On July 15, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported that the United States Patent and Trademark Office ("USPTO") issued the Company a new composition of matter patent for certepetide through March 2040, with subsequent opportunity for patent term extension (Press release, Lisata Therapeutics, JUL 15, 2025, View Source [SID1234654379]).

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!

A composition of matter patent is the strongest form of intellectual property ("IP") protection, safeguarding the unique chemical structure of a substance. The U.S. Patent No. 12,351,653 includes claims to certepetide’s chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumor cancers. For Lisata, securing this patent is profoundly significant as it not only strengthens Lisata’s robust IP estate, but, more importantly, grants exclusive rights to the drug itself, preventing others from manufacturing or selling it.
"This new patent marks a key milestone, significantly boosting the value of both certepetide and the Company by delaying generic encroachment for essentially the next two decades," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "This extended patent protection aids our commercialization efforts by offering long-term market exclusivity and enhances the potential future development and commercialization of certepetide. It not only secures our IP but also greatly strengthens our negotiating position with potential partners, increasing the potential for sustained growth and value creation for our shareholders."

About Certepetide

Certepetide (formerly LSTA1), an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).

On July 15, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported it has received notification of allowance from the China National Intellectual Property Administration (CNIPA) for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry (Press release, BioAffinity Technologies, JUL 15, 2025, View Source [SID1234654378]).

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!

China represents a large prospective market for CyPath Lung with more than 300 million people who smoke, or nearly one-third of the world’s total smokers, according to the World Health Organization. The China cancer registry estimated 1.06 million new cases of lung cancer were diagnosed in 2022.

"This patent is another step forward in our strategy to safeguard and expand the reach of our proprietary diagnostic platform internationally," said Maria Zannes, President and CEO of bioAffinity Technologies. "With lung cancer representing a major health burden globally and particularly in China, we believe that securing this intellectual property positions us well for future opportunities in one of the world’s largest and most underserved healthcare markets. It reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives."

The newly allowed Chinese patent—titled "System and Method for Determining Lung Health"—protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.

CyPath Lung is the Company’s first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. In the study, CyPath Lung detected all forms of lung cancer and 80% of cancers that were Stage 1.

This newly allowed patent complements bioAffinity’s expanding global patent estate, which now includes multiple patents in the U.S, China, Japan, Australia, Mexico, Canada and the EU.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On July 15, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported that it has received an additional advance of US$2.0M from Hanmi Pharmaceutical Co. Ltd. ("Hanmi"), as part of a US$8.5M loan facility agreement with Hanmi (the "Loan Agreement") announced prior on June 20, 2025 (Press release, Aptose Biosciences, JUL 15, 2025, View Source [SID1234654377]). To date, Aptose has received an aggregate of US$4.5M under the Loan Agreement.

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!

"Tuspetinib in combination with venetoclax and azacitidine (the TUS+VEN+AZA triplet) continues to demonstrate exciting antileukemic activity and safety across genetically diverse populations of newly diagnosed AML patients – including TP53-mutated AML and wildtype AML, representing large AML populations for which there are few treatment options," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "We are very grateful to Hanmi for its continued support to help advance tuspetinib clinical development and further extend Aptose’s ability to fund this important study."

Tuspetinib is a convenient once daily oral agent that potently inhibits targets that drive excessive proliferation and anti-apoptotic mechanisms, including SYK, mutated and wild type forms of FLT3, mutated KIT, JAK1/2, and RSK2 kinases. Yet, TUS maintains a favorable safety profile by avoiding typical toxicity concerns observed with other agents. The ongoing TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax in newly diagnosed patients with AML who are ineligible to receive induction chemotherapy. At the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June, Aptose reported early data from the first two dose cohorts that have demonstrated safety, CRs and minimal residual disease (MRD) negativity across patients with diverse mutations.

On July 15, 2025 Adagene Inc. ("Adagene or the Company") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported outcomes from its Type B meeting with the United States Food and Drug Administration (FDA). Adagene has received written feedback from the FDA on its clinical development plan to evaluate muzastotug (ADG126) in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab: 200 mg, Q3W) in patients with microsatellite stable colorectal cancer (MSS CRC) (Press release, Adagene, JUL 15, 2025, View Source [SID1234654376]).

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!

ADG126 is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on MSS CRC. To date, over 150 patients have received ADG126, either as monotherapy or in combination with anti-PD-1 therapy. Adagene has completed patient enrollment for the MSS CRC dose expansion cohorts of the ADG126 + pembrolizumab combination (NCT05405595). The phase 2 trial will be conducted primarily to identify which of the two doses of ADG126 will be used in the phase 3 trial.

Key Outcomes from the FDA Type B Meeting

● Patient Population: Future trials will enroll late-line patients with MSS CRC without liver metastases, including those with peritoneal metastasis/involvement.

● Dose and Regimen: Phase 2 will randomize patients to either 10 mg/kg or 20 mg/kg of ADG126 in combination with pembrolizumab, using an induction-maintenance regimen, without cycle limitations of ADG126.

● Phase 2 Trial Design: Approximately 30 patients will be enrolled in each arm of the Phase 2 study, without a requirement for an ADG126 monotherapy arm.

● Phase 3 Trial Design: The FDA agreed with Adagene’s proposed standard-of-care (SOC) control arm for the Phase 3 clinical trial and confirmed that an ADG126 monotherapy arm is also not required in the pivotal study.

● Phase 2 Endpoints: The primary endpoint of the Phase 2 trial will be overall response rate (ORR). Secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

● Phase 3 Endpoints: The primary endpoint of the Phase 3 trial will be OS. Secondary endpoints will include PFS, DOR and ORR.

"Receiving the FDA’s endorsement to explore ADG126 at doses 10 to 20 times higher than other anti-CTLA-4 antibodies, without limitations on treatment cycles, has demonstrated a nearly two-fold increase in ORR from 17% at 10 mg/kg to 29% at 20 mg/kg, while Grade 3 treatment-related adverse events (TRAEs) remain approximately 20% at comparable drug exposures for ADG126 at 10 mg/kg Q3W versus 20 mg/kg Q6W. These results highlight the wide therapeutic index and favorable safety profile we have seen to date in the clinic" said Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope.

Peter Luo, Ph.D., CEO and President of R&D at Adagene added, "Our Phase 1b/2 trial has produced robust dose-dependent efficacy data with a potential best-in-class safety profile, identifying two optimized dose levels for the Phase 2, consistent with Project Optimus. With the FDA’s endorsement to advance into the Phase 2 part of the clinical trial, we’d like to thank our strategic partner, Merck, for supplying pembrolizumab to support this exciting randomized dose optimization cohort to identify a single dose to take into Phase 3, a critical step towards registrational trial for FDA approval."

On July 14, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported the closing of its best-efforts offering of 1,500,000 shares of its common stock (Press release, Cel-Sci, JUL 14, 2025, View Source [SID1234654373]). Each share of common stock was sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $5.7 million.

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!

The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity acted as the sole placement agent for the offering.

The securities were offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering was made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering has been filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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