On May 14, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive results from the Phase II CITYSCAPE trial, the first randomised study evaluating the efficacy and safety of tiragolumab plus Tecentriq (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 14, 2020, View Source [SID1234557961]). Tiragolumab is a novel cancer immunotherapy designed to bind to TIGIT, an immune checkpoint protein expressed on immune cells. Both TIGIT and PD-L1 play an important role in immune suppression, and blocking both pathways could enhance anti-tumour activity. The full results will be presented in an oral abstract session (Abstract #9503) at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program organised by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which will be held 29-31 May 2020.

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"We are pleased to share these first randomised anti-TIGIT results, showing that tiragolumab, our novel cancer immunotherapy, has encouraging efficacy and safety in combination with Tecentriq," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "TIGIT, an immune checkpoint protein expressed on immune cells, was identified by our own scientists. By blocking both TIGIT and PD-L1 pathways simultaneously, we hope to deepen patient responses to immunotherapy and widen the circle of people who may benefit."

At the primary analysis, tiragolumab plus Tecentriq met both co-primary endpoints in the intention-to-treat (ITT) population, showing an improvement in the objective response rate (ORR) (31.3% vs 16.2%) and a 43% reduction in the risk of disease worsening or death (progression-free survival; PFS) (median PFS= 5.4 vs 3.6 months; hazard ratio (HR)=0.57, 95% CI: 0.37–0.90) compared with Tecentriq alone.

An exploratory analysis in people with high levels of PD-L1 (TPS ≥50%) showed a clinically meaningful improvement in ORR (55.2% vs 17.2%) and a 67% reduction in the risk of disease worsening or death (median PFS=not reached vs 3.9 months; HR=0.33, 95% CI: 0.15–0.72) with the combination compared with Tecentriq alone.1

The data suggest that the combination of tiragolumab plus Tecentriq was well-tolerated, showing similar rates of all Grade 3 or more all-cause adverse events (AEs) when combining the two immunotherapies compared with Tecentriq alone (41.8% vs 44.1%).

At a six-month follow-up, the improvement in the ORR and PFS in the tiragolumab plus Tecentriq arm persisted in both the ITT and the PD-L1-high populations, and no new safety signals were observed.
As part of Roche’s commitment to explore new immunotherapy options and combinations, the company recently initiated two Phase III clinical trials evaluating tiragolumab plus Tecentriq for people with certain types of lung cancer (SKYSCRAPER-01 and SKYSCRAPER-02). Tiragolumab is also being evaluated in other solid tumours as well as in hematological cancers. Additional Phase 1a/b results in solid tumours will be presented at an upcoming medical meeting.

About CITYSCAPE study 1
CITYSCAPE is a global Phase II, randomised and blinded study evaluating tiragolumab plus Tecentriq compared with Tecentriq alone in 135 patients with first-line PD-L1-positive, locally advanced unresectable or metastatic non-small cell lung cancer. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit. Co-primary endpoints are ORR and PFS. Secondary endpoints include safety and overall survival.

Efficacy results

ITT (TPS≥1%)
N=135 PD-L1-high (TPS≥50%)
N=58 PD-L1-low (TPS1-49%)
N=77
Arms tiragolumab + Tecentriq

(n=67) placebo + Tecentriq
(n=68) tiragolumab + Tecentriq
(n=29) placebo + Tecentriq
(n=29) tiragolumab+ Tecentriq
(n=38) placebo +
Tecentriq
(n=39)
ORR, %
(95% CI) 31.3
(19.5, 43.2) 16.2
(6.7, 25.7) 55.2
(35.3, 75.0) 17.2
(1.8, 32.7) 13.2
(1.15, 25.2) 15.4
(2.8, 28.0)
Odds ratio (95% CI) 2.57
(1.07,6.14)* 5.91
(1.76,19.81)✝ 0.83
(0.23, 3.00)✝
Median PFS (95% CI) 5.4
(4.2, NE) 3.6
(2.7, 4.4) NE
(5.4, NE) 3.9
(2.1, 4.7) 4.1
(1.6, 5.6) 3.6
(1.5, 5.0)
HR (95% CI) 0.57
(0.37,0.90)* 0.33
(0.15, 0.72)✝ 0.85
(0.49, 1.48)✝
*stratified
✝unstratified

At a six-month follow-up, the improvement in ORR (37.3% vs 20.6%) and PFS (median PFS=5.6 month versus 3.9 months) in the tiragolumab plus Tecentriq arm persisted in the ITT population. Results in the PD-L1-high population were also consistent with the first analysis and the median PFS was still not reached.

