testing NSCLC patients for these alterations.

[Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (SA) and potential acquired resistance (AR) mechanisms. Abstract #9511.]

In a retrospective analysis, researchers compared more than 325,000 tumor tissue samples to over 28,000 patient-matched plasma samples to understand the clinical validity of liquid biopsy CGP in detecting kinase fusions. Kinase gene fusions identified by tissue-based CGP were also detected by liquid biopsy CGP in temporally-matched plasma samples, with high positive percent agreement between tissue and liquid biopsies. The analysis of liquid biopsy samples also identified acquired alterations consistent with known mechanisms of resistance.

[Pan-tumor analyses of kinase fusions detected in circulating tumor DNA (ctDNA) and concordance with paired tissue. Abstract #3517. Poster #247.]

A clinically advanced prostate cancer study used CGP on pre-treatment primary tumor biopsy, post-treatment metastatic biopsy and liquid biopsy to uncover differences in genomic alterations and potential impact on treatment selection. The study demonstrated how systemic treatment resulted in genomic changes in metastases as the tumor evolves to survive. Given the variance between metastatic sites, liquid biopsy may capture a broader range of therapy opportunities for patients.

[Contrasting genomic profiles in post-systemic treatment metastatic sites (MET), pretreatment primary tumors (PT), and liquid biopsies (LB) of clinically advanced prostate cancer (PC). Abstract #5534. Poster #115.]

Complex Biomarkers as Predictor of Immunotherapy Response

In an analysis of the Phase III IMvigor130 study, researchers explored the potential predictive role of TMB, PD-L1 expression and T-effector gene expression biomarkers in patients with metastatic urothelial cancer. The results reinforce the potential predictive nature of biomarkers associated with response or resistance to atezolizumab monotherapy or atezolizumab in combination with platinum-based chemotherapy.

[Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study. Abstract #5011.]

The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.

Abstract #

Title

Collaborator

Clinical Science Symposia

9511

Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (SA) and potential acquired resistance (AR) mechanisms

Dana Farber Cancer Institute

5011

Tumor, immune, and stromal characteristics associated with clinical outcomes with atezolizumab (atezo) + platinum-based chemotherapy (PBC) or atezo monotherapy (mono) versus PBC in metastatic urothelial cancer (mUC) from the phase III IMvigor130 study

Poster Discussion

3517

Pan-tumor analyses of kinase fusions detected in circulating tumor DNA (ctDNA) and concordance with paired tissue

Poster Presentations

1050

Patient-matched tissue and liquid biopsies identify shared and acquired genomic alterations in breast cancer

5534

Contrasting genomic profiles in post-systemic treatment metastatic sites (MET), pretreatment primary tumors (PT), and liquid biopsies (LB) of clinically advanced prostate cancer (PC)

TPS2087

A multi-stakeholder platform to prospectively link longitudinal, real-world clinico-genomic, imaging and outcomes data for patients with metastatic lung cancer

Flatiron Health

3060

Characteristics and outcomes of real-world (RW) patients (pts) with microsatellite instability-high (MSI-H) solid tumors treated with pembrolizumab monotherapy (P) after FDA approval

Flatiron Health

9591

Real-world (RW) outcomes for non-small cell lung cancer (NSCLC) patients (pts) with EGFR exon 19 deletions (x19del) stratified by deletion size

Flatiron Health

3622

Increased tumor purity and improved biomarker detection using precision needle punch enrichment of specimen paraffin blocks: method validation and implementation in a prospective clinical trial

3620

Pan-cancer analysis of FGFR1-3 genomic alterations to reveal a complex molecular landscape

5527

Association of BRCA alteration (alt) type with real-world (RW) outcomes to PARP inhibitors (PARPi) in patients (pts) with metastatic castrate resistant prostate cancer (mCRPC)

On May 14, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, reported financial results for the three months ended March 31, 2020 (Press release, BioLife Solutions, MAY 14, 2020, View Source [SID1234558088]).

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Total revenue for the first quarter of 2020 was $12.2 million, a 111% increase over the first quarter of 2019 and a 47% increase over the fourth quarter of 2019. Revenue growth was driven by significantly higher revenue from biopreservation media, which increased 50% year-over-year and 67% sequentially, and accounted for approximately 71% of total revenue. Sales of BioLife’s ThawSTAR, evo and Custom Biogenic Systems (CBS) freezer products accounted for the balance of revenue and were in line with management’s expectations.

