Cancer/Oncology Stocks to Watch; (Nasdaq: $GLSI) (NYSE American: $CLDI) (Nasdaq: $FUSN) (NASDAQ: $ACHL)

 Cancer/Oncology Stocks to Watch; (Nasdaq: $GLSI) (NYSE American: $CLDI) (Nasdaq: $FUSN) (NASDAQ: $ACHL)

 

Focus on Biotech Stocks: (Nasdaq: $GUTS) (NYSE: $ANRO) (Nasdaq: $KYTX) (Nasdaq: $BYSI)

 

 

 

March 6, 2024 – (Investorideas.com Newswire) Investorideas.com, a global news source and expert investing resource, announces today’s roundup of stocks to watch in the Biotech sector.

 

Read this in full at https://www.investorideas.com/news/2024/main/03061Stocks.asp

 

The newest biotech companies are focused on cancer treatment, oncology, metabolic therapeutics, autoimmune diseases and neurobiology.

 

New Stocks Added to the Biotech Directories:

Fractyl Health, Inc. (Nasdaq:GUTS) is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including T2D and obesity. Despite advances in treatment over the last 50 years, T2D and obesity continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Lexington, MA.

 

Alto Neuroscience, Inc. (NYSE: ANRO) is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto’s Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto’s clinical-stage pipeline includes novel drug candidates in depression, PTSD, schizophrenia, and other mental health conditions.

 

Kyverna Therapeutics, Inc. (Nasdaq:KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead product candidate, KYV-101 is advancing through clinical development across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1 trials in the United States and Germany for patients with lupus nephritis.

 

Greenwich LifeSciences, Inc. (Nasdaq:GLSI) is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, Flamingo-01.

 

Calidi Biotherapeutics, Inc. (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California.

 

Fusion Pharmaceuticals Inc. (Nasdaq: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 clinical trial; and FPI-2059, a small molecule targeting neurotensin receptor 1, currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors and immuno-oncology agents. The Company received IND clearance for FPI-2068, the first novel TAT under the collaboration, which targets EGFR-cMET. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion has a Good Manufacturing Practice compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. The Company has signed strategic actinium supply agreements with Niowave, Inc. and BWXT Medical.

 

Achilles Therapeutics Plc ADR (NASDAQ:ACHL) is a clinical-stage biopharmaceutical company developing AI-Powered precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

 

BeyondSpring Inc. (Nasdaq:BYSI) is a global clinical-stage biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs. The Company is advancing its first-in-class lead asset, Plinabulin, as a direct anti-cancer agent in various cancer indications and to prevent chemotherapy-induced neutropenia. Its pipeline also includes three preclinical immuno-oncology assets. Additionally, BeyondSpring’s subsidiary, SEED Therapeutics, leverages a proprietary targeted protein degradation (TPD) drug discovery platform and has an initial R&D collaboration with Eli Lilly.

 

The directories are not meant as recommendations but as a research tool to discover opportunities and trading ideas in a particular sector.

 

Research more biotech stocks with Investorideas Biotech stock directory

https://www.investorideas.com/BIS/Stock_List.asp

 

 

 

 

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Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market (NASDAQ: $ONCY) (TSX: $ONC.TO) (NASDAQ: $BLRX) (NASDAQ: $IMRX) (NASDAQ: $CADL) @Oncolytics @BioLineRx_Ltd @Immuneering @CandelTx

 

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market (NASDAQ: $ONCY) (TSX: $ONC.TO) (NASDAQ: $BLRX) (NASDAQ: $IMRX) (NASDAQ: $CADL) @Oncolytics @BioLineRx_Ltd @Immuneering @CandelTx

 

A Race worth Winning

 

March 6, 2024 -  Investorideas.com, a global investor news source covering biotech and pharma stocks issues a sector snapshot on developments for pancreatic cancer treatments, featuring Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology.

 

Read this article, featuring ONCY in full at: https://www.investorideas.com/news/2024/biotech/03061Pancreatic-Cancer-Market-Stocks.asp

 

Research Nester says, “The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036. The market is poised to garner a revenue of USD 36 billion by the end of 2036, up from a revenue of ~USD 6 billion in the year 2023. The incidence of pancreatic cancer is increasing globally, which is driving the growth of the market.”

 

The American Cancer Society’s estimates for pancreatic cancer in the United States for 2024 are: “About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer. About 51,750 people (27,270 men and 24,480 women) will die of pancreatic cancer. Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths.”

 

Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

 

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology just announced it has submitted an amendment to GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq^®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI; Germany’s regulatory body) for approval before patient enrollment can begin. The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being supported by the US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer.

 

“We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFOLFIRINOX or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy¹. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel (link to the PR, link to the poster). This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible.”

 

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial commented, “One of the reasons for pancreatic cancer’s poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumor microenvironment (TME)². Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems while driving the remodeling of the tumor microenvironment. Positive results from the Phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer.”

 

“This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients,” commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “The mFOLFIRINOX cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumor responses. We look forward to building on PanCAN’s strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the GOBLET study.”

