Deal Watch: GSK Furthers Cancer Gene Therapy Plans Via Lyell Collaboration
Executive Summary
GSK hopes the San Francisco biotech’s technology can help its cell therapy pipeline address solid tumors. Avacta partners with ADC on antibody-drug conjugates.
Scrip regularly covers business development and deal-making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Strategic Transactions.
GSK Teams With Lyell On Solid Tumor T-Cell Therapies
GlaxoSmithKline PLC has spoken a lot lately about its ambitions in cancer under CEO Emma Walmsley and her hand-picked chief scientific officer Hal Barron, particularly in terms of catching up with the field in cell and gene therapy. In line with those ambitions, the pharma unveiled a five-year collaboration with Lyell Immunopharma on 8 October to apply the biotech’s technology to its T-cell candidates for solid tumors. No financial terms were disclosed.
Privately held Lyell, run by Rick Klausner (founder and co-director of Juno Therapeutics Inc. and co-founder of Grail Inc.), focuses specifically on exploring the concept of T-cell exhaustion. (Also see "Culture Change At GSK: 'We’re Doing What We Said We’d Do'" - Scrip, 9 Oct, 2019.) Klausner and Barron are convinced Lyell's research could unlock the potential of chimeric antigen receptor T-cell (CAR-T) and T-cell receptor modified T-cell (TCRT) therapies in solid tumors, a breakthrough which would make the technology far more commercially and clinically valuable.
Lyell says it can offer approaches to improve T-cell function and increase T-cell “fitness,” which might enhance response rates for T-cell therapies in solid tumors and prevent relapses associated with loss of T-cell functionality. Klausner said the firm’s work is investigating new ways to prepare patients’ cells to be converted into immunotherapies, modulate T-cells’ function so they maintain their activity in the tumor microenvironment, and achieve better specificity and safety of tumor-directed therapy.
Initially, the collaboration will focus on optimizing GSK’s Phase II TCR candidate GSK3377794, which targets the NY-ESO-1 antigen found in many cancer types. The therapy is in Phase II in sarcoma and earlier-stage clinical work in ovarian cancer, melanoma, multiple myeloma and non-small cell lung cancer.
Avacta And ADC Therapeutics Partner On Multiple ADCs
Avacta Group PLC announced on 10 October that it will collaborate with ADC Therapeutics SARL on the development of antibody-drug conjugates (ADCs) for the treatment of blood cancers and solid tumors. It’s the latest deal by Avacta, which also is collaborating with Moderna Inc. and LG Chem . (Also see "Asia Deal Watch: Takeda, Eisai Team With Non-Profit On Review Of Novel Targets For Antibiotics" - Scrip, 12 Dec, 2018.)
UK-based Avacta will develop Affimers – its proprietary non-antibody binding protein candidates – against three undisclosed cancer targets. ADC will use them to target its pyrrolobenzodiazepine (PBD) cytotoxic warheads to cancer cells. ADC will pay Avacta’s costs during the collaboration, for which the Swiss company will get options to exclusively license the ADCs for clinical development and commercialization.
Avacta will receive option fees, development and commercialization milestones, and single-digit royalty on sales if the ADCs reach the market. The biotech also is developing its own pipeline of therapeutic candidates, with a targeted doxorubicin expected to enter clinical studies in the second quarter of 2020. Its first Affimer-based PD-L1 antagonist immune-oncologic is expected to enter the clinic in the four quarter of 2020.
ADC announced at the start of October it was withdrawing its US initial public offering registration statement, citing adverse market conditions, while adding that it had a strong balance sheet, highly supportive investors, alternative financing options and a steady flow of forthcoming milestones. (Also see "IPO Update: 35 Biopharmas Provide -6.1% Average Return; New Offerings Feel Stock Market Impact" - Scrip, 2 Oct, 2019.)
Reata Unwinds AbbVie Partnership, Regains Bardoxolone Rights
As the regulatory picture for diabetic kidney disease candidate bardoxolone improves, Reata Pharmaceuticals Inc. has regained rights to the compound outside of Asia from AbbVie Inc., which inherited rights licensed for $450m up front by predecessor company Abbott Laboratories Inc. in 2010. [See Deal] Reata will pay AbbVie $330m in installments, with $75m up front, for non-Asian rights to bardoxolone, omaveloxelone and other next-generation Nrf2 activators covered by the 2010 deal.
In addition to the initial payment, Reata will pay AbbVie installments in the second quarter of 2020 and the fourth quarter of 2021 to fulfill the agreement. The pharma also can earn low, tiered, single-digit royalties on global sales of omaveloxelone and the second-generation candidates, should they reach market. There are no earn-outs tied to bardoxolone for AbbVie.
Excluded from the agreement are rights to bardoxolone out-licensed by Reata to Kyowa Hakko Kirin Co. Ltd. in 2010, covering Japan, China, South Korea, Taiwan and other southeast Asian markets. Reata realized a $30m milestone under that agreement in August 2018 when bardoxolone entered a Phase III trial in Japan. (Also see "Pay Day For Reata As Bardoxolone Progresses For Kidney Disease In Japan " - Scrip, 31 Aug, 2018.)
In February, Reata reported that the drug demonstrated kidney benefit in a fourth CKD indication in the Phase II proof-of-concept PHOENIX study, potentially putting bardoxolone on track to approval after years of setbacks. (Also see "Reata Expands Options For Bardoxolone With New CKD Data" - Scrip, 20 Feb, 2019.) The antioxidant inflammation modulator (AIM) is in Phase III for polycystic kidney disease and pulmonary arterial hypertension.
Reata said it is actively preparing for commercial launch of bardoxolone in the US, as well as omaveloxelone in Friedrich’s ataxia, and will now start considering ex-US commercial activities.
