Monica May of Russo Partners

The spring issue of LifeLines published last week, featuring a front-page article written by Russo Partners’ Monica May. LifeLines is the quarterly newsletter of BIOCOM, a non-profit association focused on advancing initiatives that positively influence the Southern California life science community. BIOCOM’s services for the region include group purchasing, public policy, capital formation, workforce development and networking events.

The article discusses the economic strengths of the Southern California life sciences industry, focusing on data from BIOCOM’s recent economic impact report as well as findings from additional sources. Based on this research, the region’s life science community was found to be deep-rooted and thriving, as evidenced by grants awarded, venture capital funding, jobs created and presence of large pharma companies.

In addition to the LifeLines article, Russo Partners has worked with BIOCOM on other projects, including raising awareness of BIOCOM’s Second Annual Global Life Science Partnering Conference. We look forward to continuing to work with the organization as they support programs and policies that benefit the Southern California life sciences community.

Please click on the link below to read the full LifeLines article:

LifeLines

Alder BioPharmaceuticals

In April, Alder BioPharmaceuticals raised $38 million in a Series D financing that will accelerate the development of its pipeline of antibody therapeutics, including ALD403, a calcitonin gene-related peptide (CGRP)-inhibiting antibody for the treatment of migraine, as well as ALD518, an IL-6-inhibiting antibody that is currently in Phase 2 clinical studies for cancer-related indications. Alder retained the rights to develop ALD518 in cancer-related indications as part of a partnership formed with Bristol-Myers Squibb in 2009.

The round was led by new investor Novo Ventures and joined by existing investors Sevin Rosen Funds, Ventures West, HIG Ventures, TPG Biotech, Delphi Ventures and WRF Capital. Read more about this announcement in the following article from Xconomy and news brief from Fortune.

Xconomy

Fortune

Argos Therapeutics

Also in April, Argos Therapeutics closed a $25 million Series D financing to support the initiation of a Phase 3 study, ADAPT, evaluating lead therapeutic AGS-003 in newly diagnosed metastatic renal cell carcinoma (mRCC). AGS-003 is a personalized dendritic cell immunotherapy created using the company’s Arcelis technology, which optimizes a patient’s autologous dendritic cells to trigger a tumor- or pathogen-specific immune response.

The financing was led by Forbion Capital and included other existing investors TVM Capital, Lumira Capital, Intersouth Partners, Caisse de depot et placement du Quebec, Morningside Group and Aurora Funds. Read more about this announcement in the following articles from BioWorld Today and The News & Observer, a regional publication covering news from the Research Triangle area.

BioWorld Today

The News & Observer

Sutro Biopharma

In May, Sutro Biopharma closed a $16.5 million second tranche of a Series C financing that will advance its next-generation antibody programs, including the development of antibody drug conjugates and bispecific antibodies. Sutro’s therapeutics are created using the company’s cell-free biochemical synthesis technology, which allows the production of proteins that cannot be produced using conventional technologies.

The financing was led by Skyline Ventures and included the participation of Lilly Ventures, Amgen Ventures, SV Life Sciences and Alta Partners. Read more about this news in the following articles from the San Francisco Business Times and FierceBiotech.

San Francisco Business Times

FierceBiotech

Vintafolide is currently being evaluated in a Phase 3 trial, PROCEED, for platinum-resistant ovarian cancer and a Phase 2 trial for non-small cell lung cancer (NSCLC). The drug targets the folate receptor (FR), which is overexpressed in many cancers that include breast, colon and kidney and is being developing with a companion diagnostic, etarfolatide (EC20), that identifies patients that express the biomarker.

Vintafolide is a small molecule drug conjugate (SMDC) comprised of a highly potent chemotherapy drug linked to a small molecule that targets the FR, and etarfolatide is a SMDC that also targets the FR, however the chemotherapy drug is replaced with an imaging agent for identification of patients expressing the receptor. Endocyte is also developing SMDCs targeting activated macrophages, which has applications for autoimmune disorders.

Merck plans to develop vintafolide in six other cancer indications, and, if the drug is approved, Endocyte will be able to co-promote the drug in United States while Merck has the right to promote the drug in the rest of the world. Endocyte is responsible for the majority of the costs to complete PROCEED, and Merck will fund all other developmental activities as well as hold all decision rights for the drug.

Russo Partners worked with both parties to develop key messages for the announcement, anticipated questions and a joint news release. Additionally, we secured coverage of the partnership by newswires and trade publications, with profile articles appearing in BioCentury, The Pink Sheet DAILY, BioWorld Today and Scrip, as well as regional outlets, including Lafayette-based Journal and Courier.

You may read more about the partnership in the following articles from The Wall Street Journal/Dow Jones Newswires and FierceBiotech.

