On October 10, 2023 NanOlogy LLC, a clinical-stage oncology company, reported that initial safety and clinical outcomes from a Phase 2 clinical trial of intratumoral (IT) large surface area microparticle paclitaxel (LSAM-PTX) in locally advanced pancreatic cancer (LAPC) were published online ahead of print in Pancreas and two posters were presented at the ninth AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer in Boston reporting downstaging and immune data from the trial (Press release, NanOlogy, OCT 10, 2023, View Source;utm_medium=rss&utm_campaign=interim-results-from-a-nanology-phase-2-clinical-trial-of-its-intratumoral-investigational-drug-in-the-treatment-of-locally-advanced-pancreatic-cancer [SID1234635812]).

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The research article entitled Response of Locally Advanced Pancreatic Cancer to Intratumoral Injection of Large Surface Area Microparticle Paclitaxel: Initial Report of Safety and Clinical Outcome provides safety and response data from dose escalation and 2-injection cohorts. Clinical investigators included Neil Sharma, MD, Simon Lo, MD, Mohamed Othman, MD, and Antonio Mendoza-Ladd, MD.

"Pancreatic cancer is among the most lethal cancers with 5-year survival of only 12%," said lead investigator and author, Neil Sharma, MD. "The interim results from this study, particularly the potential for downstaging and immunomodulation, are encouraging and warrant expanded studies to further evaluate the clinical benefit of neoadjuvant IT LSAM-PTX in combination with standard of care therapy."

The dose escalation/expansion trial (NCT03077685) enrolled 54 subjects across four clinical sites in three cohorts including one-injection escalation (n=10), two-injection expansion (n=25), and four-injection expansion (n=19). The research article reports data from evaluable subjects in the first two cohorts while the third is pending final readout. Highlights include:

Most treatment-emergent adverse events (84%) were mild to moderate and considered related to underlying disease and comorbidities. No confirmed treatment-related severe adverse events or pancreatitis were reported. The most common adverse events were abdominal pain and nausea. Plasma paclitaxel levels attributed to LSAM-PTX were unremarkable throughout the study.
In the 2-injection cohort, 8 of 22 (36%) evaluable subjects were downstaged from nonresectable to resectable disease. Six subjects underwent surgery with five R0 resections and one R1 resection. Mean survival increased in resected subjects to 35 months versus 19 months for nonresected subjects.
Tissue was available pre/post LSAM-PTX treatment for immunophenotypic profiling via multiplex immunofluorescence from the 6 subjects undergoing resection. Despite pancreatic cancer being considered a "cold" tumor, favorable antitumor immunomodulation was observed with increases in concentrations of immune effector cells and NK cells along with decreases in concentrations of immune suppressor cells.
In evaluable subjects from the 2-injection cohort, disease control rate was 82% (18/22) at 3 months and 94% (16/17) at 6 months.
Additionally, two posters presented downstaging and immune data from the Phase 2 trial following IT LSAM-PTX at the recent AACR (Free AACR Whitepaper) Special Conference on Pancreatic Cancer.

The first poster (B004) entitled: "EUS guided local administration of large surface area microparticle paclitaxel with neoadjuvant chemotherapy in locally advanced pancreatic cancer: A single center experience" was presented by Harishankar Gopakumar, MD (University of Illinois College of Medicine).

Data were collected prospectively on 6 of 13 (46%) LAPC subjects in the second cohort of the trial who received 2 monthly endoscopic ultrasound-guided fine needle injections (EUS-FNI) of LSAM-PTX in addition to neoadjuvant chemotherapy at Parkview Health and subsequently underwent surgery from 2018 to 2019.
EUS-FNI of LSAM-PTX, added to neoadjuvant chemotherapy, was safe and resulted in a significant reduction in tumor volume, significant tumor necrosis on pathology exam, and favorable changes in TME immunophenotypic configuration.
The preliminary results suggest that adding LSAM-PTX to neoadjuvant chemotherapy could increase the rate of downstaging of LAPC to resectable disease and improve clinical outcomes.
The second poster (A048) entitled: "Enhancing the immune response in locally advanced pancreatic cancer (LAPC) with intratumoral of large surface area microparticle paclitaxel (LSAM-PTX)" was presented by Andrew Hendifar, MD (Cedars-Sinai Medical Center).

