On July 24, 2024 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported that the American Medical Association (AMA) has granted a PLA code for the PurISTSM pancreatic cancer test (Press release, GeneCentric Therapeutics, JUL 24, 2024, View Source [SID1234645075]). PurIST is commercially available under a collaboration agreement with Tempus AI, Inc. (NASDAQ: TEM) and run on its xR platform. The PurIST PLA code is the first CPT code created to describe an algorithm-only analysis from previously sequenced, LDT, transcriptomic (RNA) data and represents a meaningful step toward reimbursement for AI-enabled algorithms.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Receipt of a PurIST-specific PLA test code further supports the significance of GeneCentric’s pipeline of next-generation AI-derived tests," said Michael Milburn, PhD, President and CEO of GeneCentric Therapeutics. "This is a key step toward reimbursement and successful commercialization for PurIST, and we’re excited about the importance of this test in guiding first-line treatments for pancreatic cancer patients."

Pancreatic cancer has one of the highest mortality rates among all major cancers, and there has been limited availability of validated diagnostic tests or biomarkers to guide first-line treatment selection. The PurIST test classifies the tumors of patients with unresectable stage III or stage IV pancreatic ductal adenocarcinoma (PDAC) as either a basal or classical subtype and can help guide first-line therapy.

About the PurIST Test

PurIST identifies the molecular subtype of patients with unresectable stage III or stage IV PDAC and classifies patients with PDAC into either a basal or classical subtype and may help inform first-line therapy management. Tempus and GeneCentric recently completed a new clinical validation study demonstrating that PurIST can be used to help predict overall survival of classical patients between standard-of-care first-line therapies, FOLFIRINOX and gemcitabine nab-paclitaxel. The PurIST test is available for ordering as part of the on-line Tempus HUB or via paper requisition forms for orders in the United States. Providers and patients can learn more about the PurIST test on the Tempus website.

About Pancreatic Cancer

Pancreatic cancer is the 10th most commonly diagnosed cancer in the U.S. and the 12th most common cancer worldwide. The National Cancer Institute estimates there will be over 64,440 new cases and more than 51,750 deaths in the U.S. alone in 2024, making it the third-leading cause of cancer-related deaths in the U.S. with one of the highest mortality rates of all major cancers. More than 90% of pancreatic cancers are pancreatic ductal adenocarcinoma (PDAC), and the 5-year overall survival for resectable/borderline-resectable and non-resectable PDAC is approximately 20% and 1-3%, respectively. The three main treatments for PDAC are surgical resection (if diagnosed early), radiation therapy and chemotherapy. For resectable tumors, surgical resection is provided with curative intent, however, for non-resectable tumors, chemotherapy such as FOLFIRINOX or gemcitabine with nab-paclitaxel is often used.

On July 24, 2024 Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, reported the publication in the August edition of Haematologica of preclinical data from the University of Nantes (CRCI2NA) further supporting the therapeutic activity of Step’s highly selective CTPS1 inhibitors in the treatment of blood cancers (Press release, Step Pharma, JUL 24, 2024, View Source [SID1234645044]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The therapeutic activity was observed for mantle cell lymphoma (MCL), including difficult-to-treat in vitro and in vivo models. Furthermore, Step Pharma’s CTPS1 inhibitors show significant synergy when combined with venetoclax, a selective BCL2 inhibitor that is commonly used to treat certain types of lymphoma and leukaemia.

CTPS1, an enzyme crucial in pyrimidine synthesis, plays a significant role in cancer cell proliferation. Step Pharma’s compounds selectively inhibit the de novo pyrimidine synthesis pathway by targeting CTPS1, providing a novel approach to cancer treatment. The Company’s lead asset, dencatistat (STP938), a first-in-class, highly selective, orally bioavailable CTPS1 inhibitor, is currently in phase 1 clinical development for T cell and B cell lymphoma (NCT05463263) with study sites open in France, the UK, and the USA.

MCL accounts for approximately 5% of B cell lymphoma. Despite recent advancements in the treatment of MCL, there is still an unmet clinical need for those who have not responded to Bruton’s Tyrosine Kinase (BTK) inhibitor therapy.

