1stOncology™: Cancer Intelligence Service – Page 7 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Persevere Therapeutics Announces Treatment of First Patient in its MIROC-1 Phase 2a Ovarian Cancer Clinical Trial

On September 24, 2026 Persevere Therapeutics, Inc., a clinical-stage oncology company developing misetionamide — a first-in-class inhibitor of MYC, historically viewed as undruggable and coined ‘the grand orchestrator of cancer growth’ — reported that the first patient has been enrolled and treated in MIROC-1, the company’s Phase 2a clinical trial evaluating misetionamide as monotherapy in patients with platinum-resistant ovarian cancer (PROC). The first patient was treated at the Abramson Cancer Center of the University of Pennsylvania, one of four leading cancer centers participating in the trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

MIROC-1 (Misetionamide in Platinum-Resistant Ovarian Cancer) is an open-label, single-arm Phase 2a trial designed to evaluate the safety and efficacy of misetionamide as monotherapy in patients with platinum-resistant ovarian cancer. The trial will enroll 18 patients across four leading U.S. academic cancer centers. Participating sites include: University of Pennsylvania (Philadelphia, PA) — first patient treated; Rush University Medical Center / MD Anderson Cancer Center (Chicago, IL) — currently screening; Beth Israel Deaconess Medical Center / Harvard Medical School (Boston, MA) and University of Kansas Cancer Center (Kansas City, KS) — both expected to begin screening within the month.

"Treating the first patient in MIROC-1 is a defining moment for Persevere Therapeutics and, more importantly, for the women living with platinum-resistant ovarian cancer who urgently need new treatment options," said Seymour Fein, MD, Chief Medical Officer of Persevere Therapeutics. "Misetionamide’s unique ability to target MYC — a driver of tumor growth and proliferation that has proven impervious to prior therapeutic approaches — gives us genuine hope that we can meaningfully change outcomes for these patients. We are deeply grateful to our clinical partners, and above all, to the patients and families who are placing their trust in this program."

Platinum-resistant ovarian cancer represents one of the most challenging malignancies in oncology. According to the American Cancer Society approximately 21,000 women are diagnosed with ovarian cancer in the United States each year, and the majority will eventually develop platinum-resistance, at which point treatment options are limited and median survival is measured in months. 12,400 women die each year of ovarian cancer.

(Press release, Persevere Therapeutics, SEP 24, 2026, View Source [SID1234671068])

NANOBIOTIX Provides First Half 2026 Operational and Financial Update

On September 24, 2026 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 an update on operational progress and announced financial results for the first six months of 2026.

"Our progress in the first half of 2026 continues to support our belief that a physics-based approach to the design and development of nanotherapeutics has the potential to revolutionize treatment possibilities for millions of patients around the world," said Laurent Levy, Chief Executive Officer and Chairman of the Executive Board at Nanobiotix. "The JNJ-1900 (NBTXR3) clinical development program continued to produce encouraging data across multiple indications, and adjustments to the Phase 3 NANORAY-312 protocol streamlined the study toward the final analysis. Longstanding shareholders and new investors alike expressed confidence in our vision through our recent capital raise. We enter the second half strategically, operationally, and financially equipped to continue supporting Nanoradioenhancer JNJ-1900 (NBTXR3) and advancing next wave nanotherapeutic platforms such as Nanoprimer."

