In the organization’s own words, "The American Society of Breast Surgeons, the primary leadership organization for general surgeons who treat patients with breast disease, is committed to continually improving the practice of breast surgery by serving as an advocate for surgeons who seek excellence in the care of breast patients (Press release, Dune Medical Devices, APR 19, 2018, View Source [SID1234525547]). This mission is accomplished by providing a forum for the exchange of ideas and by promoting education, research, and the development of advanced surgical techniques. Founded in 1995, the Society has grown to more than 3000 members in the United States and 35 countries throughout the world."

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The Society’s Annual Meeting, May 2-6, 2018 in Orlando, is the breast cancer community’s greatest opportunity to connect, collaborate and collectively advance the standard of care for tens of thousands of breast cancer patients.

We want physicians interested in reducing positive margins and improving the patient experience to visit us at booth #101 to discuss MarginProbe’s ability to detect microscopic cancer intraoperatively and review the latest clinical data supporting its use. We want attendees to appreciate the value of MarginProbe in significantly reducing the risk of positive margins thereby preventing additional surgeries. As a result, patients avoid disruption to their adjuvant care plan, reduce the risks and costs associated with additional surgeries and return to their lives prior to their cancer diagnosis.

MarginProbe will also be discussed in the Wednesday May 2nd 7am – 4pm: Beginner and Intermediate Oncoplastic Breast Surgery Skills Courses with Cadaver Lab with Drs. Dennis Holmes and Julie Reiland.

You can find the MarginProbe team throughout ASBrS 2018 at booth #101.

On April 19, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has received Orphan Drug Designation from the U.S. FDA for Oraxol for the treatment of angiosarcoma (Press release, Athenex, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343439 [SID1234525530]). Oraxol, an innovative development in the treatment of cancer, is a novel oral formulation of paclitaxel, a very effective and commonly used chemotherapy treatment for many cancers, combined with HM30181A (a novel orally non-absorbable gastrointestinal tract P-glycoprotein pump inhibitor).

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Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are pleased to receive Orphan Drug Designation for Oraxol for the treatment of angiosarcoma, a form of malignant blood vessel cancer. This designation represents our commitment to expand the use of Oraxol, in which the active pharmaceutical ingredient is paclitaxel, to additional clinical indications based on the known efficacy of paclitaxel and the observed improved pharmacokinetic profile of Oraxol. This is a parallel development with our clinical studies in metastatic breast cancer and gastric cancer, in which Oraxol has already shown promising efficacy and safety profile. We will be initiating the angiosarcoma clinical study soon."

The FDA grants Orphan Drug status to support development of medicines for the treatment of diseases that that affect fewer than 200,000 people in the United States. Orphan Drug Designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Athenex previously announced that it had met its enrollment target for the second interim analysis for the Oraxol Phase III clinical trial for metastatic breast cancer and is scheduled to conduct this interim analysis in the third quarter of 2018. Additionally, the Company announced the receipt of the Promising Innovative Medicine designation for Oraxol by the United Kingdom Medicines and Healthcare products Regulatory Agency on December 27, 2017, qualifying Athenex to apply for Step II of the Early Access to Medicines Scheme to provide patients early access to Oraxol prior to receiving marketing authorization. Athenex also recently announced that the Chinese FDA has allowed the Investigational New Drug application for Oraxol on January 8, 2018. Athenex also announced initial results of a clinical study in Taiwan in patients with metastatic breast cancer, as well as results of the first cohort of patients in a study in Taiwan on the combination with ramucirumab (Cyramza, Eli Lilly’s monoclonal antibody against VEGFR2) in patients with gastric cancer.

Oraxol was initially discovered by Hanmi Pharmaceuticals and licensed to Athenex, in territories including North and Latin Americas, Europe, Japan, greater China and Southeast Asia, Australia and New Zealand. Athenex is leading the registration effort from IND and clinical studies.

