On May 5, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that confirms Clarity and its clinical development programs are unaffected by Novartis’ recent suspension of production of Lutathera and Pluvicto/ 177Lu-PSMA-617 at its facilities in Ivrea, Italy and Millburn, New Jersey (Press release, Clarity Pharmaceuticals, MAY 5, 2022, View Source [SID1234614044]).

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On 5 May 2022, Novartis released an update regarding the suspension due to potential quality issues identified in its manufacturing processes and expects a resolution of these issues, and resumption of some supply, in the next 6 weeks. The production suspension impacts commercial and clinical trial supply as Novartis put a temporary hold on screening and enrollment for 177Lu-PSMA-617 clinical trials globally, and Lutathera clinical trials in the US and Canada.1

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "Clarity and our clinical development programs are not impacted by the Novartis production disruption as our Targeted Copper Theranostics (TCTs) are wholly independent of the Lutathera and Pluvicto supply chains and other first generation radiopharmaceuticals."

"Our greatest concern at this time is for the patients who need these important products now, and we hope that Novartis can re-commence supply shortly. As we have seen to date, the biggest threat to radiopharmaceuticals is not the efficacy of radiopharmaceutical products, but the ongoing sustainable supply of these products to patients. It has been known for many decades that radiation is a powerful weapon in the management and treatment of cancer; however, the lack of secure supply jeopardises market acceptance and confidence of clinicians and patients in these therapies," Dr Taylor added.

TCTs employ copper-64 (Cu-64) and copper-67 (Cu-67) for diagnosis and therapy respectively utilising proprietary SAR technology. TCTs are a next-generation disruptive platform in radiopharmaceuticals, which delivers a compelling combination of high accuracy and high precision in the treatment of a range of cancers, while providing supply and logistical advantages over current theranostics.

Cu-67 is produced domestically in the US on electron accelerators with high purity and high specific activity and Cu-64 is produced on cyclotrons around the world. Both isotopes have half-lives that favour centralised manufacture and broad distribution. The TCT platform also has a number of environmental benefits, including the clean production of isotopes without the creation of highly toxic and long-lived waste products during manufacture.

Utilising the many benefits of Clarity’s SAR technology, all TCT products are manufactured at room temperature, significantly lowering the risk of batch failures, in contrast to first generation radiopharmaceuticals, including Lu-177 based products, which require heating the biological targeting agents to 90°C during manufacture. Furthermore, as the majority of nuclear reactors are located outside of the US2, reactor based radiopharmaceuticals also require long transit times into the US from other jurisdictions.

In recent times, a number of complications have arisen with nuclear reactor produced radiopharmaceuticals, most recently being the outage at the High Flux Reactor (HFR) in Petten, Netherlands, in February 20223,4,5,6. The EU has flagged this as a significant issue and advised that the European research reactors are approaching their "end-of-life". Without replacing this aging infrastructure, the EU could experience significant radioisotope shortages and impede access to vital treatments for its citizens. These shortages may impact the roll-out of lutetium-177 (177Lu) based products, which will severely hinder the growth of radiopharmaceuticals moving forward.7

"Clarity’s TCT platform of products aims to minimise all of these risks by clearly differentiating ourselves from the current pack of first generation radiopharmaceuticals and fully exploiting the many benefits of the "perfect pairing" of copper isotopes, including security and control of the entire supply chain, as we advance towards our ultimate goal of better treating children and adults with cancer," Dr Taylor concluded.

Puma Biotechnology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 5, 2022 Illumina, Inc. reported a long-term strategic collaboration with Janssen Biotech, Inc. (Janssen) to accelerate the development of precision medicines (Press release, Illumina, MAY 5, 2022, View Source [SID1234613845]).

