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Venture Funding Deals: Takeda Ups Its Bet On Immuno-Oncology Play Maverick

Executive Summary

Biscayne and Japanese CRO SNBL create spin-outs to advance programs; liver disease specialist Ascletis gains funds as it shifts away from HCV; Neon gets $100m to put into its cancer vaccines; and other highlights of recent VC funding.

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Venture Funding Deals column provides a comprehensive monthly review of emerging biopharmaceutical companies that have received venture funding. This month’s column covers deals announced in December 2016 and January 2017.

Allinaire Gets Undisclosed Funds In First Financing Round

Allinaire Therapeutics LLC received significant, but undisclosed, Series A funding from BioCrossroads' Indiana Seed Fund II, BioMotiv, and Indiana University's Innovate Indiana Fund. (Jan.)

The company was recently launched and is based on discoveries by Matthias Clauss at Indiana University School of Medicine and Irina Petrache at National Jewish Health. Clauss and Petrache are scientific founders of Allinaire and found that symptoms of chronic obstructive pulmonary disease and AAT deficiency can be alleviated by reducing the activity of certain secreted proteins. The company plans to use the proceeds to develop therapies for AAT deficiency, COPD, and other respiratory disorders including acute lung injury.

Ascentage Pharma Closes $72m Series B Round

Ascentage Pharma Group Corp. Ltd. raised $72m through its Series B round from Future Industry Investment Fund (the lead investor; managed by SDIC), new buyers Shiyu Capital, Hidragon Capital, and Founder KIP Capital, and returning backers Yuanming Capital, Oriza Venture Fund, and Efung Capital. It was advised by China Renaissance. Proceeds will support development activities for apoptosis-targeted small molecule therapeutics for cancer. The company recently announced IND approval of its APG1252, a Bcl-2/Bcl-XL inhibitor for cancers including small-cell lung. (Jan.)

Ascletis Raises $100m In Series B Round

Ascletis Inc. raised $100m in its Series B financing led by C-Bridge Capital, which was joined other Series A backers Goldman Sachs and Tasly Pharmaceutical and new investors including QianHai Equity Investment FOF, FOCUS Media Jiangnanchun Foundation, and WTT Investment. The company plans to use the funds for ongoing pipeline development and sales force expansion. Ascletis has been focusing on therapies for hepatitis C but now plans to move into hepatitis B and other liver diseases. (Jan.)

Biscayne Neurotherapeutics Spins Out Of Biscayne Pharmaceuticals

Biscayne Pharmaceuticals Inc. is spinning out Biscayne NeuroTherapeutics Inc. (BNT) to advance the former's Phase I epilepsy compound BIS001. BNT concurrently completed a $3m Series B round co-led by Quark Venture and GF Securities, which together invested $1.6m through the Global Health Sciences Fund; each also added a member to the new company's board. Mesa Verde Venture Partners, other existing Biscayne Pharmaceuticals backers and new private investors also participated. (Jan.)

Predecessor company Biscayne Pharmaceuticals was founded in 2013 with growth hormone-releasing hormone (GHRH) agonist cardiology and GHRH antagonist oncology programs licensed from the University of Miami. It gained BIS001 and related technology when it merged with Insero Health in 2015. (Insero initially acquired the IP behind BIS001 in 2012 from Harvard University, where it was discovered by Steven Schachter.) BNT's takeover of the development of BIS001 will enable Biscayne Pharmaceuticals to work on its GHRH programs. A synthetic extract of a traditional Chinese medicine huperzine A, a well-known cognitive disorder treatment, BIS001 is an acetylcholinesterase (AChE) inhibitor that offers high penetration of the brain. BNT will develop BIS001 for children with the genetic seizure disorder Dravet syndrome and adults with refractory complex partial seizures (CPS). Refractory epilepsy is a drug-resistant form of the disorder, not controlled with seizure medications. Preclinical studies demonstrated the compound's efficacy in eliminating seizures in animal models of CPS and a Phase I trial in drug-resistant epilepsy patients showed BIS001 to be safe. BNT will use the proceeds of the Series B round to run a Phase Ib proof-of-concept trial for an extended-release formulation of BIS001 in refractory complex partial epilepsy. The trial is expected to begin mid-year and if successful, the company hopes to proceed with a Phase IIa trial next year and to continue BIS001's development in hard-to-treat epilepsies.

