On May 28, 2024 Kinomica Ltd., a developer of KScan precision oncology diagnostics, reported the company and collaborators from King’s College London and King’s College Hospital NHS Foundation Trust will be presenting at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which will be held May 31 – June 4, in Chicago, IL (Press release, King’s College London, MAY 28, 2024, View Source [SID1234643752]).

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Debashis Sarker MBChB FRCP PhD, Reader in Experimental Oncology, King’s College London and Consultant Medical Oncologist at King’s College Hospital, part of King’s Health Partners, will present the results of the collaboration in a poster titled ‘Identification of a predictive phosphoproteomic signature of response to atezolizumab and bevacizumab (AB) in patients with advanced hepatocellular carcinoma (aHCC)’.

Details of the poster presentation are as follow:

Poster Session: Developmental Therapeutics—Immunotherapy

Session Date and Time: Saturday June 1, 2024, 9:00 AM – 12:00 PM CDT

Poster Board Number: 110

Abstract Presentation Number: 2631

"We look forward to sharing our important work that for the first time describes a promising biomarker signature with the potential to predict response to the immunotherapy atezolizumab and bevacizumab in patients with aHCC," said Dr Sarker. "An important characteristic of the study is that the biomarkers have been derived from real-world Tru-Cut biopsies taken at diagnosis providing confidence in their potential clinical utility."

"This collaborative effort, drawing on multidisciplinary expertise and rich clinical proteomic data demonstrates the predictive power of the KScan diagnostic platform," said Tim Fell PhD, Executive Chair of Kinomica. "We look forward to extending this collaborative research to determine predictive biomarkers to other approved aHCC therapies and the creation of a multi-drug diagnostic to aid therapy selection."

Kinomica will be attending ASCO (Free ASCO Whitepaper). Please contact us to request a meeting.

On May 28, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that it has entered into a clinical trial agreement with the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) and Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI), a specialized international biopharmaceutical company (Press release, BerGenBio, MAY 28, 2024, View Source [SID1234643751]).

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The parties will collaborate to study BerGenBio’s selective AXL inhibitor, bemcentinib, in combination with Sobi’s pacritinib in patients with advanced lung adenocarcinoma. The clinical study is externally funded and is complementary to BerGenBio’s ongoing Ph1b/2a clinical study in first-line Non-Small Cell Lung Cancer patients with mutations in the STK11 gene.

Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase, a promising therapeutic target for serious diseases. Pacritinib (marketed as VONJO) is a JAK2 inhibitor indicated for treatment of myelofibrosis, a bone marrow disorder, and works by blocking certain growth factors and cytokines.

The clinical study will advance the ground-breaking work of Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Assistant Professor in the Division of Hematology and Oncology at UT Health San Antonio. Dr. Taverna’s prior research has demonstrated that AXL and JAK-STAT3 work together to transmit signals that promote tumor growth and metastasis in advanced lung cancer. The study will be performed in collaboration with Sobi and will be led by Dr. Taverna as the principal investigator and is funded by a grant received from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).

Martin Olin, Chief Executive Officer of BerGenBio stated, "We are excited to work with two stellar partners to bring this intriguing area of research to patients. This study will further extend our knowledge of the role of selective AXL inhibition with bemcentinib in lung cancer, our area of highest strategic focus."

Dr. Taverna commented, "Our data suggests that targeting the AXL-STAT3 pathway with bemcentinib and pacritinib can prevent tumor cells from recruiting tumor-associated macrophages and other aggressive host cells into the tumor microenvironment, disrupting tumor growth and metastatic spread. Understanding this discovery could shed light on novel therapeutic strategies for lung cancer."

On May 28, 2024 Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG reported to have have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi (golimumab) (Press release, BioThera Solutions, MAY 28, 2024, View Source [SID1234643750]).

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Under the agreement, Bio-Thera Solutions ("Bio-Thera") will maintain responsibility for development, manufacturing, and supply of BAT2506. STADA Arzneimittel AG ("STADA") will have exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries.

Bio-Thera will receive an upfront payment of US$10 million, as well as further development and commercial milestones of up to US$147.5 million, subject to the fulfillment of certain conditions.

"STADA is one of the premier biosimilar companies in Europe, and we are pleased to establish a partnership with STADA for BAT2506", said Dr. Shengfeng Li, CEO of Bio-Thera. "We look forward to working with STADA to bring BAT2506 to immunology patients in Europe."