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Illumina can help deliver precision medicine at scale

This is the first of what we expect will be many pharmaceutical strategic partnerships as the industry leverages the power of Illumina to create precision medicine at scale. Illumina brings four key attributes to such strategic CDx partnerships:

Enabling data-driven insights that drive innovative strategies for new drug target discovery using deep learning and AI-based genome interpretation tools such as PrimateAI, which leverages a dataset of human variants and over 300,000 common missense variants from six non-human primate species. Common missense variants in other primate species are largely clinically benign in humans, enabling pathogenic mutations to be systematically identified by the process of elimination. SpliceAI is another tool utilizing deep learning to identify splicing sites in noncoding regions of the genome with high accuracy.
Supporting innovation and discovery using whole-genome sequencing (WGS) and other multi-omic methodologies using Illumina Lab Services to deliver evidence in a hypothesis-supporting manner. Exploratory work on samples provided by pharma collaborators can unlock novel discoveries that improve human health.
Access to a formal CDx program aimed at therapeutic selection that can help doctors reach the intended patient population with precision therapies targeted at the unique biomarker in their tumor.
Global commercial reach through the largest install base of NGS instrumentation in the world.
As health care moves from a centralized diagnostic approach using large laboratories to run samples to a decentralized lab ecosystem with in-hospital and in-clinic diagnostic capacity, patient care teams will understand individual cancers faster and can begin precision therapies in days, not weeks.

Treatment for cancer should begin as soon as possible, but the current turnaround time for sample sequencing means many patients begin on standard-of-care treatment, which may close the door to precision therapies targeted to their unique tumor biomarkers.

As part of the collaboration, Illumina, together with Janssen, will co-develop CDx programs on Illumina’s TruSightOncology Comprehensive, a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient’s cancer. With its global launch, announced in March and first taking place in Europe, the in vitro diagnostic (IVD) comprehensive genomic profiling (CGP) kit will help inform precision medicine decisions for patients across the continent.

The collaboration will also explore the potential benefits of accessing Illumina’s new and cutting-edge technologies to develop a target discovery engine, which has the potential to support new drug and biomarker target discoveries.

The movement from comprehensive oncology panels to a multi-omic approach to diagnosis and treatment has been enabled by Illumina’s broad range of research products and network of partnerships, including:

Our DRAGEN Bio-IT Platform, which provides accurate, ultra-rapid analysis of WGS data. The platform can process data for an entire human genome at 30× coverage in about 25 minutes.
An agreement with SomaLogic to create an end-to-end proteomics solution on Illumina’s NGS platforms, which, combined with the scale and speed of our NGS technology. With the scale and speed of Illumina NGS technology, researchers can more effectively and efficiently make biological connections from genetic sequence (genotype) to cellular function (phenotype) and accelerate opportunities for clinical impact.
A deal with Nashville Biosciences to map WGS data onto existing patient records in the system’s electronic health record (EHR) system using a de-identified data set of approximately 250,000 human DNA samples. This work can help better identify disease associations and intervention targets.
As Illumina’s Matt Nelson and Janssen’s Flora Berisha noted during their presentation on the opening day of the World CDx Summit, together we can do more. Precision medicine is a key component of pharma’s R&D strategy, and Illumina stands ready to support the development of precision diagnostics through our best-in-class portfolio of products across the oncology care continuum.

On May 5, 2022 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported first quarter 2022 financial results and provided a business update (Press release, NextCure, MAY 5, 2022, View Source [SID1234613819]).

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"In the first quarter, we continued to advance our pipeline of four product candidates towards key clinical milestones," said Michael Richman, NextCure’s President and Chief Executive Officer. "In the second half of 2022, we anticipate clinical trial updates for NC318, NC410, and NC762, as well as an IND filing for NC525. We also expect our quarter-end cash position of $201.3 million will fund our operations into the first quarter of 2024."

Expected Milestones

We believe we are on track to meet the following milestones during the second half of 2022:

NC318 Phase 2 update: fourth quarter of 2022 (Amended Phase 2 with patient selection and increased dosing).
NC318 anti-PD-1 combo initial data second half of 2022 (Yale University Investigator-Initiated trial).
NC410 Phase 1 update: second half of 2022.
NC762 Phase 1 initial data: second half of 2022.
NC525 Investigational New Drug Application (IND) filing: fourth quarter of 2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.

