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Arrowhead Pharmaceuticals Reports Fiscal 2018 Year End Results

On December 11, 2018 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal 2018 fourth quarter and year ended September 30, 2018 (Press release, Arrowhead Research Corporation, DEC 11, 2018, View Source [SID1234532026]). The company is hosting a conference call at 4:30 p.m. EST to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6744427.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6744427.

Selected Fiscal 2018 and Recent Events

Hosted an Analyst R&D Day in September 2017 to highlight the following:

The Targeted RNAi Molecule platform, or TRiMTM, which utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting, while being structurally simple. The TRiMTM platform offers several potential competitive advantages including:

A more sophisticated RNAi trigger selection and screening process that identifies potent sequences rapidly in locations that RNAi competitors may miss

Multiple routes of administration including subcutaneous, intravenous, and inhaled

Faster time to clinical candidates

Optimal pharmacologic activity and long duration-of-effect

Potentially wide safety margins

Simplified manufacturing at reduced cost

And, the promise of taking RNAi to tissues beyond the liver

Presented new clinical data at HEP DART 2017 and EASL 2018 demonstrating up to 5.3 Log10 reduction in HBV s-antigen and a Sustained Host Response in 50% of hepatitis B patients following first generation RNAi therapy, ARC-520, in the 2001 open label extension study

One patient serocleared all viral markers, including HBsAg

Began a Phase 1 study of ARO-AAT, Arrowhead’s second generation subcutaneously administered RNAi therapeutic being developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency

Began a Phase 1/2 study of ARO-HBV, a third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential treatment for patients with chronic hepatitis B virus infection

Announced that Amgen had administered the first dose of AMG 890, formerly ARO-LPA, in a Phase 1 clinical study, which earned Arrowhead a $10 million milestone payment

Presented clinical data on ARO-AAT at the Alpha-1 National Education Conference and at the AASLD Liver Meeting 2018 demonstrating:

Three monthly doses of 300 mg ARO-AAT led to reductions in serum alpha-1 antitrypsin to below the level of quantitation in 100% of subjects

Reductions were sustained for greater than 14 weeks indicating that quarterly or less frequent dosing appears feasible

Single and multiple doses of ARO-AAT appeared to be well-tolerated at all doses tested

Presented clinical data on ARO-HBV at the World Gastroenterologists Summit and at the AASLD Liver Meeting 2018 demonstrating:

Mean HBsAg reduction of -1.9 Log10 (-98.7%) with a range of -1.3 Log10 (-95.0%) to -3.8 Log10 (-99.98%)

ARO-HBV appeared to be well-tolerated at monthly doses up to 400 mg

Signed a license agreement with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceuticals Companies of Johnson & Johnson, for ARO-HBV and a collaboration agreement for up to three RNAi therapeutic candidates that use our proprietary TRiMTM platform against new targets to be selected by Janssen

The total potential deal value is approximately $3.7 billion plus royalties on commercial sales

Received $175 million as an upfront payment and received $75 million in the form of an equity investment by Johnson & Johnson Innovation – JJDC, Inc., at a price of $23.00 per share of Arrowhead common stock

Hosted an R&D Day in October 2018 to discuss in more detail our emerging pipeline of RNAi therapeutics that leverage the TRiMTM platform

Filed for regulatory clearance to begin a Phase 1 study of ARO-ANG3, an RNAi-based investigational medicine targeting angiopoietin like protein 3 (ANGPTL3) being developed for the treatment of dyslipidemias and metabolic diseases

NW Bio Announces Non-Dilutive Funding of Approximately $47.3 Million

On December 11, 2018 Northwest Biotherapeutics (OTCQB: NWBO) — ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancer, reported that it has entered into agreements with a large multi-national corporation for a package transaction involving the Company’s property located near Cambridge, UK. Pursuant to these agreements, (Press release, Northwest Biotherapeutics, DEC 11, 2018, View Source [SID1234532024])

•The Company will sell most of its UK property to the multi-national corporation.

•The Company will receive £37.5 million (approximately $47.3 million) cash payment at closing.

•The Company will retain ownership of 17 acres of the property, which are excluded from the sale and which the Company believes will have substantial additional value in the future.

•The Company will retain a lease-back of the approximately 87,000 square foot manufacturing facility which the Company has been developing on the site, along with substantial adjacent areas, for up to 40 years on favorable terms.

The cash purchase price to be paid for the sale of most of the UK property will provide approximately $47.3 million of non-dilutive gross proceeds. Transaction expenses for broker and legal fees are expected to total about £1.3 million. The Company plans to use the transaction proceeds for Company obligations and operations.

