On December 1, 2020 CANbridge Pharmaceuticals Inc., a company developing and commercializing innovative drugs to treat rare diseases and targeted cancers, reported that it has completed a US$43 million Series E financing, led by 3W Fund Management (Press release, CANbridge Life Sciences, DEC 1, 2020, View Source [SID1234572045]). New investors include Casdin Capital, Summer Capital, SPDBI and Yaly Capital, with additional participation by existing investors, including Hudson Bay Capital Management, RA Capital Management, Hangzhou Tigermed Consulting Co. Ltd and LYFE Capital. The raise, which was expanded due to high demand, is a follow-on of the US$98 million Series D financing, completed in February. The proceeds will be used to expand the CANbridge rare disease pipeline through internal development and external partnerships, accelerate the clinical development of pre-clinical stage assets, prepare the commercial launch of CAN101 (Hunterase) and supplement working capital.

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CANbridge recently received marketing approval in China for its first rare disease candidate, Hunterase, for the treatment of Hunter syndrome (mucopolysaccharidosis II or MPS II). In addition, it has a deep rare disease pipeline, which includes an ongoing strategic partnership for rare disease treatment development with WuXi Biologics and two collaborative agreements with the Horae Gene Therapy Center at the UMass Medical School for rare disease gene therapy research. In addition, CANbridge recently received marketing approval for its second commercial product, NERLYNX (neratinib), in Taiwan, for early stage HER2-positive breast cancer.

"We are grateful and humbled by the tremendous investor enthusiasm in CANbridge," said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. "Since closing our $98 million Series D financing in February, CANbridge has strengthened its operating capabilities and achieved a number of milestones, including three marketing approvals, as the China rare disease market continues to generate momentum in the positive direction."

"As a leading pharmaceutical company in the rare disease sector, we believe CANbridge is well-positioned for commercialization of innovative drugs, and applaud its successful execution in drug development," said Cathy Chen, Managing Director of 3W Fund. "We are impressed by Management’s extensive experience and past track record and are truly excited to share in the next chapter of CANbridge’s success."

On December 1, 2020 Proscia, a leading provider of digital and computational pathology solutions, reported that it has secured $23 million in Series B funding led by Scale Venture Partners, with participation from Hitachi Ventures, the strategic corporate venture capital arm of Hitachi, Ltd., bringing its funding total to $35 million (Press release, Proscia, DEC 1, 2020, View Source [SID1234572044]). The company will use the investment to accelerate its global growth and strengthen its position of leadership in transforming cancer research and diagnosis at a time when demand for modernizing pathology is higher than ever.

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The practice of pathology sits at the core of biomedical research and cancer diagnosis. Until recently, this practice has remained largely unchanged in its 150-year history, depending solely on the human eye recognizing patterns in tissue under the microscope. With its Concentriq software platform, Proscia is accelerating the transformation to digital pathology, which centers around high-resolution images of tissue biopsies, as the new standard of care. Concentriq combines enterprise scalability with powerful AI applications to help laboratories, health systems, and life sciences companies unlock new insights, accelerate breakthroughs, and improve patient outcomes.

"Digitization has swept through almost every domain of healthcare, and we are now seeing its revolutionary impact on pathology," said Alexander Niehenke, Partner at Scale Venture Partners. "Proscia is a high-growth company with a unique platform-plus-AI approach that is enabling it to capitalize on a multi-billion-dollar market opportunity. We’re excited to be a part of Proscia’s success as it expands its leadership position in pathology’s shift from analog to digital."

The infusion of capital will enable Proscia to continue to meet growing demand for digital pathology across research and diagnostics. The company will use the funds to accelerate commercial expansion, ramping up its global sales, marketing, and support teams. Proscia will also further drive pathology’s data-driven future by expanding its data assets and AI application portfolio, building off of the initial success of its DermAI application. The investment will additionally advance Proscia’s regulatory strategy to secure FDA clearance, drawing on the foundation that the company has established with its CE Mark and MDSAP certification.

Since closing its Series A round in 2018, Proscia has amassed a customer base of laboratory titans and digital pathology pioneers as well as 10 of the top 20 pharmaceutical companies. This includes Johns Hopkins School of Medicine and the Joint Pathology Center (JPC), the premiere pathology reference center for the U.S. government. JPC selected Concentriq to drive a complete modernization of its pathology practice and digitize the world’s largest human tissue repository of over 55 million slides, unleashing a transformative wave of biomedical research. Proscia also recently established a Computational Pathology Center of Excellence with University Medical Center (UMC) Utrecht, one of the first organizations in the world to implement digital pathology. As part of this collaboration, UMC Utrecht will deploy Proscia’s AI applications into its high-throughput workflows leveraging Concentriq.