Series A Lands $40m For CiVi

CiVi Biopharma Inc. raised $40m in its Series A financing to Tavistock Life Sciences' Boxer Capital. (Jan.)

The company will use some the funds to finish preclinical and early Phase I trials of its PCSK9 inhibitor, which it concurrently licensed from Hoffmann-La Roche. The candidate is based on Roche's locked nucleic acid technology and is expected to enter the clinic later this year. Other money will support in-licensing of additional therapies aimed at cardiometabolic diseases. CiVi was founded in 2016.

Cue Biopharma Raises $16.4m Through Series A Round

Immunotherapy start-up Cue Biopharma Inc. raised $16.4m through its Series A round. MDB Capital led and was joined by over 100 additional investors, according to a Form D filing. (Jan.)

Formerly known as Imagen Biopharma, Cue is developing therapeutics designed to modulate disease-relevant T-cell subsets and control immune response in patients with cancers and autoimmune diseases. Using technology developed by Albert Einstein College of Medicine’s Steven Almo (also a scientific founder of Cue), Cue’s work focuses on generating a specific immune response from disease-relevant T-cells without activating T-cells not involved in the targeted condition. Lead candidates are CUE101 for HPV-related cancers (cervical, head and neck, and anal) and CUE102 (melanoma, synovial sarcoma, prostate, and head and neck tumors). The company previously raised $10m through a seed round in 2015, the year it was founded.

EndoCeutics Secures $85m Venture Debt Facility

Private Canadian biotech EndoCeutics Inc., a division of EndoResearch Inc. mostly focused on therapies for women's health and sexual dysfunction, secured from CRG LP an $85m senior credit facility, which it will use to fund the commercialization of Intrarosa (prasterone) and additional R&D for its pipeline candidates. Intrarosa (formerly known as Vaginorm) received FDA approval in November 2016 for postmenopausal dyspareunia (moderate-severe pain during sexual intercourse, a symptom of vulvovaginal atrophy due to menopause); EndoCeutics licensed worldwide rights to Bayer under a 2010 agreement. The company also has five Phase III candidates, including Femivia – a prasterone/acolbifene combination hormone replacement therapy for vaginal atrophy and menopause symptoms, including osteoporosis – and two Phase I/II anti-androgen compounds for prostate cancer. It was advised by Evolution Life Science Partners. (Jan.)

Eternygen Raises €8m In Series A Round; Includes Investment From Partner Evotec

Metabolic disease-focusedEternygen GMBH raised €8m ($8.3m) in its Series A financing round led by Epidarex Capital, along with VC Founds Technologie (managed by IBB Beteiligungsgesellschaft), and two family offices. The round also includes participation from partner Evotec AG. (Jan.)

Eternygen and Evotec originally allied under a May 2014 collaboration to develop small molecule inhibitors for metabolic diseases. Eternygen will put the funds toward selecting a lead preclinical program. Founded in 2012, the company is focused on the sodium-coupled citrate transporter, a target that is a key regulator of energy metabolism involved in nonalcoholic fatty liver disease, nonalcoholic steatohepatitis (NASH), diabetes and obesity.

Evotec Launches Fibrocor, Gets Funding From Mars Innovation

Evotec AG is launching fibrotic disease-focused firm Fibrocor Therapeutics LP, which is concurrently raising $Cdn2.8m ($2.1m) from MaRS Innovation. (Jan.)

Evotec will help conduct drug discovery activities for the start-up and receives an equity stake in the company. Fibrocor's technology is based on work done at St. Michael Hospital and Mount Sinai Hospital. The firm seeks to identify targets and molecular pathways from a tissue bank of diseased and non-diseased individuals in an effort to create therapies that can prevent, slow, and even reverse the course of fibrosis. It also plans to expand access to tissue samples including those of the lung, liver, kidney, colon and skin. Fibrocor has identified a lead program and in partnership with Evotec it expects to select a candidate for development in 2018.

