On May 14, 2020 Strata Oncology, a precision oncology company advancing molecular indications for cancer therapies, reported that three studies will be presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) demonstrating the benefits of increased patient access using the StrataNGS comprehensive genomic profiling (CGP) assay (Press release, Strata Oncology, MAY 14, 2020, View Source [SID1234558094]).

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One study shows an expanded proportion of patients with actionable biomarkers due to the capability of the StrataNGS test with small tissue samples. The results from an analysis of data collected in the Strata Trial demonstrated that less than half of >20,000 FFPE tumor tissue samples met tumor surface area requirements for leading commercial hybrid-capture CGP tests. StrataNGS, a PCR-CGP test, successfully reported results in 96% of all samples received. Another study discusses the benefits of implementing a genomic oncology program for patients with advanced cancer in a community oncology network.

"These studies underscore the importance of the Strata Oncology CGP assay and precision oncology services in supporting widespread implementation of a robust precision oncology program. Given the pace of innovation for targeted and immunotherapies, it is critical that we work toward a future where every patient with advanced cancer is molecularly profiled and receives their best possible treatment outcome," said Scott Tomlins, M.D., Ph.D., Chief Medical Officer of Strata Oncology. "We are excited to showcase research demonstrating our commitment to enabling broad patient access to molecular profiling through system-wide implementation of a CGP test with industry-low tumor tissue requirements."

All abstracts became available online May 13, after 5 pm ET. Posters will be available on the Strata Oncology website (www.strataoncology.com) with recorded presentations by the studies’ lead authors once they are presented.

"PCR-based Comprehensive Genomic Profiling: Feasibility From >20,000 Tumor Tissues Specimens and Predicted Impact on Actionable Biomarker Identification Versus Hybrid Capture and Plasma," presented by Scott Tomlins, M.D., Ph.D., Strata Oncology, (Abstract 3574);
"Implementing a Genomic Oncology Program in an Integrated Health Care Network with Large Scale Genomic Next Generation Sequencing (NGS) Testing of Advanced Cancers in a Community Setting," Marie Suga, M.D., Kaiser Permanente Northern California, lead author (Abstract e19185);
"The Impact of Tumor NGS Testing on Hereditary Cancer Risk Assessment and Population Management in an Integrated Community Health Care System," presented by Sachdev Thomas, M.D., Kaiser Permanente Northern California (Abstract # 312647).
About StrataNGS

StrataNGS is a comprehensive genomic profiling assay that assesses DNA and RNA in solid tumors. The assay requires industry-low tumor tissue samples (0.5mm2). StrataNGS is performed on co-isolated RNA and DNA and detects all classes of genomic alterations, including SNVs, small insertions and deletions, gene fusions, exon skipping mutations and copy number changes. Results include MSI and TMB. to help inform immunotherapy decisions.

On May 14, 2020 Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology reported its Q1 2020 financial results and provides a business update (Press release, Pulmatrix, MAY 14, 2020, View Source [SID1234558093]).

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"We are excited to join the fight against COVID-19 with the announcement of our Sensory Cloud worldwide partnership for the development and commercialization of an over-the-counter version of NasoCalm, our proprietary anti-contagion product. This partnership builds upon our former biodefense history and we hope to aid in the effort against this virus," said Ted Raad, Chief Executive Officer of Pulmatrix. "On the clinical front, we are committed to the safety of our study subjects during this pandemic. Due to the impact of COVID-19, enrollment in our Phase 2b clinical study of Pulmazole for the treatment of ABPA has been temporarily paused. In our collaboration with Johnson & Johnson*, we currently plan to initiate the PUR1800 Ph1b clinical study and chronic toxicology studies in the second half of 2020."

Q1 and Recent Highlights:

Entered into a strategic partnership with Sensory Cloud to develop and commercialize over-the-counter nasal administration of PUR 003 and PUR 006, the Company’s proprietary formulations which have demonstrated the potential to reduce the pathogenic risk and transmissibility of contagions, including COVID-19.
Received U.S. FDA Fast Track designation for Pulmazole for the treatment of ABPA.
Announced kinase inhibitor licensing and development agreement with the Lung Cancer Initiative at Johnson & Johnson*. The agreement provides the Lung Cancer Initiative option to access a portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer interception.
Announced research collaboration with Nocion Therapeutics to explore inhaled drug delivery technologies for its respiratory compounds.
Completed a registered direct offering in April 2020, resulting in $8.0 million in gross proceeds to support ongoing development activities.
Financials

As of March 31, 2020, Pulmatrix had $24.4 million in cash and cash equivalents, compared to $23.4 million as of December 31, 2019. In December 2019, Pulmatrix executed a Licensing Agreement with the Lung Cancer Initiative at Johnson & Johnson and in January 2020, received a $7.2M upfront payment with an option to access a portfolio of narrow spectrum kinase inhibitors intended for development in lung cancer.

Pulmatrix reported $2.8 million of revenue in the first quarter of 2020; no revenue was recorded in the first quarter of 2019. The increase was the result of revenue recognized from our collaboration agreement with Cipla Technologies and the license agreement with Johnson & Johnson.

Research and development expenses for the first quarter of 2020 were $5.3 million compared to $2.2 million for the same period last year. The $3.1 million increase was primarily due to increased spend of $1.9 million on the PUR1800 project due primarily to manufacturing costs, $0.9 million on the Phase 2b Pulmazole clinical trial and $0.3 million on employment costs in support of our programs.

General and administrative expenses for the first quarter of 2020 were $2.2 million compared to $2.0 million for the same period last year. The increase was due to professional consulting cost of $0.2 million.

