On September 17, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a certificate of grant for the Company’s "proenzyme composition" patent was received from the US Patent & Trademark Office (USPTO) (Press release, Propanc, SEP 17, 2025, View Source [SID1234656035]). The patent specifically captures a future clinical dose of the Company’s lead asset, PRP. This is the fourth US patent granted in this key strategic jurisdiction. Currently, the Company’s intellectual property portfolio consists of 90 patents filed in major jurisdictions relating to the use of PRP against solid tumors.

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The proenzymes composition patent is an important part of the IP portfolio covering a possible future clinical dose of PRP, as the Company advances to a Phase 1B, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The patent has also been granted in other major jurisdictions such as Europe, Japan and throughout Southeast Asia. PRP is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 billion by 2027, according to Emergen Research.

"We continue to grow our intellectual property portfolio in the United States, which is our most important jurisdiction," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Our lead asset, PRP, is an exciting method to prevent and treat metastatic cancer from solid tumors without the severe, or even serious side effects often associated with standard therapies. PRP is relatively non-toxic because it does not kill cancer cells directly but induces cell differentiation so that they become less malignant and die off naturally. This unique phenomenon is specific to PRP, which acts as an ‘EMT (epithelial to mesenechymal transition) modulator’, enforcing the cancer cells to behave more as a normalized cell so that it is no longer a threat. We are pushing towards the commencement of the Phase 1B study next year. We are also pursuing every avenue for raising sufficient capital and employing a digital asset diversification strategy to ensure optimal cash flow as we advance PRP towards important clinical milestones."

On September 17, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a certificate of grant for the Company’s "proenzyme composition" patent was received from the US Patent & Trademark Office (USPTO) (Press release, Propanc, SEP 17, 2025, View Source [SID1234656035]). The patent specifically captures a future clinical dose of the Company’s lead asset, PRP. This is the fourth US patent granted in this key strategic jurisdiction. Currently, the Company’s intellectual property portfolio consists of 90 patents filed in major jurisdictions relating to the use of PRP against solid tumors.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The proenzymes composition patent is an important part of the IP portfolio covering a possible future clinical dose of PRP, as the Company advances to a Phase 1B, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The patent has also been granted in other major jurisdictions such as Europe, Japan and throughout Southeast Asia. PRP is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 billion by 2027, according to Emergen Research.

"We continue to grow our intellectual property portfolio in the United States, which is our most important jurisdiction," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Our lead asset, PRP, is an exciting method to prevent and treat metastatic cancer from solid tumors without the severe, or even serious side effects often associated with standard therapies. PRP is relatively non-toxic because it does not kill cancer cells directly but induces cell differentiation so that they become less malignant and die off naturally. This unique phenomenon is specific to PRP, which acts as an ‘EMT (epithelial to mesenechymal transition) modulator’, enforcing the cancer cells to behave more as a normalized cell so that it is no longer a threat. We are pushing towards the commencement of the Phase 1B study next year. We are also pursuing every avenue for raising sufficient capital and employing a digital asset diversification strategy to ensure optimal cash flow as we advance PRP towards important clinical milestones."

On September 17, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) for patients with advanced cancers (Press release, Nanobiotix, SEP 17, 2025, View Source [SID1234656034]). These findings were presented at the 2025 ImmunoRad conference in Paris, France on September 17.

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Patients with anti-PD-1 resistant primary cutaneous melanoma in the study had advanced disease that progressed despite multiple prior lines of therapy, including anti–PD-1, ipilimumab, T-VEC, TIL, and radiotherapy ("RT"), among others. All patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) followed by RT and sequential anti–PD-1 therapy. As of the August 21, 2025, data cutoff, 21 patients had been injected with JNJ-1900 and 19 were evaluable for tumor response (2 patients were not evaluable due to lack of post-treatment imaging).

"The patients in this analysis represent one of the more difficult clinical challenges we face as many have exhausted standard therapies, including checkpoint inhibitors," said Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center. "While these data are preliminary, the responses we’re seeing provide a strong signal that this treatment approach could potentially offer a new possibility for patients who need more options."

Safety and Feasibility

All 21 patients with primary cutaneous melanoma had shown prior resistance to anti-PD-1 and treatment with RT-activated JNJ-1900 (NBTXR3) followed by anti-PD-1 showed a favorable safety profile:

Injection feasibility was confirmed at the recommended Phase 2 dose (33% GTV)
In total, 16 patients experienced grade 1, grade 2, or grade 3+ TEAEs related to the overall therapeutic regimen (RT, anti-PD-1, JNJ-1900 (NBTXR3), and injection procedure)
Of which 5 patients experienced grade 1, grade 2, or grade 3+ treatment-emergent adverse events (TEAEs) related to JNJ-1900 (NBTXR3) and/or the injection procedure
Of these patients, 1 patient experienced grade 3+ TEAEs (hypotension and pleuritic pain)
Early Signs of Efficacy

JNJ-1900 (NBTXR3) demonstrated preliminary signals of efficacy in 19 patients who were evaluable for tumor response:

A best observed objective response rate ("ORR") in all lesions of 47.4% (9/19) per RECIST 1.1, including 4 complete responses and 5 partial responses
A best observed disease control rate ("DCR") in all lesions of 78.9% (15/19) per RECIST 1.1
In JNJ-1900 injected & irradiated tumors, a DCR of 100% (19/19) was observed
A median Overall Survival (mOS) of 14.6 months [95% CI: 10.7 months; 16.7 months] in all patients treated (n=21)
Notably, a relationship was observed between the depth of local response and systemic tumor regression, suggesting a possible priming or re-activation of immune response.

