SN BioScience Propels SNB-101 to Phase 2 with IND Clearance from FDA

On January 10, 2025 SN BioScience reported that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial (Press release, SN BioScience, JAN 10, 2025, View Source [SID1234649601]). This achievement follows the designation of SNB-101 as an orphan drug for small cell lung cancer in 2023 and its Fast Track designation in 2024. With this latest clearance, SNB-101 is rapidly advancing toward early commercialization in the U.S. market. SN BioScience expects to initiate the clinical trials in Q2, 2025.

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Validated for ES-SCLC, SNB-101 Eyes 2028 U.S. Market Launch
SN BioScience has revealed details of its Phase 1b/2 clinical trial for SNB-101, targeting patients diagnosed with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The trial will concentrate on dose escalation and optimization to improve both efficacy and safety. Approximately 55 patients will be enrolled, with a focus on reflecting the racial diversity of the U.S. population. Furthermore, the study, aimed at supporting Phase 2 clearance in Europe, will be conducted across South Korea, the U.S., and Europe. Efficacy, safety, and pharmacokinetics will serve as the primary endpoints. Following the dose optimization phase, the company plans to assess SNB-101’s efficacy and safety in approximately 100 patients through a single-arm, single-dose, open-label monotherapy study. If the results are positive, SN BioScience targets early U.S. commercialization, with market entry expected as early as 2028.

Small cell lung cancer (SCLC), representing 12-15% of all lung cancer cases, is an aggressive disease with a poor prognosis. Around 70% of patients are diagnosed at an extensive stage, where the cancer has already spread, resulting in a five-year survival rate of less than 7%. Despite these challenging statistics, the SCLC treatment market is expected to grow at a compound annual growth rate (CAGR) of 7-10% from 2023 to 2030, according to Evaluate Pharma, highlighting the urgent need for more effective therapies. In this context, SNB-101 emerges as a highly promising treatment option, offering the potential to significantly improve patient outcomes.

SN BioScience aims to establish its treatment as a second- or third-line option for patients resistant to existing therapies. Ultimately, the company seeks to position the therapy as a first- or second-line standard treatment, potentially in combination with immuno-oncology agents.

Aileron Therapeutics Announces Rebranding to Rein Therapeutics

On January 10, 2025 Rein Therapeutics ("Rein") (NASDAQ: RNTX), formerly known as Aileron Therapeutics, Inc. ("Aileron") (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, reported that it has changed its name to Rein Therapeutics, Inc (Press release, Aileron Therapeutics, JAN 10, 2025, View Source [SID1234649585]). The new name, logo, website, and branding elements reflect the Company’s mission to develop first-in-class treatments to rein in diseases. The Company’s common stock will begin trading under the Nasdaq ticker symbol "RNTX" effective January 13, 2025. The CUSIP number for the Company’s common stock is not affected by the name change. The Company also highlighted its recent clinical and corporate achievements and provided its key strategic objectives for 2025.

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"Our rebrand to Rein Therapeutics reflects our unwavering commitment to address the critical needs of underserved patients with fibrotic diseases," said Brian Windsor, Ph.D., President and Chief Executive Officer. "This new chapter for the Company underscores our focus on reining in fibrosis and advancing our pipeline of novel candidates. We look forward to the initiation of a Phase 2 clinical trial for our lead candidate, LTI-03, in the first half of this year, aiming to bring hope to those affected by idiopathic pulmonary fibrosis."

Recent Clinical Achievements

LTI-03, a Caveolin-1 related peptide:
In November 2024, the Company announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of inhaled high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients with idiopathic pulmonary fibrosis (IPF). Four biomarkers showed statistical significance in the combined Cohort 1 and Cohort 2 dataset, and five demonstrated dose dependence with respect to low dose (2.5 mg BID) Cohort 1, indicative of active pharmacodynamics. High dose LTI-03 continued to exhibit a favorable safety profile.
2024 Corporate Highlights:
In March 2024, Brian Windsor, Ph.D., was appointed Chief Executive Officer of the Company, marking the Company’s sole focus on advancing a pipeline of first-in-class therapies for orphan pulmonary and fibrosis indications.