Series C Brings In $43m For Frontier Biotech

Frontier Biotechnologies Inc. raised $43m in a Series C financing led by Chinese RMB fund Huaxin Century Investment Group, which was joined by Shenzhen Capital and Efung Capital. (Jan.)

The company's lead compound is albuvirtide, which received an NDA in China in July 2016. Should albuvirtide receive approval it would be the first available long-acting HIV drug worldwide. Frontier Biotech is also developing a patch for treating musculoskeletal pain. The firm was founded in 2002.

Ironshore Pharmaceuticals Completes $200m Debt Round

Through a private placement, Highland Therapeutics Inc. subsidiary Ironshore Pharmaceuticals & Development Inc. sold $200m of senior secured notes due 2024. Morgan Stanley was the placement agent. (Jan.)

Ironshore was formed to manufacture, develop, and commercialize Highland's lead attention-deficit/hyperactivity disorder (ADHD) candidates – HLD200 (also known as Benjorna) and HLD100 – and explore additional pipeline opportunities. HLD200 is a next-generation oral formulation of methylphenidate, which uses the company's delayed-release and extended-release DELEXIS delivery technology to enable night-time dosing of patients, to eliminate impaired early-morning functioning and achieve greater control over ADHD symptoms. Following two successful pivotal Phase III studies completed in 2016, the FDA accepted the company's NDA filing in December 2016 and the expected action date is July 30.

Ironshore's HLD100 (amphetamine), which also uses the DELEXIS platform, is in Phase II and also intended for once-daily evening dosing to control symptoms of ADHD upon awakening and throughout the day. Pivotal Phase III trials are expected to begin sometime this year. The company will use the proceeds from the financing to help it transition from an R&D operation to a true pharmaceutical company (hiring medical affairs personnel) and to fund pre-commercialization and commercial launch activities for HLD200.

Jupiter Orphan Therapeutics Raises $2.5m In Debt And Equity

Orphan disease specialist Jupiter Orphan Therapeutics Inc. secured $2m through a convertible note financing from Tarnagulla Ventures. The company received $1m immediately with the remaining $1m expected when certain milestones are met. Natalie McNamee of Tarnagulla joined the company's board. Jupiter simultaneously raised $500,000 in an equity financing from a charity-based financing group. (Jan.)

Founded in 2015, Jupiter is a specialty pharmaceutical company developing products for rare diseases linked to single gene deficiencies. The company had a pipeline of five candidates in varying phases of development. The two most advanced are JOT101 for Friedrich's Ataxia (currently in Phase II) and JOT106 for Alzheimer's Disease (also in Phase II). Jupiter is also developing JOT102 for MPS, JOT104 for pancreatic cancer, and JOT105 for Machado-Joseph's Disease. The company has developed a unique formula of resveratrol (JOTROL), a dietary polyphenol in grapes, red wine, berries, and nuts.

Matrisys Brings In $1.5m Via Debt Round From Tech Coast Angels

The microbiome therapeutics start-up MatriSys Bioscience Inc., which is focusing on dermatologic indications, raised $1.5m through a convertible note financing round led by Tech Coast Angels, which contributes a member to the MatriSys board. (Jan.)

The company's live biologic therapeutics (LBTs) platform is derived from skin microbiome research conducted by the University of California, San Diego's Richard Gallo, who discovered that increasing the beneficial bacteria on the skin, while simultaneously and selectively eliminating the damaging microbes, rebalances the bacterial species present on the skin to normal and healthy levels. MatriSys, which was founded last year, has applied the technology licensed from UCSD to its LBT pipeline, which includes lead candidate MSB01, in Phase I/II trials for atopic dermatitis/eczema. MSB01 uses the good bacteria S. hominis Sh-A9 against the harmful S. aureus bug (known to play a role in eczema), destroying the harmful pathogens without affecting the beneficial microbes.