On April 19, 2018 Omeros Corporation (NASDAQ: OMER) reported that the results of four real-world clinical studies evaluating the benefits of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% were presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting held in Washington, D.C., April 13-17, 2018 (Press release, Omeros, APR 19, 2018, View Source;p=RssLanding&cat=news&id=2343403 [SID1234525548]). The studies examined the use of OMIDRIA in both routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.

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The first presentation, a retrospective analysis, assessed whether the use of OMIDRIA in femtosecond laser-assisted cataract surgery (FLACS) – a procedure that is known to cause miosis (pupil constriction) due to the increased inflammation generated by the laser – leads to a reduction in the need for pupil expansion devices and in surgical time. Investigators compared 100 consecutive femtosecond-assisted cataract procedures in which epinephrine was used in the irrigation solution to 100 consecutive femtosecond-assisted procedures performed with OMIDRIA. In the epinephrine group, 12 eyes (12 percent) required a Malyugin Ring to maintain or improve pupil size versus 2 eyes (2 percent) in the OMIDRIA group (p=0.009). Surgical times in the OMIDRIA group were reduced by an average of 78 seconds compared to those in the epinephrine group (p = 0.007). The authors conclude that use of OMIDRIA achieves faster surgery and a more manageable pupil.1

The second clinical study assessed the effects of OMIDRIA on pupil dilation when used early in patients undergoing both FLACS and traditional cataract surgery. A total of 77 patients underwent either traditional phacoemulsification (n=57) or FLACS (n=20), all of whom received OMIDRIA in the irrigation solution and administered through the side-port incision at the beginning of the case. Pupil diameter was measured before and after OMIDRIA administration as well as prior to intraocular lens (IOL) insertion. In the traditional phacoemulsification cases, the mean pupil diameter was 6.65 mm at baseline and 7.42 mm intraoperatively before IOL insertion. Similarly, in the FLACS group, the mean pupil diameter was 6.69 mm at baseline and 7.65 mm prior to IOL insertion. The study demonstrates that OMIDRIA is effective in maintaining and even increasing pupil size in traditional as well as in femtosecond laser-assisted cataract procedures, which, without OMIDRIA, frequently induce miosis.2

A third study evaluated the effect of OMIDRIA on pupil dilation, iris billowing and iris prolapse in patients at high risk for intraoperative floppy iris syndrome (IFIS). The randomized, double-masked, investigator-initiated study enrolled 50 male subjects (50 eyes) who had been exposed to tamsulosin (Flomax), a prostate drug that causes IFIS, prior to cataract surgery. The 50 patients were randomized 1:1 to receive either OMIDRIA or control. All subjects underwent routine cataract surgery recorded endoscopically from the perspective of the ophthalmic microscope. Investigators assessed pupil diameter and IFIS symptoms in all 50 subjects (50 eyes). Mean pupil diameter during surgery for the control group was 5.92mm and was 7.08mm for the OMIDRIA-treated group (p < 0.001). Symptoms of IFIS were observed in all 25 (100 percent) patients in the control group and in only 3 (12 percent) of patients who received OMIDRIA. Iris prolapse occurred in 14 (56 percent) subjects in the control group versus 3 (12 percent) in the OMIDRIA group. Iris billowing, graded according to a new grading scale for intraoperative iris abnormalities, averaged 2.36 in the control group and 1.68 in the treatment group, with Stage 3 (severe) billowing seen in 10 (40 percent) vehicle subjects and 1 (4 percent) treatment subject. All of the comparisons related to IFIS symptoms were statistically significant with p < 0.001. The authors conclude that OMIDRIA offers significant benefits in IFIS cases and could reduce the complexity and unpredictability of such cases.3

A fourth study assessed clinical outcomes and surgical practice patterns for cataract patients treated with either OMIDRIA or epinephrine. This retrospective chart review included patients who received treatment at one of two clinics by a single surgeon practicing at both locations. A total of 635 eyes in 375 patients underwent cataract surgery with either OMIDRIA (n=275) or epinephrine (n=360) in the irrigation solution. Mean surgical time was significantly shorter with OMIDRIA versus epinephrine (16.5 min vs 17.8 min; p = 0.006), and only 6 (2.2 percent) pupil expansion devices were required in the OMIDRIA group vs 24 (6.7 percent) in the epinephrine group (p = 0.008). Investigators conclude that OMIDRIA reduced surgical time and decreased the need for pupil expansion devices compared to the use of intracameral epinephrine.4

Detailed descriptions of all four clinical studies have been accepted for publication by, or are planned for submission to, peer-reviewed journals.