"With global sales in 2023 of US$2.2 billion, including more than US$1 billion outside of the US, golimumab represents a compelling opportunity to broaden patient access to biological treatments and build scale in immunology alongside our approved adalimumab and ustekinumab biosimilars. Bio-Thera’s broad expertise in biologic medicines, including with two biosimilars already approved by the US Food and Drug Administration, makes it an attractive partner for STADA," commented STADA’s head of Global Specialty, Bryan Kim.

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers.

On May 28, 2024 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will present at the William Blair 44th Annual Growth Stock Conference in Chicago, IL on Tuesday, June 4, 2024 at 8:00 AM CT (Press release, West Pharmaceutical Services, MAY 28, 2024, https://www.westpharma.com/investors/press-releases?utm_source=SitecoreSend&utm_medium=Email&utm_campaign=Investors_Email&campaignid=null&utm_content=28_May_2024&utm_term=null&creative=null&device=null&matchtype=null#2024-may-28-west-to-participate-in-upcoming-investor-conference [SID1234643749]).

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A live audio webcast of the event will be available in the "Investors" section of the Company’s website at www.westpharma.com. Replay of the webcasts will be available for approximately 90 days after the event.

On May 28, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported interim clinical data as of a March 6, 2024 data cutoff from the ongoing phase 1/2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab (Press release, Merus, MAY 28, 2024, View Source [SID1234643748]). These data will be presented by Dr. Jerome Fayette M.D. Ph.D., Centre Léon Bérard, Lyon, France at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Monday, June 3 at 8 a.m. CT.

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"In this interim dataset, petosemtamab in combination with pembrolizumab has demonstrated clinically meaningful activity in first line head and neck cancer, with a 67% response rate overall, observed across tumor PD-L1 expression levels and HPV status and with encouraging safety," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "I’m excited to announce plans to initiate a phase 3 registration trial of petosemtamab in combination with pembrolizumab, regardless of HPV status, in first line, PD-L1 expressing, head and neck cancer, which we expect will start by year end 2024."

"Despite recent advancements, head and neck squamous cell carcinoma remains a deadly disease with limited treatment options," added Dr. Fayette. "Based on these data, I’m optimistic petosemtamab, in combination with pembrolizumab, has the potential to become a new standard of care for patients with previously untreated head and neck cancer."

Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics): Solid Tumors

Rapid oral presentation title: Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 study
Observations in the presentation include:

As of a March 6, 2024 data cutoff date, 45 patients (pts) were treated
26 patients were enrolled as of the abstract cutoff date
The efficacy population consisted of 24 patients who had the opportunity for 4 or more months follow up, with ≥2 treatment cycles and ≥1 post-baseline tumor assessment; or who discontinued early due to disease progression or death
Two patients were not included: One patient withdrew consent prior to first tumor assessment and the other patient discontinued due to toxicity with less than 2 cycles of treatment
Response rates overall (N=24): 67%, including 1 confirmed complete response, 12 confirmed partial responses (PRs) and 3 unconfirmed PRs (all of whom confirmed after the data cutoff) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including
3 of 4 patients with HPV associated cancer responded
Responses observed across PD-L1 levels (CPS 1-19: 60% [6/10]; CPS ≥ 20: 71% [10/14])
At the time of data cutoff, 32 patients of the 45 enrolled, remained on treatment, including 14 of 16 responders and 18 of the initial 26 patients enrolled
Median follow up of 3.6 months for the 45 patients
In 45 patients the combination was well tolerated and no significant overlapping toxicities with pembrolizumab were observed
Treatment-emergent adverse events (AEs) were reported in 45 pts
Most were Grade (G) 1 or 2 in severity (no G4–5 were observed)
Infusion-related reactions (composite term) were reported in 38% (all Gs) and 7% (G3) of pts, most occurred during the first infusion and resolved
Presentation Details:
Abstract #: 6014
Session Title: Head and Neck Cancer
Session Date and Time: June 3, 2024, 8:00-9:30 a.m. CT

As full presentations become available at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, they will contemporaneously be available on the Merus website.

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on Tuesday, May 28, 2024 at 8:00 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time.

Date & Time: May 28, 2024 at 8:00 a.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: 1 (800) 715-9871/ International: 1 (646) 307-1963
Conference ID: 4160163