Andrew Parker, Chief Executive Officer of Step Pharma, commented

"The publication in Haematologica of these preclinical data provides additional evidence of the importance of inhibiting CTPS1 for the treatment of blood malignancies, including T and B cell lymphoma. The findings further support our approach as we continue to progress our phase 1 trial to develop targeted and efficient treatment options for individuals with blood cancer."

David Chiron, CNRS researcher at CRCI2NA, Nantes University, added

"These data represent a significant advancement in our understanding of blood cancer biology, particularly regarding the role of CTPS1. Our research on inhibiting CTPS1 emphasises the potential of this approach to fill an important gap in current treatment methods. These findings support the targeted inhibition of CTPS1 as a promising therapeutic strategy and pave the way for further research to gain a deeper understanding of its role and broader applications in different types of blood cancers."

On July 24, 2024 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended June 29, 2024 (Press release, Thermo Fisher Scientific, JUL 24, 2024, View Source [SID1234645045]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter 2024 Highlights

•Second quarter revenue was $10.54 billion.
•Second quarter GAAP diluted earnings per share (EPS) increased 15% to $4.04.
•Second quarter adjusted EPS increased 4% to $5.37.

•Advanced our proven growth strategy, launching a range of high-impact, innovative new products during the quarter. This included a number of analytical instruments introduced at the American Society for Mass Spectrometry conference, including the Thermo Scientific Stellar mass spectrometer, which validates proteins of clinical interest discovered through our groundbreaking Thermo Scientific Orbitrap Astral mass spectrometer; and three new built-for-purpose editions of the Thermo Scientific Orbitrap Ascend Tribrid mass spectrometer tailored to MultiOmics, Structural Biology and BioPharma applications. To help our customers meet their sustainability goals, we also launched: a first-of-its-kind biobased film for our bioprocessing containers, which uses plant-based materials to deliver lower-carbon solutions in the manufacturing of therapies; and a new line of ENERGY STAR-certified Thermo Scientific TSX Universal Series ULT Freezers, which deliver industry-leading performance and energy efficiency.

•Continued to strengthen our industry-leading commercial engine and deepen our trusted partner status with customers to accelerate their innovation and enhance their productivity. In the quarter, we expanded our leading clinical trial supply services with a new ultra-cold facility in Bleiswijk, the Netherlands and a new state-of-the-art innovation lab at our site in Center Valley, Pennsylvania, to enable our pharmaceutical and biotech customers to accelerate the development of therapies and medicines. Also in the quarter, to support Indonesia’s growing investments in healthcare, scientific research, and renewable energy, we expanded our presence and capabilities in the country, further demonstrating our relevance to customers around the world.

•Shortly after the quarter ended, we completed our acquisition of Olink, a provider of differentiated next-generation proteomic solutions. The addition of Olink’s technology extends our capabilities and further advances our leadership position in protein research,enabling our customers to meaningfully accelerate discovery and scientific breakthroughs while delivering on the promise of precision medicine.

"Our excellent execution enabled us to deliver another quarter of strong financial performance and share gain," said Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher Scientific. "We continue to see the benefit of our proven growth strategy and the impact of our PPI Business System in our performance. Shortly after the quarter ended, we were also pleased to welcome our Olink colleagues to Thermo Fisher and are excited about the power of this new combination to better serve our customers and advance science."

Casper added, "We have made very good progress through the halfway point of the year and are in a great position to deliver differentiated performance in 2024. We’ve further extended our industry leadership and positioned our company for an even brighter future."

Second Quarter 2024

Revenue for the quarter declined 1% to $10.54 billion in 2024, versus $10.69 billion in 2023. Organic revenue was 1% lower and Core organic revenue growth was flat.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2024 increased 15% to $4.04, versus $3.51 in the same quarter last year. GAAP operating income for the second quarter of 2024 grew to $1.82 billion, compared with $1.58 billion in the year-ago quarter. GAAP operating margin increased to 17.3%, compared with 14.8% in the second quarter of 2023.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2024 increased 4% to $5.37, versus $5.15 in the second quarter of 2023. Adjusted operating income for the second quarter of 2024 was $2.35 billion, compared with $2.37 billion in the year-ago quarter. Adjusted operating margin increased to 22.3%, compared with 22.2% in the second quarter of 2023.