"We are excited for this next milestone in our journey," said David West, CEO of Proscia. "Over the past few years, we have battle tested Concentriq at leading organizations and demonstrated the unprecedented potential of AI. In welcoming Scale Venture Partners and Hitachi Ventures to the Proscia team, we are better positioned than ever before to drive a transformation that will impact millions of cancer patients and their families."

Proscia’s commercial traction comes amid a surge in digital pathology adoption. Laboratories have increasingly shifted to digital to overcome the manual and subjective nature of the traditional standard of care and keep pace with the rising cancer burden. In the U.S. alone, pathologists have faced a 42% rise in diagnostic workload over the last decade, a challenge that will continue to intensify as the total number of cancer cases is projected to increase by 55% by 2030. Recently, laboratories have been implementing digital pathology to maintain operations during the COVID-19 pandemic, as digitization is the only means by which they can continue to serve patients.

"Digital pathology is quickly becoming the expected standard of diagnosis," said Steve Holloway, Company Director & Principal Analyst at Signify Research. "The global pandemic has exacerbated longstanding pressures, accelerating adoption. This market has now crossed an inflection point, with a critical mass of digital laboratories creating the momentum for more widespread implementation of digital pathology and augmentation by artificial intelligence."

On December 1, 2020 Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, reported the completion of its Series A financing totaling $62 million (Press release, Tallac Therapeutics, DEC 1, 2020, View Source [SID1234572043]). Tallac is backed by a syndicate of leading global life science venture firms including venBio Partners, Morningside Venture, Lightstone Ventures, Matrix Partners China, and MRL Ventures Fund. The Company plans to use the Series A funding to advance the discovery and development of immunotherapy candidates for multiple solid tumor maligniancies. Its pipeline of next generation immunotherapies are derived from its novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform.

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Immunotherapies such as checkpoint inhibitors and adoptive CAR-T therapies have become foundational treatment options in oncology, yet the majority of patients only receive a temporary benefit or no benefit as they either develop resistance to treatment or are non-responsive to treatment. Novel immunotherapies known as Toll-like receptor (TLR) agonists are a class of immunotherapy that generates both an innate and adaptive immune response which may produce more robust and durable anti-cancer immunity to help overcome resistance.

"We believe targeting innate immunity represents a transformative approach to creating the next-generation of breakthrough therapeutics in cancer immunotherapy," said Dr. Hong I. Wan, president, CEO and co-founder of Tallac Therapeutics. "Our team has generated robust preclinical data on the Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform that we recently presented at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting. With the support of our existing and new investors, I am excited to lead the Tallac team on its mission to advance first-in-class therapies for the benefit of patients in desperate need of new treatment options."

"Tallac has developed a scientifically innovative technology platform to create potent, systemically delivered therapeutics with the potential to provide powerful innate and adaptive anti-tumor immunity across multiple tumor types," said Corey Goodman, board chair, co-founder of Tallac Therapeutics and Managing Partner at venBio. "We are pleased to see the progress made by the team during the seed stage and look forward to supporting Tallac as they advance their pipeline towards the clinic."

Tallac Therapeutics was founded in 2018 by Drs. Goodman and Wan (previously CSO of ALX Oncology) with two other co-founders, Dr. Jaume Pons (currently CEO of ALX Oncology) and Dr. Curt Bradshaw (most recently CSO at Arrowhead Pharmaceuticals), to develop technology for targeted immune activation using an antibody-immune activator conjugate. The research team at Tallac has significant biologics discovery and development expertise. Most recently, under Dr. Wan’s leadership at ALX Oncology, the team designed and advanced ALX148, a best-in-class myeloid checkpoint inhibitor, for multiple tumor indications.

On December 1, 2020 LianBio, a biotechnology company focused on bringing paradigm-shifting medicines to patients in China and other major Asian markets, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the Company’s Clinical Trial Application (CTA) to conduct the Phase 2a trial of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification (Press release, LianBio, DEC 1, 2020, View Source [SID1234572042]).

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LianBio has in-licensed the oncology rights for infigratinib from QED Therapeutics, an affiliate of BridgeBio Pharma, Inc., and is responsible for the clinical development, registration application and future commercial operations of the product candidate in Mainland China, Hong Kong and Macau.

