On December 1, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its multi-year agreement with Janssen Research & Development, LLC (Janssen) (Press release, Tempus, DEC 1, 2021, View Source [SID1234596357]). The expanded scope is anchored in new AI-based work, in which Tempus will collaborate with a multidisciplinary team of data scientists at Janssen to enhance the discovery and development of therapies for oncology indications using AI/ML and real-world evidence (RWE). This agreement leverages Tempus’ platform, including its multimodal data library, genomic sequencing offerings, and TIME Trial Network of clinical sites to advance the recruitment of patients.

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Tempus’ platform is well positioned to solve many of the challenges clinical trial sponsors face, especially finding rare biomarker-driven patient populations. This work leverages Tempus’ AI capabilities to jointly create algorithms intended to further patient pre-screening efforts for specific cancer indications, including biomarker-selected cohorts. Tempus’ multidisciplinary team’s expertise spans clinical RWE, computational biology, software engineering, machine learning, and trial matching program management, and is a key factor in successfully leveraging an AI-enabled approach to trial recruitment.

"We’re excited to expand our collaboration to apply the Tempus AI platform," said Ryan Fukushima, Chief Operating Officer of Tempus. "We will explore leveraging our data to develop and co-develop novel AI applications to identify the best treatment options for patients in need, and ultimately accelerate the drug development process, bringing novel medicines to patients in a fraction of the time."

On December 1, 2021 Curie Therapeutics Inc. ("Curie"), a biotechnology company incubated by Atlas Ventures, Access Biotechnology and RA Capital Management, reported a Series A investment of $75 million by its founding syndicate to continue the development of its multimodal pipeline of precision radiopharmaceuticals to a broad range of high unmet need solid tumors (Press release, Curie Therapeutics, DEC 1, 2021, View Source [SID1234596380]).

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Commenting on the emergence of Curie from stealth, Dr. Simon Read, Curie Founder and Chief Executive Officer, said, "We envision a world where cancer care is transformed by precision radiopharmaceuticals and a future in which these drugs are increasingly integrated into mainstream treatment."

He added, "We founded Curie to maximize the potential of targeted radiopharmaceuticals for frank tumor ablation, as well as to harness the growing understanding of how radiobiology of targeted therapies can favorably modulate the tumor microenvironment as part of a rational sequence of care. Our team is unique. We have bought together seasoned leaders from pharmaceutical biotech R&D with radiobiology and radiochemistry experts drawn from both industry and academia. Backed by a syndicate of three of the foremost incubating venture firms, we have a pipeline underway and key radionuclide supply agreements for both alpha and beta radionuclide strategies to support our vision."

Dr. Dan Becker, Partner at Access Biotechnology and a member of Curie’s Board of Directors (BoD), said "Radiopharmaceuticals are emerging as potent, safe, and commercially viable options for cancer patients. While late-stage therapeutic radiopharmaceutical pipelines are predominantly focused on metastatic castration resistant prostate cancer and neuroendocrine tumors, we see a much broader opportunity to drug a broad spectrum of targets with our high therapeutic index, precision radiopharmaceuticals."

Dr. Kevin Bitterman, Partner at Atlas Ventures and a member of Curie’s BoD said, "All three syndicate members showed an early interest in the radiopharmaceutical space. We have been incubating Curie for 18 months with a focus on building a fully integrated company in which both peptidic and non-peptidic ligand R&D, radiochemistry, CMC and clinical translation can occur under one roof."

Dr. Josh Resnick, Managing Director of RA Capital Management and a member of Curie’s BoD, added, "This founding team has the ligand discovery breadth, company formation experience, and radiobiology and CMC experience required to build the leading precision radiopharmaceutical company. We are delighted to co-lead the series A round with Access Biotechnology and Atlas Venture."

Curie Management and Board of Directors

Curie’s management includes biotech leaders with broad experience across peptide discovery and development, radiochemistry, and in building top tier clinical stage peptide, radiopharmaceutical, and platform companies, including founder Simon Read, Ph.D. as CEO (former CSO of Ra Pharma, former Entrepreneur in Residence at Atlas Venture), Alonso Ricardo, Ph.D. as CSO (former Chief Technology Officer of Ra Pharma, former Entrepreneur in Residence at RA Capital Management), and Sandy Mong, M.D. as SVP of Business Development and Operations (former VP of Business Development and Operations of BridgeBio Pharma, former Entrepreneur in Residence at Atlas Venture). The broader team includes ligand discovery, radiopharmacology, radiochemistry talent from public and private peptide companies, radiopharmaceutical companies, as well as academia.

