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 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported it has launched its EsoGuard Telemedicine Program in partnership with UpScriptHealth, a leading, nationwide, direct-to-consumer telemedicine company (Press release, Lucid Diagnostics, DEC 1, 2021, View Source [SID1234596379]).

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"Many, if not most, chronic heartburn sufferers treat their symptoms without physician supervision using widely available, heavily advertised, over-the-counter heartburn medications—entirely unaware they may be at risk for esophageal precancer and cancer"

Chronic heartburn patients in four metropolitan areas—Phoenix, Denver, Salt Lake City, and Las Vegas—can now access a Lucid-branded web-based telemedicine platform to request video evaluation of their condition by an independent UpScriptHealth-managed telemedicine physician. If clinically indicated, the patient will be referred to a local Lucid Test Center or other clinical facility offering rapid, office-based testing to detect esophageal precancer using Lucid’s EsoGuard DNA Esophageal Test ("EsoGuard"). A direct-to-consumer marketing campaign utilizing radio, television, billboards and digital media, will be launched, tested and refined in the Phoenix market before proceeding to other Lucid Test Center cities.

"Many, if not most, chronic heartburn sufferers treat their symptoms without physician supervision using widely available, heavily advertised, over-the-counter heartburn medications—entirely unaware they may be at risk for esophageal precancer and cancer," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "An important pillar of our growth strategy is to educate consumers on the link between chronic heartburn and esophageal cancer, and the availability of a rapid, office-based test to detect esophageal precancer before it progresses to cancer."

"The launch of Lucid’s EsoGuard Telemedicine Program is a very important milestone which completes the foundation for our multi-channel EsoGuard commercialization strategy directly targeting primary care physicians (PCPs), gastroenterologists and now consumers. We believe, based on the experience of other successful early cancer detection companies, that telemedicine programs with direct-to-consumer engagement can have broad reach, accelerate commercialization, and drive long-term growth. We are fortunate to have an ideal partner in UpScriptHealth, a pioneer in online healthcare prescribing with a nationwide network of telemedicine physicians, as we look to expand the EsoGuard Telemedicine Program and Lucid Test Center network regionally and nationally."

Lucid Test Centers currently operate in leased medical office suites located in three locations in Phoenix and one each in Denver, Salt Lake City and Las Vegas. Lucid plans to add upcoming test centers in the Pacific Northwest and then steadily expand nationwide. Each test center is staffed with Lucid-employed clinical personnel who use Lucid’s EsoCheck Cell Collection Device ("EsoCheck") to collect esophageal cells which are sent for EsoGuard testing. Lucid estimates that a single nurse practitioner can perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office leases costs with only a few tests per week.

Since their launch, the test centers have been seeing patients referred for EsoGuard testing by their PCPs. Now, patients who respond to direct-to-consumer engagements can request video telemedicine evaluation through the EsoGuard Telemedicine Program by contacting 1-888-FOODTUBE or registering at www.EsoGuardConsultation.com. If clinically indicated, the telemedicine physician will refer the patient to a Lucid Test Center or other clinical facility for EsoGuard testing. The EsoGuard test result will be reported to this physician who will refer the patient for gastroenterology evaluation if indicated.

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer (EAC). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment. The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths, through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer. EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at a CLIA/CAP-certified laboratory.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

On December 1, 2021 Australian clinical-stage drug development company Noxopharm (ASX:NOX) reported that it has in-licensed novel RNA technology developed by Hudson Institute of Medical Research (Press release, Noxopharm, DEC 1, 2021, View Source [SID1234596378]). The exclusive global contract aims to maximize opportunities in RNA drug discovery and mRNA vaccine manufacture through Noxopharm’s wholly owned subsidiary, Pharmorage.

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According to Noxopharm CEO and Managing Director, Graham Kelly, "Pharmorage already had a strong business relationship with Hudson with a major initiative in anti-inflammatory drug development. The RNA technology and its anti-inflammatory functions is an obvious fit, and with mRNA vaccine technology looking increasingly likely to extend eventually to most if not all viral diseases, this is an extraordinarily timely development." Noxopharm has previous experience in developing anti-inflammatory therapeutics, which led to their current lead drug candidate, Veyonda.