Operational Highlights

New data from Phase 1 NSCLC study sponsored by The University of Texas MD Anderson Cancer Center ("UT MD Anderson") presented at 2026 WCLC Meeting:
At a median follow-up of 12 months, the one-year locoregional control rate was 79%. One-year local progression-free survival ("LPFS") was 61%, and one-year overall survival ("OS") was 70% in evaluable patients.
Investigators concluded that JNJ-1900 (NBTXR3) may permit clinically meaningful local control using a substantially lower re-irradiation dose.
All 24 patients completed treatment with JNJ-1900 (NBTXR3) plus re-irradiation with no dose-limiting toxicities
No Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3) or to the injection procedure were reported
The recommended Phase 2 dose was established at 33% of gross tumor volume
Included in the Euronext Tech Leaders segment and Euronext Tech Leaders Index, a Euronext flagship initiative dedicated to increasing the visibility and attractiveness of Europe’s leading and high-growth technology companies among international investors.
Closed a global follow-on offering with underwriters’ over-allotment option fully exercised, bringing total gross proceeds to approximately €86 million that will support continued develop of Nanobiotix’s broader therapeutic platforms
Part 1 data from Johnson & Johnson ("J&J")-led Phase 2 JNJ-1900 (NBTXR3) Study in Unresectable Stage 3 NSCLC (CONVERGE) presented at ELCC 2026 and updated at ESTRO 2026
Initial investigator-reported efficacy responses observed in 7 patients following the full treatment regimen of JNJ-1900 (NBTXR3) given prior to concurrent chemoradiotherapy, and consolidation with durvalumab) showed:
Overall response rate ("ORR") = 85.7% (6/7 patients) reported at ESTRO 2026
In the same cohort of 7 patients, ORR observed at earlier time point and reported at ELCC 2026 was 71.4% (5/7 patients)
Complete response rate ("CRR") = 57.1% (4/7 patients) reported at ESTRO 2026
With the current standard of care, concurrent chemoradiation therapy (cCRT) + durvalumab, depth of response remains limited in Stage 3 unresectable NSCLC with very low rates of complete response (~15%)1
Deepening response over time suggests potential for long-term durability
The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events (TEAEs)
Early results suggest that intratumoral/intranodal injection of JNJ-1900 (NBTXR3) is feasible and can be performed safely in patients with stage III unresectable NSCLC
Protocol amendment to J&J-led global Phase 3 JNJ-1900 (NBTXR3) study in Cisplatin-ineligible Head and Neck Cancer (NANORAY-312)
Eliminated previously planned interim analysis eliminated and modified the final analysis to include fewer events than originally planned to be conducted sooner
New preclinical data presented at 2026 AACR (Free AACR Whitepaper) Meeting
Pre-treatment with Nanoprimer followed by administration of LNP-delivered recombinant DNA ("LNP-DNA") designed for anti-tumor immunotherapy showed increased systemic bioavailability, reduced hepatic toxicity, and reduced cGAS-STING related inflammation compared to LNP-DNA administered without the Nanoprimer
Half Year 2026 Financial Results

Revenue and Other Income: Revenue and other income amounted to €5.6 million for the six months ended June 30, 2026, as compared to €26.6 million for the same period in 2025. This variance is mainly due to a significant one-off non-cash revenue positive impact amounting to €21.2 million recorded over the first half of 2025 in accordance with IFRS15 revenue recognition accounting principles, further to the transfer of NANORAY-312 study sponsorship to Johnson & Johnson. In addition, Revenue and Other Income for the six months ended June 30, 2026 also included €3.1 million of clinical product supply sales to Johnson & Johnson (as compared to €3.4 million for the same period in 2025) and research tax credit income amounting to €1.9 million (as compared to €1.6 million for the same period in 2025).

Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses including employee-related payroll costs and shared-based payment charges related to the development of JNJ-1900 (NBTXR3) and of new platforms. These R&D expenses for the six months ending June 30 2026, were €12.7 million as compared to €14.5 million for the same period in 2025. The €1.8 million favorable variance was primarily driven by lower clinical development and JNJ-1900 (NBTXR3) production activities in NANORAY-312 study further to the transfer of sponsorship to Johnson & Johnson, and by less patient recruitment on the studies Study 1100 and lower UT MD Anderson studies expense during first half of 2026 as compared to the same period in 2025.