Safety results

tiragolumab + Tecentriq
n=67 placebo + Tecentriq
n= 68
All Grade 3-5 AEs 41.8% 44.1%
Treatment- related AEs (TRAEs) 80.6% 72%
Grade ≥3 TRAEs 14.9% 19.1%
AEs leading to treatment withdrawal 7.5% 10.3%
About tiragolumab and TIGIT 5
Tiragolumab is a monoclonal antibody designed to bind with TIGIT, a protein receptor on immune cells 2 3. By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the body’s immune response 4. Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T-cells and enhance NK cell anti-tumour activity 2 6 7.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
View Source

About NSCLC
Lung cancer is the leading cause of cancer death globally 8. Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day 8. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases 9. NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope 9.

On May 14, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported financial results for the first quarter 2020 (Press release, Kaleido Biosciences, MAY 14, 2020, View Source [SID1234557994]).

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"The COVID-19 pandemic is having an unprecedented impact on the global healthcare system. We continue to adapt our work to prioritize the safety of our employees, as well as patients and clinical staff as study sites limit certain activities in light of the ongoing pandemic," said Alison Lawton, Kaleido’s President and Chief Executive Officer. "We are fortunate that our product platform and efficient development model provide Kaleido flexibility in responding to the current situation. We have rapidly initiated new clinical programs aimed at addressing the unmet need for outpatients with mild-to-moderate COVID-19 disease and are further exploring the potential of MMTs in immune-mediated and inflammatory diseases in ulcerative colitis. We anticipate data readouts from these and other programs starting in Q4 2020 and throughout 2021."

Pipeline Update

COVID-19 Program and KB109

As announced separately today, Kaleido has initiated a clinical program evaluating KB109 when added to Supportive Self-Care for outpatients with mild-to-moderate COVID-19 disease. The program aims to enroll a total of approximately 400 patients in two non-IND controlled clinical studies. Top-line data from the larger, multi-center study are expected in Q4 2020.

COVID-19 infection has been associated with activation of an inappropriate inflammatory cascade, which in some patients can cause an abnormally aggressive immune response that can lead to pneumonia and respiratory failure. Scientific evidence indicates that metabolites such as short chain fatty acids (SCFAs) produced by the microbiome through fermentation of glycans, are modulators of the immune response and therefore could potentially play a role in limiting this inflammatory cascade. KB109 is Generally Recognized as Safe (GRAS) and was selected for evaluation in these COVID-19 clinical studies based on its demonstrated ability to increase production of SCFAs as well as to promote commensal bacteria and reduce pathogenic bacteria ex vivo.

Due to prioritization of KB109 in COVID-19 and anticipated delays due to the pandemic, Kaleido has elected to pause the VITORA clinical study in patients colonized with multidrug-resistant pathogens. The Company is evaluating next steps for its pathogens program, including evaluating KB109 in a patient population at high-risk of infections such as Hematopoietic Stem Cell Transplantation (HSCT) recipients.

Immune-mediated and Inflammatory Diseases Programs

In addition to exploring immune pathways involved in respiratory viral infections with the COVID-19 program, Kaleido is expanding its efforts to understand the potential of MMTs in addressing immune-mediated and inflammatory diseases, including:

Initiating a clinical study later this year evaluating a new MMT candidate, KB295, in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Top-line results are expected in mid-2021.

In its immuno-oncology program, selecting clinical ready, lead MMT candidates that improve therapeutic responses in advanced preclinical models in Q4 2020.

Identifying lead MMTs from preclinical studies in validated models of immune-mediated diseases in the first half of 2021.

Metabolic and Liver Diseases Programs

KB195 is being evaluated in a Phase 2 clinical trial (UNLOCKED) in patients with urea cycle disorders who are inadequately controlled on standard of care. Given limitations on patient visits and the impact on new enrollment due to COVID-19, the Company now anticipates the availability of top-line data will be delayed into the second half of 2021.

