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Moleculin Announces Positive Data on WP1066 in Pre-Clinical Trials

On Oct 25, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported 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 that investigators at Emory University will present animal model data supporting the potential of WP1066 to treat pediatric brain tumors at the upcoming Society for Neuro-Oncology Annual Scientific Meeting (Press release, Moleculin, OCT 25, 2018, View Source [SID1234530259]).

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"A number of independent institutions have published results supporting the potential for WP1066 to kill tumors in a range of animal models," commented Walter Klemp, Moleculin’s Chairman and CEO. "Having this corroborated yet again by data presented from Emory University just adds to the enthusiasm for testing WP1066 in humans. What makes this particularly important is that our drug showed activity against the most common form of childhood brain tumor, medulloblastoma, for which there is a desperate need for more effective treatments."

Mr. Klemp continued, "We are also proud of the fact that two different Moleculin technologies, WP1066 and WP1122 (see Moleculin press release dated October 10, 2018), are being presented at this prestigious conference on brain tumors. We believe this is a strong indicator of the breadth and significance of our development pipeline

Sitka Biopharma Announces New Investment from Global Health Sciences Fund

On October 25, 2018 Sitka Biopharma reported that Quark Venture Inc. and GF Securities, through their Global Health Sciences Fund (GHS), has invested $1.9M into Sitka – financing that will enable the company to complete critical GLP toxicology studies and GMP manufacture of clinical drug product (Press release, Sitka Biopharma, OCT 25, 2018, View Source [SID1234530250]). This in turn will allow Sitka and partner Cancer Research UK (CRUK) to complete initial Phase 1 clinical trials of STK-01, Sitka’s lead product for the treatment of bladder cancer.

A spin-off of CDRD and the University of British Columbia (UBC), Sitka Biopharma is a preclinical biotechnology company focused on developing its breakthrough nanoparticle platform technology to increase absorption of drugs in difficult-to-penetrate tissues. While STK-01 is being developed for the treatment of bladder cancer, follow-on indications of the current core formulation include intraperitoneal delivery for ovarian cancer and other indications where localized drug delivery would be advantageous but currently ineffective due to those penetration challenges.

Preclinical studies have established that Sitka’s candidate formulation significantly improved bladder tissue uptake when compared to the commercial docetaxel formulation. Furthermore, the proprietary hyperbranched polyglycerols (HPG)-docetaxel formulation demonstrated superior efficacy over commercial docetaxel – providing a preclinical proof-of-concept.

Dr. Michael Parr, Sitka’s President and Chief Scientific Officer said, "This is an extremely pivotal investment for Sitka as it means we can complete the final IND-enabling studies and take our lead therapeutic for bladder cancer into the clinic via our partnership with CRUK. This investment sets up the company for rapid progression through those initial clinical trials and we can also begin planning to expand STK-01 to additional indications."

Ms. Karimah Es Sabar, Chief Executive Officer of Quark Venture and Director of GHS Fund commented "GHS Fund believes Sitka is poised for an important medical breakthrough in bladder cancer. This initial success will be leveraged for further development of the platform in other indications, including ovarian cancer."

Bladder cancer is the 4th most common cancer in men, and has the highest per patient lifetime cost of all cancers. The challenge in bladder cancer is that because of the nature of the bladder, drugs are not well-absorbed and only stay in the bladder for as long as the patient does not void their bladder – a critical issue addressed by the Sitka technology.

This technology was initially developed through a collaboration between the UBC and CDRD. Additional early funding included grants from the Canadian Institutes of Health Research (CIHR), Genome British Columbia, and the National Research Council of Canada’s IRAP Program. Quark Venture provided the first private financing in March 2016

Cancer Therapeutics CRC signs agreement to enable Pfizer to develop novel cancer drugs

On October 25, 2018 Melbourne-headquartered Cancer Therapeutics CRC (CTx) reported a two-year research collaboration and a license agreement with Pfizer Inc. (NYSE: PFE) (Press release, Cancer Therapeutics CRC, OCT 25, 2018, View Source [SID1234530249]). Under the terms of the agreement, Pfizer will gain the rights to two novel pre-clinical cancer programs and CTx will receive US$14.2 million [AUD$20M] upfront payment, up to a potential US$460 million [AUD$648M] in development and sales milestones, as well as royalties on product sales if the program reaches commercialization. The two programs target proteins that are known to play an important role in driving the growth of both solid and blood cancers.

Brett Carter, CEO of CTx, said "We are very excited to work with a company of Pfizer’s calibre on the progression of these programs. This deal, together with the three prior deals for CTX technology, has the potential to return a billion dollars to Australia. Funds that will help support the biomedical sector and that can be ploughed into new drug discovery programs; providing opportunities for the world class team we have developed, and potentially leading to the delivery of new treatments for patients and economic benefits for the nation".

Dr. Robert Abraham, Senior Vice President and Group Head of Pfizer’s Oncology Research & Development Group said: "We are constantly searching the globe for the best science that has the potential to change the way we can treat people with cancer in the future. What we have found at CTx with these two chromatin modifying enzyme targets are very promising, differentiated programs that have the potential to provide new treatment options for patients."

Asked why CTX had achieved such great success, Dr. Ian Street, CTx CSO responded ‘Every new cancer drug starts with a great idea, however what Australia lacked was a good mechanism to convert these ideas into potential new medicines, and this is the niche that CTx has filled’

Ipsen delivers strong sales growth of 20.2% for the third quarter of 2018 and confirms full year guidance

On October 25 2018 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported sales for the third quarter of 2018.

Financial highlights

Q3 2018 Group sales growth of 20.2%1 driven by Specialty Care sales growth of 24.2%1 reflecting strong momentum for Somatuline and Dysport, continued sequential sales growth for Cabometyx and Onivyde, and growth of Consumer Healthcare sales of 5.0%2
YTD Group sales growth of 21.1%1 fueled by strong Specialty Care sales growth of 25.8%1 and Consumer Healthcare sales growth of 2.9%2
Full Year 2018 guidance confirmed with Group sales growth of greater than 19.0%1 and core operating margin of around 29.0% of sales

Pipeline highlights

Positive CHMP (Committee for Medicinal Products for Human Use) opinion for Cabometyx for the treatment of second-line patients with hepatocellular carcinoma (HCC)
First European approval for the new Somatuline delivery system

David Meek, Chief Executive Officer of Ipsen stated: "In the third quarter, we continued to execute against our 2018 objectives with industry-leading top-line growth of over 20%, driven by the powerful momentum of our Specialty Care business. During the quarter, we received a positive CHMP opinion for Cabometyx for the treatment of second-line advanced hepatocellular carcinoma and also received the first European approval for our new Somatuline delivery system. On our pipeline, we are prioritizing and rapidly advancing key programs. Looking forward, building a sustainable pipeline through externally sourcing innovation, including additional successful business development transactions, remains a top priority to sustain strong top-line growth and to deliver additional value to patients and shareholders."

Horizon Pharma plc to Participate in Investor Conferences in November

On October 25, 2018 Horizon Pharma plc (Nasdaq: HZNP) reported that the company will participate in the following conferences in November (Press release, Horizon Pharma, OCT 25, 2018, View Source [SID1234530135]):

Stifel 2018 Healthcare Conference

Date: Wednesday, Nov. 14, 2018
Presentation Time: 10:15 a.m. EST
Location: New York, NY
Jefferies 2018 London Healthcare Conference

Date: Thursday, Nov. 15, 2018
Presentation Time: 10 a.m. GMT
Location: London, United Kingdom
The presentations will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for each event.