On May 14, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that they will present new data from its ongoing clinical research evaluating the MammaPrint and BluePrint genomic tests at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place virtually May 29-May 31, 2020 (Press release, Agendia, MAY 14, 2020, View Source [SID1234558097]).

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Data will underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for patients throughout their treatment journey. This data builds upon existing clinical research that demonstrates the efficacy of Agendia’s MammaPrint and BluePrint testing to consistently inform optimal treatment planning.

Specific data selected for presentation will include: an evaluation of the concordance between human epidermal growth factor receptor 2 (HER2) status as put forth by the 2018 ASCO (Free ASCO Whitepaper)/CAP guideline classification and BluePrint genomic testing; an examination of specific oncogenes and their correlation with risk scoring and molecular subtyping results; the ability of a chemokine gene score and MammaPrint to predict pathologic complete response (pCR) following neoadjuvant chemotherapy.

Two other poster presentations will feature additional data sets from Agendia’s ongoing multicenter, prospective, observational trial for patients with Stage I, II, and III breast cancer (FLEX). Researchers will share data from FLEX analyses evaluating triple negative breast cancers (TNBC), as well as the clinical estrogen receptor status of Basal-Type tumors based on self-reported patient ethnicities, new gene expression profiles and investigator-initiated protocols in early stage breast cancer.

"Our MammaPrint and BluePrint assays have demonstrated the ability to uniquely guide the practice of precision oncology in helping patients and their healthcare providers create the most targeted and appropriate treatment plan," says William Audeh, MD, MS, chief medical officer at Agendia. "We continue to investigate biologic drivers of breast cancer to help reduce uncertainty when choosing a treatment regimen and these latest data sets offer additional clinical insights that we believe can translate to improved patient outcomes."

Following are details of the five Agendia abstracts that have been accepted for poster presentations at the 2020 ASCO (Free ASCO Whitepaper) Annual Congress:

TNBC subtype and clinical estrogen receptor status of genomically basal breast tumors in Caucasian, African American, and Latin American patients
Authors: Kaklamani, V., et al.
Session: Breast Cancer—Local/Regional/Adjuvant
Abstract #: 556

The FLEX real world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer
Authors: D’Abreo, N., et al.
Session: Health Services Research and Quality Improvement
Abstract #: TPS7088

High Risk breast cancer genes at 8q22-24 and their role in over 5000 patients evaluated with the 70-gene risk of recurrence assay
Authors: Diab, S., et al.
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract #: 3569

Adding precision to 2018 ASCO (Free ASCO Whitepaper)/CAP HER2 testing guidelines in breast cancer with genomic profiling
Authors: Brufsky, A., et al.
Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Abstract #: 3570

12-chemokine gene expression score in breast cancer patients treated with neoadjuvant chemotherapy
Authors: Soliman, H., et al.
Session: Breast Cancer—Local/Regional/Adjuvant and Developmental Therapeutics—Immunotherapy
Abstract #: 591

In addition, the European Organisation for Research and Treatment of Cancer (EORTC) will be presenting nearly nine year follow-up data from the landmark MINDACT study. The independent trial, originally published in the New England Journal of Medicine in 2016, confirmed the clinical utility of MammaPrint as a prognostic tool in identifying genomic Low Risk patients who do not significantly benefit from chemotherapy.

Please follow us on our Twitter, Facebook and LinkedIn pages for unique content we will be sharing throughout ASCO (Free ASCO Whitepaper).

The ASCO (Free ASCO Whitepaper) 2020 virtual program can be found in our Resources section of our website.

On May 14, 2020 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed with a one-hour dosing schedule for investigational agent alvocidib, a potent CDK9 inhibitor, administered in sequence after azacitidine, in the expansion of the Phase 1b/2 Zella 102 study in patients with myelodysplastic syndromes (MDS) (Press release, Tolero Pharmaceuticals, MAY 14, 2020, View Source [SID1234558096]).

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The Zella 102 study is being conducted in patients with previously untreated MDS and patients with MDS who have received fewer than six cycles of treatment with a hypomethylating agent. The initial study design was to evaluate the safety and efficacy of alvocidib using a 30-minute bolus followed by a four-hour intravenous infusion (IVI), in combination with decitabine. An amendment was made to the study design to include treatment with azacitidine, in sequence before a one-hour infusion of alvocidib.

