On July 1, 2025 Novocure (NASDAQ: NVCR) reported that it will present the final secondary endpoint results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for unresectable, locally advanced pancreatic cancer (Press release, NovoCure, JUL 1, 2025, View Source [SID1234654205]). These data from PANOVA-3 were accepted as a late-breaking abstract for oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place July 2 to July 5 in Barcelona, Spain.

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"In the PANOVA-3 trial, there was a significant improvement in overall survival and a significant delay in the progression of pain as well as delayed opioid medication use in patients treated with Tumor Treating Fields and chemotherapy compared to chemotherapy alone. Pancreatic cancer is associated with debilitating pain. Delaying these symptoms can preserve a patient’s overall quality of life, a promising outcome we observed in this trial," said Teresa Macarulla, MD, PhD, Medical Oncologist at Hospital Universitari Vall d’Hebron and Head of the Gastrointestinal and Endocrine Tumors Group at the Vall d’Hebron Institute of Oncology (VHIO). "The overall survival and quality of life results in PANOVA-3 support Tumor Treating Fields therapy with gemcitabine and nab-paclitaxel as a potential standard of care for unresectable, locally advanced pancreatic cancer."

The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields.

"The PANOVA-3 results illustrate that Tumor Treating Fields therapy can significantly improve clinical outcomes for patients, including overall survival, in unresectable, locally advanced pancreatic cancer," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "These new data show that Tumor Treating Fields therapy can also have a meaningful impact preserving patients’ quality of life by delaying worsening symptoms of pancreatic cancer. We look forward to submitting a premarket application for Tumor Treating Fields therapy to the FDA in the second half of 2025."

Results from PANOVA-3

The primary endpoint of overall survival and several secondary endpoints, including pain-free survival, from PANOVA-3 were previously reported at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

The additional secondary endpoint data to be presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 are the full quality of life outcomes as well as a post-hoc analysis of the time to first opioid use.

The quality of life outcomes were measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum scales. The EORTC QLQ-C30 and the PAN26 measure global health status and function as well as symptoms including pain (irrespective of cause), pancreatic pain, and gastrointestinal symptoms.

There was a statistically significant delay in the time to deterioration in global health status for patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.7 months, respectively, p=0.023.

The delay in time to deterioration due to pain (irrespective of cause) was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median 10.1 months compared to 7.4 months, respectively, p=0.003.

Similarly, the delay in time to deterioration due to pancreatic pain was statistically significant in patients treated with TTFields concomitant with GnP compared to patients treated with GnP alone, with a median of 14.7 months compared to 10.2 months, respectively, p=0.006.

These results complement the statistically significant extension in pain-free survival reported at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, which was defined as the time between randomization until a ≥20-point increase of pain using a visual analog scale (VAS) from baseline or death. Patients treated with TTFields concomitant with GnP had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with GnP alone; HR 0.74 (95% CI: 0.56–0.97) p=0.027.

All gastrointestinal symptom scales included in the EORTC QLQ-C30 and PAN26, except for indigestion and altered bowel habit, significantly favored patients treated with TTFields concomitant with GnP.

In a post-hoc analysis, time to first opioid use was significantly longer with TTFields and GnP compared to patients treated with GnP alone, with a median of 7.1 months compared to 5.4 months, respectively, p=0.046.

TTFields therapy was well-tolerated, no new safety signals were observed, and device related safety outcomes were consistent with prior clinical studies using TTFields. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.

The company will also present two posters of preclinical data from its pancreatic cancer development program.

Data Presentation Details

Oral Presentation: Late Breaking Abstract #LBA3: PANOVA-3: Pain and quality of life (QoL) outcomes with Tumor Treating Fields (TTFields) therapy in patients with locally advanced pancreatic adenocarcinoma (LAPC)

Presenting Author: Teresa Macarulla, MD, PhD, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Spain

Time and Location: July 3, 2:10 PM CEST / 8:10 AM EDT, Barcelona Room

Poster #311P: Effectiveness of tumor treating fields (TTFields) together with gemcitabine and nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC) preclinical models

Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

Poster #316P: Pancreatic cancer cells are sensitized to FOLFIRINOX treatment by co-application with tumor treating fields (TTFields)

Time and Location: July 3, 3:30 – 4:30 PM CEST / 9:30 – 10:30 AM EDT, Exhibition Area

About PANOVA-3

PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.

