On February 6, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the successful completion of its End of Phase 2 (EOP2) interaction with the US Food and Drug Administration (FDA), further strengthening the prospect of initiating Phase 3 in 2025 with mitazalimab, which is in development as a first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX (Press release, Alligator Bioscience, FEB 6, 2025, View Source [SID1234650074]).

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The EOP2 meeting with the FDA provided positive feedback and alignment on the non-clinical and clinical data packages to support the Biologics License Application (BLA), including the Phase 3 trial design, thus reinforcing earlier regulatory guidance from the Paul Ehrlich Institute (PEI) of Germany in July 2024. Additionally, a recent Type C Chemistry, Manufacturing, and Controls (CMC) interaction with the FDA in December 2024 confirmed that the completed and planned CMC work through early 2025 is Phase 3-enabling.

Alligator expanded patient recruitment during 2024 in the ongoing OPTIMIZE-1 study by enrolling an additional 15 patients at the 450 µg/kg dose level as per guidance received from the FDA in December 2023. Results from this cohort, along with a 24-month follow-up on the 900 µg/kg dose group, are expected during Q1 2025. Alligator updated the FDA on this activity, and no new information emerged affecting the Phase 3 dose selection.

"The successful outcome of our End-of-Phase 2 FDA interaction marks a critical milestone in our development program," said Søren Bregenholt, CEO of Alligator Bioscience. " With clear regulatory alignment on our Phase 3 trial and robust CMC progress, mitazalimab is well-positioned for Phase 3 initiation during 2025. We remain committed to addressing the unmet medical need of patients with metastatic pancreatic cancer."

On February 6, 2025 Shanghai Henlius Biotech, Inc. (2696.HK) reported it has entered into a license agreement with Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY| NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy’s") for the company’s independently developed investigational daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection (Press release, Shanghai Henlius Biotech, FEB 6, 2025, View Source [SID1234650090]). Dr. Reddy’s will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States (U.S.).

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Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including a $33 million upfront payment and additional milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s is a global pharmaceutical company, operating in over 75 countries across the globe. Through a partnership with Dr. Reddy’s, Henlius aims to boost the growth and reach of its products in the European and U.S. markets, providing local patients with enhanced treatment options.

"This collaboration with Dr. Reddy’s on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics," said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. "Dr. Reddy’s has a long-standing dedication to oncology, driven by the purpose that ‘Good Health Can’t Wait’, and is committed to timely access to affordable and high-quality medicines, which complement Henlius’ focus on addressing unmet medical needs in research and development. We are confident that this partnership will enhance the global market competitiveness of both organizations in oncology treatment, ultimately allowing us to reach and support more patients around the world."

"We are pleased to join hands with Dr. Reddy’s, signifying a pivotal moment in Henlius’ journey to expand our global partner network," said Ping Cao, Chief Business Development Officer and SVP of Henlius, "Henlius’ robust product development capabilities in biosimilars, along with its advanced manufacturing and quality systems that meet global standards, paired with Dr. Reddy’s vast experience and resources in the global commercialization of biosimilars, positions this collaboration to effectively harness the strengths of both organizations. Together, we aim to deliver more high-quality and affordable treatment options to the U.S. and European markets."

Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said: "We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the U.S., and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options."

About HLX15

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to Darzalex & Darzalex Faspro* which are indicated for the treatment of multiple myeloma. In accordance with the biosimilar guidelines of NMPA, EMA, and USFDA, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered comparable based on analytical similarity assessment and pre-clinical studies. In June 2024, the Phase 1 clinical study (NCT05679258) of HLX15 was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab. Comparative efficacy studies are currently underway.

*Darzalex & Darzalex Faspro are registered trademarks of Johnson & Johnson.

On February 5, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year (Press release, PDS Biotechnology, FEB 5, 2025, View Source [SID1234650056]).

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PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

"The integral elements for trial initiation are ready, including alignment with the FDA," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC."

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

"HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU," said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. "Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC."

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

On February 5, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that management will participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, February 12, 2025, at 12:40 pm ET (Press release, Protara Therapeutics, FEB 5, 2025, View Source [SID1234650057]).