Alexion, Stealth Partner On Mitochondrial Myopathy Candidate
Alexion Pharmaceuticals Inc. and Stealth BioTherapeutics Corp. revealed an option agreement on 10 October, giving Alexion option rights to co-develop and commercialize a Phase III candidate for primary mitochondrial myopathy, an unmet medical need in the US. The upfront payment to Stealth for rights to elamipretide includes $30m to cover development funding, an equity investment and the option rights.
Positive Phase II results for the first-in-class mitochondria-targeted therapeutic were reported at the United Mitochondrial Disease Foundation meeting in 2016, and the Boston-based company said it was preparing to advance elamipretide into Phase III. (Also see "Stealth BioTherapeutics Looks Ahead To Phase III In Mitochondrial Disease" - Scrip, 20 Jun, 2016.) Alexion’s option rights hinge on the outcome of an ongoing Phase III study of a subcutaneous formulation. If Alexion opts in, the companies also plan to study the drug in Barth syndrome and Leber’s hereditary optic neuropathy (LHON).
Neumentum Adds To Pain Portfolio With Janssen Mid-Stage Molecule
Focused on developing novel pain medications that avoid the abuse and misuse problems common for opioid analgesics, Neumentum Inc. doubled its clinical pipeline on 10 October by licensing worldwide rights to Phase II non-opioid candidate JNJ-10452032 from [Janssen Biotech NV]. No terms were disclosed for the deal, which also includes rights to backup compounds.
The candidate has completed Phase IIa clinical studies in moderate to moderately severe pain. Its mechanism of action is undisclosed – Neumentum said only that it is neither an opioid nor an NSAID. The Palo Alto, CA-based company also has NTM-001, an alcohol-free infusion formulation of ketorolac in Phase I for pain indications. Neumentum said its goal is to offer both intravenous and oral non-opioid analgesic products for acute pain relief in hospital and community settings.
Merck, 4D Collaborate On Microbiome Live Therapeutics
Merck & Co. Inc. and live biotherapeutic-focused 4D pharma PLC revealed on 8 October that they’ll partner to develop novel vaccines for up to three undisclosed indications, combining the UK biotech’s MicroRx platform with the pharma’s expertise in developing and commercializing vaccines.
4D receives undisclosed upfront cash under the agreement, can compel Merck to buy up to a $5m equity stake in itself during the first 12 months of the agreement, and can earn up to $347.5m in option fees and development and regulatory milestone payments under the deal. The biotech also could realize tiered royalties on annual net sales of any product reaching the market from the tie-up. Merck would get full development, manufacturing and commercial rights upon electing its option on any the programs.
Busy Currax Acquires Nalpropion, Licenses Migraine Drug
Currax Pharmaceuticals LLC completed a pair of deals in late September, acquiring 2018 start-up Nalpropion Pharmaceuticals Inc. on 27 September. Through the transaction, it gained worldwide rights to Nalpropion's sole product, the US Food and Drug Administration-approved Contrave (bupropion/naltrexone; sold in the EU as Mysimba) weight-loss medication.
Two days earlier, Currax obtained exclusive North American marketing rights to OptiNose Inc.’s Onzetra Xsail (sumatriptan) dry-powder formulation acute migraine treatment.
Currax's predecessor company Pernix (acquired by Currax after it filed for bankruptcy in February 2019) 201930234 already owned a 10% stake in Nalpropion, which was formed by Pernix in April 2018 as a special purpose vehicle to acquire the assets (mainly Contrave (NB32)) of the now-defunct Orexigen Therapeutics Inc., after Orexigen itself filed for Chapter 11 in March 2018. [See Deal]
Contrave was approved in 2014 for adult patients with a body mass index between 27 or greater (overweight) and 30 or greater (obese) who have at least one weight-related condition such as high blood pressure (hypertension), Type 2 diabetes or high cholesterol (dyslipidemia). (Also see "The Skinny On Labeling For Orexigen’s Contrave" - Pink Sheet, 11 Sep, 2014.)
In addition to Contrave and Onzetra, Currax now also has from Pernix’s portfolio Zohydro (hydrocodone bitartrate) for pain (acquired from Zogenix Inc. in 2015) [See Deal]; Silenor (doxepin hydrochloride) for insomnia (from its 2012 acquisition of Somaxon Pharmaceuticals Inc.) [See Deal]; and Treximet (naproxen sodium/sumatriptan) for migraine, gained from GSK under a 2014 deal. [See Deal]
Under its licensing deal with OptiNose, Currax will pay $4.48m up front ($750k of which will be held in escrow), a $1m regulatory milestone, plus a one-time 10% royalty on net sales in excess of $3m during calendar year 2020.
FDA-approved in 2016, Onzetra Xsail is administered via OptiNose's breath-powered powder exhalation delivery system (EDS), which consists of a reusable device with a flexible and adjustable-fit mouthpiece with an assembly to pierce the medication capsule. (Also see "Keeping Track: Telework Kept FDA On Track During Blizzard" - Pink Sheet, 1 Feb, 2016.) Currax also has a license to certain patent rights to the EDS.
Stay tuned for the next issue 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 "UCB To Buy Ra for $2.1bn And Plays Down Antitrust Fears" - Scrip, 10 Oct, 2019.) |
The deal, welcomed by analysts, means that the Belgian drug maker has two late-stage products for the rare disease myasthenia gravis to challenge Alexion's Soliris. |
|
(Also see "Novo Anticipates Q4 Soft Launch For Closely Watched Oral GLP-1 Agent Rybelsus In The US" - Scrip, 20 Sep, 2019.) |
Pfizer Inc. agreed to pay $250m up front for worldwide rights to a Phase II drug that could target a broad population in cardiovascular disease. Scrip talked to Pfizer's head of internal medicine research about it. |