On July 18, 2018 Moleculin Biotech, Inc. (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has begun preclinical toxicology testing of its WP1732, a fully water-soluble STAT3 inhibitor through its new subsidiary in Australia (Press release, Moleculin, JUL 18, 2018, View Source [SID1234528787]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Based on preclinical testing, we believe the discovery of WP1732, a fully water-soluble STAT3 inhibitor, has the potential to be a breakthrough discovery for rare and difficult to treat cancers. As a result of our preclinical testing, we have recieved multiple requests to commence clinical trials and we are pleased to be taking the next steps in preparing for the appropriate clinical work," commented Walter Klemp, Chairman and CEO of Moleculin. "By utilizing our subsidiary in Australia and the attractive R&D tax credits it offers, we can accelerate the preclinical work of WP1732 and maintain a strong cash balance. We believe this will allow us to complete our IND-enabling work and meet FDA submission requirements before year-end while also reducing our total cost of development."

On July 18, 2018 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease (Press release, Immunomedics, JUL 18, 2018, View Source [SID1234527766]). The PDUFA target action date is January 18, 2019. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review," commented Michael Pehl, President and Chief Executive Officer. "We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously."

The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.

About Sacituzumab Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.

On July 18, 2018 EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, reported that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT (siltuximab) for $115 million in cash (Press release, EUSA Pharma, JUL 18, 2018, View Source [SID1234553163]). The transaction is subject to review under the United States Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended, and the parties expect to close following completion of this regulatory review period and the mutual satisfaction of other remaining closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SYLVANT is approved in more than 40 countries worldwide, including the United States, the European Union, the Republic of Korea and Canada, for the treatment of idiopathic multicentric Castleman’s disease (iMCD), a rare, life threatening and debilitating orphan condition. Idiopathic MCD is an inflammatory lymphoproliferative disorder, which causes the abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.1 The disease can affect individuals at any age, with iMCD representing one-third to half of all multicentric Castleman’s disease (MCD).2

"iMCD is a devastating disorder with few treatment options for patients, because the underlying mechanisms are so poorly understood," said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Translational Medicine and Human Genetics, and Associate Director, Patient Impact, Orphan Disease Center, at the Perelman School of Medicine at the University of Pennsylvania.

SYLVANT is the only approved treatment for iMCD in the United States and Europe. It first received approval in the United States in 2014, with subsequent approvals occurring in a number of countries thereafter. Since then, SYLVANT has achieved rapid revenue growth.

The approval of SYLVANT was based on the MCD2001 study (NCT01024036); an international, randomised, double blind, placebo-controlled trial including 79 subjects. More than one-third of subjects in the SYLVANT arm had a durable tumour and symptomatic response to treatment plus best supportive care (BSC), compared to none of the subjects who received placebo plus BSC (34% versus 0% according to stringent criteria; 95% CI: 11.1, 54.8; p=0.0012).3

"The acquisition of SYLVANT represents a significant opportunity for EUSA Pharma. As the only approved treatment for this orphan condition, SYLVANT highlights the importance of ongoing research and development in areas where there are few patients yet high unmet medical needs", said Lee Morley, EUSA Pharma’s Chief Executive Officer. "Following the recent divestment of our critical care portfolio, EUSA Pharma has transformed into a rapidly growing biopharmaceutical company focused solely on oncology and rare disease, backed by leading life science investor EW Healthcare Partners. SYLVANT is a perfect fit with our ambitious plans to roll out innovative biopharmaceutical treatments to serve the oncology and rare disease community worldwide.

On July 17, 2018 Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, reported that operational highlights and upcoming milestones, as well as revenues and cash position for Nicox and its subsidiaries (the "Nicox Group") as of June 30, 2018 (Press release, NicOx, JUL 17, 2018, View Source [SID1234527743]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated, "VYZULTA sales by our global partner Bausch + Lomb grew substantially in the second quarter, reflected by an increase of over 180% in net royalty received by Nicox compared to the first quarter of 2018. Looking ahead to the remainder of 2018, we expect to add a second revenue stream for the future through the planned launch in the fall of ZERVIATE in the United States by our U.S. partner Eyevance, and advancing towards the initiation of Phase 2 clinical studies for NCX 470 and NCX 4251."

Key Upcoming Milestones
Q3 2018: Planned start of Phase 2 clinical study for NCX 470 for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Fall 2018: Expected commercial launch of ZERVIATETM (cetirizine ophthalmic solution), 0.24% in the United States by partner Eyevance Pharmaceuticals, LLC.