Annual Guidance for 2024

Thermo Fisher is raising its full-year revenue and adjusted EPS guidance. The company is raising its revenue guidance to a new range of $42.4 to $43.3 billion versus its previous guidance of $42.3 to $43.3 billion. The company is raising its adjusted EPS guidance to a new range of $21.29 to $22.07 versus its previous guidance of $21.14 to $22.02.

On July 23, 2024 Mendus AB ("Mendus" publ; IMMU.ST) reported that it has entered into a collaboration with Institut Bergonié, a leading cancer center in Bordeaux, France to study the Mendus’ intratumoral immune primer ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, a multicenter, prospective open-labeled phase 1/2 trial combining regorafenib and avelumab in solid tumors (Press release, mendus, JUL 23, 2024, View Source [SID1234645014]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on promising signs of clinical efficacy in a wide range of solid tumors and following the successful implementation of manufacturing process improvements, Mendus had previously communicated its decision to move the ilixadencel program forward in hard-to-treat solid tumors, with soft tissue sarcomas as a prioritized indication. Mendus announces today a collaboration with Institut Bergonié, Bordeaux, France to study ilixadencel as a novel immunotherapy in combination with the tyrosine kinase inhibitor (TKI) regorafenib and the immune checkpoint inhibitor avelumab as part of the REGOMUNE trial, which is coordinated by Institut Bergonié. Bayer AG supplies regorafenib and Merck KGaA supplies avelumab as study drug for the trial.

"To study ilixadencel in soft tissue sarcomas provides for the opportunity to assess the relevance of intratumoral immune priming with ilixadencel in hard-to-treat tumors that are poorly responding to currently available therapies", says Jeroen Rovers, Chief Medical Officer at Mendus. "Based on our completed clinical trials we are confident that ilixadencel can be safely combined and may act synergistically with tyrosine kinase inhibitors and immune checkpoint inhibitors. This provides for a solid basis to study the combination with regorafenib and avelumab in collaboration with Institut Bergonié as part of the REGOMUNE trial."

The REGOMUNE trial (ClinicalTrials.gov ID: NCT03475953) is a prospective open-labeled phase 1/2 trial combining regorafenib and avelumab in multiple solid tumors, led by Dr Sophie Cousin and Prof Dr Antoine Italiano. Following a phase 1b dose escalation study design, the combination of regorafenib with avelumab is being evaluated in 17 cohorts of advanced or metastatic tumors in independent phase 2 trials. The trial is recruiting patients in 7 specialized cancer hospitals throughout France. As part of the trial, Mendus will supply ilixadencel as study drug to treat up to 43 patients suffering from soft tissue sarcomas (STS).

Institut Bergonié is a comprehensive cancer center which, is the regional reference center for oncology in the Nouvelle-Aquitaine region of France. The center has a long history in cancer research and recently celebrated its centennial anniversary. Institut Bergonié is part of UNICANCER, a national hospital network of 20 French Comprehensive Cancer Centers (FCCC) which are entirely devoted to fighting cancer with the same unique model based on patient care, research and oncology education.

"Institut Bergonié is committed to provide access to all areas of cancer research to patients", says Prof Dr Antoine Italiano, principal investigator of the REGOMUNE trial and head of the Department of Medicine at Institut Bergonié. "Through our own research and in collaboration with external partners, we develop innovative treatments where they are most needed and the REGOMUNE trial is an excellent example of how we bring together promising new combination therapies to address hard-to-treat tumors. Based on its promising signs of efficacy and excellent safety profile, we look forward to add ilixadencel to the combination of regorafenib and avelumab for treatment of soft tissue sarcomas in the REGOMUNE trial."

Mendus and Institut Bergonié expect to complete the preparations for the ilixadencel treatment arm within the REGOMUNE trial in the second half of 2024 and first patient data to be available first half of 2026.