Wall Street Journal/Dow Jones Newswires

FierceBiotech

John Sterling, editor in chief of Genetic Engineering & Biotechnology News

Last week Russo Partners attended BIOCOM’s breakfast meeting, one of a series of events featuring a panel of experts discussing key issues in the life sciences industry. This discussion focused on the promise of personalized medicine as well as challenges facing the space and was moderated by John Sterling, editor in chief of Genetic Engineering & Biotechnology News.

Insights into the personalized medicine space were provided by a panel consisting of Mark Erlander, Ph.D., chief scientific officer of bioTheranostics, David Nelson, Ph.D., president & CEO of Epic Sciences, Darlene Solomon, chief technology officer of Agilent Technologies, and Ashley A. Van Zeeland, Ph.D., co-founder, Cypher Genomics, and director of strategic partnerships at the Scripps Translational Science Institute. Russo Partners was especially interested in this topic as many of our clients are involved in the personalized medicine space, such as Endocyte, a company co-developing targeted cancer therapeutics with companion diagnostics.

Key points from the discussion included:

• Beyond  validity and accuracy, companion diagnostics must demonstrate clinical utility – the ability of the test to show that it is improving patient outcomes
• Companion diagnostics lower the technical risk involved in developing therapeutics, however business risks exist for diagnostics companies
• Currently, there is an unprecedented level of interest from big pharma in developing companion diagnostics
• While it may seem expensive to invest in developing a companion diagnostic, especially for small and medium  size biopharma companies, it is also costly to treat a patient with an ineffective drug

BIOCOM events such as these provide the life sciences industry in Southern California with a valuable opportunity to discuss key issues affecting the space as well as network with peers. Russo Partners has worked with BIOCOM in the past to raise awareness of other initiatives that support the community, including BIOCOM’s Second Annual Global Life Science Partnering Conference, and we are currently working with BIOCOM to develop the front-page article of LifeLines, the organization’s quarterly newsletter. We look forward to working with BIOCOM as they continue to work to support the Southern California life sciences community.

Based on these positive data, Roche plans to file for approval of the drug in the European Union and United States this year. The results from the study will likely be presented at the American Society of Clinical Oncology (ASCO) Annual meeting in June.

ADCs are a new class of therapeutics comprised of an antibody linked to a chemotherapy drug. Often described as “smart bombs,” ADCs hold much promise due to their targeted and potent nature, which allows the therapeutic to deliver an active chemotherapy drug to a specific cell while minimizing damage to healthy cells. Because of this ability, ADCs are currently being developed for cancer indications; they can, however, be directed to other types of targets beyond tumor cells that are implicated in autoimmune or cardiovascular disorders.

Due to the promise and potential of these drugs, there has recently been a surge of interest in ADCs, with both big pharma as well as small biotechnology companies pursuing programs. Companies developing ADCs include Ambrx and Sutro Biopharma, which are both developing next-generation ADCs. Ambrx is utilizing its protein medicinal chemistry technology to precisely link the antibody to the drug, creating an ADC with a potentially improved safety and efficacy profile. Sutro is using its protein synthesis technology to create best-in-class ADCs and bispecific antibodies, as well as proteins that have previously been inaccessible when using other technologies.

Russo Partners looks forward to bringing awareness to Ambrx’s and Sutro’s ADC programs in the coming months as interest in the space continues to grow.

Find out more information about Roche’s announcement in the following article from The Wall Street Journal:

The Wall Street Journal

Discussing the state of antimicrobial resistance at a recent conference, the director-general of the World Health Organization (WHO), Dr. Margaret Chan, made it clear that there is a significant need for new antimicrobial therapeutics.

Hospitals have now become hotbeds for highly resistant pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA), she said, and diseases that were curable, such as tuberculosis, are now are becoming harder and more complicated to treat. The lack of effective antibiotics can even make surgical procedures and certain cancer treatments too risky, even dangerous to undertake. Common occurrences such as strep throat or a child’s scratched knee could become lethal again, essentially, she said, the “end of modern medicine.”

Recognizing the critical unmet need for new antibacterial therapeutics, Cempra Pharmaceuticals (Nasdaq: CEMP) is pursuing the development of therapeutics targeting drug-resistant bacterial infections. With approximately $54.7 million raised from a recent IPO, including the overallotment option, the company plans to use the funds to advance its two late-stage programs.

A Phase 3 trial of lead therapeutic CEM-101 (solithromycin) for community-acquired bacterial pneumonia (CABP)is planned for later this year, and Cempra is also planning a Phase 2 trial for another antibiotic in development, Taksta™ (CEM-102), for treatment of prosthetic joint infections. The active compound in Taksta, fusidic acid, has a long history of safety and efficacy outside of the United States, with demonstrated activity against gram-positive bacteria, such as MRSA.

