Investorideas.com newswire, breaking biotechnology and pharma news

Wednesday, March 20, 2024

Doctor’s Orders-Biotech Stocks to Watch (NASDAQ: $LVTX) (NASDAQ: $NKGN) (Nasdaq: $KNSA) (Nasdaq: $GOSS)

 Doctor’s Orders-Biotech Stocks to Watch (NASDAQ: $LVTX) (NASDAQ: $NKGN) (Nasdaq: $KNSA) (Nasdaq: $GOSS)

 

Life Sciences Stocks to Watch: (OTCPink: $MRDH) (NASDAQ: $PBM) (OTCQB: $KRBP) (NASDAQ: $OCEA)

 

 



 

 

March 20, 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/Life Sciences sector.

 

Read this in full at: https://www.investorideas.com/news/2024/main/03201Stocks.asp

 

The newest biotech companies are involved in immuno-oncology, cell therapeutics and biopharmaceuticals.

 

The latest life sciences companies are involved in developing scientifically compelling assets from research universities, biotherapeutics, natural psychedelics and management services for healthcare settings.

 

New Stocks Added to the Biotech Directories:

LAVA Therapeutics N.V. (NASDAQ: LVTX) is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens.

 

NKGen Biotech, Inc. (NASDAQ: NKGN) is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (NK) cell therapeutics. NKGen is headquartered in Santa Ana, California, USA.

 

Kiniksa Pharmaceuticals (Nasdaq:KNSA) is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation.

 

Gossamer Bio (Nasdaq:GOSS) is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients suffering from, pulmonary hypertension.

 

Ocean Biomedical, Inc. (NASDAQ: OCEA) is a Providence, Rhode Island-based biopharma company with an innovative business model that strives to accelerate the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical intends to deploy the resources and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic to the world. Ocean Biomedical is currently developing five discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team’s goal is to work on solving some of the world’s toughest problems, for the people who need it most.

 

Kiromic BioPharma, Inc. (OTCQB: KRBP) is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas.

 

Psyence Biomedical Ltd (NASDAQ:PBM) is a life science biotechnology company with a focus on natural psychedelics. Psyence Biomed works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name "Psyence" combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.

 

Meridian Holdings, Inc. (OTCPink: MRDH) is in the business of acquisition-oriented holding company focused on building, operating, and managing a portfolio of business-to-business companies. It seeks to acquire majority or controlling interests in companies, which will allow the holding company to actively participate in management, operations, and finances. The Company's network of affiliated companies is designed to encourage maximum leverage of information technology, operational excellence, industry expertise, and synergistic business opportunities. Meridian Holdings, Inc., provides management services and support to the following business units: InterCare Rx, Dozie and Dozie's Pharma and Meridian Health Systems ACO Corporation (“MHSACO”) a Multi-National healthcare supply chain and medical services management entity.

 

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

 



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About Investorideas.com - Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all. Our original branded content includes podcasts such as Exploring Mining, Cleantech, Crypto Corner, Cannabis News, and the AI Eye. We also create free investor stock directories for various sectors, including gaming, biotech, tech and sports. Public companies within the sectors we cover can use our news publishing and content creation services to help tell their story to interested investors. Paid content is always disclosed.

 

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/

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Tuesday, March 19, 2024

Biotech Stock News Bite - Elicio Therapeutics, Inc. (Nasdaq: ELTX) Rises on Funding News

Biotech Stock News Bite - Elicio Therapeutics, Inc. (Nasdaq: ELTX) Rises on Funding News: Biotech Stock News Bite - Elicio Therapeutics, Inc. (Nasdaq: ELTX) Rises on Funding News

Oncology Stock News Bite - Fusion Pharmaceuticals (NASDAQ: FUSN) Soars on News it's to be Acquired by AstraZeneca (NASDAQ: AZN)

Oncology Stock News Bite - Fusion Pharmaceuticals (NASDAQ: FUSN) Soars on News it's to be Acquired by AstraZeneca (NASDAQ: AZN): Oncology Stock News Bite - Fusion Pharmaceuticals (NASDAQ: FUSN) Soars on News it's to be Acquired by AstraZeneca (NASDAQ: AZN)

Biotech Stock News Bite - Enveric Biosciences (NASDAQ: ENVB) Trends on News of Pursuing Exclusive Out-Licensing of New Chemical Entities for Pharmaceutical and Non-Pharma Applications in Joint Disease

Biotech Stock News Bite - Enveric Biosciences (NASDAQ: ENVB) Trends on News of Pursuing Exclusive Out-Licensing of New Chemical Entities for Pharmaceutical and Non-Pharma Applications in Joint Disease: Biotech Stock News Bite - Enveric Biosciences (NASDAQ: ENVB) Trends on News of Pursuing Exclusive Out-Licensing of New Chemical Entities for Pharmaceutical and Non-Pharma Applications in Joint Disease

Monday, March 11, 2024

Watching Biotech & Life Science Stocks: (Nasdaq: $IXHL) (Nasdaq: $ATRA) (ASX: $CHM.AX)(Nasdaq: $IMRX)

 Watching Biotech & Life Science Stocks: (Nasdaq: $IXHL) (Nasdaq: $ATRA) (ASX: $CHM.AX)(Nasdaq: $IMRX)

 

Transportation Stocks on the Move: (Nasdaq: $DUOT) (Nasdaq: $RVSN) (NYSE: $ASC)

 



 

 

March 11, 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 and Transportation sectors.

