On July 4, 2025 AstraZeneca reported that Imfinzi (durvalumab) has been approved in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) (Press release, AstraZeneca, JUL 4, 2025, View Source [SID1234654238]).

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The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a statistically significant 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.

Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus the comparator arm (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.

In 2024, over 35,000 people in the five major European countries were treated for MIBC.1 Despite this representing a curative-intent setting, many patients experience disease recurrence after surgery with current standard-of-care neoadjuvant chemotherapy.2

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, said: "The durvalumab-based perioperative regimen is an important new treatment option for patients in Europe with muscle-invasive bladder cancer, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder. The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival, underscoring its potential to transform clinical practice in this curative-intent setting."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Imfinzi is poised to transform the standard of care for muscle-invasive bladder cancer in Europe as the first and only perioperative immunotherapy for these patients. In the NIAGARA Phase III trial, more than 80 per cent of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades."

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events were consistent with the known profile of Imfinzi, manageable and mostly low-grade.

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) has published its assessment of the NIAGARA regimen against the Magnitude of Clinical Benefit Scale (MCBS), awarding it the highest possible grade of "A" in the curative setting.3 The ESMO (Free ESMO Whitepaper)-MCBS facilitates improved decision-making regarding the value of anti-cancer therapies and is used in several ways, including in clinical guidelines and in health technology assessments in a growing number of countries.4

Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications for this indication are currently under review in Japan and several other countries. Imfinzi is also approved in other curative-intent settings based on the PACIFIC and AEGEAN Phase III trials in non-small cell lung cancer (NSCLC), and in limited-stage small cell lung cancer (SCLC) based on the ADRIATIC Phase III trial.

Notes

Muscle-invasive bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.5 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.6 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.6 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.2 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting.

The trial is being conducted at 192 centres in 22 countries across North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response at the time of cystectomy. Key secondary endpoints are OS and safety.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

In lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.

On July 3, 2025 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and Antibody Drug Conjugate (ADC)-based therapies, reported that Boehringer Ingelheim has selected a third drug candidate, which will now advance into IND-enabling studies under their ongoing collaboration (Press release, Oxford BioTherapeutics, JUL 3, 2025, View Source [SID1234656420]). The target, OB33, was identified using OBT’s proprietary OGAP-Verify discovery platform. As a result of this milestone, OBT will receive a payment from Boehringer.

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Immuno-oncological therapies have transformed the cancer treatment landscape. They are however only effective in a subset of patients, requiring the identification of novel immunotherapy targets. The collaboration with Oxford BioTherapeutics complements Boehringer Ingelheim’s development of next-generation potentially life-changing cancer immunotherapies with the identification of unique and specific cancer targets.

Dr. Christian Rohlff, Chief Executive Officer, said: "We are pleased to see our partnership with Boehringer Ingelheim reach an important preclinical milestone. It reflects the strength of our collaboration and the scientific excellence of our OGAP discovery platform. This achievement reinforces our strategy of partnering with world-class organizations to translate breakthrough science into potential new cancer therapies. We look forward to the next phase of this highly successful partnership and to continuing to work together to develop innovative first-in-class treatments for patients with difficult to treat cancers."

OBT’s recently launched enhanced OGAP-Verify discovery platform allows for enhanced sensitivity and target selection, addressing key challenges in the design of therapeutic antibodies and diagnostic tools. This has resulted in an increased overall success rate of these novel compounds transitioning into clinical development.

Under the multi-year collaboration, OBT has identified targets using the OGAP-Verify platform, while Boehringer is responsible for the development and commercialization of resulting product candidates.

The OBT–Boehringer partnership began in 2013 and has expanded through subsequent agreements in 2020 and 2022 to include additional programs. The collaboration has yielded multiple development-stage assets, with two candidates currently in clinical trials, one compound now in IND enabling studies, and a fourth target recently optioned by Boehringer Ingelheim.

On July 3, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that on July 2, 2025 the Company granted (i) non-qualified stock options to one newly-hired non-executive employee to purchase a total of 30,000 shares of the Company’s common stock at an exercise price per share of $1.12, which was the closing price per share of the Company’s common stock as reported by NASDAQ on July 2, 2025, the options grant date, and (ii) restricted stock units (RSUs) representing 37,900 shares of its common stock to two newly-hired non-executive employees (Press release, Fate Therapeutics, JUL 3, 2025, View Source [SID1234654234]). The grants were approved by the Compensation Committee of the Company’s Board of Directors and granted under the Company’s Amended and Restated Inducement Equity Plan as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date and the remaining 75% vesting in approximately equal monthly installments over the following thirty-six months, subject to the employee being continuously employed by the Company through each vesting date. The RSUs will vest over four years, with 25% of the shares underlying each RSU award vesting on each anniversary of the grant date, subject to the employees being continuously employed by the Company through each vesting date.

