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.

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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."

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]).

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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 Exelixis, Inc. (Nasdaq: EXEL) reported that its second quarter 2018 financial results will be released on Wednesday, August 1, 2018 after the markets close (Press release, Exelixis, JUL 17, 2018, View Source;p=RssLanding&cat=news&id=2358696 [SID1234527742]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 5668207 to join by phone.

A telephone replay will be available until 8:30 p.m. EDT on August 3, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 5668207. A webcast replay will also be archived on www.exelixis.com for one year.

On July 17, 2018 Cellectar Biosciences (Nasdaq: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that a patient in the lymphoplasmacytic lymphoma (LPL) arm with advanced Waldenstrom macroglobulinemia, enrolled in the CLR 131 Phase 2 trial, showed a 94% reduction in tumor burden and complete resolution in four of five targeted tumor masses (Press release, Cellectar Biosciences, JUL 17, 2018, View Source [SID1234527741]).

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Prior to study enrollment, this 67-year-old female patient was diagnosed with Waldenstrom macroglobulinemia and had received two lines of multi-drug therapy with the most recent treatment achieving a best response of disease progression. As part of Cellectar’s Phase 2 study in hematologic cancers, the patient received a single 25mCi/m2 dose of CLR 131 over a 30-minute infusion period. On day 52 post infusion, a CT scan showed a >50% reduction in tumor volume and was classified as a partial response.

Based on this initial response and additional clinical factors, the treating physician, Sikander Ailawadhi, M.D., Associate Professor, Division of Hematology/Oncology, Department of Medicine, The Mayo Clinic, Jacksonville, Florida, administered a second dose of CLR 131 on day 123. A CT scan taken 64 days after the second dose, showed a 94% overall reduction in tumor burden and complete resolution in four of five targeted tumor masses. The total targeted tumor mass shrank from approximately 4700mm2 prior to the first CLR 131 infusion to approximately 500mm2 at last reading, and we continue to monitor the patient’s progress.

"In addition to a robust clinical response, we were also happy to see resolution of symptoms that affected the patient’s quality of life, including shortness of breath associated with moderately-sized pleural effusion shortly after the patient’s first dose of CLR 131," stated Dr. Ailawadhi. "CLR 131 has shown good clinical response in LPL as well as other hematologic indications and could provide an excellent addition to the treatment armamentarium."

About Waldenstrom Macroglobulinemia

Waldenstrom macroglobulinemia is a rare type of cancer that begins in the white blood cells, according to the Mayo Clinic. Patients with Waldenstrom macroglobulinemia, typically have bone marrow that produces too many abnormal white blood cells, crowding out healthy blood cells. The abnormal white blood cells produce a protein that accumulates in the blood, impairs circulation and causes complications. Waldenstrom macroglobulinemia is considered a type of non-Hodgkin’s lymphoma and is sometimes called lymphoplasmacytic lymphoma or LPL.

About the Phase 2 Study of CLR 131

The Phase 2 study is being conducted in approximately 10 leading cancer centers in the United States for patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).

The study’s primary endpoint is clinical benefit response (CBR), with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180 days later.

In addition to the CLR 131 infusion(s), MM patients will receive 40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. Cellectar has been awarded approximately $2 million in a non-dilutive grant from the National Cancer Institute to help fund the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference NCT02952508.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. The company is currently initiating a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and is planning a second Phase 1 study in combination with external beam radiation for head and neck cancer.

On July 17, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported that Sharron Gargosky, PhD, Chief Clinical and Regulatory Officer, presented a clinical update of the Company’s intratumoral therapy, ImmunoPulse tavokinogene telseplasmid (TAVO), as well as an overview of the ongoing and anticipated clinical programs involving TAVO in triple-negative breast cancer (TNBC) (Press release, OncoSec Medical, JUL 17, 2018, https://ir.oncosec.com/news/detail/1950/oncosec-presents-update-from-triple-negative-breast-cancer-program-at-3rd-global-insight-conference-on-breast-cancer [SID1234527738]). The presentation, titled "Intra-tumoral delivery of tavokinogene telseplasmid (pIL-12) by electroporation: immunomodulation in melanoma and triple negative breast cancer," took place at the 3rd Global Insight Conference on Breast Cancer in Valencia, Spain.

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"We were grateful for the opportunity to present at the 3rd Global Insight Conference on Breast Cancer and share progress from our TAVO clinical programs with the clinicians, biotechnology executives, and industry opinion leaders in attendance. Metastatic TNBC is a heterogeneous cancer with a poor prognosis where less than five percent of pre-treated patients achieve an objective response to PD-1/PD-L1 checkpoint treatments," said Dr. Gargosky. "The marked synergy shown in these patients strongly suggest that IL-12 may have primed the tumor microenvironment, impacting the clinical result. The combination of TAVO and checkpoint inhibition represents a highly promising new therapeutic approach for TNBC and warrants a formal evaluation given the extremely low response rate in women who have failed multiple prior therapies."

The ongoing Phase 1 TNBC study, OMS-140 (NCT02531425), is designed to determine whether TAVO as a single cycle of monotherapy can elicit a pro-inflammatory molecular and histological signature in treated as well untreated tumors. The study has reached its target enrollment of 10 patients. Several of these patients were subsequently treated with an anti-PD-1 checkpoint inhibitor treatment(s) as their next therapy. As previously reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, immunological signals were observed on an individual patient basis, and clinically meaningful objective tumor responses have been observed in both TAVO treated and untreated lesions following the anti-PD-1 checkpoint inhibitor treatment. A detailed case study of one such patient, along with information regarding clinical observations and safety data, were presented at this conference.

Following these observations, the Company entered a clinical collaboration with Merck to evaluate the combination of TAVO with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase 2 clinical trial, KEYNOTE-890 (NCT03567720). KEYNOTE-890 is a study of TAVO in combination with KEYTRUDA in TNBC patients with inoperable locally advanced or metastatic TNBC who have progressed on more than one line of prior therapy. Patients will be treated with the combination of TAVO with pembrolizumab. The proposed primary endpoint is to assess efficacy as measured by objective response rate (ORR) by independent central review (ICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. KEYNOTE-890 is expected to initiate in the third quarter of 2018.