About Pancreatic Cancer

Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the U.S.i and the fifth most frequent cause in Europe.ii While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.iii It is estimated that approximately 67,000 patients are diagnosed with pancreatic cancer each year in the U.S.iv and the global incidence is more than 500,000.v Pancreatic cancer has a five-year relative survival rate of just 13%.vi

Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, most locally advanced cases are diagnosed when the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On July 1, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, reported that new data from the ongoing OPTIMIZE-1 study, evaluating the CD40 agonist mitazalimab in combination with mFOLFIRINOX in metastatic pancreatic cancer, will be presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place in Barcelona on 2–5 July (Press release, Alligator Bioscience, JUL 1, 2025, View Source [SID1234654190]).

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The poster includes 24-month efficacy results and dose characterization data from OPTIMIZE-1 (NCT04888312), a Phase 1b/2 trial in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients receiving 900 μg/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.

A comparison between the 900 μg/kg and 450 μg/kg cohorts revealed a higher response rate for 900 μg/kg of 54.4% versus 22.7%. This indicates a dose-response relationship further supporting mitazalimab’s contribution to the positive clinical response data observed in OPTIMIZE-1, reinforcing the candidate’s favorable safety profile and supporting 900 μg/kg as the recommended Phase 3 dose — a decision recently endorsed by the FDA.

Poster presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 24-month follow up and dose characterization from the OPTIMIZE-1 study
Topic: Upper digestive – Biliary, ampullary and pancreatic cancer
Presentation number: 265P
Session: Poster display session 1 and coffee break
Date: Thursday, 3 July 2025
Time: 15:30–16:30 CEST
Location: Foyer
Presenter: Dr. Aurélien Lambert

On July 1, 2025 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported that it has closed the acquisition of SpringWorks Therapeutics, Inc., for an enterprise value of $3.4 billion (approximately €3 billion)*, following regulatory clearances and the fulfillment of other customary closing conditions (Press release, Merck KGaA, JUL 1, 2025, View Source [SID1234654206]).

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The definitive agreement between Merck KGaA, Darmstadt, Germany and SpringWorks, based in Stamford, Connecticut, was announced on 28 April, 2025. It represents one of the biggest M&A deals in the global biopharma sector so far in 2025. The business combination will immediately contribute to Merck KGaA, Darmstadt, Germany’s revenues and is expected to be accretive to the company’s earnings per share pre (EPS pre) by 2027.

"Today, we officially welcome SpringWorks to Merck KGaA, Darmstadt, Germany. The acquisition of SpringWorks illustrates our decisive portfolio approach to further position Merck KGaA, Darmstadt, Germany as a globally diversified science and technology powerhouse," said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. "This is the largest acquisition we have made for our Healthcare business sector in nearly 20 years, marking an exciting new chapter for Healthcare. Furthermore, we remain committed to identifying M&A opportunities across our three business sectors, with a focus on Life Science, prioritizing strategic fit, financial robustness, and long-term value creation."

"This acquisition is a significant step forward in bringing innovation to patients living with rare and often debilitating tumors—many of whom are young and facing a long, uncertain journey with limited treatment options," said Danny Bar-Zohar, CEO of Healthcare and member of the Executive Board at Merck KGaA, Darmstadt, Germany. "By combining our global reach with SpringWorks’ expertise, we are expanding access to life-changing therapies for patients around the world. At the same time, this move strengthens our foundation for further expansion in rare tumors and adjacent disease areas. I’d like to warmly welcome the SpringWorks team to Merck KGaA, Darmstadt, Germany."

SpringWorks’ portfolio features two highly innovative products for the treatment of rare tumors in areas of high unmet need where limited treatment options exist. U.S. Food and Drug Administration (FDA)-approved, OGSIVEO (nirogacestat) is a first-in-class therapy for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. In June 2025, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of nirogacestat.

GOMEKLI (mirdametinib) is the first and only FDA-approved therapy for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. In May 2025, the CHMP adopted a positive opinion recommending the approval of mirdametinib.

SpringWorks’ portfolio complements Merck KGaA, Darmstadt Germany’s progress in building a rare tumor business with Merck KGaA, Darmstadt, Germany having worldwide commercialization rights for pimicotinib, an investigational therapy developed by Abbisko Therapeutics Co., Ltd. for patients with tenosynovial giant cell tumor (TGCT). Global regulatory filings for pimicotinib are underway. The joint portfolio will serve a broad range of patients with rare tumors who have high unmet medical needs.

