Deal Watch: Lilly Turns To Oblique For Antibody Discovery

Firm Also Expands Emgality Commercialization Pact With Organon

Plus deals involving Lilly/Oblique, Rafael Holdings/Cyclo, ADCendo/Multitude, Ocuvex/Visiox and more.

Deal Watch 2021
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Scrip regularly covers business development and deal making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker.

Lilly Teams With Oblique On Antibody Discovery For Undisclosed Target

Eli Lilly and Company inked a research collaboration on 22 August with Oblique Therapeutics AB to apply the Swedish firm’s Oblique’s AbiProt technology to generate antibodies against a “high value” target. No specific financial terms were disclosed but Oblique can earn milestones and royalties under the agreement.

AbiProt uses proteases as molecular probes to scan an entire intact protein, Oblique said, which can identify accessible antibody binding sites. As a result, the platform can identify new therapeutic antibodies that not only bind to a target protein with high specificity and affinity but also possibly can be programmed for a particular pharmacological function.

The two companies already have an existing agreement in place signed in November 2023, but Oblique’s participation was not publicly disclosed at the time. This agreement will expand the collaboration to a second high-value target, the firms said.

Lilly Gets $22.5m Up Front For Emgality Rights In 11 Markets

Already partnered on commercialization of migraine-prevention drug Emgality (galcanezumab) in Europe, Lilly and Organon BioSciences N.V. agreed on 20 August to expand their agreement, adding 11 countries to Organon’s geographic rights to the CGRP antagonist. Lilly will get $22.5m up front for the expanded commercial rights as well as sales-based milestones.

Along with the EU, Organon now will market Emgality in Canada, Colombia, Israel, South Korea, Kuwait, Mexico, Qatar, Saudi Arabia, Taiwan, Turkey and the United Arab Emirates. On 18 December, Organon paid Lilly $50m up front for rights to the product in Europe. (Also see "Deal Watch: Lilly Sends European Commercial Rights For Two Migraine Drugs To Organon" - Scrip, 20 December, 2023.)

Rafael To Acquire Cyclo, Complete Niemann-Pick Phase III Trial

Rafael Holdings, already a shareholder, announced on 22 August that it will acquire Cyclo Therapeutics, Inc. in a stock-swap transaction and will finance development of Trappsol Cyclo through Phase III for the rare lysosomal storage disorder Niemann-Pick disease type C1. The deal, expected to close in late 2024, will value shares in Cyclo at $0.95 apiece.

Rafael first invested in Cyclo in March 2023 and has committed to funding the Phase III Transport-NPC trial through to a 48-week interim analysis. The two companies think that study could provide data to back a new drug application filing of Trappsol Cyclo for Niemann-Pick C1.

If it reaches the market, the intravenous drug would likely compete with IntraBio Inc.’s oral modified amino acid IB1001, which is under review at the FDA with a 24 September action date, or Zevra’s heat shock protein amplifier Miplyffa (arimoclomol), which has a 21 September action date. (Also see "10 Approvals To Watch Out For In Q3" - Scrip, 9 August, 2024.) Currently, there are no approved drug therapies for Niemann-Pick C1.

After its March 2023 investment in Cyclo, Rafael, a holding company with interests in clinical and early-stage biopharmaceutical companies, led another financing in 2023 and has supported Cyclo’s operations through convertible debt transactions this year. Cyclo said it also has Trappsol Cyclo in Phase IIb for Alzheimer’s disease and is working on other possible indications for the candidate.

ADCendo Licenses Tissue Factor-Targeting ADC From Multitude

Denmark-headquartered ADCendo ApS agreed on 21 August to acquire worldwide development and commercialization rights, except for Greater China, to Multitude Therapeutics’s preclinical antibody-drug conjugate (ADC) candidate ADCE-T02. The tissue factor (TF)-targeting candidate is expected to enter Phase I development in Australia during Q4, and an investigational new drug (IND) application to the US FDA is planned.

According to ADCendo, ADCE-T02 will be the first ADC with a topoisomerase I inhibitor-based linker/payload to enter clinical development in the US, Europe or Australia. Targeting TF should offer therapeutic benefit in non-small cell lung, colorectal, cervical cancer, esophageal, head and neck, bladder and certain gastrointestinal cancers because it is highly expressed in those tumor types but not in normal, healthy tissue.

The candidate offers properties such as an antibody design that minimizes impact on coagulation pathways, Multitude said, that should translate into a superior therapeutic window, better safety profile, enhanced response rates and longer response durations through reduced-toxicity-driven treatment terminations, interruptions or dose reductions.

Under the agreement, Redwood City, CA-based Multitude will get an undisclosed upfront payment. Its total consideration under the deal, including development, regulatory and commercial milestones could exceed $1bn, and the biotech could also realize sales royalties.

After Failed SPAC Deal, Visiox Will Merge With Ocuvex

Visiox Pharma, LLC signed a definitive agreement on19 August to be acquired by fellow ophthalmology-focused company Ocuvex Therapeutics, with the combined business to operate under the Ocuvex name. Terms were not disclosed.

