An Early February Focus on U.S.-Asia Drug Development Deals - UPDATED
Cross-continental drug development and commercialization deals are good for business, and imperative for patients to receive access to the most valuable scientific breakthroughs. This month has already brought a number of these partnerships for the treatment of cancer and other diseases with a significant medical need. Here’s a look at four of them.
Illumina and Sequoia Capital China Incubating Genomics Talent
On Monday, leading DNA sequencing and array-based technologies company, Illumina, announced a deal with global venture capital firm, Sequoia Capital China, to incubate life sciences startups specializing in genomics.
Accepted companies will benefit from $500, 000 investment and business guidance and a minimum of $100, 000 prioritizing investments from Sequoia Capital China in the next series of financing, along with access to Illumina’s sequencing systems, reagents, and genomics knowledge.
The new operation, “Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina” will be a fully operational laboratory space and joins existing Illumina accelerators in the San Francisco Bay Area, and Cambridge, UK.
“Illumina has a successful track record of creating venture-backed genomics startup companies through Illumina Accelerator in the U.S. and UK,” “Together with Sequoia Capital China, we will now partner with leading entrepreneurs in China to build genomics startup companies that unlock powerful breakthrough genomics applications and clinical sequencing solutions that harness the unique strengths and dynamic markets in China,” said Illumina Chief Executive Officer, Francis deSouza.
Applications to be one of the accelerator’s inaugural benefactors are open until June 1, 2021, and the first funding cycle will begin in the Fall of 2021.
Coherus Partners With Junshi Biosciences to Develop Immunotherapy Drug
California-based Coherus BioSciences, Inc. kicked off February by announcing a partnership with Shanghai Junshi Biosciences Co. Ltd. to collaborate on the development and commercialization of the latter’s anti-PD-1 antibody, toripalimab in the U.S. and Canada.
With an up-front $150 million payment to Junshi, Coherus essentially announced its shift away from a longtime focus on biosimilars – at least until 2025 when it expects to receive U.S. Food and Drug Administration (FDA) approval for its biosimilar of AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.
For Junshi, the deal comes with $1.11 billion (USD) in upfront payments, an exercise fee, and milestone payments from Coherus for toripalimab, as well as two option programs. Coherus receives co-development rights of toripalimab and will be fully responsible for all U.S. and Canadian commercial activities.
Toripalimab (TUOYI®) is the first domestic anti-PD-1 monoclonal antibody to gain marketing approval in China, with conditional approval from China’s National Medical Products Association (NMPA) for the second-line treatment of patients with unresectable or metastatic melanoma. It also owns U.S. Food and Drug Administration (FDA) breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for nasopharyngeal carcinoma, mucosal melanoma, and soft tissue sarcoma.
Clinical development is underway for the evaluation of toripalimab in a broad range of solid tumors including lung, esophagus, stomach, bladder, breast, and skin cancers.
Under the agreement, Coherus also received options for an anti-TGIT antibody, JS006, and a next-generation engineered IL-2 cytokine called JS018-1, along with first negotiation rights to two early-stage checkpoint inhibitor antibodies.
“Toripalimab has a compelling clinical profile with impressive efficacy and safety, and we are thrilled to collaborate with Junshi Biosciences to deliver patient benefit in the United States and Canada,” said Coherus CEO, Denny Lanfear. “Our mission has always been to increase patient access to important medicines and to deliver significant health care system savings. This transaction builds on that mission to include the rapidly growing checkpoint inhibitor market, which is expected to exceed US$25 billion by 2025, and provides us the essential backbone drug for development of next-generation combination therapies.”
Moving east along the continent, Ribon Therapeutics has announced an exclusive license agreement with Osaka, Japan-based Ono Pharmaceutical Co. Ltd. to develop and commercialize its first-in-class PARP7 inhibitor, RBN-2397 in Japan, South Korea, Taiwan, and other Association of Southeast Asian Nations (ASEAN).
RBN-2397, which is currently in Phase I clinical development for the treatment of cancer, acts as an inhibitor of PARP7 expression, an upregulated response to cellular stress, including instability in cancers.
“This agreement enables us to strategically expand our program in support of Ribon’s mission to bring therapeutics targeting stress support pathways for the treatment of cancer to as many appropriate patients as possible,” said Ribon President and Chief Executive Officer, Victoria Richon. “We believe that RBN-2397 could serve as a meaningful intervention for the treatment of tumors with PARP7 expression, which has been shown to play a key role in cancer survival. We look forward to working with Ono, a global leader in immuno-oncology, to unlock the potential of RBN-2397 for patients in Japan, South Korea, Taiwan and ASEAN countries.”
Under the terms of the alliance, Ono will pay Ribon approximately $16.3 million in addition to other potential milestones of up to around $132 million.
Ono, which focuses on diseases in oncology, immunology, and neurology with high medical needs, would seem to be an appropriate fit for Ribon, a clinical-stage biotech developing first-in-class therapeutics for patients with limited therapeutic options.
“We believe that RBN-2397 could have a profound impact on patients with cancer, given the potential of the therapy’s dual mechanism to suppress tumor growth and enhance immune reaction to tumor cells. We look forward to developing RBN-2397 with Ribon by harnessing our experience and expertise in oncology,” said Ono president and representative director Gyo Sagara at the time of the announcement.
Thermo Fisher and JW Therapeutics Align to Deliver CAR-T Therapies to China
Thermo Fisher Scientific, the world leader in serving science, has expanded its collaboration with one Asian partner. Today, the company struck a deal to grant Chinese cell-based immunotherapy leader, JW Therapeutics non-exclusive commercial access to its Gibco CTS Dynabeads platform.
The access will help to ease the transition of JW Therapeutics’ lead product, relmacabtagene autoleucel ("relma-cel"), a promising anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma, from clinical development to commercial manufacturing.
"This partnership is a natural extension of an already strong collaboration. As we approach critical milestones in our commercialization strategy, this partnership will ensure we have the supply to scale up and meet the unmet medical needs of Chinese patients,” said JW Therapeutics Executive Vice President and Chief Technology Officer, Dr. Harry Lam.
JW Therapeutics presented data from its pivotal RELIANCE trial of relma-cel at the 62nd Amerian Society of Hematology (ASH) Annual Meeting in December. Of the 58 patients evaluated, the best overall response rate was 75.9%, the Best Complete Response 51.7%. The company also revealed that relma-cel showed similar efficacy and pharmacokinetic profiles when compared with other anti-CD19 CAR-T therapies currently approved in the US and Europe.
The Chinese National Medical Productions Association (NMPA) has accepted a new drug application (NDA) for Relma-Cel, which is expected to be the first CAR-T therapy approved as a Category 1 biologics product in China.