Kaleido has received IND clearance and CTA approvals in nine countries, activated more than 20 sites and recently submitted a protocol amendment that expands the eligibility age to adolescents as young as 12 and adults up to age 70 (previously between 18 and 65), which will help facilitate enrollment.

In the hepatic encephalopathy program, Kaleido is ready to initiate the next clinical study evaluating KB174 in patients with the disease. Study initiation is dependent on partnering the program and resolution of COVID-19 impact at trial sites.

Preclinical work for the cardiometabolic and liver diseases program remains on track for results in Q4 2020.

Key Anticipated 2020 Milestones

Abstracts featuring clinical and ex vivo data from KB174 have been accepted for poster presentations during The Digital International Liver Congress (EASL 2020), rescheduled for August 27-29, 2020. Two of these abstracts were accepted for presentation and published to the online portal for Digestive Disease Week, which was cancelled due to the COVID-19 pandemic.

Top-line data from clinical study of KB109 in patients with mild-to-moderate COVID-19 disease expected in Q4 2020.

Data from preclinical programs in immuno-oncology and cardiometabolic and liver diseases expected in Q4 2020.

First Quarter 2020 Financial Results

For the first quarter 2020, Kaleido reported a net loss of $19.6 million, or $0.64 per common share, compared to $20.2 million, or $1.56 per common share, for the first quarter 2019. The 2020 first quarter net loss includes non-cash stock-based compensation expenses of $2.7 million, as compared to $2.5 million in the first quarter of 2019.

Research and development (R&D) expenses were $13.1 million for the three months ended March 31, 2020, compared to $15.2 million for the three months ended March 31, 2019. The decrease in R&D expense was primarily driven by decreased external manufacturing and research costs.

General and administrative (G&A) expenses were $5.9 million for the first quarter 2020, compared to $5.4 million for the first quarter of 2019. The first quarter 2020 increase in G&A, as compared to the first quarter of 2019, was primarily due to increased facility-related expenses.

As of March 31, 2020, the Company reported cash and cash equivalents of $53.8 million. Kaleido continues to manage its operating expenses in-line with its pipeline priorities and, as a result, has extended its cash runway further into the first quarter of 2021.

Conference Call and Webcast Information

Kaleido will host a conference call and webcast today, May 14, 2020, at 8:30 a.m. ET to discuss these pipeline updates. To access the live conference call, please dial (833) 423-0448 (domestic) or (956) 394-3566 (international) and reference conference ID 4182326. The live webcast can be accessed in the Investors & Media section of Kaleido’s website at: View Source Due to current high volume accessing virtual events, participants are encouraged to connect at least 15 minutes prior to the call to ensure a timely connection or to utilize the webcast link for listen-only access. An archived webcast will be made available on Kaleido’s website shortly after the event and accessible for 90 days.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On May 14, 2020 Applied DNA Sciences Inc. (Nasdaq: APDN) ("Applied DNA" or the "Company") a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, reported consolidated financial results for the fiscal second quarter and the six months ended March 31, 2020 (Press release, Applied DNA Sciences, MAY 14, 2020, View Source [SID1234558023]).

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"Continued execution on our strategic priorities in our second fiscal quarter resulted in an expansion of our linear DNA story to include COVID-19 vaccine candidate and diagnostic kit programs and the addition of new development customers. These new development customers, several of which are leaders in the field of gene and redirected-cell therapies, demonstrate broadening interest and adoption of our proprietary linear DNA approach to preclinical biotherapeutics and diagnostics development and further validate linear DNA as a viable alternative for plasmid DNA," stated Dr. James A. Hayward, president and CEO of Applied DNA.

"Most of our activities during the quarter were devoted to our COVID-19 development programs that serve to also elevate the profile of our PCR-based LinearDNA platform to the biopharma industry as a powerful, large-scale tool for the rapid manufacture of DNA-based therapeutics," continued Dr. Hayward. "The global focus on the pandemic and the speed with which vaccine candidates are being developed are laying bare the limitations of modern vaccine development that are almost-exclusively reliant on plasmid-based technologies that are often slow and require much more downstream processing. Because our linear DNA approach does not require bacterial fermentation and has the added advantage of essentially no risk of contamination by genes for antibiotic resistance and other genetic contaminants, we believe our platform is well suited for such DNA-based therapeutics as engineered T cells, gene therapies, RNAi, and vaccines, such as for COVID-19 or future emerging infectious diseases. One new development customer, a global Top-20 pharmaceutical manufacturer, is evaluating the full scope of our platform to potentially serve as a foundational tool for their future genetic therapy pipeline. As the industry comes to terms with the limitations of plasmid-based technologies in terms of production speed and risk, we believe this will set the stage for a paradigm shift towards the rapid manufacturing of linear DNA vaccines with our LinearDNA platform as the accelerator."