Selling, General and Administrative ("SG&A") Expenses: SG&A expenses consist primarily of administrative employee-related payroll costs, share-based payment charges, insurance, IP, legal, audit and other professional fees. Total SG&A expenses for the six months ending June 30, 2026, were €10.8 million, as compared to €11.3 million for the same period in 2025. The €0.5 million favorable variance is mainly due to the impact of social charges related to stock-option plan and severance expenses occurred over the first half of 2025.

Net loss: Net loss attributable to common shareholders for the six months ending June 30, 2026, was €34.3 million, or a €0.70 basic loss per share. This compares to a net loss attributable to common shareholders of €5.4 million, or €0.11 basic loss per share, for the same period in 2025.

Cash and Cash Equivalents: Cash and Cash Equivalents as of June 30, 2026 were €110.9 million, compared to €52.8 million as of December 31, 2025.

Financial Guidance: Based on the current operating plan and financial projections, the Company anticipates that the cash and cash equivalents of €110.9 million as of June 30, 2026 will fund its operations into 2029.

Availability of the Half Year 2026 Financial Reports

The 2026 half-year financial report has been filed with the French financial market authority (Autorité des marchés financiers) and with the U.S. Securities and Exchange Commission on September 24, 2026. It is available to the public on the Company’s website, www.nanobiotix.com.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when in the presence of radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Proof-of-concept was demonstrated in a randomized Phase 2/3 soft tissue sarcoma study sponsored by Nanobiotix in 2018.

JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. 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 February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of 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.

In 2023, Nanobiotix announced a license agreement for the global development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company. Studies being led by Johnson & Johnson include NANORAY-312 (NCT04892173), a global, randomized Phase 3 study in platinum-based chemotherapy-ineligible, locally advanced head and neck squamous cell cancers; LUMIRAY (NCT07219212), a global, phase 1b, open-label study in locally advanced head and neck squamous cell cancers; and CONVERGE (NCT06667908), a phase 2, randomized, open-label, active-controlled study in locally advanced and unresectable Stage III non-small cell lung cancer (NSCLC).

(Press release, Nanobiotix, SEP 24, 2026, View Source [SID1234671067])

ADARx Pharmaceuticals Announces Pricing of Upsized $446.3 Million Initial Public Offering

On September 24, 2026 ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation siRNA therapeutics, reported the pricing of its upsized initial public offering of 26,250,000 shares of common stock at a price to the public of $17.00 per share. All of the shares of common stock are being offered by ADARx. The gross proceeds to ADARx from the offering, before deducting underwriting discounts and commissions and offering expenses payable by ADARx, are expected to be approximately $446.3 million. In addition, the underwriters have a 30-day option to purchase up to an additional 3,937,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

The shares are expected to begin trading on The Nasdaq Global Select Market on September 25, 2026, under the ticker symbol "ADRX." The offering is expected to close on September 28, 2026, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Morgan Stanley, TD Cowen and UBS Investment Bank are acting as lead book-running managers for the offering. LifeSci Capital is acting as a book-running manager for the offering.

Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 24, 2026. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a prospectus forming part of the registration statements relating to these securities. When available, copies of the final prospectus relating to the initial public offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] and [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at 1-866-718-1649, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or UBS Securities LLC, Attention: Equity Syndicate, 11 Madison Avenue, New York, NY 10010 or by email at [email protected].

In addition, AbbVie has agreed to purchase, in a concurrent private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the Securities Act), a number of shares of ADARx’s common stock that would result in AbbVie owning approximately 4.9% of ADARx’s outstanding shares of common stock following the closing of the initial public offering and the concurrent private placement, at a price of $17.00 per share; provided, however, that in no event would AbbVie purchase more than $100.0 million in shares of common stock. The aggregate gross proceeds to ADARx from the initial public offering and the concurrent private placement, before deducting underwriting discounts and commissions, placement agent fees and other offering and private placement expenses payable by ADARx, are expected to be approximately $535.2 million, excluding any exercise of the underwriters’ option to purchase additional shares of common stock. The concurrent private placement is also scheduled to close on September 28, 2026, subject to the satisfaction of customary closing conditions. The closing of the concurrent private placement is contingent and conditioned upon consummation of the initial public offering. However, the closing of the initial public offering is not contingent on the consummation of the concurrent private placement.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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 jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act.

