On March 19, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an upcoming poster presentation for the pivotal TACTI-004 Phase III trial (Press release, Immutep, MAR 19, 2025, View Source [SID1234651268]). The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, "We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date."

Details for the poster presentation:
Title: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C
Presentation number: 131TiP
Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau
Session Date and Time: 26 March 2025, 13:50 CET

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

About Eftilagimod Alpha (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On March 19, 2025 Servier, an independent global pharmaceutical group governed by a non-profit foundation, and Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported a strategic worldwide licensing agreement for BDTX-4933, a potential best-in-class targeted therapy for solid tumors (Press release, Black Diamond Therapeutics, MAR 19, 2025, View Source [SID1234651252]). Under this global agreement, Servier will develop and commercialize BDTX-4933, a small molecule designed by Black Diamond Therapeutics to address unmet medical needs in RAF/RAS-mutant solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time," said Claude Bertrand, Executive Vice-President of R&D at Servier. "We look forward to accelerating the development of this therapy as a potential best-in-class treatment for cancer patients."

"This agreement supports our mission to advance oral cancer therapies designed to give patients the opportunity for longer, healthier, and more active lives," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Servier’s commitment to innovation and deep expertise in oncology make it an ideal partner for Black Diamond as we work to develop breakthrough cancer treatments."

Under the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including non-small cell lung cancer (NSCLC), with potential applications in other solid tumors. Black Diamond Therapeutics will receive an upfront payment of $70 million and will be eligible to receive up to $710 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales.

Currently in Phase 1 development, BDTX-4933 is uniquely designed to target RAS and RAF alterations in solid tumors. The dose escalation and expansion cohort first-in-human study aims at evaluating safety and tolerability, the preliminary recommended Phase 2 dose, and antitumor activity of BDTX-4933 in adults with recurrent advanced/metastatic cancers harboring BRAF, CRAF, or NRAS mutations.

On March 19, 2025 Akebia Therapeutics, Inc. ("Akebia") (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported the pricing of its underwritten public offering (the "Offering") of 25,000,000 shares of its common stock at a public offering price of $2.00 per share (Press release, Akebia, MAR 19, 2025, View Source [SID1234651269]). All shares are being offered by Akebia. The gross proceeds to Akebia from the Offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be $50.0 million. In addition, Akebia has granted the underwriters a 30-day option to purchase up to 3,750,000 additional shares of its common stock at the public offering price, less underwriting discounts and commissions. The Offering is expected to close on March 21, 2025, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Leerink Partners and Piper Sandler & Co. are acting as joint bookrunning managers for the Offering. BTIG, LLC is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the Offering.

The shares are being offered by Akebia pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on September 3, 2024 and declared effective by the SEC on September 12, 2024.

The Offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the Offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the Offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800)-808-7525, ext. 6105, or by email at [email protected]; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at (800)-747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 19, 2025 Niagen Bioscience, Inc. (Nasdaq: NAGE) (formerly ChromaDex Corp.), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, reported it has changed its corporate name to Niagen Bioscience, Inc. ("Niagen Bioscience" or the "Company") and the Company’s common stock will begin trading under the new Nasdaq symbol "NAGE" at stock market open today, Wednesday, March 19, 2025 (Press release, ChromaDex, MAR 19, 2025, View Source [SID1234651885]). The CUSIP number for the Company’s common stock will remain the same.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ChromaDex Evolves into Niagen Bioscience, Marking a New Era of Uncovering the Potential of NAD+ with Precision Science

Share
With a legacy spanning over 25 years, this strategic evolution underscores the Company’s true identity as the pioneer of NAD+ research and innovator behind transformative NAD-boosting healthy-aging solutions. At the forefront is Niagen Bioscience’s clinically proven, patented flagship nicotinamide riboside (NR) ingredient, Niagen – the most well-researched, efficient, and high-quality, and legal NAD+ booster available.

"This is more than a name change; this is a turning point in our story," said Rob Fried, CEO of Niagen Bioscience. "We have achieved several scientific, financial, and strategic milestones. As Niagen Bioscience, the global leader in NAD+ science and commerce, we have the opportunity to help every living being around the world age better."

Building on a 25+ year legacy, Niagen Bioscience’s renewed mission is simple yet powerful: "There’s a better way to age." The Company remains dedicated to addressing one of life’s most complex challenges—aging. Embodying precision science, Niagen Bioscience is distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and independent research collaborations with renowned investigators and institutions worldwide.

