On December 10, 2020 Creatv MicroTech, a privately-held biotechnology company reported that it has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT) (Press release, CREATV MICROTECH, DEC 10, 2020, View Source [SID1234572626]). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. "We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood," said Dr. Cha-Mei Tang, CEO of Creatv. "Now, patients who are not responding to CRT can be identified quickly for alternative therapy." Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

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In the United States, 18,440 new cases are expected in 2020 for esophageal cancer, a disease that has the sixth highest cancer mortality rate. Even localized disease has a 5-year survival rate of less than 50%, making timely treatment decisions critical to patient outcome. The ability to monitor a patient’s response to therapy throughout treatment will allow for more precise adjustment to therapeutic regimes to optimize the management of the disease. In a completely novel concept, the test analyzes patients’ immune response to the presence of cancer, isolating cells from cancer sites that have migrated into the blood stream. Creatv demonstrated that a particular subtype of cell, Cancer Associated Macrophage-Like cells (CAMLs), tracks the patient’s response to therapy in real time. CAMLs are phagocytic myeloid cells that reveal the patient’s immunological response to active malignancy. CAMLs are not found in the blood of normal, healthy individuals.

Creatv has previously shown that in solid tumors, patients with CAMLs larger than 50 µm in size have a poorer prognosis, with shorter progression free survival (PFS) and overall survival (OS). In this paper, Creatv presents the findings from a two-year single blind prospective study of 32 esophageal cancer patients with Stage I-III treated with standard CRT. A CAML size of ≥50 µm in blood drawn immediately after the completion of CRT indicates a poor prognosis compared to patients with CAMLs < 50 µm, with a Hazard Ratio (HR) =12.0 for progression free survival (PFS) 95% CI 2.7-54.1, p=.004.

The paper is available here.

About LifeTracDx Liquid Biopsy

Creatv’s liquid biopsy assays (LifeTracDx) are commercialized Research Use Only tests designed for analysis of CAMLs and Circulating Tumor Cells (CTCs). LifeTracDx tests are applicable for cancer screening, companion diagnostics, prediction of treatment response (including immunotherapy) and prognosis. LifeTracDx tests also provide unfragmented tumor DNA for sequencing and can predict minimal residual disease (MRD) and early detection of cancer recurrence. LifeTracDx tests are currently used in more than 20 clinical trials, from basic research to drug development. Creatv’s publications have shown that LifeTracDx liquid biopsy can be used for multiple solid tumor cancers as an early predictor of patient response to therapy.

On December 10, 2020 Purple Biotech Ltd. (the "Company") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that it has changed its corporate name from Kitov Pharma Ltd. to Purple Biotech Ltd (Press release, Kitov Pharmaceuticals , DEC 10, 2020, View Source [SID1234572643]). The name change will be effective for trading purposes on the Tel Aviv Stock Exchange (TASE) and the NASDAQ Capital Market (NASDAQ) as of market open on December 22, 2020. At that time, the Company’s ordinary shares and American Depositary Shares (ADSs) will begin to trade under the new ticker symbol, "PPBT," on the TASE and NASDAQ, respectively. The Company’s ordinary shares will continue to trade on the TASE and its ADSs will continue to trade on NASDAQ under the ticker symbol "KTOV" through market close on December 21, 2020. The Company’s ADSs were assigned a new CUSIP number (74638P109), effective on December 22, 2020, as described above.

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"Over the past few years, our business has evolved significantly towards an exciting new vision and our new name, Purple Biotech, completes the transformation to our focus on advancing first-in-class oncology therapies," said Isaac Israel, the Company’s Chief Executive Officer.

"2020 has been a year of substantial achievements for our company. We recently initiated Phase 1/2 clinical studies for NT219 and expect to begin our Phase 1/2 studies for CM24 shortly. We also successfully completed over $60 million in financings this year to support our clinical development and strategic plans. As we head into 2021, we look forward to leveraging the compelling opportunities that lie ahead of us and to advancing our objectives to increase the longevity and the quality of life of cancer patients", added Isaac Israel.

The Company will also be relocating its corporate headquarters shortly to the Science Park near the Weizmann Institute in Rehovot, Israel, a key regional biotech hub.

No action is required by shareholders and holders of ADSs in connection with the corporate name change. The number of outstanding ordinary shares and ADSs are not affected by the name change. In connection with the name change, the Company expects to make additional ordinary course filings with the U.S. Securities and Exchange Commission.

On December 10, 2020 Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, reported financial and operating results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, Biodesix, DEC 10, 2020, View Source [SID1234572611]).