About OMIDRIA

Omeros’ OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown (1) to be effective in patients with intraoperative floppy iris syndrome (IFIS), pseudoexfoliation and other ophthalmic conditions, (2) to significantly reduce complication rates, use of pupil-expanding devices, and surgical times, and (3) to significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the above outcomes are not in its currently approved labeling. Surgical time was not an endpoint in the OMIDRIA Phase 3 clinical trials and did not reach statistical significance in post hoc analysis of the Phase 3 data.

Important Safety Information for OMIDRIA

Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.

On April 19, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, and Beijing Apollo Venus Biomedical Technology Limited, an affiliate of ApolloBio Corp. (NEEQ: 430187), a biopharmaceutical company focused on oncology (collectively, "ApolloBio"), reported they have entered into a license agreement providing ApolloBio with an exclusive license to develop and commercialize Toca 511 & Toca FC within the greater China region, including mainland China, Hong Kong, Macao and Taiwan (Press release, Tocagen, APR 19, 2018, View Source [SID1234525818]).

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Toca 511 & Toca FC is a cancer-selective immunotherapy currently under evaluation in an international Phase 3 trial, called Toca 5, for patients with recurrent high grade glioma (HGG), a type of brain tumor. The product candidate has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).

Under the terms of the agreement, ApolloBio will make an upfront payment of $16 million to Tocagen, plus potential payments of $4 million in near-term development milestones, including completion of enrollment in the Toca 5 study. Tocagen will be eligible for additional future payments totaling up to $111 million upon meeting certain development and commercial milestones. In addition, low double-digit tiered royalty payments will be made based on net sales. ApolloBio will be responsible for all development and commercialization costs in the licensed territory.

"As an innovative biopharmaceutical company in China, ApolloBio is well positioned to leverage China’s recent regulatory changes supporting the development of new medicines," said Marty Duvall, chief executive officer of Tocagen. "ApolloBio brings valuable regional expertise in product development, regulation and healthcare access, positioning our lead product to advance towards patients in the greater China region as quickly and efficiently as possible."

The total number of new diagnoses of HGG expected in 2018 is about 180,000 worldwide and about 47,000 in the greater China region. Standard treatment for newly diagnosed HGG includes safe surgical removal of as much of the tumor as possible, followed by radiation therapy and chemotherapy. However, HGG recurs in most patients even after maximal treatment and there are currently very few treatment options available.

"We are committed to accelerating the availability of novel immuno-oncology treatments to patients with high unmet medical needs in the greater China region," said Dr. Weiping Yang, chief executive officer of ApolloBio. "Toca 511 & Toca FC is a highly promising, best-in-class cancer-selective immunotherapy and we look forward to working with Tocagen to advance this innovative late-stage product towards commercialization."

The license grant to ApolloBio is subject to the satisfaction of customary conditions and is expected to become effective in the second quarter of 2018. For more details, please refer to the corresponding Form 8-K filed today with the U.S. Securities and Exchange Commission (SEC).

About Toca 511 & Toca FC

Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprised of an investigational biologic, Toca 511 and an investigational small molecule, Toca FC. Toca 511 (vocimagene amiretrorepvec) is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered, extended-release formulation of the prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells in the tumor microenvironment resulting in anti-cancer immune activation and subsequent tumor killing.

About ApolloBio Corp.

