Pipeline and Partnerships

A diversified pipeline of wholly-owned and partnered next generation and novel therapeutics.

In pursuit of our vision, we have created a portfolio of therapeutics, produced by our patented Pfenex Expression Technology platform, based on our deep institutional knowledge of protein therapeutic development. Whether wholly-owned or developed in collaboration with one of our partners, each of the product candidates in our pipeline is being developed with the intent to address an important unmet medical need.

It includes PF708 (teriparatide Injection), a therapeutic equivalent candidate to Forteo® approved in the U.S. for the treatment of osteoporosis in certain patients at high risk for fracture; hematologic oncology product candidates in collaboration with Jazz Pharmaceuticals; and novel, wholly-owned, internally developed programs.

Our Programs

Pre-clinical

Phase 1

Phase 2

Phase 3

Reg. Filing

Commercial

Partner

PF708

Teriparatide – Osteoporosis

Phase: Reg. Filing

Partner: Alvogen & NT Pharma

PF708 - Teriparatide – Osteoporosis

PF743 (JZP-458)

Recombinant Erwinia Asparaginase

Phase: Phase 3

Partner: Jazz Pharmaceuticals

PF743 (JZP-458) - Recombinant Erwinia asparaginase

PF745(JZP-341)

Long-acting Recombinant Erwinia Asparaginase

Phase: Preclinical

Partner: Jazz Pharmaceuticals

PF745(JZP-341) - Recombinant long-acting Erwinia asparaginase

PF690

Arcellx CART – SparX

PF690 - Arcellx CART - sparX

CRM197

Carrier Protein

Phase: Pneumosil – Reg. Filing

Phase: Meningococcal Vaccine – Phase 3

Phase: Add’l Programs – Pre-clinical

Partner: Serum Institute of India PVT. LTD.

CRM197 - Carrier Protein

CRM197

Carrier Protein

Phase: Phase 3

Phase: Add’l Programs – Pre-clinical

Partner: Merck

CRM197 - Carrier Protein

CRM197

Carrier Protein

Phase: Phase 2

Partner: Various undisclosed partnerships

CRM197 - Carrier Protein

Various undisclosed partnerships

PCV-15

V114

PCV-15 V114

Pneumosil

10-Valent Pneumococcal Vaccine

Pneumosil 10-valent Pneumococcal vaccine

Pentavalent Meningococcal Conjugate Vaccine

Pentavalent Meningococcal Conjugate Vaccine

PF810

Recombinant Peptide

Phase: Pre-clinical

Partner: Pfenex Biopharmaceuticals

PF810 - Recombinant Peptide

PF753

Arcellx ARC-T – sparX

Phase: Pre-clinical

Partner: Arcellx

PF753 - Arcellx CART - sparX

PF754

Arcellx ARC-T – sparX

Phase: Pre-clinical

Partner: Arcellx

PF754 - Arcellx CART - sparX

PF582

Arcellx ARC-T – SparX

PF582 - Arcellx CART - sparX

PF91X

Various Targets In Screening

Phase: Pre-clinical

Partner: Pfenex Biopharmaceuticals

PF91X - Various Targets In Screening

Current Collaborations

Are you interested in partnering with Pfenex? We seek co-development partnerships that leverage our platform’s capabilities, such as its rapid candidate selection, faster drug development and potentially higher success rates for a wide range of complex modalities. Success with therapeutic proteins, particularly with engineered proteins given their complexity, hinges on the ability to rapidly screen, develop, manufacture and advance clinically. Having partnered with more than 60 organizations over the last two decades, our team’s institutional knowledge, coupled with our proven platform, capabilities and pilot scale production facilities, brings a lot to a product development partnership.

Please contact info@pfenex.com to request more information about becoming a Pfenex partner.

Current Partners

Pfenex has granted Alvogen the exclusive rights to commercialize and manufacture Pfenex’s lead drug candidate, PF708, a teriparatide, which is being developed as a therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®/Forsteo®, in the United States, the European Union, certain countries in the Middle East and North Africa and the Rest of World territories outside of the countries licensed to NT Pharma including, Hong Kong, Mainland China, Malaysia, Singapore and Thailand.  PF708 was developed via the 505(b)(2) regulatory pathway in the United States and was FDA approved on October 4, 2019.

Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the counter (OTC) and biosimilar products for patients around the world. With commercial footprint in over 35 countries, Alvogen’s key regions include the U.S. and emerging markets in the CEE and APAC regions.

Pfenex has granted NT Pharma the exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide, which is being developed as a therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®/Forsteo®, in Hong Kong, Mainland China, Malaysia, Singapore and Thailand.

NT Pharma is a technology-based pharmaceutical company which is principally engaged in the investment, research and development (“R&D”), manufacturing and sales of pharmaceutical products in the People’s Republic of China and countries overseas, with its products covering therapeutic areas of severe illness such as oncology, orthopedics, Central Nervous System, hepatology and respiratory system. NT Pharma also owns several sales and distribution companies with around 1,000 sales professionals and R&D specialists. NT Pharma has an extensive promotion network in China, covering nearly 10,000 hospitals.

Pfenex granted Jazz Pharmaceuticals (“Jazz”) worldwide rights to develop and commercialize multiple early stage hematology product candidates including a recombinant Erwinia asparaginase, PF743 (JZP-458), a potential treatment option for patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products and PF745 (JZP-341), a half-life extended recombinant Erwinia asparaginase. The agreement also includes an option for Jazz to negotiate a license for a recombinant pegaspargase product candidate with Pfenex.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical company, is dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine and with a growing hematology/oncology portfolio, Jazz has a diverse portfolio of products and product candidates in development and is focused on transforming biopharmaceutical discoveries into novel medicines.

Merck & Co., Inc. currently has a license agreement for the use of Pfenex Expression Technology to produce the carrier protein CRM197 for use in conjugate vaccines they are developing.  Merck is currently utilizing Pfenex expressed CRM197 in their 15-valent Pneumococcal vaccine, V114, plus additional vaccine development programs.

For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases.

Serum Institute of India Private Limited (SIIPL) currently has a license agreement for the use of Pfenex Expression Technology to produce the carrier protein CRM197 for use in conjugate vaccines they are developing.  SIIPL is currently utilizing Pfenex expressed CRM197 in Pneumosil®, a 10-valent Pneumococcal vaccine, that achieved WHO Prequalification in December 2019. SIIPL is also developing a thermostable Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W-135, X) that is currently being evaluated in a Phase 3 clinical study plus additional vaccine development programs. In addition, SIIPL is Pfenex’s exclusive supplier of pre-clinical grade and cGMP grade CRM197 which Pfenex sells to vaccine developers globally, see www.CRM197.com for more information.

Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. Vaccines manufactured by SIIPL are accredited by the World Health Organization, Geneva and are being used in around 140 countries across the globe in their national immunization programs, saving millions of lives throughout the world.