The Company also announced an agreement for a strategic capital investment by Casdin Capital for the purchase of $20 million of primary common shares at $10.50 per share. Casdin also intends to purchase an additional $5 million of secondary common shares from an existing investor on the same terms.

Mike Rice, BioLife’s CEO, remarked, "On the heels of significantly increased demand for our products from existing customers, 40 new customers, and 13 new US FDA Master File requests, we believe it is the right time to accelerate our ongoing growth strategy. We are fortunate to have a growth equity partner in Casdin Capital that enabled us to strengthen our balance sheet to aggressively grow our portfolio of high value tools and services targeting the cell and gene therapy market. Through a combination of internal innovation, and acquisitions, co-investments and licensing of external assets, BioLife is on target to expand its business substantially over the next few years."

"Casdin Capital continues to demonstrate confidence in management and our business plan. Casdin has been a key shareholder and partner in identifying and co-investing in acquisition targets that support our strategy to further consolidate the bioproduction tools space," he added.

Key Accomplishments in the First Quarter of 2020

Biopreservation media revenue increased 50% from Q1 2019 and increased 67% from Q4 2019, as numerous customers placed replenishment and safety stock orders to ensure their clinical development programs could continue unabated during the COVID-19 pandemic.
Gained 40 new customers including 16 using biopreservation media, 6 using ThawSTAR products, 10 using evo cold chain management solutions and 8 that placed initial orders for CBS freezers and related accessories.
Processed 13 new U.S. FDA Drug Master File cross-reference requests, indicating the planned use of CryoStor or HypoThermosol in human clinical trials of new cell or gene therapies.
Granted three new patents for BioLife’s cold chain technologies. The Company’s intellectual property estate now includes 50 issued and 34 pending patents.
Financial Highlights for the First Quarter 2020

REVENUE

Total revenue of $12.2 million
Biopreservation media revenue of $8.7 million
Automated thawing product revenue of $394,000
evo cold chain management rental revenue of $438,000
CBS freezer and related accessories revenue of $2.7 million
GROSS MARGIN

Gross margin (GAAP) for the first quarter of 2020 was 57.8% compared with 71.5% for the first quarter of 2019. Adjusted gross margin (non-GAAP) for the first quarter of 2020 was 64.1% compared with 71.5% for the first quarter of 2019.
OPERATING EXPENSE

Operating expense (GAAP) for the first quarter of 2020 was $11.8 million compared with $5.2 million in the first quarter of 2019. Adjusted operating expense (non-GAAP) for the first quarter of 2020 was $6.4 million compared with $3.3 million in the first quarter of 2019.
OPERATING PROFIT

Operating profit (GAAP) for the first quarter of 2020 was $370,000 compared with $566,000 for the first quarter of 2019. Adjusted operating profit (non-GAAP) was $1.4 million for the first quarter of 2020 compared with $774,000 for the first quarter of 2019.
NET INCOME/(LOSS)

Net income (GAAP) for the first quarter of 2020 was $22.3 million compared with a net loss of $19.2 million for the first quarter of 2019. Net income (GAAP) for the first quarter of 2020 included other income of $21.9 million related to the change in fair value of outstanding warrants, and the net loss for the first quarter of 2019 included other expense of $19.7 million related to the change in fair value of outstanding warrants. Adjusted net income (non-GAAP) was $1.4 million for the first quarter of 2020 compared with $942,000 for the first quarter of 2019.
EARNINGS/(LOSS) PER SHARE

Earnings per basic share (GAAP) for the first quarter of 2020 were $0.87 compared with a loss per basic share of $1.03 for the first quarter of 2019. Adjusted fully diluted EPS (non-GAAP) for the first quarter of 2020 was $0.06 compared with $0.04 for the first quarter of 2019 on a fully diluted basis.
ADJUSTED EBITDA

Adjusted EBITDA, a non-GAAP financial measure for the first quarter of 2020 was $2.9 million compared with $1.4 million for the first quarter of 2019.
Roderick de Greef, BioLife Chief Financial Officer and Chief Operating Officer, remarked, "Based on higher-than-expected revenue, our Q1 results demonstrate the operating leverage we can realize, as evidenced by achieving adjusted EBITDA of $2.9 million or 24% of total revenue."

Withdrawal of 2020 Financial Guidance

Due to uncertainty regarding the impact of COVID-19 on BioLife and its customers, on May 1, 2020 the Company withdrew its financial guidance for 2020.

