On January 7, 2021 Werewolf Therapeutics, Inc., an oncology biotherapeutics company advancing a pipeline of next-generation, transformative cancer treatments, reported the completion of its $72 million Series B financing (Press release, Werewolf Therapeutics, JAN 7, 2021, View Source [SID1234573603]). The proceeds from the Series B financing will advance Werewolf’s lead INDUKINE product candidates, WTX-124 (interleukin-2, or IL-2) and WTX-330 (interleukin-12, or IL-12) through Phase 1 clinical proof-of-concept studies, and progress additional programs to Investigational New Drug application-readiness. INDUKINE molecules are a novel class of systemically delivered, conditionally activated proinflammatory immune modulators.

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The financing was led by RA Capital Management and joined by new investors Deerfield Management, HBM Healthcare Investments, Soleus Capital, Adage Capital, Sphera Healthcare and CaaS Capital. Also participating in the financing were Werewolf’s Series A investors including MPM Capital, Longwood Fund, Taiho Ventures, Arkin Bio Ventures, UPMC Enterprises and DC Investment Partners. In connection with the closing of the financing, Derek DiRocco, Ph.D. of RA Capital Management and Elise Wang of Deerfield Management joined the Board of Directors of Werewolf.

"This commitment from a world-class syndicate of life science investors propels Werewolf’s pipeline of potentially transformative immunomodulatory biotherapeutics into clinical development while leveraging our powerful PREDATOR protein engineering platform to identify and optimize new product candidates," said Daniel J. Hicklin, Ph.D., Founder and Chief Executive Officer of Werewolf Therapeutics. "We intend to use the proceeds from this financing to accelerate our preclinical research and discovery, advance our two lead programs to the clinic, and attract the talent needed to realize our vision of translating powerful proinflammatory mechanisms into cancer therapies that deliver a clinically meaningful impact for patients."

In support of these initiatives, Werewolf will continue adding to its team of proven oncology drug developers, building upon the recently announced appointments of Randi Isaacs, M.D. as Chief Medical Officer, and Ellen Lubman as Chief Business Officer.

"While existing cytokine therapies are known to be effective treatments for patients with cancer, resulting in cures in some instances, efficacy is not maximized due to poor tolerability. The Werewolf platform of next-generation conditionally activated cytokines aims to optimize the safety of these immunotherapies so their full efficacy can be realized and allow for combination approaches to be tested" said Derek DiRocco, Ph. D., Partner at RA Capital Management. "RA Capital is excited to support the accomplished team at Werewolf as they advance their portfolio of INDUKINE immuno-therapies into the clinic with the goal of improving outcomes for patients with cancer."

"Werewolf is positioned to become a clear leader in one of the most exciting areas of cancer treatment research and development," added Elise Wang, Partner on the Structured Finance group at Deerfield Management Company. "While immunotherapy ranks among the greatest recent advances for people living with cancer, using the body’s immune system without eliciting off-target side effects remains a challenge. We are thrilled to support Werewolf as it advances its molecules into the clinic."

Werewolf is developing treatments, administered as monotherapy or in combination with other therapies such as checkpoint inhibitors, designed to enhance the body’s immune response to cancer. These treatments leverage well-validated and emerging proinflammatory immunomodulators, including cytokines such as IL-2, IL-12 and IFNα, that have been challenging to develop as systemically delivered therapeutics due to toxicities associated with exposure to normal, non-tumor tissue. The company uses its proprietary PREDATOR protein engineering platform to create conditionally activated proinflammatory INDUKINE molecules that can be systemically administered in an inactive form. Upon entering the tumor microenvironment, the INDUKINE molecules are selectively activated to deliver the full biological potency of cytokines and to recruit a powerful anti-tumor immune response for maximum therapeutic potential, while minimizing unwanted off-target effects in non-tumor tissue.

In preclinical studies, Werewolf’s lead product candidates exhibited anti-tumor activity and favorable pharmacokinetic and safety profiles. The company was founded through an initial investment by MPM Capital, which also co-led with Longwood Fund the Company’s $56 million Series A financing.

On January 7, 2021 Scorpion Therapeutics, Inc., a next-generation precision oncology company, reported the closing of an oversubscribed Series B financing, which raised $162 million (Press release, Scorpion Therapeutics, JAN 7, 2021, View Source [SID1234573602]). The financing was led by Boxer Capital of Tavistock Group, EcoR1 Capital, LLC, Omega Funds and Vida Ventures, with participation from new investors Surveyor Capital (a Citadel company), Invus, Wellington Management Company, Nextech Invest, OrbiMed, Casdin Capital, LLC, Woodline Partners LP, Logos Capital, Janus Henderson Investors and other undisclosed institutional investors, as well as existing investors Atlas Venture and Abingworth. With this financing, Scorpion has raised approximately $270 million since the company was founded in the first quarter of 2020.

