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Haystack Oncology and Rutgers Cancer Institute Collaborate to use Haystack MRD™ in Clinical Study of Early-Stage Triple-Negative Breast Cancer

On December 14, 2023 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, reported that it has entered into a collaboration with Rutgers Cancer Institute of New Jersey to use Haystack Oncology’s industry-leading personalized MRD technology (Haystack MRD) to help evaluate therapeutic response and provide molecular insights for a Rutgers Cancer Institute clinical trial examining early-stage triple-negative breast cancer (TNBC) patients undergoing treatment in the adjuvant setting with liposomal doxorubicin and carboplatin (Press release, Quest Diagnostics, DEC 14, 2023, View Source [SID1234638573]). Rutgers Cancer Institute together with RWJBarnabas Health is the state’s only National Cancer Institute-designated Comprehensive Cancer Center.

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"We’re excited to work with Rutgers Cancer Institute in their efforts to optimize therapeutic strategies for patients with early-stage breast cancer," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "With unparalleled sensitivity, Haystack MRD provides a tool for anticipating and evaluating treatment-related benefits to a greater depth than standard clinical and radiographic metrics, making it well-equipped to support clinical studies such as this, which are essential for advancing cancer care."

"Triple-negative breast cancer is a subtype of breast cancer that is aggressive by nature with a complex biology, therefore, the disease tends to have a worse prognosis," said Mridula George, MD, associate program director of Breast Medical Oncology at Rutgers Cancer Institute and principal investigator of the study, which is also open at select RWJBarnabas Health sites across New Jersey. "We are excited to use Haystack’s MRD technology to monitor treatment response in our clinical trial that could help inform future studies and novel approaches that will result in better outcomes for our patients."

Purple Biotech Completes Patient Enrollment in Phase 2 Pancreatic Cancer Trial

On December 14, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it has completed patient enrollment in a Phase 2 study of CM24, a multi-functional immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC) (Press release, Purple Biotech, DEC 14, 2023, View Source [SID1234638572]).

The Phase 2 study (NCT04731467), in collaboration with Bristol Myers Squibb (BMS), is evaluating CM24 in combination with BMS’s nivolumab plus chemotherapy in PDAC patients as a 2nd line treatment as compared to chemotherapy alone. The primary endpoint is overall survival (OS). Approximately 60 patients have been enrolled through 18 centers in the U.S., Spain and Israel.

The trial was fully enrolled in advance of the anticipated 2024 timeline. An interim analysis of overall survival, the primary endpoint of the study is expected during 1H 2024 and topline analysis is expected in 2H 2024.

"Having completed patient enrollment, we now look forward to reporting overall survival results in 2024. We thank the patients and their families for participating in this important and promising study, which may advance CM24 toward a pivotal study for a population in dire need of an effective alternative. Survival rates in pancreatic cancer are unfortunately very low and with CM24’s novel CEACAM1 target, we believe we may have a positive impact on extending survival," stated Purple Biotech CEO, Gil Efron.

An estimated 60,000 people are diagnosed with pancreatic cancer in the U.S. alone with a 5-year survival rate of only 12%. In patients treated with chemotherapy as a 2nd line treatment, the 5-year survival drops to 3%.

Nykode Therapeutics Announces Expansion of Oncology Pipeline Aiming to Reduce the Burden of Colorectal Cancer

On December 14, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported an expansion of the pipeline with a potential first-in-class preclinical oncology vaccine program aimed at preventing and treating colorectal cancer (Press release, Nykode Therapeutics, DEC 14, 2023, View Source [SID1234638571]).

Colorectal cancer begins as a premalignant polyp that grows on the mucosal surface of the colon or rectum and transforms into malignancy. The disease development and screening programs represent an opportunity to identify and treat high-risk patients at early stages in addition to treating patients with developed malignancies.

Nykode’s novel vaccines are based on a careful selection and combination of highly expressed tumor associated antigens involved in the development and progression of colonic polyps to colorectal cancer. The program will incorporate Nykode’s 4th module proprietary second-generation technology to further optimize the immune responses tailored to diverse target populations. The program builds on Nykode’s differentiating competence of creating broad and robust CD8 T cell responses with the potential to break tolerance against tumor-associated antigens, as illustrated by data presented at Nykode’s recent Capital Market Day. Strong preclinical data generated in the discovery phase further supports the induction of potent CD8 T cell responses in both wild-type and HLA transgenic mice models.

