Author Archives: Russo Partners

Exosome Diagnostics Continues to Advance Non-Invasive Platform Technology that Overcomes Limitations of Tissue Biopsy

exosomes in science at Exosome Diagnostics, Inc.In order to diagnosis a disease, such as cancer, a biopsy is frequently taken. However, the procedure is invasive and can be a painful or life-threatening experience. If a disease requires monitoring for progression, an invasive biopsy is also a less-than-ideal option, leading to a need for non-invasive alternatives.

Plasma microvesicles visualized by cryo EM

Aiming to provide a solution to this limitation, Exosome Diagnostics is advancing non-invasive diagnostic tests based on exosomes, which are microvesicles found in blood, urine and cerebrospinal fluid (CSF). Exosomes are shed by cells under both normal and diseased conditions, and high-quality RNA and DNA can be extracted and purified for subsequent analysis, such as measuring levels of genes responsible for cancer or other diseases. The non-invasive nature of the approach also allows data to be collected in real time.

CSF microvesicles visualized by cryo EM

The company recently formed two partnerships involving this technology in the past few months, involving Mount Sinai and QIAGEN, respectively. Under the partnership with Mount Sinai, Exosome and the hospital will establish targeted research and biomarker discovery programs in oncology, inflammation and other disease areas. Exosome anticipates pursuing commercial development and FDA review of successful validations for in vitro diagnostics.

Under the partnership with QIAGEN, the two companies will develop and commercialize high-performance, co-branded kit products for the capture and processing of RNA and DNA from biofluid exosomes and other microvesicles. Initial product launches are anticipated the first half of 2014.

Read more about Exosome’s partnerships in the news releases below.

Partnership with Mount Sinai

Partnership with QIAGEN

Natera Continues to Advance Best-in-Class Non-Invasive Prenatal Test, Panorama(TM)

ImageNatera continues to advance its next-generation, best-in-class, non-invasive prenatal test (NIPT) PanoramaTM, announcing launches in additional countries and publishing data showing highly accurate detection of additional chromosomal abnormalities. Panorama is currently able to detect more abnormalities, with higher accuracy, than currently available NIPTs.

Now, Panorama is available in Brazil through a partnership with DASA Group; Switzerland and Scandinavia through a partnership with Unilabs; Spain through a partnership with Echevarne; and Germany through a partnership with amedes. Natera continues to work to make Panorama available to as many patients as possible, and additional global launches are anticipated in the year ahead.

In addition, the company published two separate studies in Prenatal Diagnosis demonstrating Panorama’s ability to highly accurately detect triploidy as well as sex chromosome abnormalities, respectively. Triploidy is a devastating, though little known, condition, despite occurring in 1 of 100 conceptions, which results in fetus death and is associated with increased health risks for the mother, including increased risk of preeclampsia, molar pregnancy and cancer.

Sex chromosome abnormalities are often overlooked, as previously they could only be detected through an invasive procedure, and at birth a child seems healthy. However, early intervention with hormone treatments can result in improved outcomes, including offsetting fertility and learning issues that present later in life. Thus, early detection can result in dramatically improved outcomes.

Read more about the non-invasive prenatal testing space and Natera’s test, Panorama, in the Fortune article below.

Fortune

Dominic Behan, Ph.D., Co-Founder, Director, Executive Vice President and Chief Scientific Officer of Arena Pharmaceuticals Selected as One of PharmaVOICE’s 100 Most Inspiring People in the Life-Sciences Industry

dom2_960_430-195x130Last week, PharmaVOICE announced its annual list of the 100 most inspiring people in the life sciences industry and selected Dr. Dominic Behan, co-founder, director, executive vice president and chief scientific officer of Arena Pharmaceuticals, as one of the PharmaVOICE 100.

Dr. Behan founded Arena with Jack Lief, Ph.D., Arena’s chief executive officer, to develop drugs that interacted with G protein-coupled receptors (GPCRs) for treatment of human diseases. Last year Arena received FDA approval of its first drug, BELVIQ® (lorcaserin HCl), the first new prescription weight-loss treatment approved by the FDA in 13 years. BELVIQ is to be used as an adjunct to a reduced-calorie diet and increased physical activity in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition, such as hypertension, dyslipidemia or type 2 diabetes.

Dr. Behan spearheaded the scientific development of BELVIQ, from discovery through FDA approval, while also building a sustainable pipeline of additional products based on Arena’s technology platform. Revenue from BELVIQ’s sales will allow Arena to continue to advance its internal pipeline, which includes candidates for the treatment of pulmonary arterial hypertension, thrombotic diseases and pain.

