Life science companies driving
innovation together with us.
- Source Company:
- Syndicate Partners:
Softbank Vision Fund2
HBM Healthcare Investments
Global Founders Capital
Sumitomo Mitsui Trust Investment
Aculys Pharma is a private biopharmaceutical company focused on the development and commercialization of innovations in the therapeutic area of CNS for the greater Japan region. It was founded by Catalys Pacific to address the increasing “drug lag” for innovative new medicines that fail to reach patients in the region. Licensed in from Bioprojet Pharma (Paris, France), Aculys’ lead asset, pitolisant, is a best-in-class treatment approved for Narcolepsy Type 1 (including cataplexy) in the US and EU and recently approved for Obstructive Sleep Apnea as well in the EU.
What is the unmet medical need addressed by Aculys’ lead asset?
Pitolisant is a selective histamine H3 receptor antagonist/inverse agonist for the treatment of sleep disorders, which result in severe health consequences for patients and significant economic loss for society. Narcolepsy is a rare neurologic sleep disorder with its primary symptom being excessive daytime sleepiness, which is a common symptom of other disorders beyond narcolepsy. This combined with the fact that narcolepsy often occurs together with other disorders and also a low-level of public awareness for the disease have resulted in a low rate of diagnosis and treatment of the disease in Japan. A fundamental factor for this low rate of diagnosis and treatment is the limited options of pharmacological therapy. With the estimates of economic burden of sleep disorder exceeding $138 billion annually in Japan alone, we believe pitolisant is a potential solution for patients, families, and healthcare providers currently faced with this unmet medical need.
Why did you chose to work with Catalys Pacific to license out your asset?
Bioprojet has licensed out our assets to companies in the US, China, and Korea, however, it was difficult to close licensing deals in Japan given a high barrier of entry into the market. Factors related to this high barrier included lack of speed and lack of committed capital to the program. Catalys Pacific worked with speed, agility, and commitment as a true partner. They founded Aculys with a team and strategy bespoke for pitolisant and the other CNS assets. We are delighted to partner with Catalys Pacific and Aculys to bring our best-in-class asset for patients, families and providers suffering from narcolepsy and other sleep disorders in Japan.
Do you think other biopharmaceutical companies in the US and Europe can benefit further by developing assets through newly created venture-backed companies, like Aculys?
Yes; Japan is the 2nd largest market in the world for innovative drugs and enjoys the benefits of a universal healthcare system that ensures immediate access and pricing for approved drugs. Many biotech companies in the US and EU do not have the capabilities to develop and commercialize programs in Japan and the other Asia countries by themselves so collaboration with a trusted regional partner is critical. Surely, this articulates an opportunity for them to partner with Catalys Pacific to bring their own innovations to patients in Japan and the greater Asia region.
THREE QUESTIONS ANSWERED BY Jean-Guillaume Lecomte
- Source Company:
Takeda Pharmaceutical Company Limited
- Syndicate Partners:
Frazier Healthcare Partners
Lightspeed Venture Partners
HilleVax is a private, biopharmaceutical company launched by Takeda and Frazier focused on the development and commercialization of novel vaccine candidates. Its initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis caused by norovirus infection.
What is the unmet medical need addressed by HilleVax’s vaccine candidate?
Norovirus is a common cause of gastroenteritis, an intestinal infection marked by diarrhea, vomiting, abdominal cramps, nausea and fever that may lead to dehydration. Norovirus is recognized as the leading cause of acute gastroenteritis across the age spectrum. It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burden. No vaccines are currently approved for norovirus infection, and this vaccine candidate is the most advanced norovirus vaccine candidate in human clinical trials. We believe that this vaccine candidate represents an important opportunity to address this immense unmet need.
Why did you chose to work with Frazier Healthcare Partners to license out your asset and have HilleVax develop it worldwide outside of Japan?
Takeda and Frazier have a history of successfully partnering together, including forming Phathom Pharmaceuticals. We are confident in HilleVax’s capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis. Takeda is committed to vaccines, and this collaboration allows us to focus our efforts and global resources on other important vaccine development programs for dengue, COVID-19, pandemic influenza and Zika, in addition to the vaccines we currently distribute in Japan.
Do you think Japan can benefit further by developing assets through newly created venture-backed companies like HilleVax?
Based on our successful experiences with Phathom and HilleVax, we will continue to consider collaborations with venture capital firms which have a broad network in the life sciences industry as well as in the sector of venture capital, including those in Japan.
Three questions answered by Dr. Rajeev Venkayya
Kirilys Therapeutics, Inc. (“Kirilys”) was founded by Catalys Pacific as a multi-asset precision oncology company. Kirilys’ lead asset is KRLS-017, a selective and potent Cyclin Dependent Kinase 7 (“CDK7”) inhibitor for multiple oncology indications, in-licensed from UBE. CDK7 has been implicated as a key regulator of both transcriptional addiction and cell cycle dysregulation in tumors and therefore represents an attractive target for therapeutic intervention across a broad range of solid tumors and hematologic malignancies. A best-in-class CDK7 inhibitor could also be optimized using a biomarker strategy to select for patient responders.