Financial Results for First Quarter March 31, 2022

Cash, cash equivalents, and marketable securities, excluding restricted cash, as of March 31, 2022, were $201.3 million as compared with $219.6 million as of December 31, 2021. The decrease of $18.3 million primarily reflects cash used to fund operations.
Research and development expenses were $15.0 million for the quarter ended March 31, 2022 as compared to $12.4 million for the quarter ended March 31, 2021. The increase of $2.6 million was driven primarily by additional clinical and lab-related costs.
General and administrative expenses were $5.8 million for the quarter ended March 31, 2022 as compared with $4.9 million for the quarter ended March 31, 2021. The increase of $0.9 million was primarily related to additional personnel-related costs.
Net loss was $20.6 million for the quarter ended March 31, 2022 as compared with $16.5 million for the quarter ended March 31, 2021. The changes in net loss from the previous year’s quarter were primarily due to increased research and development expenses.

On May 5, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended March 31, 2022 (Press release, NGM Biopharmaceuticals, MAY 5, 2022, View Source [SID1234613844]).

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"We are pleased with the progress that we have made to date in 2022, in particular with our oncology portfolio, including the advancement of our second myeloid checkpoint inhibitor program, NGM831, into the clinic," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "We plan to deliver several program updates in the second half of the year with multiple milestones expected, including topline Phase 2 data from the CATALINA trial for NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3 for patients with geographic atrophy, as well as initial interim monotherapy data from the NGM707 Phase 1 trial and updated data from the Phase 1a/1b trial of NGM120, an antagonist antibody product candidate that binds GFRAL and is designed to inhibit GDF15 signaling, both of which we are developing for the treatment of cancer."

Key First Quarter and Recent Highlights

Oncology

Initiated the Phase 1/1b clinical trial of NGM831 as a monotherapy and in combination with KEYTRUDA for the treatment of patients with advanced solid tumors.
Delivered an oral presentation at the 2022 AACR (Free AACR Whitepaper) annual meeting to showcase in vitro and in vivo research demonstrating potential advantages of dual ILT2/ILT4 inhibition with NGM707 and late-breaking poster presentations to highlight preclinical research supporting development of NGM831 and NGM438.
Retinal Disease

The U.S. Food and Drug Administration granted Fast Track designation to NGM621 for the treatment of patients with geographic atrophy, or GA, secondary to age-related macular degeneration.
Liver and Metabolic Diseases

Completed enrollment in ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated NASH cirrhosis (F4 NASH), in January 2022. A topline data readout for ALPINE 4 is expected in the first half of 2023.
Corporate Highlights

Hosted the first two sessions of a four-part virtual R&D overview event titled the "Explorer Series" showcasing NGM Bio’s discovery engine and NGM Bio’s myeloid reprogramming programs, NGM831 and NGM438, both targeting tumor stromal checkpoints.
First Quarter 2022 Financial Results

NGM reported a net loss of $32.5 million for the quarter ended March 31, 2022, compared to a net loss of $27.5 million for the same period in 2021.
Related party revenue from our collaboration with Merck was $20.9 million for the quarter ended March 31, 2022, compared to $21.6 million for the same period in 2021.
R&D expenses were $42.8 million for the quarter ended March 31, 2022, compared to $40.7 million for the same period in 2021. R&D expenses increased $2.1 million in the quarter as compared to the same period in 2021, primarily due to our ongoing clinical trials of NGM621, NGM707, NGM831 and NGM120, our preclinical study of NGM438, and personnel-related expenses partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $10.7 million for the quarter ended March 31, 2022, compared to $8.7 million for the same period in 2021. The $2.0 million increase in general and administrative expenses in the quarter as compared to the same period in 2021 was primarily attributable to compensation-related expenses driven by higher headcount and an increase in expenses associated with being a public company.
Cash, cash equivalents and short-term marketable securities were $329.8 million as of March 31, 2022, compared to $366.3 million as of December 31, 2021.