Concluded Dr. Hayward, "Looking ahead, we remain focused on driving interest and building demand for our linear DNA approach across certain highly-regulated markets, such as drug development, that we believe offer a path to higher and more recurring revenue. Takis Biotech ("Takis") has initiated preclinical animal trials of our LinearDNA version of their vaccine candidates that we believe will demonstrate similar, robust immune responses to their plasmid-based constructs, but with the added advantage of speed and scalability to manufacture for global use. Concurrently, we are preparing for the possibility for Takis to progress to human trials this fall by readying our facility for compliance with the FDA’s cGMP regulations that govern the quality of biologics for human use. We have also developed our Linea COVID-19 high-throughput and high-sensitivity SARS-CoV-2 detection kit to enable mass-testing that can be a crucial tool in the toolbox of health systems and governments in the fight to further ‘flatten the curve’. Having received Emergency Use Authorization from the FDA today, we are now focused on the commercialization of our kit to assist frontline workers leading the charge against the pandemic. Pharmaceutical molecular tagging is another target market and one where the FDA has granted us entry into its Emerging Technology Program that gives us a path to drive the industry’s adoption of our authentication technologies and mitigate participation of counterfeit and adulterated drugs in the legitimate pharmaceutical supply chain. We will continue to build our business development pipeline and execute on our strategy to advance and prove the capabilities of linear DNA to drug developers and the broader pharmaceutical industry."

Fiscal Second Quarter 2020 Financial Results:

·Revenues decreased 29% for the second quarter of fiscal 2020 to $552 thousand, compared with $778 thousand reported in the same period of the prior fiscal year and decreased 13% from $634 for the first quarter of fiscal 2020. This decrease in revenues year over year is due to a decrease of $305 thousand in service revenues, offset by an increase of $79 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019 and a decline in precommercial feasibility projects in both textiles and cannabis. The increase in product revenues was primarily related to an increase in biopharmaceutical revenues during the quarter ended March 31, 2020.

·Total operating expenses decreased to $3.1 million for the second fiscal quarter of 2020, compared with $3.3 million in the prior fiscal year’s second quarter. This decrease is attributable to a decrease in professional fees of approximately $183 thousand due to reduced legal fees. To a lesser extent, the decrease relates to a reduction of approximately $64 thousand in travel fees as result of travel restrictions associated with COVID-19. This decrease was offset by an increase in research and development expenses of $52 thousand.

·Net loss for the quarter ended March 31, 2020 was $3.0 million, or $0.79 per share, compared with a net loss of $2.7 million, or $3.22 per share, for the quarter ended March 31, 2019, an increase of 10%, and a net loss of $2.7 million, or $1.12 per share, for the quarter ended December 31, 2019.

·Excluding non-cash expenses, Adjusted EBITDA was negative $2.6 million and a negative $2.3 million for the quarters ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.

·Cash was $8.7 million at March 31, 2020 that includes the exercise of warrants associated with the November 15, 2019 underwritten public offering ("the offering") totaling approximately $2.8 million in net proceeds. Subsequent to March 31, 2020 the Company received a further $2.9 million of net proceeds through the exercise of warrants associated with the offering. There are a total of approximately 1.5 million warrants outstanding from the offering at May 14, 2020.

Six Months Ended March 31, 2020 Financial Results:

·Revenues decreased 29% for the first half of fiscal 2020 to $1.2 million, compared with $1.7 million reported in the same period of the prior fiscal year. This decrease in revenue year over year is due to a decrease of $472 thousand in service revenues and a decrease of $5 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019.

·Total operating expenses decreased to $6.1 million for the six months ended March 31, 2020, compared with $7.2 million in the prior fiscal year’s first six months. This decrease is primarily attributable to decreases in payroll of approximately $272 thousand, attributable to headcount reductions, a decrease in stock-based compensation expense of approximately $262 thousand as well as decreases in legal and professional fees of $139 thousand, consulting fees of $121 thousand, reduced travel expenses of $110 thousand and research and development of $93 thousand.

