Posts Tagged partnering

WSGR 2017 Medical Device Conference


With shrinking pool of serious early stage life science investors and stringent capital requirements, the path for medtech companies has become greatly challenging.  As is the case every year, Wilson Sonsini Goodrich & Rosati 2017 Medical Device Conference provided a forum for addressing challenges faced by new medtech companies as well as opportunities presented by current trends.


Various speakers and panels addressed these issues from diverse angles and perspectives.  Following a welcome address by
Casey McGlynn, an early morning panel moderated by Donna Petkanics addressed new models for medtech investing.  Panelists Andrew ElBardissi (Deerfield Capital), Eric Milledge (Endeavor Vision SA), Leighton Read (Brandon Capital Partners), and Valeska Schroeder (KCK Group)  discussed how the investors are adapting their financing strategies and business models in response to the newer challenges that medical device companies face.  Milledge opined that it is now crucial for medtech companies to get some regulatory approval before seeking to raise money. Even CE mark could help, said Milledge. ElBardissi offered that if the company is US based and focused on US commercialization strategy then EU approval does not help. He advised that medtech companies “keep the head down and focus on US approval UNLESS there is capital efficient advantage of focusing on EU”. Schroeder said their fund was “geographically agnostic” but they believed that for an early stage medtech company it is important that they not “simply throw capital without a plan”.  but there are values you can get out which may not be revenue based but you can get close to your customer base etc… not go in every country but choosing a small no. of country to go through. Read observed that a company seeking to create larger returns must go after larger markets.

Image result for wilson sonsini medical device conference 2017With the current challenges medtech world has become more global as companies and investors are finding win-win solutions through newer models of partnering by going across continents and countries. Geographically, Pacific Rim has emerged as hot collaboration frontier. A panel moderated by Elton Satusky with CEOs Yue-Teh Jang (Medeon Biodesign), Kewen Jin (Serica Partners, Trevor Moody (M. H. Carnegie & Company), and Norman Weldon (Partisan Management Group), who completed such collaborations, financings and mergers with companies and investors in Asia discussed how these transactions may be structured.  Another panel moderated by Jack Moorman (US-Japan MedTech Frontiers – USJMF), with panelists Kenichi Hata (Terumo Corporation), Masazumi Ishii (AZCA Inc.), Yuichiro Morimoto (Enplas Corporation), and Richard Packer (Asahi Kasei Corporation) discussed collaborations between Japan and Silicon Valley.  Japan has emerged as a major partner in medtech OUS financing and growth strategy.  

Image result for medtech investmentIncreasingly there is a pressure on medtech industry that is unlike most other industries, to show value. Many organizations have now come up with ways to define and measure value creation. Among them, AdvaMed has developed a new framework to assess the value of medical technologies and diagnostics in a broad, patient-centric approach. A panel moderated by Donald May (AdvaMed) with panelists Maneesh Arora (Exact Sciences Corp), Jeff Farkas (Medtronic), and Jo Carol Hiatt (Kaiser Permanente) addressed how companies may leverage value creation to make internal business decisions to allow for more efficient use of capital and to drive discussions with potential investors as well as to keep track of milestones during the commercialization process.

AdvaMed model focuses on following drivers of value creation, 1) clinical outcomes, effectiveness and utility measures 2) non clinical patient impact including impact on caregivers, families, ease of product use, ease of care, financial impact etc. 3) new drivers around value based purchasing, care delivery costs, reduction in readmissions etc. from provider perspectives, and 4) broader public impact on population and communities in terms of whether or not the technology reduces overall cost to the system, helps identify diseases, helps employers reduce absenteeism and so on. May said the model begins with the patient and goes on to incorporate multiple stakeholders and values for all may not always be aligned or the time frames may differ. As an industry, “we need to think of appropriate levels and types of evidence as we think of new value based models of integrated care”, said May. Speakers discussed the need to move away from one number and focus on broad picture with many factors that include clinical as well as economic value, in order to get better outcomes while reducing costs.

Image result for wilson sonsini medical device conference 2017As is the case, WSGR medtech conference provides an excellent forum for investors, startups, and professionals in the industry to come together in a spirit of learning and collaboration. And compared to previous years, it seemed to be even more well attended with hallways abuzz with discussions on partnering. As always, the conference ended with short presentations from select few startups and the announcement of the $25,000 grand prize and Medtech Innovator Award.  But the best was reserved for the last. More networking happened and deals were done as attendees mingled with good food at the reception and as the best wines were uncorked and venture capitalists served as sommeliers and poured wine for the attendees.

 

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Anti-angiogenic/ Anti-Vasculogenic Therapy for Triple Negative Breast & other Cancers


Rathin Das, Founder and CEO of Synergys Biotherapeutics talked about antibody fusion therapy for cancer treatment at http://www.bio2devicegroup.org event.

Synergys is a preclinical stage biotherapeutics company, developing polyfunctional antibody drugs.  It has established an antibody-linked biological payload system called Antibody-Targeted Anti-vasculogenic Payload (A-TAP). The Company’s most advanced product candidate generated from this system is Anti-EGFR-TAP that is being developed as a new generation anti-angiogenic/anti-vasculogenic biotherapeutic for Triple Negative Breast Cancer (TNBC) and other EGFR+ malignancies.