Curie’s BoD consists of Kevin Bitterman, Ph.D. (Partner, Atlas Venture), Dan Becker, M.D., Ph.D. (Partner, Access Biotechnology), Josh Resnick, M.D. (Managing Director, RA Capital Management), and Simon Read, Ph.D. (CEO, Curie Therapeutics).

On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet (Zeta-BC-003) technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234643705]). Previously known as ZetaFuse, ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

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"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

ZetaMet (Zeta-BC-003) has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

On November 30, 2021 THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported that it has received yesterday a letter from BIOSYNEX informing it of its acquisition of a stake in its capital and the crossing of statutory thresholds, in accordance with article 12.3 of THERADIAG’s articles of association (Press release, Theradiag, NOV 30, 2021, View Source [SID1234596230]).

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Following acquisitions on the market and its participation in the Rights Issue, BIOSYNEX held 2,468,932 shares, i.e. 18.82% of THERADIAG’s share capital and 18.89% of its voting rights, as at 29 November 2021 at 8:00 a.m.

On November 30, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported its agenda and distinguished speaker list for a comprehensive Investor Update Meeting taking place Thursday, December 2nd , from 10:00am ET – 1:30pm EST (Press release, Delcath Systems, NOV 30, 2021, View Source [SID1234596248]).

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The event will focus on the company’s US product candidate, HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system), a percutaneous hepatic perfusion (PHP) system. In the United States HEPZATO is an investigational drug/device combination product. In Europe, the product is a stand-alone medical device approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver.

A distinguished panel of physicians will discuss their experience with HEPZATO in the FOCUS trial, commercial experience with CHEMOSAT and the unmet need in the treatment of liver metastases. The participating physicians will present on the following topics:

Current unmet need and treatment options for liver metastases
The longest single institution experience with PHP – The University Hospital Southampton experience
PHP quality of life and combination with immuno-oncologic therapy – The Leiden University experience
Current unmet needs in ocular melanoma
Focus Trial – efficacy and safety results
Future clinical development plans
In addition to the Delcath management team, planned speakers and panelists will include:

John Bridgewater, MRCP, PhD, FRCP
Professor and Consultant Medical Oncologist, UCL Cancer Institute, University College London, London, UK

Mark Burgmans, MD, PhD
Head of Interventional Radiology, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands

Aslam Ejaz MD, MPH
Assistant Professor of Surgery, The Ohio State University, Columbus, OH

Francesco Pier Ferrucci, MD
Director, Tumor Biotherapy Unit, Istituto Europeo di Oncologia, Milan, Italy

Evan S. Glazer, MD, PhD, FACS
Assistant Professor of Surgery, College of Medicine and Principal Investigator, Center for Cancer Research, The University of Tennessee Health Science Center, Memphis, TN

Sachin Modi, BSc (Hons), MBBS, FRCR, FRCR (IR)
Consultant Interventional Radiologist, Department of Interventional Radiology, University Hospital Southampton, Southampton, UK

Siddharth A. Padia, MD
HS Clinical Professor, Division of Interventional Radiology, David Geffen School of Medicine, University of California, Los Angeles, CA

Sapna Patel, MD
Associate Professor, Department of Melanoma Medical Oncology, MD Anderson Cancer Center, Houston, TX

Sunil A. Reddy, MD
Clinical Assistant Professor, Division of Oncology, Department of Medicine, Stanford University School of Medicine, Stanford, California

Brian Stedman, BSc, MBBS, FRCS, FRCR
Consultant Interventional Oncologist, Department of Interventional Radiology, University Hospital Southampton, Southampton, UK

Juan Valle, MD
Professor and Consultant Medical Oncologist, The Christie NHS Foundation Trust, Manchester, UK

Jonathan Zager, MD, FACS (Global Lead Investigator)
Chief Academic Officer, Director of Regional Therapies, and Senior Member, Departments of Cutaneous Oncology and Sarcoma, Moffitt Cancer Center; Chair, Department of Oncological Sciences and Professor of Surgery, USF, Morsani School of Medicine, Tampa, FL

Event Details:
Event: Delcath Systems Virtual Investor Update Meeting
Date: Thursday, December 2, 2021
Time: 10:00am – 1:30 p.m. EST