Russo Partners nominated Dr. Behan for this special issue and coordinated activities surrounding his selection as one of the PharmaVOICE 100. Read more about Dr. Behan’s background and find the complete list of the PharmaVOICE 100 in the article below.

PharmaVOICE 

Endocyte Continues to Advance Personalized Therapeutic Vintafolide, Partnered with Merck, and Companion Imaging Diagnostic Etarfolatide, Towards Potential EU Approval

Endocyte Endocyte continues to advance their personalized cancer therapeutic, vintafolide, which is partnered with Merck, and its companion imaging diagnostic, etarfolatide, towards potential conditional approval in the EU for treatment of platinum-resistant ovarian cancer. A regulatory decision is anticipated this year.

Vintafolide is a small molecule drug conjugate (SMDC) comprised of a potent chemotherapy drug linked to a small molecule targeting the folate receptor, which is overexpressed on certain cancers, including platinum-resistant ovarian cancer. The companion imaging diagnostic, etarfolatide, is also a SMDC that targets the folate receptor; however the chemotherapy drug is replaced with an imaging agent. This enables patients that overexpress the folate receptor, and thus will likely respond to treatment with vintafolide, to be identified, through a whole-body, non-invasive scan.

Vintafolide is also being evaluated in a Phase 2 trial of patients with non-small cell lung cancer (NSCLC), TARGET. Endocyte recently announced completion of enrollment in this study, with top-line results expected the first quarter of 2014.

Russo Partners handles media relations for Endocyte, and recently secured coverage of the company in Investor’s Business Daily. Read the article below for more information about Endocyte, including its personalized therapeutics and companion imaging diagnostics.

Investor’s Business Daily

OrbusNeich Launches HeartVesselHealing.com, an Online Educational Resource About the Importance of Coronary Artery Healing Following Stent Implantation

Last week, OrbusNeich launched an educational resource website, HeartVesselHealing.com, for patients and healthcare professionals regarding the risks associated with delayed arterial healing following coronary stent implantation. The website provides information about the importance of coronary artery healing following stent placement and the causes and risk factors of delayed, or impaired, healing.

orbusneichcomboOrbusNeich is a leader in coronary stent technology, recently launching the COMBO Dual Therapy Stent, the first stent to both accelerate endothelial coverage and control neo-intimal proliferation. This is achieved through the combination of OrbusNeich’s pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer, which maintains the efficacy of monotherapy drug eluting stents while promoting healing.

Russo Partners handled the development of HeartVesselHealing.com with OrbusNeich. To learn more about heart vessel healing following coronary stent implantation, please visit HeartVesselHealing.com.

Cempra’s Solithromycin Offers Promising Treatment Option for Gonorrhea, as Drug Resistance Grows

cempra-pharmaceuticalsDrug resistance is a growing public health concern, with our arsenal of antibiotics continuing to shrink as bacteria gains resistance to treatment. For gonorrhea, only one injectable antibiotic, IB ceftriaxone, remains because the bacteria that causes the disease has increased resistance to the only oral antibiotic recommended to treat the infection. In addition, the need to inject the treatment poses additional barriers for patients.

Now, however, new potential treatment options are in development for the treatment of gonorrhea: two that use existing drugs and one new therapeutic. The new antibiotic, solithromycin, is being advanced by Cempra and has performed well in a Phase 2 trial, curing the gonorrhea infections of 42 patients. This drug can be taken as an oral single dose, an advantage over the currently recommended treatment. Solithromycin is also in Phase 3 clinical development for treatment of community-acquired bacterial pneumonia (CABP).

Russo Partners secured coverage of Cempra in The Wall Street Journal. Read the article below for more about emerging treatment options for drug-resistant gonorrhea.

The Wall Street Journal

Sutro Biopharma’s Chief Scientific Officer, Trevor Hallam, writes in Scientific American Guest Blog

Sutro BiopharmaSutro Biopharma’s CSO Trevor Hallam, Ph.D., wrote a guest blog in Scientific American, “Antibody-Drug Conjugates and Cancer Treatment: Making “Smart Bombs” Smarter.” The article highlights the new efforts to improve antibody-drug conjugates (ADCs) from their first-generation counterparts.