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Third Quarter 2020 and Recent Highlights

Generated record quarterly revenue of $9.2 million for the third quarter ended September 30, 2020.
Completed initial public offering (IPO) that raised net proceeds of approximately $63 million after deducting offering costs, underwriting discounts and commissions.
Announced a strategic partnership with the Big Ten Conference whereby Biodesix is conducting ddPCR COVID-19 validation testing and managing the onsite testing of rapid antigen SARS-CoV-2 testing for all student-athletes and staff personnel involved in close contact sports competition.
Published an extended analysis of data from the company’s Nodify XL2 lung nodule test in the American College of Chest Physicians (CHEST) Journal. The data demonstrate that all nodules in the study group that were established as benign after one year remained benign after two years, the guideline-recommended surveillance period to radiologically confirm a benign diagnosis.
Presented data from three studies at the American College of Chest Physicians (CHEST 2020) Annual Meeting highlighting the clinical value of the company’s Nodify XL2 and Nodify CDT lung nodule risk assessment tests.
"We recently achieved a very significant milestone with our IPO and transition to a public company," stated Scott Hutton, Chief Executive Officer of Biodesix. "With the proceeds from the offering, we plan to continue to market our suite of commercially available diagnostic tests, including our Biodesix Lung Reflex and Nodify Lung testing strategies, in addition to our COVID-19 testing, while also investing in the discovery, development, and validation of innovative new tests leveraging our proprietary AI-driven discovery platform.

"We continue to monitor the COVID-19 pandemic carefully in light of the recent surge in case counts around the country, and we are pleased to be able to play an important part in the fight against this dangerous virus through our WorkSafe testing program. To this point, our lung disease-focused core business continues to perform well even while healthcare facilities devote time and resources to combat COVID-19 and travel restrictions affect our commercial efforts. We believe this is a testament to the valuable clinical information that our tests provide along critical points of the lung disease care continuum," concluded Mr. Hutton.

Financial Results

Revenue. Revenue for the three months ended September 30, 2020 was $9.2 million, as compared to $3.9 million for the comparable period in 2019, an increase of 133%. This increase was due to $5.5 million of revenue from our two COVID-19 diagnostic tests, partially offset by a modest decline in our non-COVID-19 diagnostic test volumes of $0.7 million as health care practitioners, including pulmonologists, were increasingly diverted to pandemic-related care. In addition, company sales efforts continued to be impacted by travel and other COVID-19 pandemic related restrictions. Revenue for the nine months ended September 30, 2020 was $18.5 million, as compared to $16.3 million for the comparable period in 2019, an increase of 14%.

Direct costs and expenses. Direct costs and expenses for the three months ended September 30, 2020 were $3.9 million, as compared to $1.5 million for the comparable period of 2019, an increase of 159%. Direct costs and expenses for the nine months ended September 30, 2020 were $7.3 million compared to $4.2 million for the nine months ended September 30, 2019, an increase of 73%. The increase in costs were primarily driven by the release of the company’s Nodify CDT test and its COVID-19 testing program in 2020.

Research and development. Research and development expenses for the three months ended September 30, 2020 were $2.7 million, as compared to $2.4 million for the comparable period in 2019, an increase of 15%. Research and development expenses for the nine months ended September 30, 2020 were $7.7 million, as compared to $8.0 million for the comparable period in 2019, a decrease of 3%.

Sales, marketing, general and administrative. Sales, marketing, general and administrative expenses for the three months ended September 30, 2020 were $7.9 million, as compared to $8.2 million for the comparable period in 2019, a decrease of 4%. Sales, marketing, general and administrative expenses for the nine months ended September 30, 2020 were $22.8 million, as compared to $24.1 million for the comparable period in 2019, a decrease of 5%. The decrease was driven by reductions in travel and related expenses as the COVID-19 pandemic reduced or eliminated the travel and related expenses.

Operating loss. Operating loss for the three months ended September 30, 2020 was $6.2 million, as compared to an operating loss of $9.0 million for the comparable period in 2019, a decrease of 31%. Operating loss for the nine months ended September 30, 2020 was $20.3 million, as compared to an operating loss of $23.2 million for the comparable period in 2019, a decrease of 13%. The decrease was due in part to higher revenue in the third quarter of 2020 as compared to the third quarter of 2019.

Net loss. Net loss for the three months ended September 30, 2020 was $8.9 million, as compared to $9.6 million for the comparable period in 2019, a decrease of 8%. Net loss for the nine months ended September 30, 2020 was $26.8 million, as compared to $24.2 million for the comparable period in 2019, an increase of 11%.

Cash and cash equivalents. As of September 30, 2020, the company held cash and cash equivalents of $6.3 million, as compared to $5.3 million as of December 31, 2019. Subsequent to the end of the third quarter, the company completed a successful initial public offering that raised net proceeds of approximately $63 million. As a result of the completion of the initial public offering, the company estimates that it has sufficient cash resources to meet its cash obligations through at least the next 12 months.

On December 10, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that new 5-year data from the NBRST trial that will be presented in a poster spotlight discussion Thursday, December 10, 2020 from 3:30pm-4:45pm CST at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) (Press release, Agendia, DEC 10, 2020, View Source [SID1234572627]).