"We are pleased that this study now includes both standard of care hypomethylating agents for patients with myelodysplastic syndromes. In addition, the expansion of this study offers an alternative alvocidib dosing schedule, which reduces the amount of time patients spend in infusion," said David J. Bearss, Ph.D., Chief Executive Officer, Tolero Pharmaceuticals, and Chief Scientific Officer and Global Head of Research, Global Oncology. "Preclinical research suggests that treatment with hypomethylating agents may sensitize MDS blast cells to suppression of MCL-1 through alvocidib. We look forward to building our understanding of the potential role of alvocidib in this patient population."

MDS is a form of cancer that can occur when cells in the bone marrow are abnormal and create defective blood cells, which often die earlier than normal cells. In one of three patients, MDS can progress into AML, a rapidly growing cancer of bone marrow cells.1

About the Zella 102 Study

The Zella 102 study is an open-label, dose-escalation Phase 1b/2 study evaluating the safety and efficacy of alvocidib, when administered in sequence after either decitabine or azacitidine, in patients with previously untreated MDS and patients with MDS who have received fewer than six cycles of treatment with hypomethylating agents. The primary objective of the Phase 1b portion of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of alvocidib, when administered in these regimens. Secondary objectives are to determine the complete response rate and if treatment with alvocidib, administered in sequence after decitabine or azacitidine, results in improvements in transfusion dependence and/or hemoglobin level.

The primary objective of the Phase 2 portion of the study will be to determine the objective response rate of alvocidib, when administered to untreated patients with de novo or secondary MDS in sequence after a hypomethylating agent, using revised International Working Group (IWG) criteria.

The trial is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03593915).

About Alvocidib

Alvocidib is an investigational small molecule inhibitor of cyclin-dependent kinase 9 (CDK9) currently being evaluated in the Phase 2 studies Zella 202, in patients with acute myeloid leukemia (AML) who have either relapsed from or are refractory to venetoclax in combination with decitabine or azacitidine (NCT03969420) and Zella 201, in patients with relapsed or refractory MCL-1 dependent AML, in combination with cytarabine and mitoxantrone (NCT02520011). Alvocidib is also being evaluated in Zella 101, a Phase 1 clinical study evaluating the maximum tolerated dose, safety and clinical activity of alvocidib in combination with cytarabine and daunorubicin (7+3) in newly diagnosed patients with AML (NCT03298984), and Zella 102, a Phase 1b/2 study in patients with myelodysplastic syndromes (MDS) in combination with decitabine or azacitidine (NCT03593915). In addition, alvocidib is being evaluated in a Phase 1 study in patients with relapsed or refractory AML in combination with venetoclax (NCT03441555).

About CDK9 Inhibition and MCL-1

MCL-1 is a member of the apoptosis-regulating BCL-2 family of proteins.2 In normal function, it is essential for early embryonic development and for the survival of multiple cell lineages, including lymphocytes and hematopoietic stem cells.3 MCL-1 inhibits apoptosis and sustains the survival of leukemic blasts, which may lead to relapse or resistance to treatment.2,4 The expression of MCL-1 in leukemic blasts is regulated by cyclin-dependent kinase 9 (CDK9).5,6 Because of the short half-life of MCL-1 (2-4 hours), the effects of targeting upstream pathways are expected to reduce MCL-1 levels rapidly.5 Inhibition of CDK9 has been shown to block MCL-1 transcription, resulting in the rapid downregulation of MCL-1 protein, thus restoring the normal apoptotic regulation.2

On May 14, 2020 Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported that it has entered into definitive agreements with several institutional and accredited investors for the purchase of 7,058,824 shares of its common stock, at a purchase price per share of $1.0625 for gross proceeds of approximately $7.5 million, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Citius Pharmaceuticals, MAY 14, 2020, View Source [SID1234558095]). Additionally, Citius has also agreed to issue to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. The closing of the offering is expected to take place on or about May 18, 2020, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.00 per share, will be immediately exercisable, and will expire five and one-half years from the issue date.

Citius intends to use the net proceeds from the offering for general corporate purposes, including clinical trial expenses, research and development expenses, manufacturing expenses and general and administrative expenses.

The shares of common stock described above (but not the warrants or the shares of common stock underlying the warrants) are being offered pursuant to a "shelf" registration statement (File No. 333-221492) filed with the Securities and Exchange Commission (SEC) and declared effective on December 15, 2017. Such shares of common stock may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by emailing [email protected] or by calling 646-975-6996.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.