Blood samples were collected before and after treatment for flow cytometry analysis from 14 subjects in the third cohort of the trial who received 4 monthly EUS-FNI of LSAM-PTX in addition to prior or current SOC therapy.
Immunophenotyping of blood from LAPC subjects treated with IT LSAM-PTX demonstrates peripheral immunomodulation to a phenotype associated with anti-tumor immune effects, including favorable immunosurveillance, and is consistent with changes found in the TME in resected tissues. Immunosuppressive cell types typically associated with poor clinical outcomes were reduced at six months.
Anti-tumor immunomodulation without immunosuppression suggests that IT LSAM-PTX may be amenable to combination with immunotherapy.

On October 10, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that new data for four approved medicines and three pipeline candidates in more than 15 types of cancer will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 in Madrid, Spain, from Oct. 20-24 (Press release, Merck & Co, OCT 10, 2023, View Source [SID1234635811]). Presentations will feature new or updated findings from Merck’s broad portfolio of cancer medicines: KEYTRUDA, Merck’s anti-PD-1 therapy; WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor; LENVIMA (lenvatinib), in collaboration with Eisai; and LYNPARZA (olaparib), in collaboration with AstraZeneca, and emphasize Merck’s commitment to improving outcomes for patients across multiple stages of cancer.

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Additionally, new data from Merck’s diverse pipeline will be shared at the congress, including from MK-1084, a KRAS G12C inhibitor being evaluated as monotherapy and in combination with KEYTRUDA; from MK-2870 (also known as SKB264), an anti-TROP2 antibody drug conjugate (ADC) being developed in collaboration with Kelun-Biotech; and from V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT) being developed in collaboration with Moderna, in combination with KEYTRUDA.

"At ESMO (Free ESMO Whitepaper) 2023, we look forward to sharing new research highlighting the breadth of our portfolio and expanding pipeline, as we pursue breakthrough innovations in oncology to address critical gaps in care for patients in need," said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. "Our continued efforts to treat cancer earlier and make a meaningful impact are fueled by one goal: To give those who are counting on us more effective ways to treat their cancer."

Key data from Merck’s portfolio to be presented at ESMO (Free ESMO Whitepaper) Congress 2023:

First presentation of survival data from the Phase 3 KEYNOTE-A39/EV-302 trial evaluating KEYTRUDA plus enfortumab vedotin as a first-line treatment for patients with locally advanced or metastatic urothelial carcinoma (Presentation #LBA6,) which will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium and as part of the ESMO (Free ESMO Whitepaper) Press Briefings;
Presentation of overall survival (OS) results from the Phase 3 KEYNOTE-671 study evaluating KEYTRUDA in the perioperative setting (neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant KEYTRUDA as a single agent) for resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) (Presentation #LBA56);
First presentation of data from the Phase 3 KEYNOTE-A18 trial evaluating KEYTRUDA plus chemoradiotherapy in patients with high-risk, locally advanced cervical cancer (Presentation #LBA38);
First presentation of data from the Phase 3 KEYNOTE-756 trial evaluating KEYTRUDA plus neoadjuvant chemotherapy and adjuvant endocrine therapy in early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer (Presentation #LBA21);
First presentation of data from the Phase 3 LITESPARK-005 trial evaluating WELIREG for the treatment of patients with advanced renal cell carcinoma (aRCC) previously treated with immune checkpoint and anti-angiogenic therapies (Presentation #LBA88);
First time presentation of progression-free survival (PFS) and OS data from the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA plus trastuzumab and chemotherapy as first-line treatment for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma (Presentation #1511O);
Updated 5-year event-free survival data from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment for patients with high-risk early-stage triple-negative breast cancer (TNBC) (Presentation #LBA18).
Key data from Merck’s pipeline to be presented at ESMO (Free ESMO Whitepaper) Congress 2023:

First-time safety and preliminary efficacy data for MK-1084, a KRAS G12C inhibitor, as a monotherapy in solid tumors and in combination with KEYTRUDA in NSCLC (Presentation #663P);
First presentation of data from a Phase 2 cohort of the Phase 1/2 trial evaluating MK-2870 (also known as SKB264) in previously treated metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Presentation #380MO);
Additional data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating V940 (mRNA-4157) in combination with KEYTRUDA as adjuvant treatment for high-risk melanoma (Presentation # LBA49).
Merck investor event