Niagen Bioscience’s clinically proven product portfolio, Tru Niagen and Niagen Plus, is the pinnacle of NAD+ supplementation. Tru Niagen, the Company’s consumer supplement featuring clinically proven food-grade Niagen (patented NR), is the number one NAD+ boosting oral supplement in the United States†. Niagen Plus features pharmaceutical-grade Niagen (NR), compounded by U.S. FDA-registered 503B outsourcing facilities. It is available by prescription as intravenous (IV) and injectable Niagen. Niagen Bioscience is the first company in the U.S. to offer a novel branded ingredient (Niagen) both as a direct-to-consumer dietary supplement (Tru Niagen) and as an intravenous and injectable pharmaceutical-grade product (Niagen IV).

"Our new identity creates a stronger foundation for expanding scientific discoveries and opens doors for potential future strategic partnerships across the bioscience and healthcare sectors," added Mr. Fried. "With this name change, we are celebrating that Niagen is a household name synonymous with healthy aging."

Niagen Bioscience recently reported its fourth quarter and full-year 2024 financial results, with strong full-year net sales at $99.6 million, up 19% from the prior year, and $44.7 million in cash and no debt position. Niagen Bioscience continues to lead the NAD+ space and is reinforced by strong financial results, Tru Niagen’s position as the number one NAD+ boosting supplement in the United States†, the onboarding of Niagen IV at 475 clinics nationwide, and the Company’s distinctive external research program, which has generated over 35 human clinical studies on Niagen.

To mark this milestone today, the Niagen Bioscience executive team will participate in the Nasdaq Closing Bell Ceremony on March 19, 2025, the same day as the official announcement. A live-stream of the Nasdaq Closing Bell Ceremony will take place at www.nasdaq.com at 3:50 pm ET / 12:50 pm PT. This event symbolizes the Company’s next chapter as the pioneer of NAD+ and healthy-aging science.

To learn more about Niagen Bioscience’s bold new chapter, visit www.niagenbioscience.com. Follow the Company’s news, research milestones, and announcements on social media here View Source

On March 19, 2025 Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in autoimmune disease and cancer, reported financial results and business highlights for the full year 2024 (Press release, Century Therapeutics, MAR 19, 2025, View Source [SID1234651253]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Today we announced a pipeline re-prioritization to streamline resources on advancing candidates that are potentially transformational or best-in-class in diseases with high unmet need. We ended the year with a strong cash position, which we will leverage to achieve meaningful milestones and drive value for all stakeholders as we take the company forward in a new direction," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "We have made the strategic decision to discontinue the Phase 1 ELiPSE-1 trial early, and we thank the patients, providers and caregivers for their support and participation. We believe CNTY-101 is well-positioned to potentially impact the standard of care meaningfully in B-cell-mediated autoimmune diseases. We are implementing key initiatives to drive toward delivering data in 2025 from the CALiPSO-1 Phase 1 trial, including new site activations and enhanced patient enrollment efforts in both the U.S. and EU, and with further insights from the CARAMEL Phase 1 investigator-initiated clinical trial which is expected to initiate in mid-2025."

Fourth Quarter 2024 and Recent Highlights

Clinical Pipeline for CNTY-101

· Phase 1 CALiPSO-1 trial site expansion in United States and Europe: The first patient in our CALiPSO-1 Phase 1 trial in autoimmune diseases is enrolled and scheduled for dosing in March 2025. Five sites in the U.S. are actively screening patients and Century has increased resourcing for trial site activation and proficient recruitment. The company is also expanding the CALiPSO-1 clinical trial to include additional sites in select European countries and expects enrollment at those sites will initiate in the second half of 2025.

· CARAMEL IIT on track to commence in mid-2025 following CTA approval: In January 2025, the company announced it had entered into an agreement for an investigator-initiated (IIT) Phase 1/2 trial by Professors Georg Schett and Andreas Mackensen of its CD19 CAR-iNK investigational cell therapy candidate CNTY-101 in patients with B-cell mediated autoimmune diseases. The IIT, which is sponsored by the Friedrich-Alexander University Erlangen-Nürnberg, represents the first evaluation by the internationally recognized Schett/Mackensen group of an allogeneic iPSC-derived CD19-directed NK cell therapy for the treatment of autoimmune diseases. The CARAMEL trial is expected to commence in mid-2025 following Clinical Trial Authorization (CTA) approval.