(Press release, ADARx Pharmaceuticals, SEP 24, 2026, View Source [SID1234671066])

Kovina Therapeutics Awarded $2.3 Million NCI Grant to Advance First-in-Class HPV Cancer Therapy Directly Targeting E6

On September 24, 2026 Kovina Therapeutics Inc., a biotechnology company developing first-in-class small molecule therapeutics targeting the Human Papillomavirus (HPV) E6 oncoprotein, reported a $2.3 million Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). The two-year award will support IND-enabling development of Kovina’s lead oral small molecule program for HPV-driven cancers.

The award follows Kovina’s recent publication in the Proceedings of the National Academy of Sciences (PNAS) validating direct pharmacologic targeting of HPV E6. The research demonstrated restoration of p53 tumor suppressor activity, selective killing of HPV-positive cancer cells and tumor growth inhibition in HPV-positive preclinical models.

"This award comes at an important point for Kovina as we move from compelling preclinical science into formal development," said Kristin Sherman, Chief Executive Officer of Kovina Therapeutics. "Together with our recent PNAS publication, the NCI support gives us significant momentum as we advance our lead program through IND-enabling development and toward the clinic."

HPV E6 is a viral oncoprotein that degrades the tumor suppressor p53 and is required for the survival of HPV-positive cancer cells. Kovina’s small molecules are designed to inhibit E6 and restore p53 function, offering a targeted approach to the underlying mechanism of these cancers.

The NCI award will support key development activities, including CMC, IND-enabling pharmacology and toxicology, and other studies required to support an Investigational New Drug application.

"HPV E6 has long been recognized as a compelling cancer target but directly inhibiting it with a small molecule has been challenging," said Elliot Androphy, M.D., Founder and Chief Scientific Officer of Kovina Therapeutics. "Our work demonstrates that E6 can be specifically targeted, restoring p53 and selectively killing HPV-positive cancer cells. This gives us a strong foundation for translating the biology into a new therapeutic approach."

Despite preventive vaccines, HPV causes an estimated 39,300 cancers each year in the United States, according to the Centers for Disease Control and Prevention, including cervical and head and neck cancers. By directly targeting HPV E6, Kovina’s approach has the potential to treat a spectrum of HPV-associated disease, from premalignant disease to invasive cancers.

(Press release, Kovina Therapeutics, SEP 24, 2026, View Source [SID1234671063])

BigHat Biosciences Announces $75 Million Series C Financing to Advance AI-Designed Therapeutics and Leading Agentic Data Platform for Rapid Protein Design

On September 24, 2026 BigHat Biosciences, a clinical-stage, AI-driven protein therapeutics platform company, reported the completion of a $75 million Series C financing, bringing its total funding raised to date to $223 million. The round was co-led by DFJ Growth & Premji Invest with participation from Catalio Capital Management, LG Technology Ventures, Sigmas Group, and existing investors including 8VC, Alexandria Venture Investments, Amgen Ventures, Andreessen Horowitz (a16z), Discovery Ventures, GRIDS Capital, Intermountain Ventures, Eli Lilly and Company, Merck Global Health Innovation Fund, Quadrille Capital, and Section 32.

BigHat has built an autonomous AI and experimental platform that generates proprietary, fit-for-purpose biological data at scale to drive today’s leading frontier models for therapeutic design. The financing will support continued growth of BigHat’s leading platform for rapid data generation to power frontier intelligence for protein design, as well as advancement of the company’s pipeline of AI-designed therapeutics, including BHB810 and BHB299, to key clinical readouts.