It also has preclinical MSB02 for bacterial skin infections and MSB03 in preclinical studies for psoriasis and Netherton syndrome (a rare hereditary disorder characterized by red, scaly, and itchy skin, fragile hair, and inability to regulate body temperature), and in Phase I for rosacea under the 505(b)(2) pathway. The company plans to pursue additional candidates in topical prescription dermatology therapeutics, cosmetics, and skin care. MatriSys will use the proceeds of this financing to further the current clinical trials of MSB01, continue preclinical work, and to pursue additional pipeline programs in other dermatology indications, including acne.

Maverick Therapeutics Brings In $23m Through Series B Round

Maverick Therapeutics Inc. raised $23m through its Series B round from founding investor MPM BioVentures 2014, UBS Oncology Impact Fund, and Takeda Pharmaceutical Co. Ltd. (Jan.)

Maverick spun out of Harpoon Therapeutics last year and is now using a T-cell engagement platform to improve the utility of T-cell redirection therapy as a method of treating cancer. The approach, which allows for antibodies to become fully active once they are in the tumor microenvironment, is designed to eliminate toxicity challenges normally encountered with T-cell redirection. Maverick announced the Series B in conjunction with details on its new relationship with Takeda. In addition to taking part in the funding round, Takeda (through its Takeda Oncology unit) and Maverick signed a five-year R&D deal surrounding T-cell redirection cancer therapies; at the end of the five years, Takeda can exercise an exclusive option to acquire Maverick. Through the alliance and its participation in the Series B, Takeda is investing about $125m in Maverick, not including any money payable should it take the M&A option.

Microbion Receives $25m In Undisclosed Round

Quark Venture and GF Securities invested $25m in Microbion Corp., a start-up aiming to treat antibiotic-resistant infections, in an undisclosed financing round. (Jan.)

The company will use the money to initiate and complete a Phase Ib/IIa trial in diabetic foot ulcer infections, including eradication of infections and of biofilms; to continue a Phase IIa trial in orthopedic infections; and to further development of an inhaled formulation of MBN101 for cystic fibrosis-related infections. Founded in 1982, Microbion recently received a fast-track designation in the adjunctive treatment of moderate to severe diabetic foot ulcers for MBN101, which the company also partnered with Haisco earlier in 2016; Haisco received rights to develop and sell MBN101 in China and related territories.

Neon Therapeutics Raises $70m In Series B Financing

Neon Therapeutics raised $70mm in its Series B financing round led by Partner Fund Management. Returning backers Third Rock Ventures and Access Industries joined new investors Fidelity Management & Research, Wellington Management Company, Inbio Ventures, and Nextech Invest. The immuno-oncology company will use the funds toward its lead program NEOPV01, a fully personalized neoantigen vaccine currently in Phase Ib trials; for preclinical development of NEOPTC01, a personalized adoptive T-cell program; and for the Shared Neoantigen Program. Neon has raised $125m to date through its A and B rounds. (Jan.)

NeRRe Therapeutics Raises $29m In Series B Round

NeRRe Therapeutics Ltd., which focuses on NK receptor antagonists for conditions caused by neuronal hypersensitivity, raised $28.5m (£23m) in its Series B financing round. New investors Fountain Healthcare Partners, Forbion Capital Partners, and OrbiMed were joined by returning backers Advent Life Sciences and Novo A/S. Fountain Healthcare and Forbion Capital both received board seats. The company will use the funds to generate Phase II data on orvepitant, its lead oral NK-1 antagonist for a common chronic respiratory condition and to further NT814, a dual NK-1,3 antagonist in Phase II trials for non-hormonal treatment of distressing post-menopausal vasomotor symptoms. A 2012 spin-off of GSK, NeRRE previously raised £11.5m in its Series A round. (Jan.)

OncoImmune Closes $15m Series A Round

Immunotherapies firm OncoImmune Inc. raised $15mm through its Series A round from lead investor 3E Bioventures Capital and other undisclosed buyers. (Jan.)