Infigratinib is an investigational oral, selective inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that has shown activity in clinical measures, such as overall response rate, in patients with chemotherapy-refractory cholangiocarcinoma with FGFR2 fusions and advanced urothelial carcinoma with FGFR3 genomic alterations [1][2]. The Phase 2a trial is a multicenter, single-arm study designed to explore and evaluate the pharmacokinetic profile, efficacy and safety of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification. Infigratinib is also currently under Phase 3 global development by LianBio and BridgeBio for patients with FGFR2 fusion positive cholangiocarcinoma.

"With strong support from our partner, BridgeBio, the exploratory study highlights LianBio’s continued commitment to expand its global footprint and develop potential breakthrough therapeutics in China," said Dr. Bing Li, Chief Executive Officer of LianBio. "Gastric cancer is the third most common cancer in China, causing approximately 300,000 deaths every year. This clearance by the China NMPA to conduct the Phase 2a trial of infigratinib in gastric cancer will enable LianBio to work towards addressing the significant unmet medical need for this growing patient population."

References

Javle M. et al. A phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor (TKI), in patients with previously-treated advanced cholangiocarcinoma containing FGFR2 fusions; ESMO (Free ESMO Whitepaper) 2018 Annual Meeting. Poster #LBA28.
Pal K. et al. Efficacy of BGJ398, a Fibroblast Growth Factor Receptor 1-3 inhibitor, in patients with previously treated advanced urothelial carcinoma with FGFR3 alterations; Cancer Discovery 2018.

On December 1, 2020 Turnstone Biologics Corp., a clinical-stage biotechnology company pioneering the development of engineered viral immunotherapies, reported enrollment of the first patients in a Phase 1/2a clinical trial (RAPTOR) of its RIVAL-01/TAK-605 candidate in patients with solid tumors, conducted in collaboration with Takeda Pharmaceutical Company Limited ("Takeda") (Press release, Turnstone Biologics, DEC 1, 2020, View Source [SID1234572041]). RIVAL-01 consists of Turnstone’s proprietary oncolytic vaccinia virus backbone encoding transgenes for Flt3 ligand, anti-CTLA-4 antibody and IL-12 cytokine, purposefully designed to work together to drive immune activity and re-program the microenvironment to be best suited for tumor eradication.

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"The enrollment of the first patients into our Phase 1/2a trial is a key milestone for Turnstone and meaningfully advances our aim of transforming the treatment paradigm for people with cancer," said Mike Burgess, Ph.D., President of R&D, Turnstone. "The meticulous design of our differentiated vaccinia virus platform enabled us to engineer RIVAL-01 to deliver three powerful immune modulating agents locally to primary and metastatic tumor sites, by either intratumoral or systemic administration. We look forward to sharing future updates as the study progresses."

Turnstone’s RIVAL therapeutic pipeline is based on its proprietary vaccinia virus platform, which has been engineered for enhanced immune-stimulation and tumor cell selectivity, potent oncolysis and large transgene carrying capacity. The transgenes are designed to be expressed when the vaccinia virus, delivered either intratumorally or intravenously, enters and replicates in cancer cells. The resulting local production of these therapeutics at the site of tumors adds to the inherent oncolytic and microenvironment-modifying properties of the virus to form a powerful multi-modal attack on the disease. RIVAL-01 is being co-developed and co-commercialized under a global collaboration with Takeda.

"Takeda’s partnership with Turnstone continues to gain momentum. Our teams successfully collaborated to establish the RIVAL-01/TAK-605 clinical development plan while simultaneously working together to advance additional novel next-generation multi-payload oncolytic virus concepts to the clinic", said Chris Arendt, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. "The trial enrollment represents an important step forward in our collaboration and ongoing efforts to leverage innate and adaptive immunity to overcome the limitations of current immuno-oncology therapies."

The RAPTOR trial will evaluate the safety and efficacy of RIVAL-01 (formerly known as TBio-6517) administered intratumorally as a single agent and in combination with Keytruda (pembrolizumab) in patients with solid tumors, including triple negative breast cancer, microsatellite stable colorectal cancer, melanoma and cholangiocarcinoma. Patients are currently enrolling in Phase 1 dose escalation, which will be followed by an expansion phase in specified tumor types in the Phase 2a portion of the trial.

Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at View Source (ClinicalTrials.gov Identifier: NCT04301011).