As a first step, Pharmorage will develop Hudson’s mRNA vaccine enhancement opportunities, as the mRNA vaccine market is predicted to reach $23 billion USD by 2035. Though mRNA vaccine technology has had a strong debut, unwanted side effects remain common, including fatigue, severe headache, chills, and injection-site pain. These are directly related to the body recognizing mRNA therapeutics through the immune sensor Toll-like Receptor 7 (TLR7). However, according to Associate Professor Michael Gantier of Hudson, "We have discovered a new class of TLR7 inhibitors that can outcompete immune sensing of therapeutic RNAs, such as those used in mRNA vaccines; we propose that these inhibitors could be used in conjunction with therapeutic RNAs to limit their side effects in patients and maximize their therapeutic potential."

Pharmorage will also focus on advancing Hudson’s several lead RNA drugs through development as treatments for autoimmune and inflammatory diseases. These RNA drugs target the root of the inflammatory response — key immune sensors. Pharmorage has experience in this area, evidenced by their work on the development of a first-in-class tank-binding kinase 1 (TBK1) inhibitor, to be used in similar conditions.

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 technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234596376]). Previously known as ZetaFuse, ZetaMet 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 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 has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

On December 1, 2021 Labcorp (NYSE: LH), a leading global life sciences company, and ConcertAI, LLC (ConcertAI), a leader in enterprise artificial intelligence (AI) and real-world data (RWD) solutions for life science companies and health care providers, reported a collaboration to optimize precision oncology research (Press release, LabCorp, DEC 1, 2021, View Source [SID1234596375]). The companies will work together to launch clinical studies in ways that minimize the burden on physician practices, drive faster patient recruitment, maximize patient retention and ensure equitable access to research as a care option.

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Through this collaboration, Labcorp will leverage ConcertAI’s suite of software-as-a-service (SaaS) offerings for clinical trial design, protocol optimization, site selection and study execution. These solutions, when paired with Labcorp’s expertise in clinical development services and diagnostic testing, will optimize oncology clinical trial design and execution using RWD and AI.

"With Labcorp, we are building an advanced network, AI technologies and SaaS solutions to further advance the industry’s goals for diversity and digital enablement in clinical development services, especially in oncology," said Jeff Elton, Ph.D., CEO of ConcertAI. "As a leading RWD and SaaS AI solutions company for evidence generation, ConcertAI is committed to advancing precision oncology in partnership with industry leaders."

ConcertAI’s offerings will allow Labcorp Drug Development to access data to make more informed decisions about oncology clinical trials. This analytical toolset drives actionable insights that will lead to a better understanding of patient profiles and treatment pathways, ultimately yielding quicker and more effective clinical trials.

Clinical trials also increasingly require analysis of potential trial sites to identify and select locations containing patients with specific characteristics. Using data to help understand the availability of patients across a sampling of oncology cancer centers helps bring health care within reach for all and ensures that the design of a trial contains a diverse set of participants to measure drug safety and effectiveness in broadly representative populations. ConcertAI and Labcorp have structured a long-term collaboration to leverage data and analytics to find solutions to these difficult problems.

"Oncology is highly complex, with hundreds of molecular targets and factors across solid tumors and hematological malignancies, so the need is great for diversity in cancer trials," said Prasanth Reddy, M.D., MPH, FACP, senior vice president and head of oncology at Labcorp. "Labcorp Drug Development, which supports more than 50% of all oncology clinical trials globally, combined with ConcertAI’s high-depth data and AI technologies, is a powerful combination to optimize trial design, improve patient access, and increase efficiency of oncology trials to bring new therapeutic options to patients who need them most."

Improved screening, along with new diagnostics and treatments in cancer have been significant contributors to recent reductions in deaths and other adverse outcomes. Health care providers and pharmaceutical companies require support to bring additional, innovative treatment options to market. Pairing ConcertAI’s RWD and AI expertise with Labcorp Drug Development’s established site relationships and patient-centric approach will provide customers with a differentiated offering, generating actionable insights and improved trial execution—ultimately yielding trials that are more cost effective, more inclusive and more likely to succeed.