OncoImmune was formed in 2000 and is now preparing its lead candidate CD24Fc for Phase II clinical trials. The compound targets the CD24-Siglec pathway, which regulates inflammatory responses to tissue injuries and is involved in the development of cancers, autoimmune diseases, and graft-vs-host disease (GvHD). CD24Fc is being studied for the prevention of GvHD in patients who have undergone myeloablative allogenic hematopoietic stem cell transplant. Series A proceeds will fund the Phase II trial, and will also be used to support other development activities.

Phasebio Gets $14.7m From Convertible Debt Sale

PhaseBio Pharmaceuticals Inc. raised $14.7m through the sale of convertible notes to returning shareholders New Enterprise Associates, AstraZeneca, Johnson & Johnson Development Corp., Hatteras Venture Partners, Fletcher Spaght Ventures, and Syno Capital. The company can opt to increase financing by up to $2.75m from additional investors. PhaseBio will use the proceeds for ongoing development of its lead compound PB1046, a once-weekly vasoactive intestinal peptide receptor agonist in Phase II for pulmonary arterial hypertension. Some money will also support additional pipeline development; the company is working on biopolymer-based therapies for cardiopulmonary disorders. (Jan.)

Pionyr Immunotherapeutics Raises $8m Through Series A-1 Round

Oncology start-up Pionyr Immunotherapeutics Inc. raised $8m through its Series A-1 round. OrbiMed and SV Life Sciences co-led and were joined by Osage University Partners, Mission Bay Ventures, private angel backers, and individual investors. (Jan.)

Pionyr was formed in 2015 as Precision Immune and is developing antibody-based therapies for cancer using its Myeloid Tuning technology. The platform and Pionyr’s work focus on altering the tumor microenvironment to put more emphasis on immune-activating cells instead of immune-suppressing cells, an action that the company believes will provide a new way of fighting cancer, especially when used in combination with checkpoint inhibitors. Company founders and executives have strong immune-oncology experience, with histories at firms including Labrys Biologics (acquired by Teva), Kai Pharmaceuticals (bought by Amgen), Gilead, Merck, and Schering-Plough. Pionyr has now raised $10m since its inception.

Prolacta Mezzanine Round Brings In $35m

Prolacta Bioscience Inc. raised $35mm in a mezzanine financing round led by new investor Essex Woodlands, which contributed a board member. Other participants included new backer Aisling Capital, returning shareholder Health Evolution Partners, and an undisclosed investor. The proceeds will enable the company, which was founded in 1999, to expand its commercial presence in Europe, fund clinical trials for its human milk-based nutraceutical products in additional indications, and further development of its human milk oligosaccharides in various microbiome-related diseases. (Dec.)

Satsuma Pharmaceuticals Spins Out Of SNBL, Raises $12.3m Series A Round

New San Francisco-based company Satsuma Pharmaceuticals Inc. was recently spun out of Japanese CRO Shin Nippon Biomedical Laboratories Ltd. (SNBL) to focus on migraine therapeutics and concurrently brought in $12.3m through a Series A round co-led by RA Capital Management and TPG Biotech, which both added members to the new company's board. One other investor joined the round, according to the Form D. (Jan.)

Satsuma was formed to expand SNBL's translational research business and will take over development of preclinical STS101 (dihydroergotamine (DHE)) for acute migraine. The start-up has an exclusive license to SNBL's technology, which creates a dry-powder formulation of DHE enclosed in a muco-adhesive carrier and administered using a nasal delivery device. The platform enables the drug's quick absorption, high bioavailability, and rapid onset of action. DHE is already available as a well-tolerated migraine treatment, but not yet in a fast-acting formulation. Satsuma will use the financing proceeds to begin clinical trials for STS101. As a CRO, SNBL will support the candidate's development. SNBL had originally licensed exclusive worldwide rights to the compound (then known as TO2070) and related technology to Transcept Pharmaceuticals in 2013, but the collaboration was terminated when Transcept merged with Paratek Pharmaceuticals the following year.