Shares in SpringWorks will no longer be traded on the Nasdaq, with Merck KGaA, Darmstadt, Germany now being the sole owner of SpringWorks. SpringWorks shareholders are being paid US$ 47 per share in cash.

*Based on SpringWorks’ cash balance as of 31 December 2024

On July 1, 2025 Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the "Company"), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported the pricing of an underwritten public offering for gross proceeds of approximately $6 million prior to deducting underwriting commissions and offering expenses (Press release, Cellectar Biosciences, JUL 1, 2025, View Source [SID1234654191]).

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The offering is comprised of (i) 865,000 Class A Units with each Class A Unit consisting of (a) one share of common stock and (b) one common warrant to purchase one share of common stock (the "Common Warrants"), and (ii) 335,000 Class B Units with each Class B Unit consisting of (a) one pre-funded common stock purchase warrant to purchase one share of common stock ("Pre-funded Warrants") and (b) one Common Warrant. The price per Class A Unit is $5.00 and the price per Class B Unit is $4.99999 (collectively, the "Offering"). The Common Warrants will have an exercise price of $5.25 per share, will be exercisable upon issuance, and have a term expiring five years from issuance.

Ladenburg Thalmann & Co. Inc. is acting as sole bookrunning manager in connection with this Offering.

The closing of the Offering is expected to take place on or about July 2, 2025, subject to the satisfaction of customary closing conditions.

In addition, the Company has granted the underwriter a 45-day option to purchase up to 180,000 additional shares of common stock and/or 180,000 Common Warrants, solely to cover over-allotments, if any, at the public offering price, less the underwriting discounts and commissions.

The gross proceeds from the Offering to the Company, before deducting underwriting discounts and commissions and other Offering expenses and excluding any proceeds that may be received upon the exercise of the Common Warrants and the exercise of the underwriter’s option to purchase additional shares of common stock and/or Common Warrants, are expected to be approximately $6 million. The Company currently intends to use the net proceeds of the Offering for general corporate purposes, including working capital and operating expenses, and to initiate a Phase 1b clinical study of our compound CLR 121125 (CLR 125) in triple-negative breast cancer.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-288333), which was declared effective by the United States Securities and Exchange Commission ("SEC") on July 1, 2025. A preliminary prospectus relating to the securities being offered was filed with the SEC on June 30, 2025, and is available on the SEC’s website at View Source The securities are being offered only by means of a prospectus which forms part of the effective registration statement and is available on the SEC’s website located at View Source A final prospectus relating to this Offering will be filed by the Company with the SEC. Electronic copies of the preliminary prospectus and the final prospectus, when available, may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

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

On July 1, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported encouraging clinical findings among patients with advanced metastatic colorectal cancer ("mCRC") previously treated with leronlimab (Press release, CytoDyn, JUL 1, 2025, View Source [SID1234654192]). The final results indicate that 3/5 patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later.

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Dr. Benjamin Weinberg, Associate Professor at Georgetown University and Principal Investigator of CytoDyn’s colorectal cancer ("CRC") program, will present the Company’s clinical data at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025 taking place in Barcelona, Spain from July 2 to July 5, 2025.

The results, from patients treated under a compassionate use protocol, reiterate a favorable safety profile of leronlimab as well as its potential for clinical benefit in patients with mCRC. They also support the rationale for the design and therapeutic potential of CytoDyn’s ongoing Phase II trial in patients with relapsed/refractory microsatellite stable CRC. CytoDyn recently announced the dosing of the first patient in this study, and is now enrolling additional patients across multiple clinical sites.

If the observed results in the previously treated CRC patients are confirmed prospectively, the Company believes leronlimab could be used effectively to treat a wide range of solid tumor types. In addition to its potential as a "stand-alone" agent in oncology, the Company presented exciting evidence of leronlimab’s activity as a "priming" agent for cancer patients with low levels of PD-L1 who were previously unresponsive to, or ineligible for, checkpoint inhibitors at the 2025 ESMO (Free ESMO Whitepaper) Breast Cancer meeting. The data driving this working theory has shown particular promise in the treatment of patients with advanced metastatic triple-negative breast cancer ("mTNBC").

"At the 2025 ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, Dr. Weinberg will share the data and evidence that form the basis for our belief in the potential of leronlimab as a treatment in CCR5 positive solid tumor oncology," said Dr. Jacob Lalezari, CEO of CytoDyn. "Our ongoing Phase II trial in patients with mCRC was designed to prospectively confirm these observations, and we look forward to enrolling additional patients as we pursue clinical confirmation of our working theory."