On October 15, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX) (the "Company"), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,125,000 of the Company’s American Depositary Shares ("ADSs"), each representing 2,000 ordinary shares at a purchase price of $0.80 per ADS in a registered direct offering.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

In addition, in a concurrent private placement, the Company will issue unregistered Series E Warrants to purchase up to 3,125,000 of the Company’s ADSs and unregistered Series F Warrants to purchase up to 3,125,000 of the Company’s ADSs, each at an exercise price of $0.98 per share. The Series E Warrants will be exercisable on the date of shareholder approval (the "Shareholder Approval Date") for the exercisability of the warrants and have a term of five years from the initial exercise date. The Series F Warrants will be exercisable on the Shareholder Approval Date and have a term of thirty months from the initial exercise date. The offering is expected to close on or about October 16, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $2.5 million. The Company intends to use the net proceeds for working capital, general corporate purposes, and continued research and development ("R&D"). Specifically with regard to its focused R&D work, the Company intends to use these funds to generate differentiated data on the novel ADC payload that highlights its unique action against cancer and builds on new data being presented at the upcoming Society for Immunotherapy Cancer Society Annual Meeting in early November.

The ADSs (but not the warrants issued in the private placement or the ADSs underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-289056) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2025 and declared effective by the SEC on July 31, 2025. The ADSs to be issued in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting Ladenburg Thalmann & Co. Inc., 640 Fifth Avenue, 4th Floor, New York, NY 10019, by phone at (212) 409-2000, or by email at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

(Press release, Akari Therapeutics, OCT 15, 2025, View Source [SID1234656670])

On October 15, 2025 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2025.

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Third-quarter sales increased 6.9 percent on a reported basis, 5.5 percent on an organic basis, or 7.5 percent when excluding COVID-19 testing-related sales1.
Third-quarter GAAP diluted EPS of $0.94 and adjusted diluted EPS of $1.30, which excludes specified items.
Year-to-date sales increased 6.1 percent on a reported basis, 6.4 percent on an organic basis, or 7.7 percent when excluding COVID-19 testing-related sales2.
Abbott reaffirms previously provided full-year 2025 organic sales growth guidance.
Abbott reaffirms the midpoint of previously provided full-year 2025 adjusted diluted EPS guidance range and narrows the range to $5.12 to $5.18, reflecting double-digit growth at the midpoint.
In July, Abbott announced it received regulatory approval in Japan for TriClip, a first of-its-kind, minimally invasive treatment option for patients with tricuspid regurgitation, or a leaky tricuspid heart valve.
In August, Abbott announced it received CE Mark for an expanded indication for the company’s Navitor transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery.
In August, at the European Society of Cardiology (ESC) Congress, new treatment guidelines were issued that provide additional support for the use of MitraClip and TriClip in treating valvular heart disease. These new guidelines were backed by evidence from multiple clinical studies.
"Our third-quarter results demonstrate our ability to deliver consistent, high-quality performance," said Robert B. Ford, chairman and chief executive officer, Abbott. "Our differentiated product pipeline continues to power our performance and positions Abbott to deliver durable long-term value to our shareholders."

THIRD-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand the underlying performance of the company as the demand for COVID-19 tests has significantly declined following the transition from a pandemic to endemic phase.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical
Devices

U.S.

4,299

888

886

—

2,521

International

7,070

1,265

1,367

1,511

2,927

Total reported

11,369

2,153

2,253

1,511

5,448

% Change vs. 3Q24

U.S.

2.3

(6.5)

(14.1)

n/a

13.8

International

9.9

13.3

(1.0)

7.5

15.6

Total reported

6.9

4.2

(6.6)

7.5

14.8

Impact of foreign exchange

1.4

0.2

1.2

0.4

2.3

Organic

5.5

4.0

(7.8)

7.1

12.5

Impact of COVID-19 testing sales 1

(2.0)

—

(8.2)

—

—

Organic (excluding COVID-19 tests)

7.5

4.0

0.4

7.1

12.5

Organic

U.S.