Drug Delivery Company scPharmaceuticals Raises $45.6m In Series B

Subcutaneous drug delivery firm scPharmaceuticals Inc. raised $45.6m in its Series B financing round co-led by OrbiMed and a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. Returning backers 5AM Ventures and Lundbeckfond Venture also participated. ScPharmaceuticals has now raised over $60m to date through its A and B rounds. The company will use the proceeds for the development of the operational and commercial infrastructure needed to bring Furoscix, a diuretic for treatment of heart failure, and sc2Wear Infusor, a patch pump device that facilitates subcutaneous drug administration, to market in the US, and toward further development of antibiotic products in its pipeline. (Jan.)

Suzhou Connect Biopharmaceuticals Raises $20m Through Series A Round

Suzhou Connect Biopharmaceuticals Ltd., which is working on treatments for autoimmune and inflammatory diseases, raised $20m through its Series A round. Qiming Venture Partners led (and takes a board seat) and was joined by Northern Light Venture Capital, Lapam Capital, and Cowin Venture Capital. (Jan.)

Connect will use the proceeds to continue development of its drug candidates, specifically an upcoming Phase II trial with lead compound CBP307, an S1P1 agonist for inflammatory bowel disease, and IND-enabling/Phase I trials with CBP201, a monoclonal antibody for atopic dermatitis and asthma. The company is also developing CBP174, a GPCR inhibitor in preclinical studies for allergic rhinitis and atopic dermatitis that it in-licensed from Arena Pharmaceuticals in 2012. Connect previously raised $5m from Cowin, Anlongmed Fund, and XinYue Equity through what the company terms a “Pre-A round.”

Genome Engineering Biotech Synthego Raises $41m In Series B

Synthego Corp. raised $41m in its Series B financing round led by technology venture firm 8VC. New investors AME Cloud Ventures, Elements Capital, OS Fund, Alexandria Equities, ZhenFund, and individuals Jennifer Doudna and Jamie H. Doudna Cate joined returning backers Founders Fund, Menlo Ventures, WI Harper Group, and SciFi VC. (Jan.)

Synthego will use the proceeds to grow its commercial operations, expand internationally, and introduce new products. The company has now raised $50m to date since its inception in 2012. Synthego's flagship product, CRISPRevolution, is a portfolio of synthetic RNA designed for CRISPR genome editing and research. The company seeks to bring precision and automation to genome engineering, which will enable rapid and cost-effective research.

Vaccines Company Vaccibody Raises $26m In Private Financing

Vaccibody AS grossed $26.4mm (NOK220mm) in what appears to be its fourth financing round through the sale of 880k shares at NOK250 to undisclosed investors. (Dec.)

The company will use the proceeds to fund its early stage clinical development for personalized cancer neoantigen vaccines; it currently has two Phase I trials underway. Vaccibody's first candidate, VB10.16, is targeted to treat HPV16-induced precancerous cervical lesions. The company's vaccine technology is made up of three modules (targeting module, dimerization module, and antigen module) and the vaccines can be delivered as DNA, RNA or protein.

Vir Launches And Gets Over $150m In Funding

Vir Biotechnology Inc. has launched and is raising more than $150m in Series A money. Lead investors were Arch Venture Partners, which itself committed $150m, and the Bill & Melinda Gates Foundation, as well as sovereign wealth funds, public mutual funds, and individuals and family offices. (Jan.)

Arch's Robert Nelsen founded Vir and will join the company's board along with another Arch representative. The start-up will be headed up by former Biogen CEO George Scangos. (Also see "VC Roundup: Infectious Disease Startup Snags $150m And Former Biogen CEO Scangos" - Scrip, 8 Jan, 2017.) Vir is focused on using immune programing to manipulate pathogen-host interactions and create cures, therapies, and preventive medicine for infectious diseases. The company will use the proceeds for targeted academic research, in-house R&D activities, and in-licensing opportunities. Vir is taking on a broad technological portfolio, including the viral vectors obtained through the acquisition of TomegaVax. The IP originated at Oregon Health & Science University.

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