What is the unmet medical need addressed by Kirilys’ lead asset?
Worldwide, an estimated 19.3 million new cancer cases and almost 10.0 million cancer deaths occurred in 2020. Despite the development of a variety of new drugs for the treatment of cancers, the disease has not yet been eradicated, requiring the development of drugs with new mechanisms of action. Kirilys’ lead asset, KRLS-017, is targeting the ubiquitously expressed CDK7 in a variety of cancer types, which could be a novel treatment for cancers with high unmet medical needs including lung and ovarian cancer. In preclinical studies, KRLS-017 demonstrated best-in-class potency, selectivity, and anti-tumor efficacy along with very favorable properties for an oral drug, and thus is expected to make a great contribution for the treatment of cancers with high unmet medical need.
Why did you chose to work with Catalys Pacific to license out and develop the asset in the US?
UBE is a drug discovery and API manufacturing company and it does not have the required capability to take molecules to clinical development. Our business strategy is to develop molecules with novel targets for the treatment of diseases with high unmet medical needs and, when it reaches near an IND filing, to license the molecules to external partners. One of the fields with high unmet medical needs is that of antitumor drugs, and we have high hopes that KRLS-017 can contribute as one of the new treatment options in this area. Kirilys was founded to promote the development of therapeutics that combine innovative science in precision oncology with excellent drug discovery from Japan. We believe that the involvement of Kirilys, founded by Catalys Pacific with members having a high level of expertise and abundant experience in antitumor drug development, in the development of KRLS-017 will further raise the possibility to achieve our purpose.
Do you think Japan can benefit further by developing assets through newly created venture-backed companies, like Kirilys?
Catalys Pacific founded Kirilys as a multi-asset precision oncology company to combine groundbreaking science in precision oncology from D2G Oncology with excellent drug discovery from Japan. Kirilys has completed a seed financing led by Lightspeed Venture Partners. We believe the partnership with D2G Oncology and capital committed from global top-tier venture capital firms will help to maximize the value of KRLS-017 with a significant potential to address unmet medical needs for patients worldwide. Catalys Pacific’s “Company Creation Model” is an extremely attractive one for not only Kirilys, but also UBE and any Japan pharmaceutical company or drug discovery company. There are no other venture capital firms in Japan that can create the bespoke vehicles to advance the development of our assets.
Three questions answered by Yoichi Funayama
- Source Company:
Mitsubishi Tanabe Pharma Corporation
- Syndicate Partners:
HBM Healthcare Investments Ltd
Adams Street Partners
Mineralys Therapeutics is a private, clinical-stage biopharmaceutical company committed to developing best-in-class, novel therapy for the treatment of hypertension – the leading cause of heart and kidney disease. Mineralys is driven to break the “trial and failure” approach and bring a personalized, targeted approach to the management of hypertension. Through its expertise and focus on the patient, Mineralys aims to change the way hypertension is diagnosed, managed and treated.
Could you tell us about the research on aldosterone synthase inhibitors at your Mitsubishi Tanabe and its successful development of such a highly selective inhibitor?
Mitsubishi Tanabe had been developing an aldosterone synthase inhibitor for many years for the treatment of cardiovascular disease such as hypertension. The inhibition of aldosterone synthase (CYP11B2) can result in a reduction of plasma aldosterone. MT-4129 (Mineralys code: MLS-101), our licensed compound to Mineralys, has extremely high selectivity for aldosterone inhibition, and its selectivity is approximately 400-fold between aldosterone synthase (CYP11B2) and cortisol synthase (CYP11B1). This allows us to significantly reduce aldosterone levels in plasma without affecting other hormones such as cortisol. Phase 1 clinical trials in healthy subjects were completed, and aldosterone-lowering effects were demonstrated in human with a safe and tolerable clinical profile.
Why did you chose to work with Catalys Pacific to license out your asset and have Mineralys develop it in the US?
The value proposition by Catalys Pacific of creating a dedicated new company in the US to develop MLS-101 was extremely attractive. The US is the world’s largest pharmaceutical market and, vis-à-vis Mineralys, we are able to maximize this value directly. Although Mineralys is newly formed company, Catalyst Pacific has pulled together a world class team specifically designed to develop MLS-101 and it has already shown its benefits in terms of quality and speed. Mineralys has designed a remarkable clinical development plan, which allows us to maximize the value of this drug. The team is led by global specialists with decades of experience in the area of hypertension and endocrinology. As a result, the U.S. Food and Drug Administration (FDA) has accepted their Investigational New Drug Application (IND) for Phase II trial. Also, in March 2021, Mineralys closed a $40M Series A financing. These achievements are great benefits derived from this collaboration.
