On July 25, 2024 Nectin Therapeutics, Ltd., a biotechnology company developing novel immunotherapies and antibody drug conjugates (ADC) to address tumor resistance, reported a global, exclusive license agreement with Immunome Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies (Press release, Nectin Therapeutics, JUL 25, 2024, View Source [SID1234645093]). Under the terms of the license, Immunome received exclusive rights to a panel of antibodies targeting an undisclosed target.

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"This agreement allows Nectin to realize value while further pursuing and enabling the focus on our first-in-class anti-PVR program (NTX1088) through its ongoing clinical study in tumor types with high unmet need as well as advance our novel ADCs into clinical development. Immunome’s leadership team’s track record of developing and commercializing novel ADC therapies makes it an ideal partner to advance these promising assets," said Fabian Tenenbaum, Chief Executive Officer of Nectin Therapeutics.

"Immunome believes the next generation of transformative antibody drug conjugates will address novel targets by pairing high-quality antibodies with innovative linker-payload technology," said Clay Siegall, PhD, President and Chief Executive Officer of Immunome. "We appreciate the work Nectin has done on these antibodies and look forward to advancing them further."

Under the terms of the agreement, Nectin granted Immunome an exclusive, worldwide, all-fields license to monoclonal antibodies that are directed to a single undisclosed target. Immunome will be responsible for the research, development, manufacturing and commercialization of products incorporating these antibodies. Nectin will receive an upfront payment and will be eligible for milestones and royalties.

On July 25, 2024 Bio-Thera Solutions Inc. (688177: SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that dosing has recently begun in an integrated Phase I / Phase III clinical study for BAT3306, a proposed biosimilar of Keytruda (pembrolizumab) (Press release, BioThera Solutions, JUL 25, 2024, View Source;phase-iii-clinical-trial-for-bat3306-a-proposed-biosimilar-of-keytruda-pembrolizumab-302206502.html [SID1234645094]). The clinical study is a randomized, double-blind, parallel group, active control study to compare the pharmacokinetics, efficacy and safety of BAT3306 to Keytruda in non-squamous non-small cell lung cancer (nsNSCLC) patients. The study is expected to enroll approximately 676 patients.

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"Keytruda is the most important innovative cancer therapy currently in use," said Shengfeng Li, CEO at Bio-Thera. "Bio-Thera is committed to expanding access to this important cancer therapy with the development of BAT3306."

Bio-Thera Solutions is developing a large pipeline of biosimilars that include BAT1806, a tocilizumab has been approved by FDA, EMA and NMPA, BAT1706, a bevacizumab has been approved by FDA and NMPA. BAT2206, a ustekinumab has been filed with FDA, EMA and NMPA. Bio-Thera Solutions is also pursuing biosimilar versions of golimumab, secukinumab, and mepolizumab.

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]).

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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]).

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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 24, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model (Press release, AIM ImmunoTech, JUL 24, 2024, View Source [SID1234645033]).

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"Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1" was published in the peer-reviewed journal Vaccines.

AIM Medical Officer David Strayer, MD, stated: "This new pre-clinical data further demonstrates Ampligen’s therapeutic potential when used with dendritic-cell vaccines, with anti-PD-L1 checkpoint inhibitors, or in combination with both. The data supports AIM’s belief that we are on the right path in our ongoing development of Ampligen as an anti-tumor therapy."