Investment by Casdin Capital

The Company executed a securities purchase agreement with existing shareholder Casdin Capital, a New York based life science focused investment firm with approximately $1 billion in assets under management. The agreement specifies the purchase of $20 million of BioLife Solutions common shares at $10.50 per share. The transaction was negotiated over the last several weeks, and the 30-day volume weighted average price was $11.32 as of market close yesterday. Casdin also intends to purchase an additional $5 million of BioLife Solutions common shares from a long-term shareholder at the same terms.

Conference Call & Webcast

The Company will discuss first quarter 2020 financial results today after market close on a conference call and live webcast at 4:30 p.m. ET (1:30 p.m. PT). Management will provide an overview of the Company’s financial results and a general business update.

To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you may access the live conference call by dialing (844) 825-0512 (U.S. & Canada) or (315) 625-6880 (International) with the following Conference ID: 2085346. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.

On May 14, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that new and updated analyses on the ongoing studies of savolitinib, surufatinib, and fruquintinib will be presented at the upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, taking place on May 29-31, 2020 (Press release, Hutchison China MediTech, MAY 14, 2020, https://www.chi-med.com/asco20-virtual-scientific-program/ [SID1234557962]).

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Chi-Med plans to hold a conference call on the following Monday, June 1, to discuss the results.

SAVOLITINIB
Title: Phase II study of savolitinib in patients (pts) with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping
Lead Author: Shun Lu, MD, PhD., Shanghai Chest Hospital, Shanghai Jiao Tong University
Session: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: 9519

Title: SAVOIR: A phase III study of savolitinib versus sunitinib in pts with MET-driven papillary renal cell carcinoma (PRCC)
Lead Author Toni K. Choueiri, MD, Dana-Farber Cancer Institute and Harvard Medical School
Session: Genitourinary Cancer—Kidney and Bladder
Abstract Number: 5002

SURUFATINIB
Title: Efficacy and safety of surufatinib in United States (US) patients (pts) with neuroendocrine tumors (NETs)
Lead Author: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4610

Title: Health-related quality-of-life results from SANET-ep: A phase III study of surufatinib versus placebo for advanced extrapancreatic neuroendocrine tumors
Lead Author Chunmei Bai, MD, Peking Union Medical College Hospital
Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Abstract Number: 4613

FRUQUINTINIB (Publication only)
Title: Early carcinoembryonic antigen (CEA) dynamics to predict fruquintinib efficacy in FRESCO, a 3+ line metastatic colorectal carcinoma (mCRC) phase III trial
Lead Author: Yuxian Bai, Harbin Medical University Cancer Hospital
Abstract Number: e16001

Title: Efficacy and safety of fruquintinib in the treatment of poor patients with metastatic gastrointestinal cancer
Lead Author: Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University
Abstract Number: e16028

About Savolitinib
Savolitinib is an inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies.

A New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission. We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET. Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.

Chi-Med currently retains all rights to surufatinib worldwide.

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate, for the treatment of patients with metastatic colorectal cancer ("CRC"). We also intend to initiate a Phase III registration study for CRC in the U.S., Europe and Japan. A Phase III registration study is also ongoing in China for the treatment of patients with gastric cancer, in combination with paclitaxel. Additionally, fruquintinib is in several other proof-of-concept trials in China and the U.S., including in combination with immunotherapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.

On May 14, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) reported updated results from the ongoing Phase 2 L-MIND study investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Press release, MorphoSys, MAY 14, 2020, View Source [SID1234557995]). The results, based on a November 30, 2019 data cut-off, corroborate previously reported primary analysis data.

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In this long-term analysis of the L-MIND data, 80 study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis. After a minimum of two years’ follow-up, outcomes from the L-MIND study are consistent with the primary analysis and confirm the durability of the response (DoR) and overall survival (OS) of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with r/r DLBCL. Assessment by an independent review committee (IRC) at data cut-off showed an objective response rate (ORR) of 58.8% (47 out of 80 patients) and a complete response (CR) rate of 41.3% (33 out of 80 patients). Median duration of response (mDOR) was 34.6 months, with median overall survival (mOS) of 31.6 months and median progression-free survival (mPFS) of 16.2 months. The safety profile was consistent with that observed in previously reported studies of tafasitamab in combination with lenalidomide. The full analysis will be presented virtually at the 25th EHA (Free EHA Whitepaper) Annual Congress to be held June 11-14, 2020.

"We are extremely encouraged by the long-term data from our L-MIND study which confirms the previously reported results from the primary analysis," commented Dr. Malte Peters, Chief Research and Development Officer, MorphoSys. "Tafasitamab in combination with lenalidomide has the potential to address the significant medical need in patients suffering from r/r DLBCL, and we are working diligently towards our key priority of making tafasitamab available to eligible patients."