Merck will host an Oncology Investor Event to coincide with the ESMO (Free ESMO Whitepaper) Congress 2023 on Sunday, October 22, 2023, 7:00 p.m. CEST/1:00 p.m. ET, at which senior management will highlight key data presentations. The event will take place virtually and will be accessible via webcast. Investors, analysts, members of the media and the general public are invited to listen to a webcast of the presentation at: View Source;LangLocaleID=1033

Details on abstracts listed above and additional key abstracts related to Merck’s portfolio and pipeline at ESMO (Free ESMO Whitepaper) Congress 2023:

Breast cancer

SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial. Y. Yin.

Presentation #380MO, Mini oral session – Breast cancer, metastatic

Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase 3 KEYNOTE-522 study. P. Schmid.

Presentation # LBA18, Proffered Paper session – Breast cancer, early stage

KEYNOTE-756: Phase 3 study of neoadjuvant pembrolizumab (pembro) or placebo (pbo) + chemotherapy (chemo), followed by adjuvant pembro or pbo + endocrine therapy (ET) for early-stage high-risk ER+/HER2– breast cancer. F. Cardoso. (Led by Kelun-Biotech)

Presentation # LBA21, Proffered Paper session – Breast cancer, early stage

Gastrointestinal cancers

Pembrolizumab versus chemotherapy in microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) metastatic colorectal cancer (mCRC): 5-year follow-up of the randomized phase 3 KEYNOTE-177 study. K. Shiu.

Presentation #LBA32, Mini oral session – Gastrointestinal tumours, lower digestive

Impact of baseline molecular alterations on the efficacy of tucatinib (TUC) plus trastuzumab (Tras) for HER2+, RAS WT metastatic CRC (mCRC) in MOUNTAINEER. J. Strickler. (Led by Seagen)

Presentation #551O, Proffered Paper session 1 – Gastrointestinal tumours, lower digestive

Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Survival results from the phase 3, randomized, double-blind, placebo-controlled KEYNOTE-811 study. Y. Janjigian.

Presentation #1511O, Proffered Paper session 1 – Gastrointestinal tumours, upper digestive

Health-related quality of life (HRQoL) analysis from KEYNOTE-859: First-line (1L) pembrolizumab (pembro) + chemotherapy (chemo) for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. M. Lowery.

Presentation #1516P, Poster

Genitourinary cancers

EV-302/KEYNOTE-A39: Open-label, randomized phase 3 study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). T. Powles.

Presentation #LBA6, Presidential 2

Phase 2 LITESPARK-003 study of belzutifan in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC). T. Choueiri.

Presentation #LBA87, Proffered Paper session 2 – Genitourinary tumours, non-prostate

Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Randomized open-label phase 3 LITESPARK-005 study. L. Albiges.

Presentation #LBA88, Proffered Paper session 2 – Genitourinary tumours, non-prostate

Safety and efficacy of two doses of belzutifan in patients (pts) with advanced RCC: Results of the randomized phase 2 LITESPARK-013 study. N. Agarwal.

Presentation #1881O, Proffered Paper session 2 – Genitourinary tumours, non-prostate

Gynecologic cancers

Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: A randomized, double-blind, phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. D. Lorusso.

Presentation #LBA38, Proffered Paper session 1 – Gynaecological cancers

Updated response data and analysis of progression free survival by mechanism of mismatch repair loss in endometrial cancer (EC) patients (pts) treated with pembrolizumab plus carboplatin/paclitaxel (CP) as compared to CP plus placebo (PBO) in the NRG GY018 trial. R. Eskander.

Presentation #LBA43, Mini oral session – Gynaecological cancers

Lung cancer

Overall survival in the KEYNOTE-671 study of perioperative pembrolizumab for early-stage non-small-cell lung cancer (NSCLC). J. Spicer.

Presentation #LBA56, Proffered Paper session – Non-metastatic NSCLC and other thoracic malignancies

Safety and preliminary efficacy of the KRAS G12C inhibitor MK-1084 in solid tumors and in combination with pembrolizumab in NSCLC. C. Rojas.