 

BioLineRx Ltd. (NASDAQ: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases recently announced that the first patient has been dosed in the randomized CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line PDAC. The investigator-initiated trial is being conducted in collaboration with Columbia University and is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.

 

"Pancreatic ductal adenocarcinoma (PDAC) has had limited responses to traditional immunotherapy, resulting in a poor prognosis for patients and an urgent need for new treatment approaches," said Philip Serlin, Chief Executive Officer of BioLineRx. "We are encouraged by our early pilot data and look forward to continuing to advance the expanded, randomized Phase 2 CheMo4METPANC trial for patients living with this cancer."

 

From the news: Findings from the single-arm pilot phase of the CheMo4METPANC trial were shared by Dr. Gulam Manji, MD, PhD, of Columbia University at the 10th Annual Immuno-Oncology (IO) 360° Summit in Brooklyn, New York on Thursday, February 29, 2024. The findings were previously presented during an oral presentation at the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer in Boston, Massachusetts, September 28, 2023. As of July 2023, 7 of the 11 patients (64%) in the pilot phase experienced a partial response (PR) of which 5 (45%) were confirmed PRs at the time of the data cut; one patient experienced resolution of the hepatic (liver) metastatic lesion; and three patients (27%) experienced stable disease, resulting in a disease control rate of 91%.

 

From the news: Motixafortide, BioLineRx's lead therapeutic candidate, was approved by the U.S. Food & Drug Administration (FDA) in September 2023, in combination with filgrastim (G-CSF), to mobilize hematopoietic stem cells for collection and subsequent autologous transplantation in patients with multiple myeloma, under the brand name APHEXDA®. Motixafortide is also being evaluated in a Phase 1 clinical trial evaluating motixafortide as a monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in sickle cell disease (SCD).

 

Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients announced in February that the FDA granted Fast Track designation for its lead clinical-stage program, IMM-1-104, for the treatment of patients with PDAC who have failed one line of treatment. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.

 

“We welcome FDA’s decision to grant Fast Track designation for IMM-1-104. Our Phase 1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer, as well as a number of other tumor types associated with the RAS pathway. We look forward to a data-rich 2024 as we plan to provide multiple readouts from our study this year,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.

 

From the news: Vincent Chung, M.D., FACP, Professor, Department of Medical Oncology and Therapeutics Research, is the principal investigator of the Phase 1/2a clinical study with IMM-1-104 at City of Hope, one of the largest cancer research and treatment organizations in the United States.

 

“The FDA’s decision reinforces the importance of developing effective, novel treatments to improve the health outcomes of patients with pancreatic ductal adenocarcinoma. The development of well-tolerated oral medicines would improve the lives of these patients. City of Hope offers many clinical trials testing innovative treatments for people with pancreatic cancer," Chung said.

 

Candel Therapeutics, Inc.(Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, previously announced that the FDA granted Fast Track Designation for its lead investigational adenovirus asset CAN-2409 plus prodrug (valacyclovir) for the treatment of patients with PDAC to improve overall survival.

 

“We are pleased with the FDA's decision to grant Fast Track Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. “This milestone follows our first interim data report from the randomized phase 2 clinical trial in patients with borderline resectable PDAC that showed prolonged and sustained survival after experimental treatment with CAN-2409, especially when compared to real-world data on patients receiving radiotherapy treatment. Candel remains on track to release updated overall survival data from the interim analysis of this clinical trial in the second quarter of 2024. We are grateful to the patients, caregivers, investigators and clinical sites that have taken part in this clinical trial.”

 

With lives at stake and market opportunity in front of them, the race is on for companies aiming to fast track solutions for pancreatic cancer. It’s a race worth winning!

 

References

1.    Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. https://doi.org/10.1172/jci.insight.150453.

2.    Yoon JH, et al. Immunotherapy for pancreatic cancer. World J Clin Cases. 2021 May 6;9(13):2969-2982. doi: 10.12998/wjcc.v9.i13.2969. PMID: 33969083; PMCID: PMC8080736.

 

 

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Increasing Incidence Of Pancreatic Cancer Leading To A $6.85 Billion Dollar Market Size For New Treatments; @FNMgroup @Oncolytics

 

Increasing Incidence Of Pancreatic Cancer Leading To A $6.85 Billion Dollar Market Size For New Treatments; @FNMgroup  @Oncolytics

 

Palm Beach, FL – March 5, 2024 – FN Media Group News Commentary – Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for the drugs used in the treatment. Moreover, the prevalence is significantly higher in the geriatric population compared to other types of cancers. Thus, an increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth. The incidence is significantly higher in the geriatric population above 65 years of age compared to other types of cancers.  A report from Fortune Business Insights said that: “the pancreatic cancer treatment market size is projected to grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during 2022-2029. North America dominated the global market with a share of 46.97% in 2022. The increase in the number of patients suffering from the condition has increased the demand for the drugs used in treatment. These are some factors driving the growth during the forecast period.  Companies engaged in manufacturing cancer drugs have increased their focus on R&D activities to develop new drugs for pancreatic cancer treatment. Additionally, the companies operating in the market have received approval from several regulatory bodies, such as the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) (U.K.), among others, thereby propelling the growth of the market. Moreover, new testing technologies are being adopted by hospitals and diagnostic centers to diagnose cancer. The increase in the diagnosis rates is driving the demand for drugs, thereby providing opportunities for the players.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Ocean Biomedical, Inc. (NASDAQ: OCEA), LAVA Therapeutics N.V. (NASDAQ: LVTX), Merck & Co., Inc. (NYSE: MRK), AbbVie Inc. (NYSE: ABBV).