"The updated data for L-MIND reinforce the potential of tafasitamab in combination with lenalidomide as treatment for patients with r/r DLBCL. We look forward to working with our partners at MorphoSys as we seek to bring this new therapeutic option to eligible patients globally," Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte.

A Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for r/r DLBCL is currently under Priority Review by the U.S. Food and Drug Administration (FDA) (PDUFA action date August 30, 2020). The BLA is based on data including the primary analysis of L-MIND with a previous cut-off date as of November 30, 2018, and the primary analysis data from the retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received lenalidomide monotherapy.

In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved, MorphoSys and Incyte will co-commercialize tafasitamab in the United States while Incyte has exclusive commercialization rights outside the United States.

About L-MIND
L-MIND is a single arm, open-label Phase 2 study, investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy and subsequent autologous stem cell transplantation. The study’s primary endpoint is objective response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). In May 2019, the study reached its primary completion. Primary analysis data with a cut-off date of November 30, 2018 included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update were based on response rates assessed by an independent review committee for all 80 patients.

About Re-MIND
Re-MIND, an observational retrospective study, was designed to isolate the contribution of tafasitamab in the combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory DLBCL who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys’ L-MIND trial. Re-MIND collected the efficacy data from 490 r/r DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible Re-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective response rates (ORR) were validated based on this subset of 76 patients in Re-MIND and L-MIND, respectively. The primary endpoint of Re-MIND has been met and shows a statistically significant superior best ORR of the tafasitamab/lenalidomide combination compared to lenalidomide monotherapy.

About tafasitamab
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. In January 2020, MorphoSys and Incyte Corporation entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. If approved in the U.S., MorphoSys and Incyte will co-commercialize tafasitamab; Incyte will have exclusive commercialization rights outside the U.S. Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials, including L-MIND and Re-MIND. Additionally, tafasitamab is being evaluated as part of the ongoing Phase 3 study B-MIND study assessing the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL. Tafasitamab is also currently being investigated in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after discontinuation of a prior Bruton tyrosine kinase (BTK) inhibitor therapy (e.g. ibrutinib) in combination with idelalisib or venetoclax.

On May 14, 2020 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the first quarter ended March 31, 2020, and provided an overview of recent developments (Press release, Atreca, MAY 14, 2020, View Source [SID1234558024]).

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"While the COVID-19 pandemic has presented unexpected challenges, we continue to execute on our pipeline and business strategy, and we look forward to further progress throughout 2020," said John Orwin, Chief Executive Officer. "Patients continue to be enrolled and treated in our Phase 1b dose-escalation clinical trial evaluating ATRC-101 in multiple solid tumors. In addition, we believe our recently announced alliance with BeiGene and IGM Biosciences to help address the COVID-19 pandemic underscores the potential of our differentiated discovery platform, and we are working closely with our partners to advance research and development as quickly as possible."

Recent Developments and Highlights

In February 2020, Atreca commenced patient dosing in a Phase 1b first-in-human clinical trial evaluating ATRC-101 in patients with select solid tumor cancers. Patient screening continues in the study and, to date, three subjects have been enrolled in the first dose cohort. The ongoing COVID-19 pandemic is likely to impact our ability to initiate additional clinical trial sites quickly, which may ultimately result in enrollment delays.

Atreca announced a collaboration with BeiGene, Ltd. and IGM Biosciences, Inc. to discover and develop a novel antibody treatment for COVID-19. The alliance will utilize Atreca’s proprietary discovery platform to generate the sequences of antibodies made by particular B cells found in blood obtained from acutely infected COVID-19 patients.
Upcoming Milestone

Atreca will present a trial-in-progress poster at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program being held from May 29 to May 31, 2020. The poster will describe the design of Atreca’s ongoing Phase 1b first-in-human clinical trial evaluating ATRC-101 in patients with select solid tumor cancers.
First Quarter 2020 Financial Results

As of March 31, 2020, cash, cash equivalents and investments totaled $166.3 million.

Research and development expenses for the three months ended March 31, 2020 were $14.2 million, including non-cash share-based compensation expense of $1.1 million.

General and administrative expenses for the three months ended March 31, 2020 were $7.1 million, including non-cash share-based compensation expense of $1.4 million.

Atreca reported a net loss of $20.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.73, for the three months ended March 31, 2020.