On August 27, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will be attending the following conferences (Press release, Personalis, AUG 27, 2025, View Source [SID1234655536]):

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Morgan Stanley 23rd Annual Global Healthcare Conference on Wednesday, September 10, 2025, at the Sheraton New York Times Square Hotel in New York, NY
Lake Street 9th Annual Best Ideas Growth Conference on Thursday, September 11, 2025, at the Yale Club in New York, NY

On August 27, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in three upcoming investor conferences, including fireside chats at two conferences (Press release, Nuvation Bio, AUG 27, 2025, View Source [SID1234655535]):

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Cantor Global Healthcare Conference 2025 on Thursday, September 4, 2025, at 2:10 p.m. ET in New York, NY
H.C. Wainwright 27th Annual Global Investment Conference on Tuesday, September 9, 2025, at 11:30 a.m. ET in New York, NY
The management team will participate in one-on-one meetings at the Citi 2025 BioPharma Back to School Conference on Wednesday, September 3, 2025, in Boston, MA.

Live webcasts of each fireside chat will be available on the Investor Relations section of the Nuvation Bio website. An archived recording will be available for 90 days following each event.

On August 27, 2025 Oncoinvent reported continued progress in the ongoing Phase 2 trial in ovarian cancer with a strong focus on advancing the program and maximizing recruitment (Press release, Oncoinvent, AUG 27, 2025, View Source [SID1234655534]).

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Highlights for the first half of 2025:

Radspherin

Positive final data from Phase1/2a trial in colorectal cancer patients
Positive interim 18-months data from Phase1 trial in ovarian cancer patients
Positive read-out of safety lead-in cohort and opening of randomized part of Phase 2 trial in ovarian cancer patients
Regulatory approvals for additional sites for the randomized Phase 2 trial in ovarian cancer, with expected onboarding before end of 2025
Corporate

Operating expenses reduced by 28% versus last year
Merger with BerGenBio
Fully guaranteed rights issue of NOKm 130
CEO Øystein Soug and CFO Tore Kvam will present the results for the first half of 2025 at a webcast available at https://channel.royalcast.com/landingpage/hegnarmedia/20250827_3/, Wednesday 27 August at 08:00 CEST. The presentation and Q&A will be held in English. A recording of the webcast will be made available on our website shortly after the presentation.

On August 27, 2025 ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, and its wholly owned subsidiary Cordex Biologics, reported the conditional marketing authorization of Zemcelpro by the European Commission (EC) for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available (Press release, ExCellThera, AUG 27, 2025, View Source [SID1234655533]). This EC decision authorizes the marketing of Zemcelpro in all European Union member states, as well as Iceland, Norway and Liechtenstein.

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Zemcelpro, also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

In Europe, over 10,000 patients each year are diagnosed with haematological malignancies—including leukemias and myelodysplastic syndromes—that require stem cell transplant. While access to transplant has improved in recent years, a number of patients still cannot access suitable donor cells. Barriers include the absence or unavailability of a compatible donor or the inability to secure donor cells within the therapeutic window for transplant, which can be especially short in urgent cases. Unlike documented transplant procedures which are well-tracked through national registries, no official statistics exist for patients who miss the opportunity for a potentially curative transplant—a group that includes a disproportionately high number of individuals from ethnic minority backgrounds.

"The curative potential of allogeneic stem cell transplantation is still limited by the access to a suitable donor. The access to stem cell donation according to the stringent disease course is one of the major limiting factors for success," said Dr. Fabio Ciceri, Professor of Hematology, Vita-Salute San Raffaele University, Millan, Italy. "UM171 Cell Therapy offers an option timely available for patients in need."

Patients with blood cancers who do not receive the stem cell transplant they require represent a significant burden to healthcare systems, driven by ongoing medical needs, disease progression, complications, hospitalizations and supportive/palliative care. Beyond this, the societal impact is profound, with premature deaths leading to lost productivity and considerable emotional and economic strain on families and communities.

"Each year, thousands of people across Europe are diagnosed with blood cancers that require potentially life-saving allogeneic stem cell transplantation. Yet some are left without access to suitable donor-derived blood stem cells, facing a critical and unmet medical need," said Dr. J. (Jurjen) Versluis, Internist-Hematologist and Principal Investigator, Erasmus MC, Rotterdam, The Netherlands.