Presentation #663P, Poster

Melanoma

Pathologic response and exploratory analyses of neoadjuvant-adjuvant versus adjuvant pembrolizumab (PEM) for resectable stage IIIB-IV melanoma from SWOG S1801. S. Patel.

Presentation #LBA48, Proffered Paper session – Melanoma and other skin tumours

mRNA-4157 (V940) individualized neoantigen therapy + pembrolizumab vs pembrolizumab in high-risk resected melanoma: Clinical efficacy and correlates of response. J. Weber.

Presentation # LBA49, Proffered Paper session – Melanoma and other skin tumours

On October 10, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS) (Press release, Merck & Co, OCT 10, 2023, View Source [SID1234635810]). At a pre-specified interim analysis, KEYTRUDA plus chemotherapy before surgery (neoadjuvant), followed by resection and KEYTRUDA as a single agent after surgery (adjuvant), demonstrated a statistically significant and clinically meaningful improvement in OS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.

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The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified. Full results from this analysis of KEYNOTE-671 will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 and shared with regulatory authorities worldwide.

"This is a significant milestone in the treatment of resectable non-small cell lung cancer, as it represents the first Phase 3 study to show a statistically significant overall survival benefit for these patients with stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer. These results build upon the previously reported event-free survival data, and demonstrate the potential for this KEYTRUDA-based regimen to help extend the lives of these patients," said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. "We’re excited by the progress we have made to help patients with earlier stages of non-small cell lung cancer, who are in need of additional treatment options."

As previously announced, at the first interim analysis, KEYNOTE-671 met the other one of its dual primary endpoints, event-free survival (EFS), as well as its key secondary endpoints of pathological complete response (pCR) and major pathological response (mPR). These results were presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and, based on these data, the U.S. Food and Drug Administration (FDA) has accepted Merck’s new supplemental Biologics License Application (sBLA) with a Prescription Drug User Fee Act (PDUFA), or target action, date of October 16, 2023.

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. Key studies in earlier stages of NSCLC and small cell lung cancer (SCLC) include KEYNOTE-671, KEYNOTE-091, KEYNOTE-867, KEYLYNK-012, KEYVIBE-006 and KEYLYNK-013.

About KEYNOTE-671

KEYNOTE-671 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03425643) evaluating neoadjuvant KEYTRUDA plus chemotherapy, followed by adjuvant KEYTRUDA as a single agent versus placebo plus neoadjuvant chemotherapy, followed by adjuvant placebo in patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC. The trial’s dual primary endpoints are EFS and OS. Key secondary endpoints include pCR and mPR. The study enrolled 786 patients who were randomly assigned (1:1) to receive either:

KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W] for up to four cycles) plus chemotherapy (cisplatin [75 mg/m^2, IV; given on Day 1 of each cycle] and either gemcitabine [1000 mg/m^2, IV; given on Days 1 and 8 of each cycle) or pemetrexed [500 mg/m^2, IV; given on Day 1 of each cycle]) as neoadjuvant therapy prior to surgery, followed by KEYTRUDA (200 mg IV Q3W for up to 13 cycles) as adjuvant therapy post-surgery, or
Placebo (saline IV Q3W for up to four cycles) plus chemotherapy (cisplatin [75 mg/m^2, IV; given on Day 1 of each cycle] and either gemcitabine [1000 mg/m^2, IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m^2, IV; given on Day 1 of each cycle]) as neoadjuvant therapy prior to surgery, followed by placebo (saline IV Q3W for up to 13 cycles) as adjuvant therapy post-surgery.
About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2020 alone, there were more than 2.2 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 81% of all cases. In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 25%, which is a 21% improvement over the last five years. Improved survival rates are due, in part, to earlier detection and screening, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced. Only 5.8% of people in the U.S. who are eligible were screened for lung cancer in 2021.

On October 10, 2023 I-Mab (Nasdaq: IMAB) (the "Company"), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, reported multiple recent developments in TJ-L14B/ABL503, a differentiated PD-L1 x 4-1BB bispecific antibody developed in collaboration with ABL Bio (Kosdaq: 298380) (Press release, I-Mab Biopharma, OCT 10, 2023, View Source [SID1234635809]). TJ-L14B/ABL503 is designed to address tumors resistant to PD-(L)1 antibodies through its unique ability to conditionally activate 4-1BB upon binding to its target, PD-L1. I-Mab owns 50% of the global rights of TJ-L14B/ABL503.