 

Read this in full at https://www.financialnewsmedia.com/increasing-incidence-of-pancreatic-cancer-leading-to-a-6-85-billion-dollar-market-size-for-new-treatments/

 

Fortune Business Insights continued: “Shifting the focus of key players in extensive R&D activities to develop new drugs and an increase in funding for cancer research led to the development of new drugs for treatment. Additionally, several pharmaceutical companies are involved in clinical trials to develop new drugs and explore the potential of the molecule to treat the disease.  Thus, with the increased funding for R&D activities, companies are focused on developing new drugs, thereby contributing to the overall rise in demand for drugs for pancreatic type of cancer treatment. Thus, increasing aging population and rising government initiatives to create awareness for the diagnosis of the condition are some factors propelling the market growth.”

 

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) Files Amendment to Initiate New Pancreatic Cancer GOBLET Cohort Supported by PanCAN – US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab – Oncolytics Biotech® Inc., a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI; Germany’s regulatory body) for approval before patient enrollment can begin. The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being supported by the US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer.

 

“We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFOLFIRINOX or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel (link to the PR, link to the poster). This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible.”

 

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, “One of the reasons for pancreatic cancer’s poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumor microenvironment (TME). Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems while driving the remodeling of the tumor microenvironment. Positive results from the Phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer.”

 

“This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients,” commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “The mFOLFIRINOX cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumor responses. We look forward to building on PanCAN’s strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the GOBLET study.”  CONTINUED… Read these full press releases and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/    

 

Other recent developments in the biotech industry of note for cancer events include:

 

Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company which endeavors to accelerate the development of compelling discoveries from top research scientists, recently congratulated its joint venture partner, Virion Therapeutics, LLC, a clinical-stage biotechnology company developing T cell-based immunotherapies, for the acceptance of their abstract highlighting the first-ever human data from its novel checkpoint modifier immunotherapy for HBV functional cure, for late breaker oral presentation at the upcoming 33rd Annual Meeting of APASL (The Asian Pacific Association for the Study of the Liver), taking place in Kyoto, Japan from March 27-31, 2024.

 

The late breaker presentation will highlight the safety data observed, to date, in the ongoing Phase 1B clinical trial of VRON-0200. “This accepted abstract highlights Virion’s commitment to finding a functional cure for chronically HBV-infected patients – and the first-ever human data for a genetically encoded checkpoint modifier T cell vaccine of any kind. VRON-0200 is uniquely developed to stimulate a patient’s own immune response to the virus. Additionally, its mechanism of action and intramuscular administration were designed to limit safety issues for this novel therapy,” said Dr. Sue Currie, COO of Virion, and one of the study authors. “We look forward to sharing these late breaking clinical HBV data at APASL, one of the leading meetings on the treatment of liver diseases in the world.”

 

LAVA Therapeutics N.V. (NASDAQ: LVTX), recently announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc. (NYSE: MRK), Rahway, NJ, USA to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207, a Gammabody® designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC).

 

Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide pembrolizumab for the dose escalation and expansion phases of LAVA’s ongoing Phase 1/2a study of LAVA-1207 (NCT05369000), with the combination arm expected to be initiated in the first half of 2024. Enrollment and dose escalation will also continue in the LAVA-1207 monotherapy and interleukin-2 arms of the study.

 

“We are excited to work with Merck & Co., Inc., Rahway, NJ, USA as we continue to unlock the therapeutic potential of LAVA-1207 and explore its potential capabilities in combination with KEYTRUDA®,” said Stephen Hurly, President and Chief Executive Officer, LAVA. “To date, LAVA-1207 has demonstrated a favorable safety profile and shown preliminary signs of anti-tumor activity. Prostate cancer has presented challenges for immune checkpoint therapies in the past – we are hopeful the combination of our products may deliver important clinical outcomes.”

 

AbbVie Inc. (NYSE: ABBV) and OSE Immunotherapeutics SA, a clinical-stage immunotherapy company, recently announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.

 

OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils.

 

“This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally,” said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. “By leveraging our expertise in immunology drug development, we look forward to advancing OSE-230, which offers a novel mechanism-of-action to treat chronic inflammation.”

 

“We are very pleased to collaborate with AbbVie, a global leader in the development and commercialization of innovative medicines, to drive our OSE-230 program forward,” said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics. “This partnership represents a major milestone in our company’s progress and recognizes the value of our innovative R&D capabilities. I would like to thank all our employees who helped us reach this milestone through dedication and hard work.”

 

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