Zemcelpro is an innovative, one-time cell therapy with curative intent, developed to give blood cancer patients without access to suitable donor cells the transplant they urgently need. By enabling more patients to receive a life-saving transplant, Zemcelpro has the potential not only to save lives but also to reduce the healthcare and societal burden associated with these devastating conditions.

The timing of Zemcelpro availability in individual countries will depend on several factors, including the completion of national reimbursement procedures. In the meantime, Cordex Biologics is working closely with national health authorities to enable early access for eligible patients ahead of the reimbursement process, and is engaging with leading stem cell transplantation centers to establish a network of treatment centers for the future administration of Zemcelpro.

"This authorization marks a pivotal milestone in delivering on the therapeutic promise of Zemcelpro for adults battling life-threatening haematological malignancies. As the first and only cell therapy approved for patients without access to suitable donor cells, Zemcelpro offers a vital new stem cell transplant option — and renewed hope — for those who have been left without one," said David Millette, CEO of ExCellThera and Cordex Biologics.

Additional regulatory filings are planned for Zemcelpro with other health authorities, including in the US, Canada, the UK, and Switzerland. Cordex Biologics is also actively seeking strategic partnerships to support and accelerate the commercialization of Zemcelpro in Europe and other international markets.

The safety of Zemcelpro is consistent with the well-characterized safety profile of conventional allogeneic blood stem cell transplantation for haematological malignancies following myeloablative conditioning.

For full details on the Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) of Zemcelpro.

About Conditional Marketing Authorizations (CMAs)

CMAs are for medicines that fulfil a significant unmet medical need such as being for serious and life-threatening diseases, where no satisfactory treatment methods are available or where the medicine offers a major therapeutic advantage. A CMA is granted where comprehensive clinical data is not yet complete, but the benefit of the medicine to address a significant unmet need outweighs the need for data that will become available in the future. CMAs are valid for one year and renewable annually with ongoing regulatory review of data.

About Zemcelpro

Zemcelpro, also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro, developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro has been tested in Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.

Zemcelpro is a registered trademark of Cordex Biologics.

The product safety and efficacy have not yet been established by other regulatory agencies, such as the FDA, the MHRA and Health Canada.

On August 27, 2025 Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of high-risk infections and pre-cancerous lesions caused by human papillomavirus (HPV) in women, reported positive top-line results from the company’s Phase 1b/2 clinical trial of ABI-2280, an investigational topical treatment for oncogenic (high-risk) cervical HPV (hrHPV) infection (Press release, Antiva Biosciences, AUG 27, 2025, View Source [SID1234655532]). The study achieved its primary endpoint with patients receiving ABI-2280 demonstrating statistically significant improvements in the rate of hrHPV negativity at Week 12 as compared with placebo. Additionally, the trial showed ABI-2280 treatment to be safe and well tolerated with the most commonly reported adverse events (AEs) categorized as mild and moderate and localized to the treatment area.

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"Women with persistent high-risk HPV have an approximately one-in-five chance of their infection progressing to pre-cancer or worse over four-to-six years, yet they do not have any options to treat the infection in the hopes of halting disease progression before this occurs. This reality highlights the clinical importance of the data generated in this study of ABI-2280, which demonstrated a 30 percent improvement in hrHPV negativity as compared to placebo, combined with a favorable safety and tolerability profile," said Margaret Stanley, OBE, FMedSci, Hon FRCOG, FFPH, Professor Emeritus, University of Cambridge. "Equally encouraging is the durability of the efficacy demonstrated by ABI-2280, which provides optimism that the treatment has the potential to keep HPV undetectable for long periods of time."

Each year in the United States, it is estimated that over six million women become newly infected with cervical hrHPV. When cervical hrHPV infections persist, they can lead to precancerous changes in the cervix and, ultimately, cervical cancer. There are no approved therapeutic options for treatment of hrHPV infections. Instead, these patients are counseled to wait and see if their infection clears or progresses to higher grade disease. During this wait and see period, patients are also at risk of transmitting this oncogenic virus to sexual partners. Approximately 30 percent of women with hrHPV fail to clear the virus within 12 months. These patients are considered to have persistent cervical hrHPV infections.