·Net loss for the six-month period ended March 31, 2020 was $5.6 million, or $1.76 per share, compared with a net loss of $5.9 million, or $6.51 per share, for the six months ended March 31, 2019, an improvement of 5%.

·Excluding non-cash expenses, Adjusted EBITDA was negative $5.0 million and a negative $4.9 million for the six months ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.

Select Quarterly Operational Highlights:

Applied DNA progressed its COVID-19 development program that spans both vaccine development and clinical diagnostic kit development:

·On May 14, 2020, Applied DNA announced that it had received Emergency Use Authorization for its COVID-19 diagnostic Assay kit from the U.S. Food and Drug Administration ("FDA"). Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments can immediately begin ordering and using the LineaTM COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19;

·On May 5, 2020, the Company announced that it had applied to the U.S. FDA for Emergency Use Authorization for its COVID-19 diagnostic kit, Linea COVID-19, a RT-PCR-based, high-sensitivity and high-throughput COVID-19 diagnostic test;

·On May 4, 2020, Applied DNA and its COVID-19 development partner, Takis, announced that the first injections of their DNA vaccine candidates against the Spike protein (‘S’ gene) of the SARS-CoV-2 virus that causes the COVID-19 disease, have produced neutralizing antibodies in test animals. The studies were completed at the renowned Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. These initial results were obtained using plasmids (the templates for LinearDNA) to baseline results; Applied DNA’s linear DNA dose-response trials begin in the week of May 4, 2020;

·On April 21, 2020, the Company signed an agreement with Stony Brook University Hospital to validate and implement the Company’s COVID-19 diagnostic test: Linea COVID-19. The diagnostic test targets the SARS-CoV-2 Spike (S) gene, which is also the subject of the Company’s COVID-19 vaccine development program;

·On April 15, 2020, Applied DNA announced that it had shipped five linear DNA versions of COVID-19 vaccine candidates to its drug development partner, Takis, to support the immediate start of preclinical animal testing. Shipment of the vaccine candidates follows Takis’ receipt of approval from Italy’s Ministry of Health to begin preclinical testing. Concurrent with Takis’ animal trials, Applied DNA is preparing for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall; and

·On March 24, the Company announced that it had filed a provisional patent application with the U.S. Patent and Trademark Office for a diagnostic assay for COVID-19.

The Company’s LinearDNA platform for preclinical biotherapeutic (gene and redirected-cell therapies) and diagnostic applications development continued to shift towards broader adoption:

·On March 26, the Company announced that it had shipped CAR T amplicons proprietary to a new development customer, the biologics subsidiary of a U.S.-based, global biopharmaceutical company, for use in evaluating the use of linear DNA; and

·On March 20, Applied DNA announced the signing of a research agreement with a new development customer, a global Top-20 pharmaceutical manufacturer, to evaluate the full scope of the Company’s linear DNA platform to potentially improve the efficacy and safety of the customer’s CAR T therapy pipeline. The research agreement includes the Company’s patented technologies to maximize protein expression and unique linear DNA anti-CD19 CAR T construct for the treatment of acute lymphocytic leukemia.

The Company’s DNA tagging business for supply chain security continued to build awareness and adoption:

·On February 24, the Company announced the receipt of international patents on its Beacon secure optical molecular market technologies in China, Canada, and the U.S., each a key market for brand protection and assurance for Applied DNA;

·On February 20, Applied DNA received Pareve kosher certification for products within its SigNature and CertainT brands from Orthodox Union, the world’s largest and most widely recognized international kosher certification agency. Certification supports the Company’s business development efforts in the food, pharmaceutical, and dietary supplements markets to maximize adoption of its molecular-based tagging platform; and

·On February 19, the Company entered the dietary supplements market with a multi-year contract with Nutrition21, a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry. Under the terms of the contract, the application of Applied DNA’s CertainT platform to Nutrition21’s leading sports supplement, Nitrosigine, offers Nutrition21 the certainty of its ingredients all the way through to their customers’ finished products and onto retail shelves and online stores. Separately, the two companies signed an additional agreement to enable Nutrition21 to represent the CertainT platform throughout Nutrition21’s extensive network in the dietary supplement market.