With the recent FDA approval of Roche’s Kadcyla and Seattle Genetics’ Adcetris, the ADC space is heating up, and new technologies will further advance the next generation of ADCs. Sutro’s cell-free protein synthesis technology enables the incorporation of non-natural amino acids at any site in the antibody structure, resulting in single-species ADCs with site-specific conjugation of linker and drug. Because the ADCs can be synthesized rapidly and in parallel, hundreds of variants can be generated and screened quickly. This shortens development times to as little as weeks, as opposed to years. Sutro’s technology is currently used to create next-generation ADCs and bispecific antibodies.

Sutro is collaborating with Celgene Corporation, as well as some other biotech and pharmaceutical companies, on the design and development of next-generation ADCs and bispecific antibodies.

Scientific American

Ambrx Forms Innovative Deal with China’s Zhejiang Medicine Co. Ltd

This month Ambrx formed a partnership with Zhejiang Medicine Co. Ltd toAmbrx logodevelop and commercialize Ambrx’s most advanced internally developed antibody drug conjugate (ADC), ARX788, which targets HER2, for both breast cancer and gastric cancer indications.

Under this unique partnership which enables Ambrx to gain access to the Chinese market, Zhejiang will bear the ongoing development costs, in exchange for commercial rights in China. Ambrx retains commercial rights outside of China and receives royalties on sales of the product in China. WuXi Pharma Tech, a contract research giant, will provide integrated services for the antibody drug conjugate, including development and manufacturing. Financial details were not disclosed.

ambrxadcFirst-generation technologies to create ADCs create heterogeneous mixtures of the drugs, resulting in suboptimal safety and efficacy properties. To overcome this limitation, Ambrx’s technology enables the site-specific conjugation of the antibody to the drug, which enables a best-in-class ADC to be created. In the past few months, the company has four partnerships with multiple big pharma companies, including Bristol-Myers Squibb, Astellas and Merck.

Russo Partners worked to secure coverage of the news across industry publications, including Xconomy, BioWorld Today and Scrip, as well as regional publications, including the San Diego Business Journal. Read more about the collaboration below in the article from Xconomy

Xconomy

The Growing Role of Social Media in Corporate Communications

This month, Russo Partners attended the Social Media Strategies Summit 2013, held June 12-13 in New York City. The conference brought together experts in social media for B2B and B2C companies to discuss social media trends through keynote presentations, hands-on workshops, case studies and one-on-one networking.

Social media’s presence in the health care industry has been steadily growing, as it offers another key channel for companies to reach and engage with their target audience. Through tools such as Twitter, YouTube and Facebook, health care companies can reach patients, physicians, the investment community, media as well as other core audiences.

This year the use of social media by public companies received a stamp of approval from the Securities and Exchange Commission (SEC), with its ruling that postings on social media sites such as Facebook and Twitter are acceptable as long as the company has informed investors which outlet they intend to use. In the agency’s report it was noted that public companies are increasingly using social media to communicate with shareholders and the investment community, prompting the ruling.

Russo Partners has led social media activities for multiple clients, including OrbusNeich, an international medical device company that recently launched COMBO™, the world’s first dual therapy stent. Russo Partners worked with the company to create a Twitter account, YouTube channel and Facebook page, and spearheaded the development of content, including physician interviews, that would resonate with cardiologists.

Read more about the SEC’s ruling and view OrbusNeich’s social media channels below.

The Wall Street Journal: SEC Embraces Social Media

OrbusNeich’s Twitter

OrbusNeich’s YouTube Channel

Celebrating Another Year of Success at the Regulus Lamb Roast

ImageRecently, Russo Partners joined Regulus and others at the annual lamb roast hosted by the company’s CEO, Kleanthis Xanthopoulos, Ph.D., celebrating Regulus’ continued success.

Regulus, which underwent a successful IPO last year, is advancing therapeutics targeting microRNAs. The company recently selected a lead clinical candidate, RG-101, for the treatment of hepatitis C (HCV); RG-101 is anticipated to enter the clinic in 2014, and the company aims to nominate a second microRNA clinical candidate by year end.

Regulus continues to advance other microRNA therapeutics toward clinical development in areas such as oncology, fibrosis and metabolic diseases.

In addition, the company has formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi and a research collaboration with Biogen Idec.

The informal affair was attended by other biotech executives from San Diego and elsewhere, friends, family and company employees. Below is a link to a video demonstrating the mechanism of action of Regulus’ microRNA drugs in more detail, as well as a recent article by the U-T San Diego profiling Dr. Xanthopoulos.

Video

U-T San Diego