 

Read this in full at https://www.investorideas.com/news/2024/main/03111Stocks.asp

 

The newest biotech companies focus on cancer treatments and medical cannabis and psychedelic medicine uses.

 

The latest transportation companies provide transportation include a tanker company and rail safety companies using AI (artificial intelligence) technology.

 

New Stocks Added to the Biotech Directories:

Incannex Healthcare Inc. (Nasdaq: IXHL) is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis, inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.

 

Atara Biotherapeutics (Nasdaq: ATRA) is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases.

 

Chimeric Therapeutics (ASX: CHM) a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer, not just delay disease progression.

 

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The Company aims to achieve universal activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor currently in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor and will be evaluated in a Phase 1/2a study in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes several early-stage programs.

 

New Stocks Added to the Transportation Directories:

Ardmore Shipping (NYSE:ASC) owns and operates a fleet of MR product and chemical tankers ranging from 25,000 to 50,000 deadweight tonnes. Ardmore provides, through its modern, fuel-efficient fleet of mid-size tankers, seaborne transportation of petroleum products and chemicals worldwide to oil majors, national oil companies, oil and chemical traders, and chemical companies. Ardmore's core strategy is to continue to develop a modern, high-quality fleet of product and chemical tankers, build key long-term commercial relationships and maintain its cost advantage in assets, operations and overhead, while creating synergies and economies of scale as the company grows. Ardmore provides its services to customers through voyage charters and time charters, and enjoys close working relationships with key commercial and technical management partners. Ardmore's Energy Transition Plan ("ETP") focusses on three key areas: transition technologies, transition projects, and sustainable (non-fossil fuel) cargos. The ETP is an extension of Ardmore's strategy, building on its core strengths of tanker chartering, shipping operations, technical and operational fuel efficiency improvements, technical management, construction supervision, project management, investment analysis, and ship finance.

 

Duos Technologies Group (Nasdaq:DUOT) based in Jacksonville, Florida, through its wholly owned subsidiary, Duos Technologies, Inc., designs, develops, deploys and operates intelligent vision-based technology solutions using Machine Vision and Artificial Intelligence (“AI”) to analyze fast moving freight, passenger and transit trains and trucks streamlining operations, improving safety and reducing costs. The Company provides cutting edge solutions that automate the mechanical and security inspection of fast-moving trains, trucks and automobiles through a broad range of proprietary hardware, software, information technology and artificial intelligence.

 

Rail Vision Ltd. (Nasdaq: RVSN) is a technology company that is seeking to revolutionize railway safety and the data-related market. The Company has developed cutting-edge, artificial intelligence-based, industry-leading technology specifically designed for railways. The Company has developed its railway detection and systems to save lives, increase efficiency, and dramatically reduce expenses for the railway operators. Rail Vision believes that its technology will significantly increase railway safety around the world, while creating significant benefits and adding value to everyone who relies on the train ecosystem: from passengers using trains for transportation to companies that use railways to deliver goods and services. In addition, the company believes that its technology has the potential to advance the revolutionary concept of autonomous trains into a practical reality.

 

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

 

Read the recent AI Transportation article at:

https://www.investorideas.com/news/2024/technology/03041AI-Stocks.asp

 

Read the recent Biotech/Oncology Article at:

https://www.investorideas.com/news/2024/biotech/03061Pancreatic-Cancer-Market-Stocks.asp

 

About Investorideas.com - Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all. Our original branded content includes podcasts such as Exploring Mining, Cleantech, Crypto Corner, Cannabis News, and the AI Eye. We also create free investor stock directories for various sectors, including gaming, biotech, tech and sports. Public companies within the sectors we cover can use our news publishing and content creation services to help tell their story to interested investors. Paid content is always disclosed.

 

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/

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Wednesday, March 6, 2024

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

 

 

 

 

About Investorideas.com - Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all. Our original branded content includes podcasts such as Exploring Mining, Cleantech, Crypto Corner, Cannabis News, and the AI Eye. We also create free investor stock directories for various sectors, including gaming, biotech, tech and sports. Public companies within the sectors we cover can use our news publishing and content creation services to help tell their story to interested investors. Paid content is always disclosed.

 

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/

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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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