On March 20, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that it has elected to discontinue development of EO-3021 (Press release, Elevation Oncology, MAR 20, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-discontinue-development-of-eo-3021-advancing-eo-1022-while-evaluating-strategic-options [SID1234651308]). EO-3021 is a Claudin 18.2 antibody-drug conjugate (ADC), which Elevation Oncology was developing for the treatment of advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers. Elevation Oncology will continue to advance EO-1022, a HER3 ADC for the treatment of patients with HER3-expressing solid tumors, and, in parallel, is initiating a process to evaluate strategic options to maximize shareholder value.

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The decision to discontinue clinical development of EO-3021 was based on data from the dose escalation and expansion stages of Elevation Oncology’s Phase 1 trial, in which treatment with EO-3021 as a monotherapy demonstrated an objective response rate (ORR) of 22.2% (95% CI: 10, 39; 1 confirmed complete response and 7 confirmed partial responses) and a disease control rate (DCR) of 72.2% (95% CI: 55, 86) among 36 evaluable patients with gastric or GEJ cancer and Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+. In the safety analysis of all enrolled patients (n=85), treatment with EO-3021 was observed to be generally well-tolerated, with an adverse event profile consistent with previously reported data, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia.

"We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to other Claudin 18.2 ADCs in development," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on these data, we have decided to discontinue further development of EO-3021. I want to express my tremendous gratitude to the patients, physicians and site coordinators who participated in the EO-3021 clinical trial."

Mr. Ferra continued, "We are turning our focus to our potentially differentiated HER3 ADC, EO-1022, which incorporates glycan site-specific conjugation and is designed to address significant and emerging unmet needs in many HER3-expressing cancers. We look forward to presenting preclinical data supporting its potential at the AACR (Free AACR Whitepaper) Annual Meeting next month. In parallel, we are initiating efforts to evaluate strategic options for the company. With cash into the second half of 2026 and a disciplined operating strategy, we are well-positioned to advance EO-1022 while working to identify and capitalize on the best opportunities to maximize value for our stakeholders."

Corporate Update:

Elevation Oncology is implementing a workforce reduction of approximately 70%. The total cash payments and costs related to this reduction in force are estimated to be approximately $3 million, with a significant majority of these amounts expected to be paid though the end of June 2025. As part of this reduction, Elevation Oncology’s Chief Medical Officer, Valerie Malyvanh Jansen, M.D., Ph.D., will step down, effective March 31, 2025. Dr. Jansen will continue to support the company in a consulting capacity.

"I want to thank the employees who will be departing as part of this restructuring. Over the past five years, my colleagues have worked tirelessly to advance a novel pipeline of selective medicines, demonstrating a tremendous commitment to making a difference for people living with cancer. I am deeply appreciative of their dedication, support and contributions," added Mr. Ferra.

Based on its current operating plans, Elevation Oncology now expects that its cash, cash equivalents, and marketable securities of $93.2 million as of December 31, 2024, will be sufficient to fund its operations into the second half of 2026.

On March 20, 2025 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported a Q4 and Full Year 2024 business update (Press release, Adaptimmune, MAR 20, 2025, View Source [SID1234651305]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "2025 is the year of commercial execution for Tecelra, as we begin to generate value from our promising sarcoma franchise. The launch is going very well and each step in delivering this important medicine: activating our treatment network; identifying biomarker eligible patients; exceptional manufacturing quality and turn-around times, strengthens our sarcoma platform capabilities for both Tecelra and for lete-cel. These results give us confidence in our strategy to build value from our sarcoma franchise and our path to profitability in 2027. In the context of the current capital markets, we are assessing all strategic options to enable us to achieve these goals."

Tecelra launch momentum increasing – the first commercial product in Adaptimmune’s sarcoma franchise

● 20 Authorized Treatment Centers (ATCs) now accepting referrals
● On track to have the full network of approximately 30 ATCs open by end of 2025
● Apheresed 3 patients in 2024 and invoiced 2 with Q4 product revenue of $1.2m
● Apheresed 10 patients in 2025 to date
● Successful reimbursement with no denials to date
● 100% success rate in manufacturing to date with no capacity constraints

Lete-cel – the next product in Adaptimmune’s sarcoma franchise

● Pivotal trial met primary endpoint with 42% ORR including 6 complete responses (CTOS 2024)
● On track to initiate rolling BLA submission in late 2025; approval anticipated in 2026
● Lete-cel will expand the addressable patient population for sarcoma franchise

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.

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

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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 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 [SID1234651306]). 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.

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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 TwoStep Therapeutics, a biotechnology company developing innovative, first-in-class, multispecific targeted peptide conjugate therapies for solid tumors, reported its debut public scientific presentation on March 27, 2025, at the 4th Novel Conjugates Summit taking place in Boston, Massachusetts (Press release, TwoStep Therapeutics, MAR 19, 2025, View Source [SID1234651276]). This presentation will highlight the outstanding preclinical efficacy and safety of its lead tumor-targeted drug conjugate program, along with a first look at their new radiopharmaceutical program.

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Oral Presentation:
Title: Overcoming Tumor Heterogeneity via Multispecific Targeting
Date and Time: Thursday, March 27, 2025, at 9:00 a.m. ET
Invited Speaker: Caitlyn Miller, PhD, Co-Founder & CEO of TwoStep Therapeutics

TwoStep Therapeutics is a Stanford University spin-out launched in 2024, co-founded by Nobel Prize winner Carolyn Bertozzi, Jennifer Cochran, Ron Levy, and Caitlyn Miller, with seed investment of $8.7M to date.

"The company has made tremendous progress since our launch, and we’re excited to share our advancements at this summit," said Caitlyn Miller, CEO of TwoStep Therapeutics. "This event provides an excellent opportunity to highlight our innovative research and explore potential partnerships to further our mission of developing effective cancer therapies."