"Our mission is to design transformative therapeutics by combining frontier AI with the autonomous generation of gold-standard biological data," said Peyton Greenside, co-founder and CEO of BigHat. "This financing will help us advance both sides of that mission: our pipeline of BigHat-designed therapeutics, beginning with BHB810, one of the first AI-designed biologics to reach the clinic, and our leading platform for AI-designed biologics. We look forward to continuing to form partnerships with major technology and life sciences companies and are thrilled to partner with a group of investors who share our vision. With their support, we can continue to scale our platform and pipeline to deliver better medicines to patients more quickly."

"BigHat has uniquely enabled reinforcement learning for molecular design with a platform optimized for industry-leading speed, at the scale today’s frontier models need," said Justin Kao, Partner at DFJ Growth. "This integrated learning loop is a powerful advantage, enabling BigHat to rapidly design and optimize therapeutics with the properties needed for clinical development. The strength of the platform is reflected in both BigHat’s partnerships with pharmaceutical and tech companies and its growing pipeline of next-generation therapeutics. We’re excited to support BigHat as it scales its platform and advances these programs toward patients."

Since the company’s $80 million Series B financing in 2022, BigHat has demonstrated the versatility of its platform both within the internal BigHat pipeline and via external partnerships, and across a range of protein engineering challenges. The company has applied its integrated AI and experimental capabilities across diverse modalities, therapeutic areas and molecular design objectives while generating the gold-standard datasets needed to train and improve AI models.

Recent achievements include:

Advanced first program into the clinic: Dosed the first patient in a Phase 1 trial evaluating lead program, BHB810, a novel CDH17-directed antibody-drug conjugate (ADC) for gastric cancer and other advanced gastrointestinal tumors. BHB810 is the first clinical program from BigHat’s AI discovery platform and one of the first AI-driven biologics to reach humans.
Nominated second development candidate: Advanced BHB299, an avidity-driven T-cell engager designed to selectively target CEACAM6-expressing solid tumors, which is nearing completion of preclinical development. The company plans to begin human trials of BHB299 in 2027.
Progressed broader internal pipeline: Beyond the two lead assets, BigHat has created a proprietary preclinical pipeline of antibody therapeutics for oncology and immunology.
Achieved platform validation as partner of choice to pharma: Forged valuable collaborations with leading companies, including Amgen, Merck, Johnson & Johnson (J&J), AbbVie and Lilly. Since forming these collaborations, BigHat has announced successful completion of a strategic collaboration with J&J and three project collaborations with Merck. The company has also expanded beyond two therapeutic collaborations with Lilly by joining Lilly TuneLab to support machine learning-enabled biologics discovery.
Established frontier AI partnerships: Formed innovative partnerships with leading frontier AI companies to deploy state-of-the-art models for agentic therapeutic design.
Bolstered leadership team: Appointed Stefan Weigand, Ph.D., former Head of Large Molecule Research at Roche, as Chief Scientific Officer in June 2026, and John Corbin, Ph.D., former Chief Technology Officer at Tizona Therapeutics, as Chief Development Officer in June 2023, strengthening the company’s multidisciplinary team with experience spanning machine learning and AI, synthetic biology, protein engineering, automation, drug discovery and therapeutic development.
Raised additional funds: Closed a $44 million Series B extension in 2025, led by pharma and strategic investors.
"Biologics rarely fail in the clinic because they cannot bind a target; they fail because they lack the properties that turn a promising binder into an actual medicine. Peyton and the team built BigHat to engineer those properties in from the earliest stages of design, to address the hardest problems in the field, and the result is a clinical-stage pipeline and a data advantage that compounds with every program," said Marc Martin Casas, Vice President of Biotech and Healthcare at Premji Invest. "At Premji Invest, we partner with teams that think big and have the discipline to build enduring companies, and BigHat is exactly that. We are proud to co-lead this financing and to support the team as they bring transformative medicines to patients."

(Press release, BigHat Biosciences, SEP 24, 2026, View Source [SID1234671062])