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"We are grateful to our new and existing investors for their commitment to our bold vision of advancing precision medicine as an option for many more people diagnosed with cancer," said Gary D. Glick, Ph.D., President and Chief Executive Officer of Scorpion Therapeutics. "This financing will enable us to increase our investment in our platform technologies and programs, as we execute with equal parts urgency and rigor to transform the standard-of-care in cancer. We aim to advance new therapies that provide deeper and more durable responses, are less toxic to healthy tissues and have the potential to overcome key mechanisms of resistance. We look forward to naming our first development candidate in 2021, initiating clinical trials in 2022 and, ultimately, to delivering a pipeline of next-generation targeted cancer therapies to patients who need them."

Proceeds from the financing will be used to support the continued development of Scorpion’s drug hunting engine, which integrates state-of-the-art capabilities across multiple fields of translational medicine, chemical biology, medicinal chemistry, and data science, as well as the advancement of Scorpion’s growing portfolio, which includes several therapeutic candidates across a range of biological approaches for tumor targeting. Scorpion Therapeutics is building its pipeline in three distinct tracks: the first is focused on designing best- or first-in-class therapeutic candidates against known, high-impact oncogenes that leverage optimal therapeutic design to more exquisitely target tumor tissue across all metastatic sites; the second track moves beyond oncogenes and is aimed at developing therapeutic candidates against a set of non-enzymatic targets that have historically been classified as "undruggable;" and the third is focused on a new wave of protein targets, discovered by Scorpion Therapeutics, which have the potential to transform cancer treatment paradigms for large patient populations.

"In less than a year since its founding, Scorpion Therapeutics has grown with remarkable speed and efficiency, articulating a clear strategy for transforming standards of care in oncology, attracting an experienced and accomplished team of scientists and biotech executives and building a robust research-stage portfolio," said Otello Stampacchia, Founder and Managing Director, Omega Funds.

"Scorpion’s novel therapeutic approach represents an important advance with the potential to shift the treatment paradigm for some of the most elusive cancers and make a meaningful impact for patients. With this financing, the company is well-positioned to accelerate its platform technologies and programs into the next stage of development," said Arjun Goyal, M.D., MPhil, Co-Founder and Managing Director of Vida Ventures.

"We believe Scorpion Therapeutics’ multidimensional platform and thoughtful, data-driven approach to clinical development will enable the company to move rapidly and efficiently to deliver Precision Oncology 2.0 and we are proud to support the team in their efforts," added Oleg Nodelman, Founder and Portfolio Manager of EcoR1 Capital LLC.

"Scorpion is at a pivotal stage of its development, as it prepares to name its first development candidate and advance into clinical trials. We look forward to partnering with the management team to build out a robust pipeline, with the goal of addressing current limitations of precision oncology and transforming cancer care for patients," commented Aaron Davis, Co-Founder and Chief Executive Officer of Boxer Capital.

Presentation at the 39th Annual J.P. Morgan Healthcare Conference

Gary Glick, Ph.D., Scorpion’s President and Chief Executive Officer, will provide an overview of the company at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13 at 10:25 a.m. ET.

The live webcast can be accessed under "News" on the Scorpion website at www.scorpiontx.com. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 30 days following the presentation.

On January 7, 2021 ImaginAb Inc., a leading global provider of immuno-oncology imaging agents, reported it has signed a new multi-year, non-exclusive license with Pfizer Inc. (NYSE: PFE) to supply 89Zr CD8 Immuno-PET agent, which can be used to image CD8 T cells in cancer patients (Press release, ImaginAb, JAN 7, 2021, View Source;utm_medium=rss&utm_campaign=imaginab-announces-license-and-supply-agreement-with-pfizer-for-cd8-immunopet-technology [SID1234573559]).

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Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients.

Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. In addition, ImaginAb will provide technical, clinical, and regulatory support to Pfizer. ImaginAb will receive license fees and payments for manufacturing and other support. No other terms were disclosed.

This agreement expands upon the relationship between the companies following the pre-competitive alliance between ImaginAb, Pfizer and other global pharmaceutical companies which focused on the development of 89Zr CD8 ImmunoPET technology. The alliance, announced on October 14, 2019, has assisted in advancing the 89Zr CD8 Immuno-PET technology.