2.3

(6.5)

(14.1)

n/a

13.8

International

7.6

13.0

(3.1)

7.1

11.3

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical
Devices

U.S.

12,743

2,800

2,568

—

7,363

International

20,126

3,711

3,912

4,154

8,349

Total reported

32,869

6,511

6,480

4,154

15,712

% Change vs. 9M24

U.S.

6.4

1.4

(7.4)

n/a

14.4

International

6.0

5.3

(3.3)

5.8

11.3

Total reported

6.1

3.6

(5.0)

5.8

12.8

Impact of foreign exchange

(0.3)

(0.9)

(0.2)

(1.7)

0.4

Impact of business exit*

—

(0.2)

—

—

—

Organic

6.4

4.7

(4.8)

7.5

12.4

Impact of COVID-19 testing sales 2

(1.3)

—

(5.4)

—

—

Organic (excluding COVID-19 tests)

7.7

4.7

0.6

7.5

12.4

Organic

U.S.

6.5

1.9

(7.4)

n/a

14.4

International

6.4

6.9

(3.0)

7.5

10.7

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Nutrition

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

888

520

368

International

1,265

457

808

Total reported

2,153

977

1,176

% Change vs. 3Q24

U.S.

(6.5)

(8.4)

(3.8)

International

13.3

17.9

10.9

Total reported

4.2

2.3

5.8

Impact of foreign exchange

0.2

(0.1)

0.4

Organic

4.0

2.4

5.4

U.S.

(6.5)

(8.4)

(3.8)

International

13.0

18.2

10.2

Worldwide Nutrition sales increased 4.2 percent on a reported basis and 4.0 percent on an organic basis in the third quarter.

Growth in the quarter was led by Adult Nutrition, where sales increased 5.8 percent on a reported basis and 5.4 percent on an organic basis, led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading brand of products designed to meet the nutritional requirements for people with diabetes.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Pediatric

Adult

U.S.

2,800

1,695

1,105

International

3,711

1,377

2,334

Total reported

6,511

3,072

3,439

% Change vs. 9M24

U.S.

1.4

3.0

(0.9)

International

5.3

—

8.8

Total reported

3.6

1.6

5.5

Impact of foreign exchange

(0.9)

(0.9)

(0.9)

Impact of business exit*

(0.2)

—

(0.4)

Organic

4.7

2.5

6.8

U.S.

1.9

3.0

0.3

International

6.9

1.8

10.2

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Diagnostics

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

886

366

36

111

373

International

1,367

998

95

47

227

Total reported

2,253

1,364

131

158

600

% Change vs. 3Q24

U.S.

(14.1)

10.4

(1.5)

7.9

(33.5)

International

(1.0)

1.6

4.3

8.9

(14.2)

Total reported

(6.6)

3.8

2.6

8.2

(27.3)

Impact of foreign exchange

1.2

1.6

1.8

0.4

0.4

Organic

(7.8)

2.2

0.8

7.8

(27.7)

U.S.

(14.1)

10.4

(1.5)

7.9

(33.5)

International

(3.1)

(0.6)

1.7

7.7

(15.6)

Global Diagnostics sales decreased 6.6 percent on a reported basis, decreased 7.8 percent on an organic basis, and increased 0.4 percent when excluding COVID-19 testing-related sales1.

COVID-19 testing-related sales were $69 million in the quarter, compared to $265 million in the third quarter of the prior year.

Global Core Laboratory Diagnostics sales increased 3.8 percent on a reported basis and increased 2.2 percent on an organic basis. Growth in the quarter was impacted by challenging market conditions in China, including the impact of volume-based procurement programs.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

2,568

1,049

111

315

1,093

International

3,912

2,850

265

133

664

Total reported

6,480

3,899

376

448

1,757

% Change vs. 9M24

U.S.