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On July 3, 2025 INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported the pricing of an underwritten public offering of 14,285,715 shares of its common stock and accompanying Series A warrants to purchase up to 14,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.75 per share of common stock and Series B warrants to purchase up to 14,285,715 shares of its common stock (or pre-funded warrants in lieu thereof) at an exercise price of $1.75 per share of common stock, at a combined public offering price of $1.75 per share of common stock and accompanying Series A and Series B warrants (Press release, Inovio, JUL 3, 2025, View Source [SID1234654235]). All of the securities in the offering are being sold by INOVIO. The offering is expected to close on or about July 7, 2025, subject to the satisfaction of customary closing conditions. INOVIO also granted the underwriters an option for a period of 30 days to purchase up to 2,142,857 additional shares of the Company’s common stock and Series A warrants to purchase up to 2,142,857 additional shares of its common stock and Series B warrants to purchase up to 2,142,857 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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The gross proceeds from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by INOVIO, excluding any exercise of the underwriters’ option to purchase additional securities and assuming no exercise of the accompanying Series A and Series B warrants, are expected to be approximately $25 million.

Piper Sandler & Co. is acting as sole active book-running manager for the offering. Oppenheimer & Co. Inc. is also acting as a passive bookrunner for the offering.

A shelf registration statement relating to the shares of common stock and accompanying Series A and Series B warrants offered in the offering described above was filed with the Securities and Exchange Commission ("SEC") on November 9, 2023 and declared effective by the SEC on January 31, 2024. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by e-mail at [email protected] and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 3, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso’s first bispecific ADC to enter clinical trials (Press release, Akeso Biopharma, JUL 3, 2025, View Source [SID1234654239]).

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AK146D1 has recently received approval from the U.S. FDA, Australia’s TGA, and China’s NMPA to begin clinical trials.

Currently, Akeso’s globally first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both been approved in China. The company has also rolled out a series of leading therapeutic strategies worldwide. Akeso is the only company globally with two approved cancer immunotherapy bispecific antibodies, positioning it with a strong global leadership advantage in the IO+ADC space.

Building on this, ADC therapeutics have become a key component of Akeso’s "IO+ADC" 2.0 strategy, reshaping the global treatment landscape and setting new standards for cancer care.

Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said:
"Leveraging our extensive experience in the development of multispecific antibody drugs, the advancement of innovative bispecific ADCs like AK146D1 enables the company to unlock the global clinical potential of its innovative product portfolio, expanding opportunities for the ongoing evolution of cancer therapies."

"Our globally first-in-class bispecific antibodies cadonilimab and ivonescimab have been successfully approved in China and have shown groundbreaking clinical value across various cancer treatments. This has established a strong global advantage for the company in the IO 2.0 space. Additionally, the efficient development of ADCs, particularly a series of innovative bispecific ADCs, will further strengthen our leadership in the ADC 2.0 field. As a result, after the evolution of IO + chemotherapy, IO + ADC, and IO 2.0 + ADC, Akeso has once again created a global competitive edge in "IO+ADC" 2.0. We are excited about the potential of these next-generation treatments to benefit patients worldwide."

Trop2 and Nectin4 are highly expressed in various tumor types but exhibit relatively low expression in normal tissues, making them ideal targets for ADC therapy. By targeting both Trop2 and Nectin4, AK146D1 aims to provide a broader therapeutic window and potentially overcome resistance seen with single-target ADCs, thus improving treatment efficacy.

While there are approved monoclonal ADCs targeting Trop2 and Nectin4, AK146D1 is the first bispecific ADC targeting both markers. Preclinical studies of AK146D1 have shown promising results, demonstrating strong anti-tumor activity and favorable safety profiles in tumors expressing Trop2 or Nectin4. The development of AK146D1 holds significant potential for improving treatment outcomes for cancer patients, and Akeso is excited about the potential benefits it could offer to clinicians and patients worldwide.