· Early discontinuation of ELiPSE-1 program in late-stage R/R NHL: While the company remains encouraged by the clinical activity and tolerability profile of CNTY-101 in late-stage relapsed-refractory non-Hodgkin’s lymphoma (R/R NHL), the emerging clinical data do not meet the company’s threshold to be considered transformational in this patient population and the program is being discontinued. The company is committed to providing continued treatment access in the ELiPSE-1 trial for patients showing benefit. We believe the ELiPSE-1 data continues to reinforce the potential of CNTY-101 in autoimmune diseases: in addition to encouraging clinical activity in a difficult to treat R/R NHL population and a favorable tolerability profile, translational data also showed evidence of CNTY-101 trafficking to lymph nodes and deep B cell depletion following treatment. The ELiPSE-1 data continues to support proof-of-concept for Allo-Evasion and the ability to enable repeat dosing of the company’s cell therapies. Further data is expected to be presented in 2025.

Preclinical Pipeline

"We look forward to our planned webinar next month where we will dive deeper into the programs we are taking forward. We believe these exciting programs unlock an opportunity to replace current therapies and expand application of cell therapy to areas with serious medical need, starting with what we believe to be our unique ab CD4+/CD8+ CAR-T cells combined with our most advanced Allo-Evasion 5.0 technology ," said Chad Cowan, Ph.D., Chief Scientific Officer of Century Therapeutics. "In the case of CNTY-308 and CNTY-341 in B-cell-mediated diseases, we are aiming for comparable or better performance to approved autologous CAR-T therapies. With our combined expertise in protein engineering, cell differentiation, and manufacturing, we aim to launch allogeneic cell therapies at antibody-like scale and cost. For our solid tumor and non-immune cell programs, this brings the potential to expand access to cell therapies much more broadly."

· Announced pipeline re-prioritization and live webcast on April 22nd: Today the company announced four new prioritized programs anchored by advanced iPSC-derived ’tunable’ CD4+/CD8+ ab T cells with target profiles comparable to autologous CART cells. All four programs are engineered with the company’s proprietary immune evasion technology, Allo-Evasion 5.0, designed to enable holistic evasion of T cell, NK cell, and humoral immunity. Management will host a live webcast on Tuesday, April 22nd to discuss each of the prioritized programs in more detail.

· Advancing CNTY-308 toward product candidate selection: CNTY-308 is a CD19-targeted CAR-iT cell therapy engineered with Allo-Evasion 5.0 which has demonstrated preclinical characteristics comparable to autologous CD19 CAR-T cells, including proliferation on target engagement, cytokine secretion, cytotoxic elimination of tumor cells, persistence and proliferation on rechallenge. CNTY-308 is being developed for B-cell mediated autoimmune diseases and malignancies. The company expects to initiate IND-enabling studies with CNTY-308 in mid-2025.

· Three additional preclinical programs being taken forward based on their profiles: CNTY-341 is a CD19/CD22 dual-targeted CAR-iT cell therapy engineered with Allo-Evasion 5.0 which pairs dual targeting and primary T-cell-like functionality in an allogeneic cell with the goal of providing a differentiated therapy for B cell malignancies. The next program is the company’s first solid tumor CAR iT program exploiting Nectin-4 CAR and other validated targets, engineered with Allo-Evasion 5.0 and additional engineering aimed at overcoming the key barriers to success in treating solid tumors. In addition, the company is leveraging its expertise in selective iPSC differentiation to non-immune effector cells with opportunities to potentially accelerate in high-impact therapeutic areas where the company believes its technology and capabilities provide meaningful differentiation.

Full Year 2024 Financial Results

· Cash Position: Cash, cash equivalents, and marketable securities were $220.1 million as of December 31, 2024, as compared to $261.8 million as of December 31, 2023. Net cash used in operations was $110.1 million for the year ended December 31, 2024, compared to net cash used in operations of $88.3 million for the year ended December 31, 2023. The company estimates its cash, cash equivalents, and investments will support operations into the fourth quarter of 2026.

· Collaboration Revenue: Collaboration revenue generated through the company’s collaboration, option, and license agreement with Bristol-Myers Squibb was $6.6 million.

· Research and Development (R&D) Expenses: R&D expenses were $107.2 million for the year ended December 31, 2024, compared to $92.7 million for the same period in 2023. The increase in R&D expenses is most notably due to increase in research and laboratory costs due to progression of the ELiPSE-1 clinical trial, start-up costs relating to the CALiPSO-1 trial, and manufacturing costs related to the company’s collaboration with FujiFilm Cellular Dynamics, Inc.

· General and Administrative (G&A) Expenses: G&A expenses were $33.2 million for the year ended December 31, 2024, compared to $34.7 million for the same period in 2023. The decrease was primarily due to a decrease in employee headcount during the 2024 fiscal year.

· Net Loss: Net loss was $126.6 million for the year ended December 31, 2024, compared to net loss of $136.7 million for the same period in 2023.