Angiogenesis is the development of new vasculature from preexisting blood vessels and/or circulating endothelial cells, and is essential for neoplastic proliferation, progression, invasion and metastasis. VEGF (vascular endothelial growth factor), PDGF (Platelet-derived growth factor ), bFGF (basic fibroblast growth factor) are among the most prominent of various growth factors and their signaling pathways that support angiogenesis. Due to the commercial success of the anti-angiogenic antibody drug bevacizumab (Avastin®) by Genentech/Roche, the field of angiogenesis has been generating significant interest as potential target for possible anti-cancer therapy. Bevacizumab is an anti-VEGF MAb which blocks angiogenesis by inhibiting VEGF-A . The MAb interacts nonselectively with its receptors VEGFR1 and VEGFR2.

However, bevacizumab suffers from several safety and efficacy issues, despite its approval for various cancers, including colorectal, renal, cervical carcinoma, glioblastoma, and head and neck and others. It failed to delay the growth of metastatic breast cancers, failed to improve the quality of life of the patients, and its side effects were significant, leading to reversal of the drug’s FDA approval in 2011. Another anti-angiogenic MAb , Ramucirumab (Cyramza) from ImClone, (recently acquired by Eli Lily), targets VEGFR2, and has been recently approved. Ramucirumab has been approved for gastric cancer and NSCLC, but it failed at clinical Phase III for metastatc breast cancer.

Earlier to the development of bevacizumab, Endostatin, a 20 kDa fragment of collagen XVIII, was identified as a naturally occurring inhibitor of endothelial cell proliferation in vitro and angiogenesis in vivo. Although highly efficacious in decreasing tumor burden in animal models, and safe in humans in very high doses, no consistent evidence of antitumor activity for recombinant human endostatin (huEndo) was observed in human trials. Several explanations have been advanced for huEndo’s efficacy failure in humans, including its rapid clearance, low potency and sub-optimal presentation as the monomeric form . Despite these limitations, a proprietary formulation of endostatin (EndoStarÒ) has completed Phase III and IV testing and is now approved in China, providing further evidence of its safety and potential for efficacy, said Das.

Synergys is utilizing an anti-EGFR monoclonal antibody as a targeting domain to facilitate the delivery of a mutant form of human endostatin, huEndo-P125A (where Alanine substitution of Proline 125, significantly increases anti-angiogenic potency of endostatin), as a biological anti-angiogenic payload, for the treatment of cancer. Most importantly, unlike earlier failures of endostatin used as an anti-angiogenic in clinical trials, where monomeric form of endostatin with N-terminal amino acid deletions was used, “ in our approach a ‘dimeric’ fusion of a full-length endostatin-P125A mutant to a targeted antibody is utilized”, said Dr. Das. The “dimeric”endostatin-P125A generated by linking two molecules of endostatin-P125A to two heavy chains of an antibody molecules shows excellent inhibition of endothelial cell angiogenesis and profound inhibition of vasculogenic mimicry or VM. VM is the formation of an alternative tumor vasculature assembled directly from tumor cells and not from vascular endothelial cells.

Synergys is developing Anti-EGFR-TAP for the treatment of Triple-negative breast cancer (TNBC), which is an especially deadly subtype of breast cancer, said Das. It comprises approximately 15% of newly diagnosed breast cancer and is overrepresented in young women, in patients with BRCA1/2 mutations and in women of African ancestry (1). At present, TNBC has the poorest survival outcome of all breast cancer subtypes. TNBC lacks the three most commonly targeted receptors in human breast cancer: the estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2)/neu. However, the expression of epidermal growth factor receptor 1 (EGFR, HER1) is reported in greater than 60% of TNBC. Although no approved targeted therapy is currently available for the treatment of this highly aggressive subtype of breast cancer, several recent clinical studies involving agents for DNA repair by poly (adenosine disphosphate-ribose) polymerase (PARP inhibitors) have shown promising results in some BRCA1 and BRCA2 mutated TNBC patients. However, the role of PARP inhibitors in unselected TNBC patients is still uncertain and newer more effective targeted therapies are urgently needed for TNBC .

In addition to tumor induced angiogenesis, TNBC readily exhibits VM. Indeed Anti-EGFR-TAP demonstrated excellent inhibition of endothelial cell angiogenesis and profound inhibition of VM of TNBC cells.  Anti-EGFR-TAP treatment also showed significant inhibition of growth of triple negative breast cancer xenografts relative to those treated with cetuximab (Anti-EGFR MAb).  Various published studies have shown that none of the approved angiogenesis inhibitors inhibit VM. Indeed, not all anti-angiogenic antibodies show anti-VM activities. To this end, in a head to head comparison, three other anti-angiogenic antibodies were negative in VM assays relative to Anti-EGFR-TAP. The inhibitory effects of Anti-EGFR-TAP for both angiogenesis and vasculogenic mimicry , therefore, is both interesting as well highly promising as a potential drug for progressive cancers, said Das.  Further Das observed, it is important to inhibit both angiogenesis and VM, not just angiogenesis, to inhibit overall tumor growth.

Synergys is attempting to collect more safety and efficacy data with significant animal studies and also looking at other EGFR+ malignancies . Das said that the A-TAP technology is a new generation of cutting-edge biological payload system that is capable of generating highly efficacious polyfunctional biotherapeutics , with multibillion dollar market potential.  Currently, they are seeking financing for rapid product development. The company is also open to negotiations around partnering and structuring deals around out-licensing business model.

(Edits by Rathin Das).

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