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Corcept Initiates Trial of Relacorilant Plus Nab-Paclitaxel and Bevacizumab in Patients With Platinum-Resistant Ovarian Cancer

On April 7, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported the start of BELLA, a Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and safety in patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, APR 7, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-initiates-trial-relacorilant-plus-nab-paclitaxel-and [SID1234651814]).

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BELLA is a single-arm, open-label trial with a planned enrollment of 90 women with recurrent, platinum-resistant ovarian cancer at approximately 50 sites in North America, Europe and Asia-Pacific. Patients will receive relacorilant in combination with nab-paclitaxel and bevacizumab.

"In our pivotal Phase 3 ROSELLA trial, treatment with relacorilant and nab-paclitaxel improved patients’ progression-free and overall survival, without increasing their side effect burden," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "BELLA will examine whether combining relacorilant with two medications – nab-paclitaxel and bevacizumab – will offer patients an additional treatment option."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response, which weakens its ability to fight disease.

ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate

On April 7, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company’s potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors (Press release, ALX Oncology, APR 7, 2025, View Source [SID1234651813]). Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025.

"Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimize the targeted delivery of a powerful chemotherapy payload to tumor cells while minimizing systemic toxicity. The resulting, highly differentiated molecule has demonstrated potent anti-tumor activity in preclinical models and is a strategic addition to our clinical pipeline, which also includes multiple trials evaluating our lead therapeutic candidate, evorpacept."

EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads.

Utilizing the company’s proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect.

ALX Oncology plans to conduct an R&D call focused on ALX2004 in Q2 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025.

QIAGEN Delivers Strong Preliminary Q1 2025 Results Exceeding Outlook and Raises Full-Year 2025 Adjusted EPS Outlook

On April 6, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported preliminary Q1 2025 results that exceeded its outlook for both net sales and adjusted earnings per share (EPS), reflecting strong performances across many growth drivers (Press release, Qiagen, APR 6, 2025, View Source [SID1234651810]).

Net sales grew approximately 5% (+7% at constant exchange rates, CER) to about $483 million in Q1 2025, surpassing the previously communicated outlook for about 3% CER growth (4% CER core business excluding discontinued products such as NeuMoDx and Dialunox). Adjusted diluted EPS are expected to be at least $0.55 CER compared to the previously communicated outlook for about $0.50 CER.

Sales of the QuantiFERON latent TB test grew about 15% CER as global adoption continues to shift from the skin test to this proven, modern blood-based test. The QIAstat-Dx syndromic testing system advanced above 35% CER on continued demand for respiratory panels along with growth in gastrointestinal and meningitis testing. The QIAcuity digital PCR system and QIAGEN Digital Insights bioinformatics business both delivered high-single-digit CER gains, reflecting solid adoption across research and clinical applications. Additional growth contributions also came from higher sales of PCR consumables and from OEM products. Sample technologies sales declined 1% CER, reflecting the cautious instrument spending environment among some Life Sciences customers.

Given the positive start to 2025, QIAGEN is raising its adjusted diluted EPS outlook for full-year 2025 in light of the strong sales growth in Q1 and the overall current business trends, which includes expected headwinds from the recently announced U.S. import tariffs and a better-than-expected tax environment.

Full-year 2025, adjusted diluted EPS are now expected to be about $2.35 CER, up from the prior full-year outlook for about $2.28 CER, while reaffirming the goal to improve the adjusted operating income margin to above 30% for the year.

QIAGEN will provide additional perspectives on the outlook for full-year 2025 with the publication of full Q1 2025 results on May 7, 2025.

Additionally, QIAGEN now expects to reach the mid-term adjusted operating income margin goal of at least 31% well ahead of the original 2028 timeline, reflecting the stronger-than-anticipated improvements delivered during 2024 and 2025.

Entry into a Material Definitive Agreement

On April 4, 2025, Lipella Pharmaceuticals Inc. (the "Company") entered into an At The Market Offering Agreement (the "ATM Agreement") with H.C. Wainwright & Co., LLC ("Wainwright"), to sell shares of its common stock, par value $0.0001 per share (the "Common Stock") having an aggregate sales price of up to $2,641,881 (the "Shares"), from time to time, through an "at the market offering" program under which Wainwright will act as sales agent (Filing, 8-K, Lipella Pharmaceuticals, APR 4, 2025, View Source [SID1234651819]). The sales, if any, of the Shares made under the ATM Agreement will be made by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended.

The Company has agreed to pay Wainwright a cash commission equal to 3.0% of the aggregate gross proceeds from sales of the Shares and has agreed to provide Wainwright with customary indemnification and contribution rights. The Company has also agreed to reimburse Wainwright for certain specified expenses not to exceed $100,000 in connection with entering into the ATM Agreement. The ATM Agreement contains customary representations and warranties and conditions to the sale of the Shares pursuant thereto.

The Company is not obligated to sell any of the Shares under the ATM Agreement and no assurance can be given that the Company will sell any Shares under the ATM Agreement, or if such sales occur, no assurance can be given as to the price or number of Shares that will be sold, or the dates on which any such sales will take place. The Company or Wainwright may at any time suspend solicitation and offers of Shares thereunder and the ATM Agreement may be terminated by either the Company or Wainwright, as permitted therein. The Company currently intends to use all proceeds raised in connection with the sale of Shares for working capital and general corporate purposes.

The Shares will be issued pursuant to the prospectus supplement (the "Prospectus Supplement"), dated April 4, 2025, to the base prospectus included in the Company’s shelf registration statement on Form S-3 (File No. 333- 276815) filed by the Company with the U.S. Securities and Exchange Commission ("SEC") on February 1, 2024, and declared effective by the SEC on February 8, 2024 (the "Registration Statement").

This Current Report on Form 8-K (this "Form 8-K") shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there by any sale of shares of Common Stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

The foregoing description of the ATM Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is attached hereto as Exhibit 10.1 and which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreement were made only for purposes of such agreement and as of specific date, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. The Company is filing the opinion of its counsel, Sullivan & Worcester LLP, relating to the legality of the issuance and sale of the Shares as Exhibit 5.1 hereto. Exhibit 5.1 is incorporated herein by reference and into the Registration Statement.

RenovoRx to Present at LD Micro Invitational XV Conference in New York on April 10th

On April 4, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that Chief Executive Officer Shaun Bagai will present at the LD Micro Invitational XV: New York 2025 conference taking place at the Westin Grand Central Hotel, New York, NY on April 10, 2025 (Press release, Renovorx, APR 4, 2025, View Source [SID1234651809]).

Mr. Bagai will discuss recent corporate milestones, including an update on RenovoRx’s continued momentum of its RenovoCath commercial efforts, including new purchase orders and reorders received from cancer center customers, and the realization of initial revenues from RenovoCath sales.

Mr. Bagai will also discuss progress on RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating RenovoRx’s lead drug-device combination product candidate (intra-arterial delivery of gemcitabine via the RenovoCath catheter, known as IAG) which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). This combination product candidate, IAG, which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.

Presentation Details:
Date: Thursday, April 10, 2025
Time: 3:30 p.m. ET
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact your LD Micro representative or KCSA Strategic Communications at [email protected].