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The poster, entitled 5-year outcomes in the NBRST trial: Preoperative MammaPrint and BluePrint breast cancer subtype is associated with neoadjuvant treatment response and survival, contains the largest data set evaluating a genomic test in the neoadjuvant setting with long-term outcomes. These outcomes demonstrate the predictive and prognostic abilities of MammaPrint and BluePrint, and underpin both assays’ pre-operative utility.

In the 5-year results of the Neoadjuvant Breast Symphony Trial (NBRST), 22% of the tumors evaluated were reclassified from their original clinical subtype into a different molecular subtype by MammaPrint and BluePrint. This reclassification has significant implications for treatment planning, reinforcing the importance of the multi-disciplinary care team having this meaningful information at the earliest point after diagnosis to inform the decision for the timing of surgery and systemic therapy.

Importantly, the reclassification by BluePrint allowed researchers to detect more genomic diversity within pathologically ER+ and HER2 negative breast cancers than previously thought. 18% of those tumors were reclassified as Basal-Type by BluePrint (ER+/Basal) while 44% of pathologically HER2+ tumors were reclassified as Luminal- or Basal-Type by BluePrint. Of note, the response to treatment and longer term outcomes in those reclassified patients were distinctly different and aligned with the subtype identified by BluePrint.

"Genomic classification is uncovering the diversity in these pathologically-defined subsets," said Pat Whitworth, M.D., first author of the spotlight poster and a breast surgical oncologist at the Nashville Breast Center. "If a conventional HER2+ or an ER+/HER2 negative tumor is reclassified as BluePrint Basal-Type, switching to a different treatment approach, such as a HER2-targeted regimen with optimal basal coverage or different timing for surgery, may improve outcomes for those patients. With this extra layer of information, the patient and her care team are able to make important decisions at the very beginning of their journey that will be felt years down the line. Just as important, these patients should be the focus of upcoming trials."

In looking into the genomic makeup of the tumors, BluePrint could further stratify ER+ and HER2+ breast cancers as Luminal- or Basal-Type, which respond differently to treatment and could one day impact how these patients are treated. This observation echoes what was seen in a subanalysis of the APHINITY trial, also part of a spotlight poster discussion at SABCS 2020.

"The finding that a subset of ER+ HER2 negative primary breast cancers has a basal genotype on BluePrint analysis is a novel and very provocative result that compels us to study this further," said Joyce O’Shaughnessy, M.D., Director of the Breast Cancer Research Program for Texas Oncology and the US Oncology Network. "Should the ER+/basal breast cancers be treated as triple negative breast cancers, with platinum-based regimens, capecitabine post-op for residual disease and potentially with preop checkpoint inhibitors? We plan to study preop administration of platinum-based chemotherapy in patients with ER+/basal cancer to determine whether their outcomes parallel those of triple negative basal breast cancers."

Also presented at SABCS 2020 is a supporting poster on the NBRST study, "Molecular subtyping by BluePrint improves prediction of treatment responses and survival outcomes in patients with discordant clinical and genomic classification," which focused on the discordant groups within the 22% of BluePrint reclassifications displayed in the NBRST study. The data showed that molecular subtyping using MammaPrint and BluePrint is additive to pathologic assessment and thus facilitates more informed treatment decisions.

In addition, the supplemental NBRST poster reinforces the importance of genomic testing to further stratify Luminal patients. The data showed that Luminal A-Type patients have excellent outcomes on neoadjuvant endocrine therapy alone, an important consideration during the COVID-19 pandemic, while Luminal B-Type patients need additional systemic treatment.

According to James Pellicane, M.D., Director of Breast Oncology at the Bon Secours Cancer Institute, "These data confirm that BluePrint can be utilized as a tool to determine whether neoadjuvant systemic therapy or surgery followed by adjuvant therapy is the best option for a patient based on the molecular subtype of their breast cancer and its predicted response to therapy. What we’ve seen from NBRST is that certain patients, specifically the Luminal A subtypes, will respond to neoadjuvant endocrine therapy and have good long-term outcomes postoperatively with endocrine therapy alone. Others may respond to neoadjuvant endocrine therapy but because of their more aggressive biology, specifically the Luminal B subtypes, will benefit from cytotoxic chemotherapy in the adjuvant or sometimes in the neoadjuvant setting. As a surgeon, it’s comforting to know that you can triage these patients more effectively, having a better understanding of the biology of their breast cancer and how it will respond to different treatment algorithms and how that response corresponds with their long-term outcome."

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

On December 10, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that CEO, Gil Beyen, will present at the JMP Securities Hematology Summit Tuesday December 15th at 1:30pm EST /06:30pm GMT /7:30pm CET (Press release, ERYtech Pharma, DEC 10, 2020, View Source [SID1234572612]). The format will be a "fireside chat" discussion hosted by JMP Securities’ Reni Benjamin.

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