The Phase 1b/2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability and efficacy of ABI-2280 administered intravaginally in women diagnosed with persistent cervical hrHPV infection. The study dosed a total of 139 female patients ranging in age between 25 and 55 years old who have had a documented hrHPV infection for at least one year without evidence of precancerous lesions worse than low grade cervical intraepithelial neoplasia (CIN1). Part A of the trial evaluated multiple placebo-controlled sentinel cohorts enrolled sequentially to determine the safety, tolerability and preliminary efficacy of various dose levels of ABI-2280 in two-week and six-week dosing regimens. Following the completion of the sentinel cohorts, the top cumulative dose from each of the two-week and six-week dosing regimens was advanced into Part B expansion cohorts for further evaluation of efficacy.

Results from Part B of the study demonstrated that both ABI-2280 treatment regimens (1 mg dosed three times over two weeks for a cumulative dose of 3 mg; 1 mg dosed five times over six weeks for a cumulative dose of 5 mg) drove increased hrHPV negativity rates at Week 12 as compared to placebo. For the primary efficacy endpoint, 46% of patients in the more frequently dosed 3mg cohort achieved hrHPV negativity at Week 12 for all hrHPV genotypes present at baseline as compared to only 16% of placebo patients (p=0.0077). The 3mg cohort also achieved statistically significant improvements over placebo for both Week 12 secondary endpoints of complete hrHPV negativity at Week 12 and two or more consecutive hrHPV negative tests by Week 12. While 32% of patients in the less frequently dosed 5mg cohort also achieved hrHPV negativity at Week 12 for all genotypes present at baseline, this result did not achieve statistical significance compared with placebo.

Both ABI-2280 treatment cohorts demonstrated clear separation from placebo in hrHPV negativity at every observed timepoint in the study (Weeks 2, 4, 8 and 12). Notably, interim Week 24 data demonstrated durability of therapeutic activity for ABI-2280. Interim data for all patients in the study who have reached Week 24 showed 87% of patients who were hrHPV negative at Week 12 following ABI-2280 treatment maintained hrHPV negativity at Week 24.

ABI-2280 demonstrated favorable safety and tolerability across all dose levels and regimens in the study. Among patients treated with ABI-2280, the most frequently reported adverse events were deemed to be mild or moderate and were localized to the lower genitourinary tract, consistent with the site of topical administration.

"We are very pleased with the top-line data readout from this trial of ABI-2280 as we believe it provides strong support for moving into a Phase 2b trial in women with high-risk HPV infections," said Elaine Chien, MD, FACOG, chief medical officer of Antiva. "We are thrilled to achieve clinically meaningful and statistically significant hrHPV negativity with the most frequently administered dose which provides a roadmap for potentially achieving even greater efficacy with optimized dosing strategies in Phase 2b."

ABI-2280 is expected to have potent activity across all genotypes of HPV worldwide and works by blocking HPV replication and inducing apoptosis in HPV-infected cells. Antiva has leveraged its development expertise to formulate a vaginal insert of ABI-2280 that enables at home self-administration at diagnosis.

About HPV-Related Diseases and Cervical Cancer

Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections that the body is capable of clearing, but this typically takes months to years. When HPV infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers.

The prevalence of cervical high-risk HPV (hrHPV) infection is estimated to be 20% among U.S. females of reproductive age, or approximately 19 million women. Each year in the U.S., it is estimated that over 6 million women become newly infected with hrHPV. There are currently no treatment options for hrHPV and these patients are counseled to wait and see if their infection clears or progresses to higher grade disease. During this wait and see period, patients are also at risk of transmitting this oncogenic virus to sexual partners. Approximately 30 percent of women with hrHPV fail to clear the virus within 12 months. These patients are considered to have persistent hrHPV and have an estimated 20 percent chance of having their infection progress to pre-cancer or cancer over the following four-to-six years. Women diagnosed with hrHPV often experience significant stress due to the social stigma of a sexually transmitted infection and the association with cervical cancer. The lack of available treatments further contributes to increased anxiety and emotional distress.

The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in major territories such as the US, EU, and Japan, coverage of only 50% of all known oncogenic HPV genotypes with the most broad-spectrum vaccines currently available, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need.

Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 660,000 women were diagnosed with cervical cancer worldwide and approximately 350,000 women died from the disease in 2022.