Asia Deal Watch: I-Mab Partners With Sinopharm As It Readies First Regulatory Filing

I-Mab sets commercial plans with Sinopharm for felzartamab in multiple myeloma. Legochem and Antengene team up on antibody-drug conjugates, Luoxin licenses respiratory drug from Marinomed.

Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker.

I-Mab Readies For Commercial Activity Via Pact With Sinopharm

Planning to file anti-CD38 agent felzartamab for approval in third-line multiple myeloma before the end of 2021, Shanghai-based I-Mab Biopharma Co., Ltd said it will transition into a commercial biopharma with the help of Sinopharm Group Co. Ltd. under an agreement that will see 300-plus Sinopharm subsidiaries create a distribution channel for I-Mab therapies across China. No financial terms were disclosed for the partnership announced on 27 October.

While it expects felzartamab, partnered with MorphoSys AG under a 2017 licensing deal, to become its first commercial product for the third-line MM indication, I-Mab said it also is enrolling a Phase III study testing combination therapy of the antibody with Bristol Myers Squibb Company’s Revlimid (lenalidomide) in second-line MM. In a validation-providing tie-up, I-Mab out-licensed anti-CD47 candidate lemzoparlimab to AbbVie Inc. in September 2020 for $200m up front. (Also see "$2bn AbbVie Deal Puts I-Mab On Global Immuno-Oncology Map" - Scrip, 4 Sep, 2020.)

LegoChem, Antengene To Collaborate On New ADC Candidates

Antengene Corporation announced a research collaboration and option agreement on 21 October with LegoChem Biosciences, Inc. to develop new antibody-drug conjugates (ADCs). Under the agreement, the companies will jointly generate and evaluate ADC candidates using Antengene’s antibodies and LCB’s next-generation ADC technology platform.

Antengene gets an exclusive option to license global rights for the development and commercialization of the resulting ADC candidates. When the option is exercised, LCB will be eligible to receive upfront and milestone payments, as well as tiered royalties. In addition, LCB can earn a prespecified percentage of any sublicensing income received by Antengene.

LCB says its ConjuAll technology is a next-generation ADC platform utilizing novel linker chemistry combined with site-specific conjugation. It provides solutions for site-specific conjugation enabling high-purity final ADCs with defined Drug-to-Antibody Ratio (DAR), plasma stability and tumor-selective efficient payload release, the biotech said, which are major unmet needs in ADC development.

Shandong Luoxin Gets Allergic Rhinitis Candidate From Marinomed

Luoxin Biotechnology (Shanghai) Co Ltd. signed a licensing agreement on 21 October with Marinomed Biotechnologie GmbH, conferring to the Chinese firm exclusive rights for the development, manufacture and commercialization of Budesolv (a new formulation of the glucocorticoid budesonide, a steroid nasal spray indicated for allergic rhinitis) in greater China (including Hong Kong, Macao SAR and Taiwan).

Under the agreement, Luoxin will pay to Marinomed $2m up front along with potential development and sales milestone not to exceed $20M. Once the product is launched, the Austrian firm also can realize tiered royalties based on net sales.

Oncodesign, TiumBio Partner On Novel Fibrosis Therapies

France’s Oncodesign SA and TiumBio Co., Ltd. unveiled a research collaboration on 21 October focused on potential novel therapies for fibrosis. Oncodesign will be responsible for identification, chemical synthesis and optimization of Nanocyclix drug candidates and their early-stage analysis, while TiumBio will evaluate the resulting candidates for efficacy against fibrosis. South Korea-based TiumBio will finance the initial partnership work.

Oncodesign said it will use its Nanocyclix proprietary medicinal chemistry technology, which is based on the macrocyclization of lead-like small molecules, to identify starting points satisfying TiumBio’s initial criteria. TiumBio gets an exclusive option to in-license global development and commercialization rights for the discovered drug candidates after their evaluation upon reaching predefined success criteria. Financial terms, including option fees, were not disclosed.

Takeda Revises Pact With WAVE, Licenses Two Drugs To Calithera

On 18 October, Takeda Pharmaceutical Co. Ltd. amended a 2018 partnership with WAVE Life Sciences Ltd. to end its options to acquire preclinical antisense therapies for central nervous system indications. Takeda paid the Singapore-based firm $22.5m to cover research and preclinical development expenses from the collaboration. The pharma had paid $110m up front and made a $60m equity investment in Wave Life under the February 2018 agreement. (Also see "Takeda Catches Rising Tide Of Antisense Neuroscience R&D" - Scrip, 21 Feb, 2018.)