Fiscal Second Quarter 2020 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal second quarter-end 2020 results on Thursday, May 14, 2020 at 4:30 PM EDT. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free: 1-844-887-9402
·Participant Toll: 1-412-317-6798
·Please ask to be joined to the Applied DNA call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through May 21, 2020):

·Participant Toll Free: 1-877-344-7529
·Participant Toll: 1-412-317-0088
·Participant Passcode: 10141899
·Webcast replay: View Source

For those unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

On May 14, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of two abstracts in connection with the upcoming ASCO (Free ASCO Whitepaper) Virtual Annual Meeting on May 29-31 (Press release, Oncolytics Biotech, MAY 14, 2020, View Source [SID1234558039]). The first abstract "("Multiple Myeloma Abstract"), which has been accepted as an electronic poster, reports on viral replication, tumor immune responses, and treatment safety in multiple myeloma patients treated with pelareorep in combination with carfilzomib (Kyprolis). The second abstract ("Pancreatic Cancer Abstract") reports on treatment tolerability and efficacy in pancreatic cancer patients treated with pelareorep, in combination with pembrolizumab (Keytruda).

Multiple Myeloma Abstract
Abstract ID: 8535
Session: Hematologic Malignancies-Plasma Cell Dyscrasia
Poster ID: 435
Abstract Title: Oncolytic virus pelareorep plus carfilzomib phase I trial in carfilzomib-refractory patients (NCI 9603): Responses with cytokine storm
Presenter: Craig Hofmeister, M.D., MPH, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine

•Reported selective infection of cancerous cells with pelareorep, with associated CD8+ and natural killer (NK) cell recruitment, PD-L1 upregulation, activated caspase-3 expression, and increased pelareorep protein production within myeloma cells.
•Two patients achieved unconfirmed partial responses, two patients had stable disease, and two patients had progressive disease. All patients had advanced and challenging to treat carfilzomib-refractory disease.
•Of the two responding patients, one patient developed a fever and grade 4 thrombocytopenia that resolved, and the other patient developed a cytokine storm, associated with rapid tumor lysis.
•Data supports the potential of future studies investigating pelareorep, carfilzomib, and immune checkpoint inhibitor combination therapy in multiple myeloma patients.
•Additional data to be presented at the poster session on May 29, 2020.

Pancreatic Cancer Abstract
Abstract ID: e16789
Abstract Title: Pembrolizumab in combination with the oncolytic virus pelareorep in patients progressing on systemic chemotherapy for advanced pancreatic adenocarcinoma, a Phase II study
Presenter: Devalingam Mahalingam, MD, Ph.D., Associate Professor of Medicine at Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University

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•Preliminary data indicate that the combination of pelareorep and pembrolizumab resulted in tumor-specific replication, a high degree of T cell repertoire turnover, and the creation of new T cell clones in the peripheral blood during treatment.
•The treatment was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2.
•One patient achieved a partial response and three achieved stable disease, with an overall disease control rate of 30% in evaluable patients.
•The study will not proceed to stage 2 in unselected patients, however further evaluation of the anti-tumor activity of pelareorep and anti-PD-1 therapy is now planned in biomarker defined pancreatic patients in a subsequent study.
•Detailed translational and biomarker data from this study will be published later in the year.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 14, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone) (Press release, Seattle Genetics, MAY 14, 2020, View Source [SID1234558056]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of peripheral T-cell lymphomas (PTCL), including sALCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on March 27, 2020.

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"The approval of ADCETRIS in combination with CHP for use in the European Union for patients with previously untreated sALCL represents a significant advance for patients who previously were treated with CHOP chemotherapy regimen that was often unsuccessful in leading to long-term remissions," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "The outstanding results from the ECHELON-2 phase 3 trial, which demonstrated superior progression-free survival and overall survival compared to CHOP, led to this important regulatory milestone. We are pleased that our partner Takeda is able to make this clinically meaningful therapeutic option available to patients in Europe."

The results from the ECHELON-2 phase 3 clinical trial were published in The Lancetin December 2018. The marketing authorization for ADCETRIS is valid in all countries of the European Union, Norway, Liechtenstein and Iceland. For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.

ADCETRIS for injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, (5) for the treatment of adult patients with relapsed or refractory sALCL, and (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See U.S. important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.