Net loss was $4.7 million for the first quarter of 2020 and $5.2 million for the first quarter of 2019. The net loss for both periods was due to spend on the Pulmazole project as we continue to advance our Phase 2b clinical study and PUR1800 manufacturing costs for the upcoming planned Phase 1b clinical study.

On May 14, 2020 Menarini Ricerche reported the completion of the dose escalation part of the First in Human, phase I/II DIAMOND trial (CLI24-001; NCT03008187) currently ongoing to evaluate SEL24/MEN1703, a first in class, oral dual PIM/FLT3 inhibitor in development for the treatment of acute myeloid leukemia (AML) (Press release, Menarini, MAY 14, 2020, View Source [SID1234558092]). The results will be disclosed at the 25th EHA (Free EHA Whitepaper) virtual meeting with the e-poster entitled "Results of the dose escalation part of DIAMOND trial (CLI24-001): first in human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" (EP604).

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The primary objectives of the dose escalation part of the study were the identification of dose limiting toxicities, the determination of the maximum tolerated dose and recommended dose for the phase 2 part of the study, as well as characterization of the pharmacokinetics of SEL24/MEN1703 in AML – relapsed or refractory as well previously untreated – patients unsuitable for chemotherapy. Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. Cohort Expansion study in relapsed/refractory AML patients will further investigate the single agent activity and the safety profile of SEL24/MEN1703.

"The promising results from the dose-escalation phase of the DIAMOND trial provide a strong rationale to progress to the cohort expansion phase of the study," said Dirk Laurent, Global Therapeutic Area Head – Oncology of Menarini Ricerche. "We look forward to further revealing the potential of the SEL24/MEN1703 program to the benefit of AML patients who need innovative and effective therapeutic options."

On May 14, 2020 SkylineDx reported the publication of two ASCO (Free ASCO Whitepaper) abstracts describing a biomarker that identifies a subgroup of skin cancer (cutaneous melanoma) patients that could benefit from adjuvant therapy as their melanoma is at high risk of recurrence, but who are currently not diagnosed as high risk because they do not have metastasis in their sentinel lymph nodes (Press release, SkylineDx, MAY 14, 2020, View Source [SID1234558091]). At present only melanoma patients that have detected metastasis in their lymph nodes (clinical stage III) are referred for adjuvant therapy. In a US cohort totaling 837 patients, 637 (76%) patients had no nodal metastasis in which the biomarker (named the CP-GEP model) was able to identify 327 (51%) patients at high-risk of melanoma recurrence within 5 years. This group has a similar prognosis as the treatment eligible stage III patients [3].

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Clinical trials on adjuvant treatment are moving towards the inclusion of non-metastatic stage IIB and IIC patients. Nonetheless, a stage-specific optimization of the CP-GEP model identified an additional 45% of stage IIA patients in the above-mentioned cohort, currently excluded from trials, with a demonstrated worse prognosis than stage IIC and IIIA patients. These patients should be considered for inclusion into a trial to investigate if treatment with adjuvant systemic therapy can prevent their melanoma from returning [4]. The optimized CP-GEP model for this prognostic utility will be further researched under the Peregrine Study Initiative in the Falcon R&D Program.

Melanoma specialist, Dr. Alexander Eggermont, Chief Scientific Officer of the Princess Máxima Center in the Netherlands, says: "Over the last years significant progress has been made in advancing adjuvant treatments for metastatic stage III melanoma patients. However, large population-based studies demonstrate that approximately 50% of melanoma-related deaths occur in patients that were originally diagnosed with non-metastatic disease. The discovery of the prognostic CP-GEP model to select high-risk Stage IIA patients for adjuvant therapy is a significant breakthrough that can potentially benefit thousands of patients annually."

"One of our core value statements is to think about how our innovation can impact many lives", comments Dharminder Chahal, CEO SkylineDx. "It is confronting to see the potential undertreatment in these skin cancer patients. Some are going home, partially reassured of not having metastasis, only to find out later that the melanoma has returned relatively fast. There should be a research focus on the improvement we could achieve in defining personalized treatment pathways on the basis of individual risk."

About CP-GEP

The CP-GEP model calculates the risk of melanoma returning on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age. The model has been previously published in JCO Precision Oncology [2].The prognostic use of the CP-GEP model is the main focus of the Peregrine Study Initiative, developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.

On May 14, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Betalutin (177Lu lilotomab satetraxetan) has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan drug designation for the treatment of marginal zone lymphoma (MZL) (Press release, Nordic Nanovector, MAY 14, 2020, View Source [SID1234558090]). The positive opinion is expected to be adopted by the European Commission shortly.

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In the LYMRIT 37-01 Phase 1/2a trial, Betalutin showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) – the highest response rates of any patient sub-population in this study. This followed a once-only administration of Betalutin in this heavily pre-treated group of patients with advanced disease.

MZL is a form of indolent (slow-growing) B-cell non-Hodgkin’s lymphoma (NHL) that accounts for approximately eight percent of all NHL cases. EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare (affecting not more than five in 10,000 people in the European Union). Medicines that meet the EMA’s orphan designation criteria qualify for several incentives to help support advancement.

Betalutin received Orphan Drug Designation for the treatment of follicular lymphoma in the US and Europe in 2014.

Lars Nieba, Interim Chief Executive Officer, commented "We are very pleased to receive a positive opinion on Orphan Drug Designation in the European Union for Betalutin in MZL. There is a clear need for new therapeutic options for MZL patients who no longer respond to anti-CD20 immunotherapy (rituximab), the current backbone of treatment in first and second-line patients. We look forward to receiving the final decision by the European Commission in the coming weeks."