"Our continued research efforts and manufacturing process improvements allow us to bring ilixadencel back into clinical development and we feel privileged to work with Institut Bergonié as one of the leading cancer centers in Europe based on clinical and medical-scientific expertise", says Mendus CSO Alex Karlsson Parra. "A next wave of innovation in immuno-oncology is expected to come from novel combination approaches for tumors that are poorly responding to currently available therapies and this is where we have focused our preclinical and clinical research with ilixadencel. The REGOMUNE trial provides for an excellent opportunity to evaluate intratumoral immune priming with ilixadencel as a treatment which can have a meaningful impact in the lives of people suffering from hard-to-treat tumors."

On July 23, 2024 Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, reported financial results for the second quarter ended June 30, 2024 (Press release, Quest Diagnostics, JUL 23, 2024, View Source [SID1234645016]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We delivered another strong quarter, with base business revenue growth of nearly 4% and total revenue growth of 2.5% as well as continued improvement in productivity and profitability in the base business," said Jim Davis, Chairman, CEO and President. "This performance is due to growth of new physician and hospital customers, more favorable test mix that includes greater adoption of advanced diagnostics and continued strength in healthcare utilization. We also made progress improving our operational quality and efficiency through greater use of automation and AI."

Mr. Davis added: "In addition, we are excited to announce four acquisitions that meet our criteria for growth, profitability and returns, and that will enable us to expand in strategic growth areas. Our planned acquisition of LifeLabs will position us to help this trusted lab leader grow and better serve Canada’s growing and aging population. The acquisitions we recently announced of select outreach lab assets of Allina Health in Minnesota and Wisconsin and OhioHealth in Ohio reflect our ability to partner with high-quality health systems and extend our presence in key geographies. Our recently completed PathAI Diagnostics acquisition positions us to rapidly scale digital pathology innovation to help health systems and other providers improve cancer diagnoses."

Three Months Ended June 30,

Six Months Ended June 30,

2024

2023

Change

2024

2023

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,397

$ 2,338

2.5 %

$ 4,763

$ 4,669

2.0 %

Diagnostic Information Services revenues

$ 2,333

$ 2,268

2.8 %

$ 4,631

$ 4,527

2.3 %

Revenue per requisition

1.6 %

0.9 %

Requisition volume

1.1 %

1.4 %

Organic requisition volume

0.7 %

0.9 %

Operating income (a)

$ 355

$ 348

1.9 %

$ 655

$ 653

0.2 %

Operating income as a percentage of net revenues (a)

14.8 %

14.9 %

(0.1) %

13.7 %

14.0 %

(0.3) %

Net income attributable to Quest Diagnostics (a)

$ 229

$ 235

(2.4) %

$ 423

$ 437

(3.1) %

Diluted EPS (a)

$ 2.03

$ 2.05

(1.0) %

$ 3.75

$ 3.83

(2.1) %

Cash provided by operations

$ 360

$ 444

(18.9) %

$ 514

$ 538

(4.4) %

Capital expenditures

$ 92

$ 104

(10.8) %

$ 196

$ 231

(14.9) %

Adjusted (a):

Operating income

$ 398

$ 389

2.1 %

$ 747

$ 739

1.0 %

Operating income as a percentage of net revenues

16.6 %

16.7 %

(0.1) %

15.7 %

15.8 %

(0.1) %

Net income attributable to Quest Diagnostics

$ 266

$ 263

1.4 %

$ 496

$ 495

0.2 %

Diluted EPS

$ 2.35

$ 2.30

2.2 %

$ 4.39

$ 4.34

1.2 %

(a)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2024

The company updates its full year 2024 guidance as follows:

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$9.50 billion

$9.58 billion

$9.40 billion

$9.48 billion

Net revenues increase

2.7 %

3.5 %

1.6 %

2.5 %

Reported diluted EPS

$7.57

$7.77

$7.57

$7.82

Adjusted diluted EPS

$8.80

$9.00

$8.72

$8.97

Cash provided by operations

Approximately $1.3 billion

Approximately $1.3 billion

Capital expenditures

Approximately $420 million

Approximately $420 million

The company’s updated guidance does not include the impact of the pending LifeLabs acquisition given the uncertainty around when the transaction will close. The company continues to expect to complete the transaction by the end of the year, subject to certain customary closing conditions and approvals, including Canadian regulatory approvals.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, gains and losses associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on July 23, 2024 until midnight Eastern Time on August 6, 2024, by phone at 866-363-1805 for domestic callers or 203-369-0193 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.