"We are encouraged by these new findings and the potential signals of activity in this difficult-to-treat population," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "Notably, the relationship we observed between the depth of local response and systemic tumor regression further supports our hypothesis regarding the potentially broad applicability of JNJ-1900 (NBTXR3) for patients with cancer. We look forward to further clinical evaluation of JNJ-1900 (NBTXR3) to better understand its capacity to drive both local and systemic responses in primary cutaneous melanoma."

Nanobiotix Conference Call

Nanobiotix will host a conference call and webcast featuring Nanobiotix chief executive officer, Laurent Levy, to discuss the new data on Thursday, September 18th, 2025, at 8:00 AM EDT / 2:00 PM CET.

Details for the call are as follows:

Webcast link: View Source

Audio-only dial-in link: View Source

Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to [email protected].

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On September 17, 2025 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported that patient recruitment is complete in its advanced melanoma (MELODY-1) trial (Press release, Microbiotica, SEP 17, 2025, View Source [SID1234656033]).

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This international trial has recruited 41 patients at clinical centres in the UK, France, Italy, and Spain. Initial results are expected in the first half of 2026.

MELODY-1 is a Phase 1b study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab in patients with melanoma who demonstrate primary resistance to anti-PD-1 therapy. It is a first-in-human, randomised open-label clinical trial with all patients receiving MB097 and pembrolizumab for up to six months. Half of the participants also receive vancomycin before starting the co-therapy to determine whether it helps the bacterial strains in MB097 embed and grow in the gut more efficiently. Participants benefiting from the treatment at the end of the initial six-month period may continue to receive pembrolizumab for up to an additional 18 months (approximately 24 months total).

Melanoma is a life-threatening skin cancer that can spread to other parts of the body in its advanced stages. PD-1 inhibitor immunotherapies have revolutionised cancer treatment and are now commonly used to treat melanoma. However, new treatment options are still needed to extend the benefit to patients for whom immunotherapies do not work (treatment-resistant patients). This can be up to 50% of all advanced melanoma patients. There is a growing body of evidence demonstrating that the make-up of the gut microbiome can significantly influence a patient’s ability to respond to immunotherapy.

MB097 is a once daily, orally administered LBP consisting of a defined consortium of nine strains of commensal bacteria designed to enhance the efficacy of immune checkpoint inhibitors (ICIs). The MELODY-1 study is designed to investigate the safety, tolerability, and initial signals of efficacy of MB097 in advanced (metastatic) melanoma, in combination with KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. MSD has supplied KEYTRUDA (study identifiers NCT06540391; MSD KEYNOTE-E75; 023-507377-17) to Microbiotica.

The bacterial strains in MB097 were identified by analysing the microbiome of patients in multiple studies of ICIs in melanoma, including the MELRESIST study carried out with the company’s collaborators at Cambridge University Hospitals, UK. Collectively, the MB097 bacterial consortium provides microbiome signalling that appears to be needed for ICI response. Pre-clinical studies demonstrate that MB097 activates core pathways of the immune system including Cytotoxic T Lymphocytes and Natural Killer cells to enable them to kill tumour cells. Research to understand the mechanism of action of the nine bacterial strains has indicated that in addition to this immune-activating effect, the bacteria in MB097 produce metabolites that act directly at the site of the tumour.

Dr Robert Tansley, Microbiotica’s Chief Medical Officer, said, "It is another significant milestone that this clinical study is fully recruited. In cancer patients, the bacteria in MB097 appear to be associated with better response rates to immune checkpoint inhibitor therapies, such as anti-PD-1 drugs. MB097, with its precisely selected microbes based on data from responsive patients, in combination with ICIs, could therefore activate a therapeutic benefit for non-responding patients with advanced melanoma. Moreover, as the MB097 bacteria are found in healthy subjects as well as in patients who responded to ICIs, we anticipate a favourable safety profile. We thank the investigators and patients for participating in the study and look forward to the results."

On September 17, 2025 Arvinas, Inc. (Nasdaq: ARVN) reported an update on its collaboration with Pfizer Inc. (NYSE: PFE) for the co-development of vepdegestrant, an investigational oral PROTAC (PROteolysis TArgeting Chimera) estrogen receptor protein degrader, and announced additional corporate actions to support shareholder value creation (Press release, Arvinas, SEP 17, 2025, View Source [SID1234656032]).