Q1 2019: Planned U.S. Investigational New Drug (IND) submission to the U.S. FDA for NCX 4251 to enable a Phase 2 clinical study in patients with acute exacerbations of blepharitis, following the successful, latest pre-IND meeting with the U.S. FDA in June 2018 (discussed below).

Second Quarter 2018 and Recent Operational Highlights
Research Collaboration with Ironwood Pharmaceuticals, Inc. In June 2018, we announced that we have entered into a research collaboration with Ironwood, focused on combining Ironwood’s expertise in soluble guanylate cyclase (sGC) and our proprietary nitric oxide (NO)-donating research platform to generate novel compounds in order to identify potential new therapeutics for the treatment of certain ophthalmic conditions.
Further pre-IND meeting held for NCX 4251. In June 2018, an additional pre-IND meeting was held with the U.S. FDA, which addressed specific questions on development, including the potential primary endpoints for the Phase 2 clinical study. Based on the FDA comments from this and previous meetings, we are finalizing the design of the first in human Phase 2 clinical trial evaluating the safety and efficacy of NCX 4251 versus a vehicle comparator in subjects with acute exacerbations of blepharitis. We plan to submit an IND in Q1 2019 to enable this Phase 2 clinical study.
Presentation of scientific data at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting. In May 2018, we presented preclinical data on NCX 667, a lead molecule among our future generation stand-alone NO-donors, demonstrating the lowering of IOP in a robust, dose-dependent manner in various normotensive and hypertensive ocular models.

Opening of new U.S. development office in Research Triangle Park, North Carolina. In April 2018, we announced our decision to relocate from our prior development office in Fort Worth, Texas, and to expand our presence in the United States to focus on the planned advancement of NCX 470 and NCX 4251 into Phase 2 clinical studies.
Second Quarter 2018 Financial Highlights

As of June 30, 2018, the Nicox Group had cash and cash equivalents of €32.6 million as compared with €36.3 million at March 31, 2018 and €41.4 million at December 31, 2017. Net revenue1 for the second quarter of 2018 was €0.226 million, comprised exclusively of royalties on Q2 2018 sales of VYZULTATM by global partner Bausch + Lomb, after deduction of royalty payments due by Nicox. The Group recorded no revenues for the second quarter of 2017.

Only the figure related to the cash position of the Group as of December 31, 2017 is audited; all other figures of this press release are non-audited.
References
1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss

On July 17, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, and Strata Oncology, Inc., a precision oncology company, have entered into a collaborative agreement to accelerate patient enrollment in Puma’s ongoing Phase II SUMMIT trial of PB272 (neratinib) (Press release, Puma Biotechnology, JUL 17, 2018, View Source [SID1234527744]). The SUMMIT trial is a global, multi-histology, open-label, precision-medicine ‘basket’ study evaluating the safety and efficacy of neratinib in patients with a wide variety of solid tumors with activating EGFR, HER2 or HER4 mutations.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Neratinib, an oral irreversible pan-HER kinase inhibitor, was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX. Data published in the journal Nature earlier this year showed neratinib has activity across multiple tumor types with HER2-activating mutations.

Under the terms of the agreement, Strata will exclusively refer HER2-mutated advanced cancer patients identified through the Strata Trial for consideration of enrollment to Puma’s SUMMIT Trial for neratinib.

The Strata Trial is a screening protocol providing comprehensive tumor molecular profiling to advanced cancer patients at no cost and proactive enrollment support for a portfolio of pharma-sponsored precision therapy trials. Tumor profiling through the Strata Trial is provided as part of routine care to solid tumor patients across the Strata Precision Oncology Network, a network of 11 leading health systems representing more than 85,000 new cancer patients annually. This large network of trial-ready health systems with fully pre-screened advanced cancer populations enables rapid and predictable enrollment of precision therapy trials.

"We are pleased to partner with Puma Biotechnology to accelerate the path to new approvals for neratinib," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "We frequently identify HER2-mutant patients across the Strata Precision Oncology Network and we believe this partnership will greatly facilitate patient access to this promising clinical trial."

"Puma’s ultimate goal is to deliver new treatment options and improve the lives of patients with various types of cancer," said Alshad S. Lalani, V.P., Translational Medicine of Puma Biotechnology. "We believe Puma’s partnership with Strata will help us reach patients with multiple tumor types who may not otherwise know about the SUMMIT study, giving them a chance to participate in research that’s designed to provide important new information for future treatment."