"I am thrilled about this exciting addition to our pipeline, which underscores Nykode’s dedication to creating innovative solutions for an expanding range of patients in need of alternative therapies," said Mikkel W. Pedersen, Nykode’s Chief Scientific Officer.

"Additionally, it signifies our belief in the promise of cancer vaccines across all stages of cancer development." "The potential first-in-class program reaffirms Nykode’s vision of building a balanced cancer vaccine portfolio. We are excited about the transformative power of our next-generation technology with the potential to reduce the burden of colorectal cancer," commented Michael Engsig, CEO of Nykode.

NextCure Provides Year-End Clinical Pipeline Updates

On December 14, 2023 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 an update on its clinical pipeline (Press release, NextCure, DEC 14, 2023, View Source [SID1234638570]).

NC410 (LAIR-2 fusion)

● The Phase 1b combination trial of NC410 with pembrolizumab is ongoing.
● Given evidence of clinical activity to date, additional patients are being added to the 100 mg cohort of patients with microsatellite stable/microsatellite instable-low immune checkpoint inhibitor naïve colorectal cancer without active liver metastasis.
● The combination has been safe and well tolerated to date.
● Clinical data, including results from additional patients, are expected in the first half of 2024.

LNCB74 (B7-H4 ADC) and NC762 (B7-H4 mAb)

● Due to the competitive environment and the limited activity to date, we do not plan to further develop NC762. We are prioritizing the development of LNCB74 (B7-H4 ADC), the first antibody drug conjugate (ADC) candidate from our collaboration with LegoChem Biosciences, Inc., and shifting resources from NC762 to the ADC program.
● Based on a comprehensive preclinical data package, we plan to initiate a dose range-finding toxicology study and GMP manufacturing for LNCB74 in early 2024.

NC525 (LAIR-1 mAb)

● The Phase 1a dose escalation study in subjects with acute myeloid leukemia remains ongoing with the fourth cohort now enrolled.
● Safe and well tolerated to date.
● Clinical data are expected in the first half of 2024.
● Data defining the mechanism of action were published in Journal of Clinical Investigation in November.

Business Development

● Actively seeking strategic partners to accelerate global development of programs.

Nerviano Medical Sciences and Italfarmaco Announce Licensing of Linker-Payload Technology to Develop and Commercialize a Novel Peptide-Drug Conjugate

On December 14, 2023 Nerviano Medical Sciences S.r.l. (NMS), a clinical-stage biotechnology company member of NMS group, reported the signing of a license agreement with Italfarmaco S.p.A. (ITF), a specialty pharmaceutical company, to develop and commercialize a novel peptide-drug conjugate (PDC) (Press release, Nerviano Medical Sciences, DEC 14, 2023, View Source [SID1234638569]).

Under the terms of the agreement, ITF will use NMS’s proprietary linker-payload technology to develop a novel PDC product candidate. NMS has implemented linker-payload GMP manufacturing and supply at a CDMO referred by NMS. ITF will be responsible for generating the target peptide and all non-clinical, clinical, and commercialization activities related to any resulting proprietary product candidates. Financial details of the agreement have not been disclosed.

"NMS’s cutting-edge linker-payload technology will allow us to develop new peptide drug conjugates for the treatment of oncology indications with high unmet medical need, leveraging Italfarmaco’s state-of-the-art GMP peptide production capabilities," stated Christian Steinkühler, PhD, Italfarmaco Group’s Chief Scientific Officer. "This is an important milestone in our mission to generate a highly diversified pipeline of innovative medicines."

"We are pleased that ITF, a company with a long-standing heritage both from pharmaceutical and chemical sectors, has selected our linker-payload first platform for developing a truly novel peptide-drug conjugate. This is a significant step to broaden the applicability of our technology," said Hugues Dolgos, PharmD, Chief Executive Officer of NMS and NMS Group.