The Company acquired the property for approximately £18 million. The Company’s subsequent investments into the property have been focused on the 87,000 square foot manufacturing facility, including refurbishments, structural improvements, extension of an additional level of interior space, and buildout of initial clean-room manufacturing suites. The Company will retain the value and use of these investments through the favorable lease-back of this manufacturing facility. The Company also retains the freedom to make further alterations, additions and improvements.

The lease-back of the manufacturing facility will initially be for 20 years, with a renewal for a second 20 years on the same terms at the Company’s option. The rent is determined by valuing the entire manufacturing facility as a warehouse. No rent is payable for the first year. Starting in year two, the rent is approximately £5.76 per square foot per year, with limited adjustments once every five years.

The lease includes substantial adjacent areas, including for surface parking of 600 vehicles and for equipment, plant and facilities that support or are related to operations in the manufacturing facility. The Company believes that, with internal buildout of further manufacturing suites inside this facility, it will potentially be capable of supporting production of DCVax products for up to 10,000 patients per year.

The property and the manufacturing facility are situated in the heart of the "Golden Triangle" of leading academic centers and rapidly developing R&D centers, from which the Company can draw the technical personnel needed for its operations. The property and manufacturing facility are also situated on or near major transportation arteries, including nearby Stanstead Airport, the major air shipping hub.

"Now that the data from our Phase 3 clinical trial of DCVax-L have further matured and provided a further encouraging picture of patient survival, and we are ready to move forward with the months of work related to completion of the trial, we are very pleased to have a new war chest of funding for this work," commented Linda Powers, CEO of NWBio. "We are also looking forward to proceeding with further DCVax-Direct trials."

"We are especially pleased to obtain this funding on a non-dilutive basis, and to seamlessly continue our activities with the UK manufacturing facility under the favorable lease-back."

REMINDER: Moleculin Announces Conference Call to Discuss Recent Breakthrough Discovery and FDA Filing on Wednesday, December 12, 2018

On December 11, 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 a reminder it will host a conference call to discuss the recent discovery of a use of one of its molecules for cancer treatment and provide a business update (Press release, Moleculin, DEC 11, 2018, View Source [SID1234532019]). The call will be at 4:30 p.m. ET on Wednesday, December 12, 2018.

Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live Internet web cast, which is available in the Investor Relations section of the Company’s website at www.moleculin.com. A webcast replay will be available in the Investors section of the Company’s website at www.moleculin.com for 90 days. A teleconference replay will be available at (877) 344-7529 or (412) 317-0088, confirmation code 10126965, through December 19, 2018.

All interested parties may submit questions via email to [email protected]; management will attempt to answer these questions, time permitting during the call.

Abbott to Present at J.P. Morgan Healthcare Conference

On December 11, 2018 Abbott (NYSE: ABT) reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 8, 2019. Brian Yoor, executive vice president of finance and Chief Financial Officer, will present at the conference at 11 a.m. Central time (Press release, Abbott, DEC 11, 2018, View Source [SID1234532014]).

A live audio webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

Athenex Announces Positive Second Cohort Results of Oraxol-plus-Ramucirumab Phase 1b Clinical Trial in Gastric Cancer

On December 11, 2018 Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that its global Phase 1b clinical trial of Oraxol (oral paclitaxel plus HM30181A) plus ramucirumab (monoclonal antibody to VEGF-R2) in gastric cancer patients who failed previous chemotherapies has completed the study of the second cohort of patients (Press release, Athenex, DEC 11, 2018, View Source;p=RssLanding&cat=news&id=2380209 [SID1234532013]). The results indicated strong positive signals of efficacy and the treatment was well tolerated.

In the first cohort of six patients treated with a 200 mg/kg dose of Oraxol, partial responses were observed in 2/6 patients (33.3%) and stable disease observed in 1/6 patient (16.7%). There was one severe adverse event (SAE) of grade-4 neutropenia in one patient who had complete recovery from this event.

Athenex now reports that for the second cohort of six patients on an escalated Oraxol dose of 250 mg/kg, partial response, according to RECIST criteria, occurred in 3 patients (50%). There was one SAE of grade-3 vomiting in one patient, who elected to withdraw from the study and subsequently had complete recovery. The Oraxol dose is currently being further escalated to 300 mg/kg in the third cohort of patients and the study is ongoing.

"We are pleased by the strong positive signals of efficacy together with a good safety profile in this Phase 1b clinical trial of Oraxol plus ramucirumab in the second-line treatment of gastric cancer patients so far and look forward to further results from the continuation of this study. The results also echoed the strong positive signal that we have observed in other clinical studies of Oraxol as monotherapy for the treatment of metastatic breast cancer," stated Dr. Rudolf Kwan, Athenex’s Chief Medical Officer.

Oraxol is a novel oral formulation of paclitaxel currently in Phase 3 clinical trial in metastatic breast cancer.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company under the name CYRAMZA.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam rights of Oraxol from Athenex and is a partner in the development of Oraxol in the territory