Commenting on the announcement, Ian Wilson, Chief Executive Officer of ImaginAb said: "Pfizer continues to be a great partner and supporter of our efforts to develop this innovative PET imaging technology, and we are delighted to expand our relationship further.

Wilson continued "Imaginab is actively investing in the clinical and global supply chain development of 89Zr CD8 Immuno-PET agent to provide simple turnkey access to this novel technology. Our goal is to enable the widespread use and adoption of 89Zr CD8 Immuno-PET technology, which will help our partners to predict therapeutic efficacy and treatment outcomes in cancer patients more precisely and earlier in a clinical trial. Working with leading pharmaceutical companies such as Pfizer, will help us achieve our goal."

"CD8 T cells play such a pivotal role in immunotherapy of many cancers and our 89Zr CD8 Immuno-PET is one of the most widely used imaging technology used by pharmaceutical and biotech companies to track CD8 T cells in patients."

On January 7, 2021 Axial Therapeutics Inc., a clinical-stage biotechnology company dedicated to building a unique class of gut-restricted therapeutics for central nervous system (CNS) disorders and conditions, reported that management will participate in a fireside chat at the virtual H.C. Wainwright BioConnect Conference 2021 (Press release, Axial Biotherapeutics, JAN 7, 2021, https://axialtx.com/2021/01/axial-therapeutics-to-present-at-the-inaugural-virtual-h-c-wainwright-bioconnect-conference/ [SID1234573558]). The session will become available for on-demand viewing at 6:00 a.m. ET on Monday, Jan. 11, 2021.

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On January 6, 2021 Pacylex Pharmaceuticals, an oncology company unlocking a new approach to cancer therapy, reported the publication in the journal Breast Cancer Research and Treatment data showing treatment with an N-myristoyltransferase (NMT) inhibitor reduces viability of cultured breast cancer cells and inhibits tumor growth in a mouse xenograft mouse model of human breast cancer (Press release, Pacylex Pharmaceuticals, JAN 6, 2021, View Source [SID1234645065]). Pacylex is developing this NMT inhibitor, PCLX-001, as a first in class therapy for various leukemias and lymphomas and also plans to study its effects on various solid tumors.

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"Despite the critical role myristoylation plays in cell survival, NMT1 and NMT2 protein levels have never been systematically studied in a large series of human cancers," said John Mackey, MD, Co-founder and Chief Medical Officer of Pacylex and first author on the paper. "Not only did we find a relationship between NMT2 levels and patient survival, but an NMT inhibitor was generally effective against breast cancer cell lines and inhibited human breast cancers grown in mice."

Dr. Mackey and colleagues studied the abundance and distribution of NMT1 and NMT2 proteins in normal breast tissue and a large cohort of primary breast adenocarcinomas from a prospective phase III clinical trial (n=706). NMT1 protein was observed in normal and most transformed breast epithelial tissue and was associated with better overall histologic grade, higher Ki67, and lower hormone expression. Though NMT2 protein was readily detected in normal breast epithelial tissue, it was undetectable in the majority of breast cancers. Detectable NMT2 protein correlated with significantly worse overall survival.

This extends the proof-of-concept for NMT inhibitors as potential cancer therapeutics for blood cancers, recently published in Nature Communications, to solid tumors as well, and supports the continued preparation for the first human clinical trial set to begin in early 2021. Both lymphoma and solid tumor patients including breast cancer will be enrolled in this initial study.

A link to the publication "N-myristoyltransferase proteins in breast cancer: prognostic relevance and validation as a new drug target" can be accessed here. The Alberta Cancer Foundation and the Cure Cancer Foundation both provided support for this research.

PCLX-001

PCLX-001 is a small molecule, first-in-class myristoylation inhibitor, originally developed by the University of Dundee Drug Discovery Unit as part of a program to treat African sleeping sickness funded by Wellcome Trust. Pacylex is developing PCLX-001, which has very good oral bioavailabilty, to treat cancers low in N-myristoyltransferase 2 (NMT2), a myristoylation enzyme whose deficiency is associated with higher mortality in leukemia and lymphoma. PCLX-001 selectively kills cancer cells and completely regresses (eliminates) tumors in animal models of acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and Burkitt’s lymphoma (BL). PCLX-001 has also been shown to inhibit the growth of lung and breast cancer tumors in animal models. In tests using cultured cancer cells in vitro, PCLX-001 is at least ten times as potent as Ibrutinib (Imbruvica) and Dasatinib (Sprycel), two clinically approved drugs currently used to treat hematologic malignancies.