Also on 18 October, Takeda divested two clinical-stage cancer candidates to precision oncology-focused  Calithera Biosciences, Inc. The South San Francisco biotech obtained sapanisertib (CB-228, formerly TAK-228), a dual TORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells, and mivavotinib (CB-659, formerly TAK-659), a SYK inhibitor that targets the constitutively active BCR pathway in many non-Hodgkin’s lymphoma (NHL) cases.

Calithera said sapanisertib has demonstrated promising single-agent activity in patients with relapsed/refractory NRF2-mutated squamous non-small cell lung cancer (NSCLC) with differentiated anti-tumor activity compared to rapalog inhibitors of TORC1 in NRF2-mutant squamous NSCLC in vivo models. The company plans to initiate a Phase II study in the first quarter of 2022 investigating the compound as monotherapy in patients with squamous NSCLC harboring a NRF2 mutation. It also plans to initiate a Phase II study of mivavotinib in 2022 for the treatment of patients with diffuse large B-cell lymphoma with and without mutations in MyD88 and CD79.

Takeda gets a $10m upfront fee and $35m in stock equity under Calithera under the deal. The Japanese firm also could realize up to $470m in clinical, regulatory and sales milestones tied to the two programs, along with net sales royalties.

Those deals occurred as the Japanese pharma also continued its recent deal-making foray in the cell and gene therapy spaces, the latest transaction coming on 27 October as it exercised a buyout option under its 2017 equity investment in GammaDelta Therapeutics. Takeda has inked three gene therapy collaborations since August with Genevant Sciences, Selecta Biosciences, Inc. and Poseida Therapeutics, Inc., the last two occurring earlier in October. (Also see "Takeda Continues Recent Gene Therapy Partnering Spree With Poseida Pact" - Scrip, 12 Oct, 2021.) In addition, on 13 October, it unveiled a cell therapy tie-up with Immusoft Corporation focused on rare inherited metabolic disorders with central nervous system (CNS) manifestations. (Also see "Asia Deal Watch: Hansoh Teams Up With OliX On SIRNA Therapies" - Scrip, 14 Oct, 2021.)

Acquiring the London-based company at undisclosed terms, Takeda brought in-house GammaDelta’s allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy platforms, including both blood-derived and tissue-derived platforms, as well as early-stage cell therapy programs. Those technologies could provide new therapeutic options for solid and hematologic cancers, Takeda said.

In May 2017, Abingworth and Takeda teamed up to invest $100m in GammaDelta, whose platform attempts to create therapies for cancer and autoimmune disease by isolating gamma-delta T cells from human donor tissue. (Also see "Takeda Picks Next Big Thing In Immunotherapy: Gamma Delta T Cells" - Scrip, 15 May, 2017.) The theory was that cell therapies derived from tissue rather than blood might be more effective in addressing solid tumors. Takeda said it thinks the biotech’s programs can yield off-the-shelf therapies that it will integrate with its immuno-oncology R&D efforts.

Sumitomo Dainippon, BehaVR Ink Deal for Prescription VR-Based Digital Therapeutics

Japan’s Sumitomo Dainippon Pharma Co., Ltd. (SDP) and US virtual reality firm BehaVR, Inc. announced an agreement on 18 October to develop and commercialize prescription digital therapeutics and general wellness products globally for the treatment of social anxiety disorder, generalized anxiety disorder and major depressive disorder.

The companies’ plan is that the three prescription products would be developed in the US under the US Food and Drug Administration’s Software as a Medical Device regulatory framework and prescribed alongside other behavioral therapies, with the potential for use in a variety of settings. SDP markets the atypical antipsychotic Latuda (lurasidone) globally for a variety of disorders.

SDP will fund clinical development and global commercialization, paying BehaVR $5m up front and up to $18m in development milestone and R&D support payments, in addition to commercial and operational support fees. An additional amount up to $140m in milestones is contingent upon commercial success and BehaVR can earn tiered royalties on global sales.

SDP's US subsidiary Sunovion Pharmaceuticals signed an initial collaboration with BehaVR in June 2020 to co-develop a wellness product for general social anxiety. Kentucky-headquartered BehaVR is developing a range of clinically validated prescription digital therapeutics to prevent, manage or treat various disorders, based on immersive experiences to build short-term coping skills and long-term resiliency tools.