In May 2024, the Company completed an underwritten registered direct offering of its common stock and accompanying warrants raising net proceeds of approximately $17.7 million.
2025 Strategic Objectives and Anticipated Milestones

LTI-03: A Phase 2 trial of LTI-03 for the treatment of IPF is anticipated to be initiated in the first half of this year.

LTI-01: The Company’s Phase 2b-ready asset is a first-in-class therapy for the treatment of loculated pleural effusions (LPEs). It holds Orphan Drug Designation for the treatment of pleural empyema in the U.S and E.U. and Fast Track Designation in the U.S.

JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva® in China as Second-line Treatment in Relapsed or Refractory adult Large B-cell Lymphoma

On January 10, 2025 JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) (Press release, JW Therapeutics, JAN 10, 2025, View Source [SID1234649602]). Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.

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The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical result obtained in Chinese patients.

Large B-cell lymphoma is a highly aggressive non-Hodgkin’s lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30-40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL.

About Relmacabtagene Autoleucel Injection

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations.

About JWCAR029-216 Study (NCT06093841)

This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical study to evaluate such novel therapy in Chinese LBCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients.

The study is currently ongoing. Preliminary clinical data found Carteyva providing outstanding efficacy and good safety profile for r/r LBCL patients, with a best overall response rate of 84%.

Quanterix to Acquire Akoya Biosciences, Creating the First Integrated Solution for Ultra-Sensitive Detection of Blood- and Tissue-Based Protein Biomarkers

On January 10, 2025 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultra-sensitive biomarker detection, and Akoya Biosciences (NASDAQ: AKYA), The Spatial Biology Company, reported a definitive merger agreement under which Quanterix will acquire Akoya in an all-stock transaction (Press release, Akoya Biosciences, JAN 10, 2025, View Source [SID1234649586]). The transaction will create the first integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers.

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"Liquid biopsy will eventually surpass the market size of all other diagnostics testing combined. Enabling early disease detection, before symptoms appear, using non-invasive methods is our mission and will be the majority of Quanterix’s long-term value," said Masoud Toloue, PhD, Chief Executive Officer of Quanterix. "This transaction accelerates our progress by creating the first platform that lets researchers and clinicians track disease progression from tissue to blood. By starting with tissue and detecting early signs of complementary proteins in blood using leading ultra-sensitive SIMOA technology, we are uniquely positioned to speed up market development of new liquid biopsy tests."

Brian McKelligon, Chief Executive Officer of Akoya, said, "Joining forces with Quanterix marks a pivotal step in our journey to revolutionize the way we understand and treat disease. We are thrilled to be part of an established leader in the life science tools and diagnostics market that not only strengthens our presence in critical markets but also accelerates our ability to scale, innovate and ultimately bring to market products that impact human health. With the capital structure and significant synergies facilitated through this transaction, the combined company is well-positioned for future growth and profitability. We look forward to being part of the Quanterix team to better serve the needs of researchers and clinicians and bring substantial value to our customers and shareholders."