Russo Partners looks forward to building awareness of Cempra’s innovative antibacterial programs as they prepare to move into late-stage Phase 3 trials.

Read more about Cempra’s programs in the following article from News & Observer:

News & Observer

Leading the institute is Peter G. Schultz, Ph.D, a renowned chemist at The Scripps Research Institute and serial biotechnology entrepreneur who has founded companies such as Affymax Research Institute, Syrrx, Kalypsys, Phenomix, Symyx Therapeutics, Ilypsa, Wildcat Technologies and Ambrx.

Ambrx is a client of Russo Partners, and we are currently focused on raising awareness of the company’s antibody drug conjugate (ADC) program, which utilizes the company’s protein medicinal chemistry technology to create best-in-class ADCs.

Merck will invest $90 million into the new institute over the next seven years, during which 150 employees will be hired. Key academic institutions in the area include The Scripps Research Institute, The Salk Institute, University of California, San Diego and Sanford-Burnham Medical Research Institute.

Read more about the new institute in the following articles from Xconomy and the San Diego Union-Tribune:

Xconomy

San Diego Union-Tribune

Additionally, the company also reported positive Phase 1 data for its lead therapeutic for the treatment of castration-resistant prostate cancer (CRPC), ARN-509. The data announced are part of an ongoing open-label, dose-escalating Phase 1/2 clinical trial and demonstrated that ARN-509 was safe and well tolerated in patients with progressive metastatic CRPC. The therapeutic also demonstrated promising preliminary antitumor activity, with declines in prostate-specific antigen (PSA) observed in patients treated at all doses of ARN-509.

The financing was led by a new investor, the Topspin Fund, which is an investment group of James Simons, Leo A. Guthart and Steve Winick, and also included the participation of existing investors Aisling Capital, OrbiMed Advisors and The Column Group. With this financing, the amount of capital raised by the company since its founding in 2009 now totals $72 million.

Russo Partners worked to secure coverage of the announcement in the media, resulting in articles from newswires, including Dow Jones VentureWire, as well as trade publications, including Scrip, BioWorld Today, The Pink Sheet and Xconomy. For more information, please visit Xconomy’s coverage of the announcement.

MolecularHealth’s system is intended to help predict adverse drug events before they occur. MASE uses specific molecular information, such as drug mechanism of action and metabolism data as well as genomic factors affecting the behavior of a drug within the body, to more precisely assess and predict safety events. This is also an advantageous tool for pharmaceutical companies, as safety problems can be identified early on.

Through this collaboration, the FDA’s Center for Drug Evaluation and Research (CDER) will work with MolecularHealth to incorporate relevant, non-proprietary molecular and clinical endpoints into the system, along with non-proprietary information about patient populations, molecular modes of action and mechanisms of disease.

Russo Partners looks forward to working with MolecularHealth to raise awareness of its solutions that translate medical data into safer and more effective drug choices for patients.

Below is a Pharmaceutical Executive blog entry about the collaboration:

Pharmaceutical Executive

As part of AMDeC’s ongoing efforts to offer programs and services that will increase efficiencies and promote collaboration between biomedical researchers and the academic community, last week the consortium announced that it has implemented upgrades to AMDeC F.I.R.S.T. (Facilities Instrumentation Resources Services Technologies) as well as added information about several new vendor partners. These upgrades will allow searches to be conducted more easily and quickly, streamlining the process of finding resources such as core facilities and other research services. The addition of new vendor partners brings AMDeC’s members more opportunities to minimize research expenses.

Maria Mitchell, president of AMDeC

AMDeC is a consortium of New York-based academic medical research institutions, including Memorial Sloan-Kettering Cancer Center and Cold Spring Harbor Laboratory, with the goal of expediting discovery through collaborations between these institutions and the life science industry. Through resource-sharing and vendor partnership programs, which secure preferred pricing on products and services essential to the life science industry, AMDeC works to facilitate collaboration and the efficient use of resources needed for biomedical research. In addition to existing vendor partners, like Sigma-Aldrich and NuGEN Technologies, recently added vendor partners include QIAGEN and Xiacon.

Russo Partners continues to bring awareness of AMDeC’s services to the members of the consortium through educational events involving vendor partners at member institutions. These events are a key forum to inform members of the services they receive through their AMDeC membership, encouraging them to take advantage of the benefits they receive to support their research. Additionally, these events provide an opportunity for vendors to educate members about their services as well as answer questions about their products.

As AMDeC continues to expand its programs to support biomedical research, Russo Partners looks forward to bringing awareness to new services and products available to AMDeC’s members. You can learn more about AMDeC, its vendor partnership program and the F.I.R.S.T. registry in this interview with AMDeC’s president, Maria Mitchell, published recently in Xconomy: NYC Consortium Promotes Collaboration Among Scientific Researchers.