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Update on Pfizer Collaboration
Arvinas and Pfizer have jointly agreed to out-license the commercialization rights to vepdegestrant to a third party. Together, the companies have begun seeking a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant, if approved, for patients with ESR1-mutant, ER+/HER2- advanced or metastatic breast cancer and potentially develop vepdegestrant in new settings. The companies are aligned in their belief that finding a third-party commercial partner is the best path forward to unlock the full value of vepdegestrant and ensure vepdegestrant is available promptly if approved for use by regulatory authorities.

"Today’s announcement further supports our goal to bring vepdegestrant to patients and we are confident that vepdegestrant’s differentiated profile will attract interest from potential partners seeking to strengthen their oncology portfolios," said John Houston, Ph.D., Arvinas Chairperson, Chief Executive Officer and President. "We and Pfizer remain committed to the metastatic breast cancer community and believe vepdegestrant has the potential to be a best-in-class therapeutic option in the second-line ESR1 mutant setting."

Vepdegestrant is currently under review by the U.S. Food and Drug Administration (FDA) as a monotherapy in the treatment of estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.

Strategic Plan and Cost Optimization Measures
Following the decision to monetize the value of vepdegestrant and out-license its rights to a third party, Arvinas management and its Board of Directors conducted a thorough review of the Company’s business and strategic plan in consultation with its independent financial and legal advisors. Following this review, the Company continues to believe that its pipeline of differentiated PROTAC degraders has the potential to create important therapies for patients with debilitating and life-threatening diseases across oncology and neuroscience. Arvinas currently has three investigational PROTAC degraders in Phase 1 trials: ARV-102, a LRRK2 degrader for progressive supranuclear palsy and Parkinson’s disease; ARV-393, a BCL6 degrader for subsets of non-Hodgkin lymphoma; and ARV-806, a KRAS G12D degrader for solid tumor malignancies.

With the change to development plan for the vepdegestrant program and a refocus on its early development programs, Arvinas has determined it will take further action to optimize its organizational and cost structures and streamline operations in advance of multiple anticipated value inflection points in the coming months. These actions include:

Further limiting additional expenditures on the vepdegestrant program to support activities required for commercialization readiness and identification and out-licensing of vepdegestrant to a third party for commercialization, subject to alignment with Pfizer;
Reducing the Company’s workforce by an additional 15% to streamline operations, with the most significant reductions being roles related to vepdegestrant commercialization; and
Proactively managing pipeline cost by seeking strategic business development opportunities and by identifying further efficiencies across the business.
These steps build on prior actions by the Arvinas Board and management team to strengthen the Company’s financial profile and drive additional operational efficiencies. The planned out-licensing of vepdegestrant and the resulting cost optimization actions, when combined with the approximately $80 million in annual cost savings from the measures announced on May 1, 2025, are expected to result in overall annual cost savings of more than $100 million compared to FY 2024.

Share Repurchase Program
The Arvinas Board of Directors has authorized the repurchase of up to $100 million of the Company’s common stock. The timing and amount of any share repurchases under the share repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Arvinas’ common stock and general market conditions, and will be at the Company’s discretion. Share repurchases under the share repurchase program may be made from time to time through a variety of methods, which may include open market purchases, privately negotiated block trades, accelerated share repurchases, other privately negotiated transactions or any combination of these methods. Repurchases may also be made under a Rule 10b5-1 plan, which would permit shares to be repurchased when the Company might otherwise be precluded from doing so under insider trading laws. The share repurchase program will be funded using the Company’s working capital. The share repurchase program does not obligate Arvinas to acquire any particular amount of its common stock. The share repurchase program has no time limit and can be modified, suspended or discontinued at any time without prior notice.

The priority of the Arvinas Board of Directors and management is to drive value from the portfolio by deliberately and responsibly deploying capital to advance Arvinas’ programs, which, if successful, will deliver benefits for patients and value for shareholders.

"Arvinas’ decision to repurchase shares is a testament to our conviction in the strength of our business and our long-term growth prospects and demonstrates our commitment to maximizing value for shareholders," said Briggs Morrison, M.D., Arvinas Board Member and Lead Independent Director. "We believe our disciplined management of costs will enable us to continue advancing our PROTAC technology to create transformational therapies for patients with severe diseases, while preserving maximum value creation for shareholders as the Board continues its CEO search."

Cash Runway Guidance
Following the actions announced today, Arvinas is reaffirming its cash runway guidance into the second half of 2028. The Company currently expects that this runway will support multiple opportunities to deliver value from clinical-stage programs derived from the Company’s de-risked and clinically validated platform technology. These opportunities include clinical data readouts from its PROTAC degraders ARV-102, ARV-393, and ARV-806.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; pursuant to the original agreement, Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits, including any costs, expenses and profits that arise due to the parties’ agreement to out-license commercialization rights.

Vepdegestrant was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.