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A live webcast of the fireside chat can be accessed by visiting the Events and Presentations section of the Company’s website: View Source The webcast will be archived for a limited time following the presentation.

On February 5, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported financial results for the fourth quarter and full-year 2024 (Press release, Qiagen, FEB 5, 2025, View Source [SID1234650058]).

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Net sales for Q4 2024 increased 2% to $521 million compared to Q4 2023, while sales at constant exchange rates (CER) of $525 million rose 3% and were above the outlook for at least $520 million CER and core sales (excluding discontinued products such as NeuMoDx and Dialunox) rose 4% CER. The adjusted operating income margin improved by 2.6 percentage points to 30.6%, driven by efficiency gains and benefits from the NeuMoDx decision, enabling reinvestments into targeted growth initiatives. Adjusted diluted earnings per share (EPS) were $0.61, and CER results of $0.61 were above the outlook for at least $0.60 CER.

QIAGEN expects the solid growth pace in H2 2024 to continue in 2025. Net sales are expected to rise about 4% CER (and core sales growth of about 5% CER). Adjusted diluted EPS is expected to be at least $2.28 CER, driven by a goal to improve the adjusted operating income margin by at least 150 basis points to above 30% while absorbing lower non-operating income contributions than in 2024.

"Our teams at QIAGEN concluded 2024 with a solid performance in the fourth quarter, exceeding our outlook for net sales and profitability. These results underscore the resilience of our portfolio, with over 85% of sales coming from highly recurring revenues, and our focus on delivering solid profitable growth in an ongoing challenging environment," said Thierry Bernard, CEO of QIAGEN.

"Our solid sales growth in the second half of 2024 mirrors our plans for further strong growth in 2025 as we reconfirm our 2028 targets. QIAstat-Dx exceeded expectations with four FDA clearances for our syndromic testing system in 2024 and one already in 2025, coupled with over 660 placements in 2024 that was ahead of our target. QuantiFERON delivered 11% CER growth for 2024, with significant opportunities for further expansion since only 40% of the global latent TB testing market has so far been converted from the outdated skin test. QIAcuity also delivered solid growth despite challenging instrument purchase trends as we expanded digital PCR into clinical use in 2024 while expanding our presence with academia, pharma and other customers."

"We are pleased with our 2024 results that featured strong free cash flow combined with solid sales growth and a significant increase in the outlook for adjusted EPS during the year thanks to operational profitability improvements. Our confidence in QIAGEN’s future is reflected in the return of about $300 million to shareholders in January through a synthetic share repurchase. We remain well-positioned to execute on our 2028 commitments for solid profitable growth, supported by our differentiated portfolio and disciplined capital allocation that seeks to strengthen our business while increasing returns to shareholders," said Roland Sackers, CFO of QIAGEN.

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Thursday, February 6, 2025, at 16:00 Frankfurt Time / 15:00 London Time / 10:00 New York Time. A live audio webcast will be accessible in the investor relations section of the QIAGEN website (www.qiagen.com), with a recording available after the event. The presentation will be published ahead of the call in this section: QIAGEN Investor Relations – Events and Presentations.

Use of adjusted results

QIAGEN reports adjusted results, as well as results on a constant exchange rate (CER) basis, along with other non-U.S. GAAP (generally accepted accounting principles) measures, to provide deeper insights into its performance. These include metrics such as core sales (excluding discontinued products), adjusted gross margin, adjusted gross profit, adjusted operating income, adjusted operating expenses, adjusted operating income margin, adjusted net income, adjusted net income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted EPS, adjusted income taxes, adjusted tax rate, and free cash flow. Free cash flow is calculated by subtracting capital expenditures for property, plant and equipment from cash flow from operating activities. Adjusted results are non-GAAP financial measures that QIAGEN considers complementary to GAAP-reported results but not as substitutes. These measures exclude items that QIAGEN believes are outside of ongoing core operations, fluctuate significantly between periods, or hinder the comparability of results with competitors and prior periods. QIAGEN also uses non-GAAP and constant currency financial measures internally in planning, forecasting and reporting, and also for employee compensation. Additionally, adjusted results are used to compare current performance with historical results, which have consistently been presented on an adjusted basis.