Strategic and Financial Benefits of the Combination

Creates first integrated solution for liquid and tissue proteomic biomarkers: The integration of Akoya’s spatial biology capabilities in tissue with Quanterix’s advanced tools for the ultra-sensitive detection of biomarkers in blood will establish the first fully integrated technology ecosystem to identify and measure biomarkers across tissue and blood. Quanterix will be better positioned to serve research customers and ultimately clinicians with a broader set of technologies to improve diagnostic relevance and accuracy and enhance patient outcomes through biomarker-driven treatment decisions.
Expands technology offering across high growth markets in neurology, oncology and immunology: With Quanterix’s industry-leading position in neurology and Akoya’s focus within oncology and immunology, Quanterix will expand its technology offerings across these high-growth markets. The addition of Akoya’s cutting-edge spatial biology capabilities will enable Quanterix to capitalize on growth opportunities in a $5 billion serviceable addressable market.
Expanded lab services and clinical diagnostic market opportunity: Leveraging Akoya’s established clinical partnerships and CLIA-certified lab services, Quanterix is now strategically positioned to drive significant value creation through an expanded portfolio of lab service offerings. This collaboration establishes a clear path for Quanterix to participate in the rapidly emerging spatial biology clinical market, particularly in oncology.
Increases commercial reach and maximizes cross-selling opportunities: Quanterix and Akoya have complementary offerings and deep customer relationships across discovery, translational, and clinical research. When offered as an integrated solution, Quanterix expects significant cross-selling opportunities to a combined 2,300 instrument install-base driving strong double-digit organic revenue growth in 2026.
Accelerates path to profitability through realization of substantial cost savings: The transaction is expected to generate approximately $40 million in annual cost synergies by the end of 2026, with $20 million expected to be realized within the first year following close. These cost savings will be driven primarily by the elimination of duplicative corporate structures, streamlined commercial infrastructure, increased operational efficiencies, process improvements and footprint optimization. The synergies will be additive to the cost savings initiatives already implemented by the two organizations. Quanterix’s previous cost initiatives combined with the expected cost synergies from the transaction are expected to accelerate its path to profitability, including generating positive free cash flow in 2026.
Significant combined cash balance: For the trailing 12 months ending September 30, 2024, the combined company generated revenue of approximately $220 million. With more than $300 million in combined cash today, Quanterix expects to have approximately $175 million in cash with no expected debt at the time of closing, after accounting for debt repayment, transaction costs, and a $20 million payment for its recently announced EMISSION acquisition. Quanterix will have financial flexibility to advance the Company’s global diagnostic testing infrastructure, including for Alzheimer’s disease and other growth opportunities such as Akoya’s advancement into the companion diagnostics segment.
Transaction Terms

Under the terms of the agreement, which was approved by the Boards of Directors of both companies, Akoya shareholders will receive 0.318 shares of Quanterix common stock for each share of Akoya common stock owned. This represents a 19% premium to Akoya’s unaffected stock price on November 14, 2024, the last full trading day prior to Akoya’s announcement of its review of strategic alternatives.

Following the close of the transaction, Quanterix shareholders will own approximately 70% of the combined company and Akoya shareholders will own approximately 30%, on a fully diluted basis.

Timing, Approvals and Governance

The transaction is expected to close in the second quarter of 2025, subject to approval by both companies’ shareholders, expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and satisfaction of other customary closing conditions.

Quanterix has entered into voting agreements supporting the transaction with certain shareholders owning more than 50% of Akoya’s common stock.

Following close, Masoud Toloue will serve as Chief Executive Officer and Vandana Sriram will serve as Chief Financial Officer. The combined company will continue to operate under the Quanterix name.

Upon closing, the Quanterix Board will consist of nine members. Two current Quanterix directors will resign, and Quanterix will appoint two directors designated by Akoya from their current Board.

Conference Call and Webcast

Quanterix will host a conference call and webcast today at 8:30 a.m. E.T. to discuss the transaction. For audio, use the following dial-in number and passcode: USA & Canada – Toll-Free (800) 715-9871 Conference ID: 9092934. Interested investors can also access the live webcast from the News & Events page within the Investors section of the Quanterix website at View Source

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to Quanterix and Covington & Burling LLP is serving as its legal counsel. Perella Weinberg Partners LP is serving as financial advisor to Akoya and DLA Piper LLP is serving as its legal counsel.

AKTIS ONCOLOGY TO PRESENT AT THE 43rd ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On January 10, 2025 Aktis Oncology, an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for large patient populations not addressed by existing platform technologies, reported that Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif (Press release, Aktis Oncology, JAN 10, 2025, View Source [SID1234649603]). Dr. Roden’s presentation will take place on Monday, January 13, 2025, at 3:30 p.m. PT.

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