Do you think Japan can benefit further by developing assets through newly created venture-backed companies like Mineralys?
Mitsubishi Tanabe Pharma Corporation has recently formulated a new MISSION, “Creating hope for all facing illness.” It is an important mission for Japanese life science companies to deliver drugs developed in Japan to patients not only in Japan but around the world, and we believe that our strategic partnership with Mineralys is one exemplification of this.
Catalys Pacific is a venture capital that has a broad network in the life sciences industry as well as in the sector of venture capital both in Japan and the United States, and can realize the transpacific company creation. We hope that drugs developed by Japanese companies will continue to be a desirable option for patients around the world through various partnerships.
Three questions answered by Eiji Tanaka
Pathalys Pharma, Inc. (“Pathalys”) is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of end-stage kidney disease (“ESKD”). Pathalys’ initial asset is upacicalcet (Pathalys code: PLS240), a novel calcimimetic with the potential to improve the treatment of secondary hyperparathyroidism (“SHPT”), approved in Japan under the brand name UPASITA®. Beyond PLS240, Pathalys continues to identify other high priority needs and potential solutions for patients with chronic kidney disease (“CKD”) and ESKD.
What is the unmet medical need addressed by Pathalys’ initial asset?
With more than two million patients worldwide, SHPT is one of the complications that occurs with the progression of CKD. SHPT causes the parathyroid glands to become enlarged and hyperactive, overproducing parathyroid hormone (“PTH”). Upacicalcet is an intravenously administered novel calcimimetic that was shown through Phase III clinical trials in Japan to significantly reduce intact PTH levels in patients with SHPT receiving hemodialysis. Upacicalcet also demonstrated the potential for fewer adverse events, such as nausea and vomiting, than currently available therapies. We believe that PLS240 will contribute to addressing the unmet medical needs of patients in need of improved treatments for SHPT.
Why did you chose to work with Catalys Pacific to license out your asset and have Pathalys develop it worldwide outside of Japan and Asia?
EA Pharma was seeking a partner to develop the asset outside of Japan and certain Asian countries, in particular in the US and Europe. We found significant value in partnering with Catalys Pacific along with DaVita to out-license upacicalcet to a newly formed company they created. Catalys Pacific pulled together a world-class team with extensive knowledge and expertise in the development and distribution of dialysis drugs. Moreover, Catalys Pacific’s partnership with DaVita, a top US renal services provider, will bring advantages in both the development and marketing stages to encourage rapid product adoption. We believe this collaboration will maximize the value of our asset.
Do you think Japan can benefit further by developing assets through newly created venture-backed companies like Pathalys?
We were delighted to witness the great value that a “Company Creation Model” can bring. The flexibility this business model has, to be able to design a specialized team around the technology and to effectively collect capital for its development, is extremely attractive. There are numerous pharmaceutical companies struggling to develop their assets outside of Japan. Companies like Pathalys enable these companies to advance development across the oceans. From our experience, we can say with confidence that Japan will most definitely benefit from companies that are backed by venture capital firms like Catalys Pacific. We hope for more Japanese companies to realize the great achievements that can be brought about through the collaboration between venture capital firms and pharmaceutical companies.
Three questions answered by Takashi Shibano
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal (GI) diseases and disorders. The company is advancing the clinical drug candidate vonoprazan, a novel potassium-competitive acid blocker (P-CAB). Vonoprazan has the potential to address multiple unmet needs among patients with gastroesophageal reflux disease (GERD) and other acid-related disorders.
What is the unmet medical need addressed by your clinical drug candidate vonoprazan?
Patients with erosive esophagitis fail to respond to existing treatments with proton pump inhibitors in almost a third of cases. Vonoprazan promises to provide adequate treatment of these patients. In addition current regimens for eradicating H. pylori infection have diminished in efficacy with the standard proton pump inhibitors. Antibiotic regimens used in combination with Vonoprazan have been shown to be effective in eradicating infection in more than 90% of patients.
What is the significance of trying to develop an asset through a new company like Phathom?
Phathom combines the talents of an experienced team of clinical development experts with those of experts in new company creation backed by a strong syndicate of investors. New companies so constituted have proved to be highly efficient and resourceful in developing new medicines to bring them to patients quickly and with minimum of expense.
Do you think Japan can benefit further by developing assets through newly created venture-backed companies like Phathom?
Japan has proved to be a fertile environment for the discovery of new medicines because of its strong science base and deep knowledge of Pharmaceutical development. To date Japan has not been less successful in translating these qualities into evolution of a vibrant venture-backed biotech sector. Phathom and one of it’s investors, Catalys Pacific, provides one opportunity which we hope will help to bring about change in this situation. It also illustrates how global large pharmaceutical companies are increasingly partnering their assets with start-up companies like Phathom to develop some of their assets taking advantage of alternative sources of funding as well as the productivity of a focused experienced team unfettered by the usual impediments encountered in large companies.