Investor Ideas, Trading Ideas and Stocks to Watch

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

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Friday, March 08, 2024

Mining Stocks to Watch: (TSX: $ATCU.TO) (NYSE: $CTGO) (NYSE: $ARCH) (ASX: $ARL.AX)

Powering up with Rare Earth and Lithium Stocks: (ASX: $ADC.AX) (TSX: $ARA.TO) (ASX: $CXO.AX) (ASX: $DYM.AX)

Mining Stocks to Watch: (TSX: $ATCU.TO) (NYSE: $CTGO) (NYSE: $ARCH) (ASX: $ARL.AX)

March 8, 2024 – (Investorideas.com Newswire) Investorideas.com, a global news source and expert investing resource, announces today’s roundup of stocks to watch in the Mining sector.

Read this in full at https://www.investorideas.com/news/2024/main/03081Stocks.asp

The newest mining companies focus on green metals such as Rare Earth Elements (REE) and Lithium, as well as gold, steel, nickel and copper.

New Stocks Added to the Mining Directories:

ACDC Metals Ltd (ASX:ADC) is an integrated mineral exploration and rare earth technology company incorporated with the aim of undertaking mineral exploration and resource development, focusing on heavy mineral sands projects located in Victoria, Australia, with the ultimate goal of producing heavy mineral sands (HMS) products and rare earth elements (REE).

Aclara Resources Inc (TSX:ARA) is a development-stage company that focuses on heavy rare earth mineral resources hosted in Ion-Adsorption Clay deposits. Its primary project is known as the Penco Module and is located in the BioBio Region of southern Chile. The Company is also working on the initial development phase of a second module, the Carina Module, located in the State of Goiás in central Brazil. Presently, Aclara has a strong focus on the development, construction, and future operation of the Penco Module, with the primary objective of establishing a processing plant designed to produce heavy rare earths concentrate. Simultaneously, alongside the development of the Penco Module, the Company intends to identify and evaluate further opportunities, such as the Carina Module, for increasing production of heavy rare earth elements. This will involve intensive greenfield exploration programs and the development of additional project "modules" within the Company's mining rights in Brazil, Chile and Peru.

Core Lithium Ltd (ASX:CXO) is an Australian lithium mining company and the 100% owner and operator of the Finniss Lithium Operation in the Northern Territory.

Dynamic Metals (ASX:DYM) is a minerals exploration and development company with a portfolio of assets in Western Australia as well as holding a minority interest in the Prospect Ridge Joint Venture in Tasmania. Dynamic Metals is committed to advancing its Australian critical minerals portfolio, after demerging the Australian Assets from Jindalee Resources Limited in 2022.

Alta Copper Corp. (TSX:ATCU) is focused on the development of its 100% owned Cañariaco advanced staged copper project. Cañariaco comprises 97 square km of highly prospective land located 150 km northeast of the City of Chiclayo, Peru, which include the Cañariaco Norte deposit, Cañariaco Sur deposit and Quebrada Verde prospect, all within a 4 km NE-SW trend in northern Peru's prolific mining district. Cañariaco is one of the largest copper deposits in the Americas not held by a major.

Contango ORE Inc. (NYSE:CTGO) owns a 30% interest in the high grade Manh Choh open pit gold mine located in Alaska in partnership with Kinross Gold Corporation - The Peak Gold, LLC (Kinross 70% and Contango 30% with Kinross as Manager and Operator). Ore from Manh Choh is being transported along year-round State maintained highways and then processed at Kinross' existing Fort Knox mill complex located near Fairbanks, Alaska. The use of the Fort Knox mill has accelerated the development of the project and resulted in significantly reduced upfront capital development costs, a smaller environmental footprint, a shorter permitting and development timeline, and less overall risk for the project. Peak Gold LLC has had a mining lease since 2008 on 675,000 acres of private lands owned by the Tetlin Tribe and administered by the Tetlin Tribal Council. The Manh Choh project has received all Federal and State permits and mining operations are underway with ore currently being stockpiled at the Mahn Choh site and transported by highway ore haul trucks to a stockpile area at the Fort Knox mill complex. Peak Gold LLC expects to build a roughly 250,000 ton stockpile and then start processing the stockpiled ore later in 2024. Annual gold production is expected to be 225,000 ounces per year with 30% or approximately 67,500 ounces credited to Contango’s account. According to the Feasibility Study Technical Report (2022), All-In Sustaining Costs (AISC) are expected be of $1,116/GEO (Gold Equivalent Ounce), meaning at current gold prices the Company will generate over $50 million in free cash flow annually and with less than 10 million shares O/S, equates to $5/share of free cash flow.The Company will also continue to work on it’s second 100% owned Lucky Shot project on the road system just north of Anchorage, Alaska. In 2023, Contango released an initial SK-1300 resource outlining 105,000 ounces of gold with Indicated grade of 14.5 g/t (0.46 oz.ton). Drilling from surface and underground is on-going to continue to explore the down-dip extension of the historically mined high-grade Lucky Shot vein, with the goal to develop enough ounces to outline 300,000 to 400,000 ounces with a viable mine plan by 2026. Lucky Shot is a fully permitted mine site.

Arch Resources Inc (NYSE:ARCH) is a premier producer of high-quality metallurgical products for the global steel industry. The company operates large, modern and highly efficient mines that consistently set the industry standard for both mine safety and environmental stewardship.

Ardea Resources Ltd (ASX:ARL) is advancing its flagship 100%-owned Kalgoorlie Nickel Project (KNP). KNP is the largest Nickel–Cobalt resource in Australia and in the top 10 globally, making it of a scale that is incredibly rare and important in the World’s journey to Net Zero. KNP was awarded Major Project Status by the Australian Federal Government, recognising the national and strategic significance of the KNP to the Australian economy and the Eastern Goldfields of Western Australia.

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

For the avid Mining Stock Investors – Check out our free comprehensive directory of Mining Stocks Mining Stocks Directory

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Wednesday, March 06, 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.

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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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