In 2023, Visiox attempted to go public by merging with special purpose acquisition company PowerUp Acquisition Corp., but PowerUp withdrew the proposal in July after Visiox failed to satisfy certain conditions.

Visiox and Ocuvex said they bring complementary product offerings to their combination. Ocuvex has not publicly disclosed its offerings, while Visiox’s pipeline includes Omlonti (omidenepag isopropyl ophthalmic solution 0.002%), a selective prostaglandin E2 (EP2) receptor agonist for reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; PDP-716 (brimonidine 0.35%), a once daily therapy for glaucoma expected to launch in early 2025; and SDN-037 (difluprednate 0.04%), a twice-daily topical difluprednate corticosteroid for control of inflammation following cataract surgery. Visiox said that the product is expected to launch in mid-2025.

In Brief:

  • Chinese biopharmas Bridge Biotherapeutics, Inc. and HitGen Inc. unveiled a joint research agreement on 22 August to accelerate discovery of new drug candidates for a first-in-class novel cancer therapeutics program. The collaboration will attempt to convert initial hit finding and identification work from HitGen’s DNA-encoded library (DEL) into novel cancer drug candidates, the companies said. They expect optimization and securing of lead compounds to accelerate during 2025.
  • UK-based Nuntius Therapeutics agreed on 16 August to partner with Japan’s Taiho Pharmaceutical Co. Ltd. by using the former’s cell-specific peptide dendrimer- and lipid-based nanocarriers to develop novel mRNA cancer immunotherapy candidates. Previously, Taiho evaluated Nuntius’s delivery capabilities, which it claims can safely target cell types outside the liver, via a feasibility study. Financial terms were not disclosed.
  • In a deal between two Israel-headquartered firms, SciSparc Ltd. granted Polyrizon Ltd. exclusive global rights on 16 August to develop and sublicense SCI-160 for the treatment of acute and chronic pain. SCI-160 is a proprietary synthetic combination of cannabinoids and N-acylethanolamines that in preclinical studies have provided mediating analgesic effects in the peripheral nervous system without significant side effects, SciSparc said. Polyrizon will pay $3m up front in the form of equity and be responsible for development milestones of up to $3m, as well as sales royalties.
  • Nanoform Finland Oyj entered a preclinical development agreement on 15 August with Takeda Pharmaceutical Co. Ltd. to develop plasma-derived therapy formulations for the treatment of rare conditions. Nanoform said its nanoforming platform can deliver large-molecule drug particles of tuneable size and morphology, while retaining biological activity. The technology can be applied to enable novel routes of delivery, enhance drug loading, tailor release profiles and engineer new drug combinations, the Finnish firm added. First results from in vitro proof-of-concept studies are expected by early 2025.
  • Abata Therapeutics got an equity investment on 15 August from Bristol Myers Squibb Company to support the development of its Treg cell therapy products. The investment will support Abata’s advancement toward clinical development, with trial initiation said to be imminent for autologous Treg therapy ABA-101 in progressive multiple sclerosis. Abata said its second program for type 1 diabetes is in IND-enabling studies.
  • Prelude Therapeutics Incorporated granted Pathos AI worldwide rights on 15 August to a Phase II-ready PRMT5 inhibitor, PRT811 for solid tumors. Financial details were not disclosed. Prelude developed PRT811 (renamed P-500) and completed a Phase I trial in early 2023 for patients with solid tumors including high-grade glioma and uveal melanoma. Pathos said it will utilize its AI-powered drug discovery platform to develop the candidate alongside pocenbrodid (formerly FT-7051), a CBP/p300 inhibitor for prostate and other solid tumors licensed from Novo Nordisk A/S in 2022.

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 "Merck & Co. Drops Kelun Claudin 18.2 ADC But Exercises Bispecific Option" - Scrip, 21 August, 2024.)

The changes mark the second major revision to the 2022 antibody-drug conjugate-focused alliance between US Merck and Chinese firm Kelun, which is now focusing on ADCs against Trop2, Nectin-4 and other undisclosed targets. Meanwhile, the results from other trials with Claudin 18.2 ADCs have used varying definitions of high expression, with differing results.

(Also see "BioMarin Recruits Amgen R&D’s Friberg, Roche Dealmaker Sabry To Leadership Team" - Scrip, 21 August, 2024.)

BioMarin, in its new profitable era, is bringing in new leadership, with Amgen VP of medical affairs for rare diseases Greg Friberg and recently retired Roche Partnering head James Sabry.

(Also see "Xbrane Reveals Urgency To Find A Partner For One Of Two Biosimilars By October" - Generics Bulletin, 19 August, 2024.)

Cash is king for fledgling biosimilar companies. Xbrane Biopharma has revealed just how close it is to the edge after Biogen unexpectedly pulled the plug on a key licensing deal, but the company is maintaining optimism.

(Also see "Apotex Leans Into Brand Ambitions With Formosa Deal" - Generics Bulletin, 15 August, 2024.)

Apotex has made another move to bolster its burgeoning branded business, striking a deal with Formosa Pharmaceuticals for Canadian rights to its novel clobetasol propionate ophthalmic suspension.

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