Deals

May 4 Quick Takes: Oxford Nanopore raises £195M ahead of planned IPO; plus Pfizer, Oculis, MoonLake, Aceragen, Yarrow-ProQR, BioLineRx and more

Sequencing company Oxford Nanopore Technologies Ltd. is preparing for a potential IPO after raising £195 million ($269.8 million) in a crossover round. New investors Temasek, Wellington Management, M&G Investments and Nikon contributed £125 million, while the remainder came from existing investors. That includes IP Group plc (LSE:IPO), which holds a 14.5% stake at a valuation of £359 million, giving Oxford Nanopore an implied postmoney valuation of about £2.5 billion. Earlier this year the company said it was planning to go public via an IPO on the London Stock Exchange in 2H21. The company has raised at least $831.3 million across 15 financings since it was founded in 2005.

ACIP calendar hints Comirnaty could get green light for kids next week

A scheduled emergency meeting of CDC’s Advisory Committee on Immunization Practices (ACIP) on May 12 could signal authorization of Comirnaty COVID-19 vaccine from  Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) in children ages 12-15 is imminent. 

Pfizer to test Comirnaty booster-pneumococcus vaccine combo

With an FDA decision on its 20-valent pneumococcus vaccine (20vPnC) due next month and plans to submit a BLA this month for COVID vaccine Comirnaty, Pfizer announced in its 1Q21 earnings a study on co-administration of the two vaccines. Safety and immunogenicity data for the combination are expected next quarter and could inform ACIP recommendations on co-delivering Comirnaty (BNT162b2) with 20vPnC or Prevnar 13. The pharma, which anticipates COVID-19 vaccine boosters may be needed, said co-administration of the vaccines to adults could receive emergency use authorization as early as this fall.

The pharma also raised its guidance on 2021 sales of Comirnaty, which BioNTech SE (NASDAQ:BNTX) co-developed, to $26 billion from $15 million based on 1.6 billion doses expected to be delivered this year under contracts signed as of mid-April.

Delay for Pfizer’s registrational study of BCMA bispecific

Three cases of peripheral neuropathy in the Phase I MagnetisMM-1 trial of elranatamab (PF-06863135) are delaying the progression of Pfizer’s registration-enabling Phase II MagnetisMM-3 study of the CD3- and BCMA-targeting bispecific antibody to treat relapsed/refractory multiple myeloma. The pharma, which disclosed the safety events in the 1Q21 earnings report, said enrollment in the Phase II study has been paused but that patients receiving clinical benefit from elranatamab may continue treatment.

Oculis raises $57M series C round

Swiss biotech Oculis S.A. raised $57 million in a series C round to advance its topical ophthalmic programs into late-stage testing, including a Phase III trial for lead molecule OCS-01 for diabetic macular edema (DME). The financing was co-led by new investors BVCF Management and Hyfinity Investments. Other new investors included VI Partners and Wille AG, while existing investors Bay City Capital, Brunnur Ventures, EarlyBird, Tekla Capital Management, Pivotal bioVenture Partners, Nan Fung Life Sciences, Novartis Venture Fund, Silfurberg and other existing investors also participated.

MoonLake launches with IL-17 Nanobody

Merck KGaA (Xetra:MRK) teamed up with BVF Partners to launch spinout MoonLake Immunotherapeutics AG. The newco licensed worldwide rights to sonelokinab from Merck, an IL-17A/F targeted Nanobody that the German pharma gained through a 2013 deal with Ablynx N.V., which is now a part of Sanofi (Euronext:SAN; NASDAQ:SNY). Last month data from a Phase IIb trial published in The Lancet showed the trispecific Nanobody met the primary and secondary endpoints vs. placebo in the treatment of psoriasis. MoonLake said it plans to start multiple Phase II trials in IL-17-driven indications such as psoriatic arthritis, ankylosing spondylitis and hidradenitis suppurativa. BVF and Merck were both investors in MoonLake’s series A round.

Aceragen debuts to tackle rare lipid storage disease

Aceragen Inc. launched with $35 million from NovaQuest Capital Management and worldwide rights to an enzyme replacement therapy from Enzyvant Sciences GmbH for acid ceramidase deficiency presenting as Farber disease. Enzyvant, a subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506), will receive an undisclosed upfront payment and is eligible for $226 million in development and sales milestones, plus tiered royalties. ACG-801 (formerly  RVT-801) is a form of recombinant human acid ceramidase (rhAC) designed to address the genetic deficiency of the enzyme that causes Farber disease, an inherited lipid storage disease in which excess fat builds up in the joints, tissues and CNS, and spinal muscular atrophy with progressive myoclonic epilepsy.

RWT newco Yarrow gains antisense program via ProQR deal

A licensing deal with ProQR Therapeutics N.V. (NASDAQ:PRQR) gives Yarrow Biotechnology Inc. its start in antisense oligonucleotides, but the newly launched company also has a target screening platform to identify potential first-in-class antisense candidates in-house. ProQR licensed an antisense oligonucleotide against an undisclosed target that falls outside its ophthalmic area of focus to Yarrow, which was created and backed with undisclosed funding by RTW Investments. ProQR will receive $115 million in upfront and milestone payments plus undisclosed equity and single-digit royalties.

BioLineRx gains on Phase III evidence of stem cell mobilization

After 18 years in drug development, BioLineRx Ltd. (NASDAQ:BLRX; Tel Aviv:BLRX) takes one step closer to the market with Phase III top-line data for lead candidate motixafortide in hematopoietic stem cell mobilization for autologous bone marrow transplant. The CXCR4 antagonist plus G-CSF met the primary endpoint in the 112 patient GENESIS study, leading to a 4.9-fold increase in the proportion of patients who mobilized at least 6 million CD34+ cells in two apheresis sessions over G-CSF alone (70% vs. 14.3%). The company plans to submit an NDA in 1H22 for stem cell transplant in multiple myeloma patients.

Cumulus raises £6M to apply remote trial monitoring tech to CNS disorders

With a £6 million investment led by the Dementia Discovery Fund (DDF), Cumulus Neuroscience is planning to advance remote trial monitoring in neurological diseases. The company is using mobile device-based data collection, a headset that captures EEG signals and AI-based analytics to monitor CNS treatment outcomes. The LifeArc medical research charity and the UK Future Fund also participated in the financing.

Daiichi adds territories for Esperion’s bempedoic therapies 

Esperion Therapeutics Inc. (NASDAQ:ESPR) hopes an expanded deal with Daiichi Sankyo Co. Ltd. (Tokyo:4568) will boost expanded the global footprint and revenues of bempedoic acid and bempedoic acid/ezetimibe combination tablet; the therapies posted U.S. sales of $6.4 million in 1Q21. Daiichi, which held European rights to the cholesterol drug, adds rights in Brazil, Macao, South Korea, Taiwan and four Southeast Asian countries, while Esperion gains $30 million in cash upfront and a potential $175 million in sales milestones, plus royalties of 5-20%. Esperion is now eligible for $1.1 billion in milestones. Esperion markets the therapy in the U.S. as Nexletol and the combination therapy as Nexlizet.

TARGETS
BCMA (TNFRSF17; CD269) – Tumor necrosis factor receptor superfamily member 17
CXCR4 (NPY3R) –CXC chemokine receptor 4
G-CSF (CSF3) –Granulocyte colony-stimulating factor
IL-17A – Interleukin-17A
IL-17F – Interleukin-17F