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On September 7, 2023, TJ-L14B/ABL503 successfully obtained patent registration in eight Eurasian countries. The patent, officially named "Anti-PD-L1/Anti-4-1BB Bispecific Antibody and Its Applications," secures patent rights extending through 2039. Furthermore, this patent has already been granted in Chile, South Africa, and Japan. Patent examinations are currently underway in over 20 countries, including the U.S., China, and Europe.

TJ-L14B/ABL503 is currently being investigated in a Phase 1 dose-escalation study in patients with progressive, locally advanced or metastatic solid tumors who are relapsed or refractory following prior lines of treatment. The dose-expansion portion of the Phase 1 study is actively progressing in the U.S. and South Korea. Currently, we have observed 1 complete response (CR), 1 partial response (PR), and 2 patients who achieved an unconfirmed objective response upon recent enrollment. While preliminary efficacy signals have emerged, the maximum tolerated dose (MTD) has not yet been reached. The Company anticipates presenting the top-line Phase 1 clinical data at a major medical conference in the first half of 2024.

"We’re encouraged by these early results of TJ-L14B/ABL503 as they continue to demonstrate the potential of this highly differentiated treatment for tumor types with significant unmet need," said Raj Kannan, CEO of I-Mab. "With the success of patent registrations across multiple countries, and promising preliminary data from the Phase 1 study, we’re reaffirming the possibility for TJ-L14B/ABL503 to make a significant impact on the lives of people with cancer. We look forward to sharing more progress on the global development of TJ-L14B/ABL503."

"The clinical responses observed in the Phase 1 clinical study of TJ-L14B/ABL503, though in early stages, not only provide validation of our technology platform but also offer proof of the mechanism behind this innovative bispecific antibody," said Sanghoon Lee, CEO of ABL Bio. "We express our heartfelt gratitude to the patients who participated in the study, healthcare professionals, study investigators, and our partners for their invaluable collaboration in achieving this milestone. Concurrently, we are expediting patent filings for TJ-L14B/ABL503 to safeguard its rights and facilitate its seamless entry into the global market."

About TJ-L14B/ABL503

Being developed jointly with ABL Bio (Kosdaq: 298380, hereafter "ABL"), TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s "Grabody-T" bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination. A Phase 1 study is currently being conducted in the U.S. and South Korea.

On October 10, 2023 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a track record of over forty years of commercial execution and a strong focus in supportive care, oncology, and rare diseases, reported the signing of a new financing agreement with BancaStato, effective from September 2023 (Press release, Helsinn, OCT 10, 2023, View Source [SID1234635808]).
This financing agreement with BancaStato replaces Helsinn’s prior credit facility agreement signed by Helsinn with a non-bank lender in December 2022. This new funding agreement offers convenient terms and conditions which will help drive the Company’s business objectives.

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Helsinn has recently undergone a strategic review to redefine its business model, activities, and investments to remain competitive in global markets. Proceeds from the recently concluded financing agreement will contribute to the implementation of the Company’s plans and will help to ensure sustainable and profitable performance in alignment with the current product portfolio as well as commercial and manufacturing capabilities – the company’s main pillars of success in the past.

Riccardo Braglia, Executive Chairman of Helsinn, commented: "Guided by our core values of respect, integrity, and quality, Helsinn’s strategy focuses on being the partner of choice as a commercial-stage enterprise with a strong focus in supportive care, oncology and rare diseases, able to reach patients worldwide through integrated CMC/manufacturing/supply and a commercial platform complemented by scientific and technological expertise.
We are very grateful to BancaStato for placing their trust in our business model and our solid commercial track record."

Dr. Melanie Rolli, Chief Executive Officer at Helsinn, said: "This new financial strength from BancaStato is a great step forward which will allow us to reach our business objectives as well as strengthen our portfolio of late- and commercial-stage supportive care, oncology and rare disease drugs and, more importantly, to continue to serve our customers around the world by identifying and collaborating with partners who share our passion and motivation: to extend and improve the lives of patients globally who use our products every day."