Pipeline & Process

Pipeline-Medication1

 

Anew Biotechnology, Inc. is developing and commercializing 4 biological drug assets with more than 12 clinical indications. The first two antibodies – Rituximab and Trastuzumab – have been approved and are commercially available in India. Additional antibody products are under consideration for future development. The extended pipeline includes Bio-Betters of these antibodies and cetuximab (Erbitux®), other “naked” antibodies such as denosumab and the checkpoint inhibitors, and antibody-drug conjugates employing Anew’s MoXY™ technology for antibody-drug conjugates.

A Phase III clinical study of the company’s version of Rituximab is being prepared for start in Q1 2016. Anew’s next product, a highly comparable version of Herceptin®, is expected to enter a Phase III study in Q2 2016, with Avastin® following in the first half of 2017 for the ocular indication. The marketed versions of the pipeline products shown below generate around $28 Billion in annual global revenue.

Multiple indications for use for Anew’s first two biotech product introductions.

Multiple indications for use for Anew’s first two biotech product introductions.

With a primary focus in the near-term on Rituxan®-like and Herceptin®-like indications, and patent expiration on Avastin®-like products not occurring until 2019 and beyond, the Company will initiate development of these products after obtaining Phase III clinical data in 2016 from Reliance Life Sciences (RLS), the healthcare arm of Reliance Industries (India’s largest private conglomerate). The ocular indications will be investigated in several animal models to provide supporting efficacy and safety data before beginning human Phase I-II studies of Bevacizumab in the five ocular indications where Avastin® is approved.
The Cetuximab (Erbitux®) patent expires in 2016, and there is limited competition in the Cetuximab biosimilar area, with only two known competitors. Thus, a glioblastoma indication, where the overall survival endpoint is only 6 months, can be expeditiously developed and approved quickly by Food and Drug Administration (FDA) and European Medicines Agency (EMA) for this indication. Cetuximab can be developed as a “naked” antibody, and a follow-on antibody-drug conjugate will be developed for other soft tumor indications such as colon cancer and lung cancer. Other potential Monoclonal Antibody (mAb) candidates include Denosomab for osteoporosis indications and the PD-1 and PDL-1 “checkpoint inhibitors” for cancer indications, whose patents expire in the late 2020’s.

Process – Gap Analysis, Strategic Plan, Plan Management, and Launch

The Anew Biotechnology process is comprised of the following elements:

  • Review the Process Development, Manufacturing, QC Testing, Clinical & Regulatory Data Package from Reliance Life Sciences (RLS).
    • At the heart and brain of the Anew Biotech process is a dedicated Team of top scientific, product development, regulatory, and biotech manufacturing experts working together in an integrated and international manner to rapidly advance our products from large randomized Phase II studies competed by our partner to large, international, adequately-powered Phase III studies leveraging the biosimilar assets obtained through our exclusive licensing agreement with RLS. The Team rigorously engages RLS to get a complete description and “data dump” of all work done to date, from the product’s DNA sequence and host cell system, to cell banking and testing, through process development and validation of all systems, to orthogonal analytics to test for comparability, through clinical manufacturing and use of GMP product lots for animal PK/PD and toxicity testing, for human PK/PD testing, followed by large, randomized Phase II-Phase III human studies evaluating the safety and comparative efficacy in patients. The Anew Biotechnology, Inc. development team then employs a standard approach to identify shortfalls or potential “gaps” in the data and works with our partner and CROs to fill gaps and “de-risk” any areas with a “risk profile” so that beginning well-designed, adequately-powered pivotal Phase III studies in a particular indication is acceptable to the regulatory authorities.
  • Clinical Development and Regulatory Strategy
    • Anew Biotechnology, Inc. has established collaborative partnerships with top international CROs and Reliance Life Science’s CRO operating out of India, Europe, and the Middle East. Leveraging RLS’s CRO will provide cost savings in recruiting a large number of patients from India, the completion of studies per FDA and EMA GCPs, and access to “naïve” patients who may have not been treated previously with the Innovator product. The international CRO will manage all data, including the RLS data, and manage the clinical trials conducted at multiple Study Centers by multiple investigators and including oversight of central labs, study audits, and the statistical analysis plan. The regulatory strategy will be submission of a full BLA/CTD in the major markets of the U.S. and Europe, while submitting applications based on “biosimilarity” in the emerging market countries.
  • Global Program Management
    • Program management will plot the course, activities, budget, and timelines for each product. Program management will harmonize the various elements of complex “Phase III” programs through proactive planning, management and communications. This critical function ensures that the program’s development pace is maintained, while all essential technical, quality and budgetary requirements are strictly adhered to. Program management leadership will report directly to the CEO of Anew and will help to keep Board appraised of milestone achievements and items in the “risk radar” that may delay or promote the accomplishment of major corporate goals. Program management will also interface with the CFO of Anew Biotechnology, Inc. to track and management program budgets and expenditures.
  • Commercial Launch Planning
    • Anew has established collaborative partnerships several regional and international commercial partners to aggressively manage the regulatory approval process and to ensure successful market penetration in emerging and major markets. Anew will launch, market and sell its biologic drugs in the U.S., Canada, and in European countries. Over the next 3 years, the Company plans to establish a marketing force and name recognition by the acquisition of a pipeline of generic oncology drugs and ancillary medical products that it can begin to market and sell in Europe initially, then in Canada and the U.S. The branding and marketing under the Anew Biotechnology, Inc. name will not only provide the infrastructure for the introduction of drugs and biologics into the marketplace, but also provide a significant baseline of near-term revenue upon which to build upon through the introduction of the biologic drugs in two-three years and longer-term.

Growth of the Pipeline

The Anew Biotechnology, Inc. pipeline will grow with the development and introduction of follow-on Bio-betters derived from our first-generation biologics, and from acquiring new classes of mAbs with patent expirations dates in 2020 and beyond. The pipeline additions include Amgen’s Proliva® and Xgena® (denosumab), and the PD-1 and PD-L1 “checkpoint inhibitors” introduced into the oncology franchise of Merck and BMS in 2015 as tremendously important new biologic drugs used for the therapy of melanoma and lung cancers. The gene convstructs for these biologic drugs have already been made and will be developed by Anew and our Partners beginning in 2019.

 

Antibody Products


Future Development – MoXY Antibody Technology – Proprietary Antibody- Drug and Toxin Conjugates (“ADCs”)

MoXY™ is an Anew proprietary technology and ADC platform strategy to link extremely potent, cytotoxic drug and toxin molecules to monoclonal antibodies (mAbs) that are internalized inside the cancer cell. The mAb (“M”) is chemically linked (“o”) to one or more clusters of synthetic drugs and/or protein toxins (“X “ and “Y”), and the MoXY™ technology represents a new and reproducible approach for the scale-up, development, and commercialization of more effective and safe ADCs. Our first patent-protected MoXY is an immunotoxin made with our anti-epidermal growth factor (“EGFR”) mAb called cetuximab. Cetiximab has been proven to bind to EGFR over-expressed on cancer cells and the complex is internalized and transported to the lysosome. EGFR is over-expressed in all of the major solid tumors including cancer of the prostate, breast, brain, colon and lung, so the cetuximab immunotoxin is an ideal MoXY candidate.

Drug ClustersThe Company’s proprietary “MoXY” technology for creation of therapeutic mAb conjugates will begin development in 2016-2017, with the licensing of complementary technology to be employed in our development efforts of antibody drug conjugates (“ADCs”) that have improved clinical efficacy and thus are exemplified as a pipeline of “Bio-Betters”.

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