Hansoh In-Licenses Silence Therapeutics’ mRNAi GOLD Platform

On 15 October, Hong Kong-listed Hansoh Pharmaceutical Group Company Limited agreed to pay $16m in upfront to Silence Therapeutics plc to use the latter’s mRNAi GOLD platform to develop small interfering RNAs (siRNAs) for three targets. London-based Silence can earn up to $1.3bn in development, regulatory and commercial milestones along with net sales royalties.

Hansoh will obtain an exclusive option to license rights in greater China for the first two targets, following the completion of Phase I studies, while Silence will retain the ex-China rights, the partners said. In addition, Hansoh will hold an exclusive option to license global rights at the point of investigational new drug (IND) filing for the third target.

Lundbeck, Aprilbio Ink $448m Neuroimmune Disease R&D Pact

H. Lundbeck A/S announced an agreement on 14 October with South Korea’s Aprilbio conferring exclusive worldwide rights to the Danish biopharma to research, develop and commercialize APB-A1, a novel and well-differentiated anti-CD40 ligand (CD40L) candidate. Aprilbio said the antibody offers significant potential across a wide array of neuroimmune diseases and will be ready for Phase I in early 2022.

Under the pact, Lundbeck will pay Aprilbio $16m up front. In addition, Aprilbio can earn development, regulatory and sales milestone payments of up to $432m related to APB-A1. Lundbeck will also pay Aprilbio tiered royalty payments and be responsible for all future development activities and expenses related to the project.

The agreement enables Lundbeck to initiate clinical activities targeting the neuroimmune system. The concept is built on research that has shown ability to therapeutically target diseases of the central nervous system, according to Aprilbio.

APB-A1 is a neutralizing anti-CD40L antibody-like drug candidate with an innovative molecular design blocking the essential CD40L/CD40 co-stimulatory interaction, Aprilbio says. Activation of the CD40L/CD40 signaling cascade is essential for the initiation of cellular and humoral immune responses and is an established and clinically validated immune pathway through its ability to trigger activation, differentiation and proliferation of B-cells, T-cells and several other immunes cells (such as monocytes, macrophages, dendritic cells and natural killer cells) to mediate immune responses, according to the partners.

Tracon Obtains CTLA-4 Antibody Rights In North America From Eucure

On 11 October, San Diego-based TRACON Pharmaceuticals Inc. said it will in-license from China's Eucure (Beijing) Biopharma Co., Ltd., a subsidiary of Biocytogen, the CTLA-4 antibody YH001 for multiple cancer types including soft tissue sarcoma, according to press release of TRACON. NASDAQ-listed Tracon will pay Eucure escalating double digit royalties on net sales of YH001 in North America. Eucure will supply YH001 for Tracon’s development activities.

Shanghai Pharmaceuticals Pays $11m For Guizhou Sinorda’s Digestive Drug

Shanghai Pharmaceuticals Holding Co., Ltd. announced that it has in-licensed X842, an oral potassium competitive acid blocker (P-CAB) drug candidate for gastroesophageal reflux disease (GERD), from Guizhou Sinorda on 9 October. The two companies will co-develop X842 for the treatment of duodenal ulcer and eradication of helicobacter pylori in China.

Shanghai will pay Sinorda an upfront CNY70m ($11m) to gain the exclusive manufacturing and commercial rights to the candidate in greater China. Additional regulatory and sales milestone payments could bring Guizhou Sinorda an additional CNY620m. Sinorda also could realize 6% to 12% royalties on annual net sales of X842 in China.

Stay tuned for the next edition of Deal Watch. You can read more about other deals that have been covered in depth by Scrip and Generics Bulletin in recent days below:

(Also see "Takeda Buys Out Partner GammaDelta In Cell Therapy Push" - Scrip, 27 Oct, 2021.)	Japanese major buys out existing cancer cell therapy research partner, exercising an exclusive option dating back to a 2017 collaboration and expanding its immuno-oncology ambitions and pipeline.
(Also see "Strides Completes Acquisition Of Endo US Facility And ANDAs" - Generics Bulletin, 27 Oct, 2021.)	Two months after announcing the deal, Strides Pharma Science has closed its acquisition of a US manufacturing site and basket of ANDAs from Endo, doubling the company’s burgeoning US business and providing much-needed cash to the US-based company.
(Also see "Takeda Continues Recent Gene Therapy Partnering Spree With Poseida Pact" - Scrip, 12 Oct, 2021.)	Takeda will use Poseida’s non-viral delivery and gene-editing capabilities for six liver- and hematopoietic stem cell-targeted gene therapies. The agreement follows recent gene therapy tie-ups with Selecta and Genevant.