ApolloBio Corp. (NEEQ:430187) is an innovative Chinese biomedical company committed to research and development of innovative new medicines, accessing such new medicines through in-licensing, and additionally providing medical services. ApolloBio is focused on pharmaceutical products with significant market potential in China in the field of oncology; providing efficient access for American biomedical companies to enter into the Chinese market; and aiming to bring the newest and best medicines across the globe to the Chinese people. For more information, visit www.apollobio.com.

On April 19, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that John A. Orwin, formerly CEO of Relypsa, has been appointed President and Chief Executive Officer of Atreca (Press release, Atreca, APR 19, 2018, View Source [SID1234525531]). He will also serve on the Company’s Board of Directors. Mr. Orwin replaces Atreca co-founder Dr. Tito A. Serafini in this role. Dr. Serafini will assume the newly created position of Chief Strategy Officer, responsible directly for research, preclinical development, technology, and intellectual property. Dr. Serafini also will remain on Atreca’s Board of Directors.

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"John Orwin is a seasoned leader with a very strong track record in scaling up clinical-stage companies. He brings core capabilities that will complement Tito’s vision and his ability to drive Atreca’s innovative science and the development and application of its broadly enabling technology platform," stated Brian Atwood, Atreca’s Chairman, and Founder and former President and CEO of Cell Design Labs. "We believe their combined talents and expertise will be highly synergistic, further differentiating the Company from others in the space and accelerating Atreca’s progress."

Mr. Atwood continued, "During Tito’s tenure leading Atreca, the Company went from early concept through the buildout of its Immune Repertoire Capture (IRC) technology, the creation of a discovery engine generating multiple scientific discoveries and a large collection of preclinical assets, and the rapid advancement of a lead candidate, with an anticipated IND filing in mid-2019. We are proud of the corporate culture of excellence Tito established, attracting a fantastic team and leading life sciences institutional investors, and for the considerable accomplishments achieved under his leadership."

"I am enthusiastically committed to Atreca, a company that I believe can both continue to transform the way new therapies are discovered and ultimately deliver life-changing treatment options to patients in need," said Dr. Serafini. "John’s joining the Company as CEO will have a profoundly positive impact on Atreca, given his successful track record scaling R&D companies, building out their clinical development organizations, manufacturing capabilities, and commercial and G&A functions. This is a very exciting time for Atreca, and I am thrilled with the Company’s prospects for continued and accelerated growth."

Mr. Orwin brings over 25 years of diverse experience in the biotechnology and pharmaceutical industries, having held senior positions at leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Affymax, Rhône-Poulenc Rorer, Genentech, and most recently Relypsa. During Mr. Orwin’s tenure at Relypsa, the company launched and commercialized its lead candidate, Patiromer (US brand name Veltassa), and was acquired by Galenica (Vifor Pharma) in a transaction worth over $1.5 billion. Prior to Relypsa, he served as Chief Executive Officer and a member of the Board of Directors of Affymax. Previously, Mr. Orwin was Senior Vice President of the BioOncology Business Unit at Genentech (now a member of the Roche Group), where he was responsible for all marketing, sales, business unit operations and pipeline brand management for Genentech’s oncology portfolio in the United States. He has also held senior marketing and sales positions at Johnson & Johnson, Alza Pharmaceuticals, Sangstat Medical Corporation, Rhône-Poulenc Rorer Pharmaceuticals and Schering-Plough Corporation. Mr. Orwin received an M.B.A. from New York University and a B.A. from Rutgers University.

"Under the collective vision of Tito and his team, Atreca has become the first mover in discovering and advancing candidates based on its unique approach of understanding the active adaptive immune response at the single cell level in patients," commented Mr. Orwin. "The Company has differentiated itself through its foundational technology, its discovery engine, its strategy for advancing candidates, and in terms of productivity, having generated a library of nearly 1,000 antibodies targeting public tumor antigens. I look forward to contributing to the next chapters of the Company’s evolution, including preparations to bring the first candidates into clinical development in 2019 and 2020."