(7.4)

8.3

(0.5)

2.4

(21.2)

International

(3.3)

(1.0)

(2.7)

(0.1)

(12.9)

Total reported

(5.0)

1.3

(2.0)

1.7

(18.2)

Impact of foreign exchange

(0.2)

(0.3)

—

(0.1)

(0.2)

Organic

(4.8)

1.6

(2.0)

1.8

(18.0)

U.S.

(7.4)

8.3

(0.5)

2.4

(21.2)

International

(3.0)

(0.7)

(2.7)

0.3

(12.4)

Established Pharmaceuticals

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,511

1,097

414

Total reported

1,511

1,097

414

% Change vs. 3Q24

U.S.

n/a

n/a

n/a

International

7.5

10.3

0.6

Total reported

7.5

10.3

0.6

Impact of foreign exchange

0.4

(0.8)

3.1

Organic

7.1

11.1

(2.5)

U.S.

n/a

n/a

n/a

International

7.1

11.1

(2.5)

Established Pharmaceuticals sales increased 7.5 percent on a reported basis and 7.1 percent on an organic basis in the third quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 10.3 percent on a reported basis and 11.1 percent on an organic basis, led by double-digit growth in several countries across Asia, Latin America and the Middle East.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

4,154

3,121

1,033

Total reported

4,154

3,121

1,033

% Change vs. 9M24

U.S.

n/a

n/a

n/a

International

5.8

7.3

1.7

Total reported

5.8

7.3

1.7

Impact of foreign exchange

(1.7)

(2.4)

0.5

Organic

7.5

9.7

1.2

U.S.

n/a

n/a

n/a

International

7.5

9.7

1.2

Medical Devices

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,521

350

322

280

280

297

196

796

International

2,927

336

383

86

465

338

58

1,261

Total reported

5,448

686

705

366

745

635

254

2,057

% Change vs. 3Q24

U.S.

13.8

21.1

13.2

10.7

8.5

10.1

3.3

18.4

International

15.6

9.3

17.6

22.6

5.5

16.9

24.9

19.9

Total reported

14.8

15.0

15.6

13.3

6.6

13.6

7.6

19.3

Impact of foreign exchange

2.3

2.0

1.9

1.2

1.9

2.3

0.8

3.1

Organic

12.5

13.0

13.7

12.1

4.7

11.3

6.8

16.2

U.S.

13.8

21.1

13.2

10.7

8.5

10.1

3.3

18.4

International

11.3

5.5

14.1

17.2

2.5

12.4

21.2

14.7

Worldwide Medical Devices sales increased 14.8 percent on a reported basis and 12.5 percent on an organic basis in the third quarter.

Sales growth in the quarter was led by double-digit growth in Diabetes Care, Electrophysiology, Rhythm Management, Heart Failure and Structural Heart.

In Diabetes Care, sales of continuous glucose monitors were $2.0 billion and grew 20.5 percent on a reported basis and 17.2 percent on an organic basis.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

7,363

994

943

824

831

868

565

2,338

International

8,349

950

1,091

249

1,381

980

171

3,527

Total reported

15,712

1,944

2,034

1,073

2,212

1,848

736

5,865

% Change vs. 9M24

U.S.

14.4

16.7

12.2

12.4

5.6

14.1

0.3

23.2

International

11.3

3.9

10.9

15.9

4.2

11.8

20.6

15.9

Total reported

12.8

10.1

11.5

13.2

4.7

12.9

4.4

18.7

Impact of foreign exchange

0.4

0.4

0.2

0.3

0.1

0.4

(0.1)

0.6

Organic

12.4

9.7

11.3

12.9

4.6

12.5

4.5

18.1

U.S.

14.4

16.7

12.2

12.4

5.6

14.1

0.3

23.2

International

10.7

3.2

10.5

14.6

4.0

11.2

20.8

14.9

(Press release, Abbott, OCT 15, 2025, View Source [SID1234656667])

On October 15, 2025 Step Pharma ("the Company"), the global leader in CTPS1 inhibition for targeted cancer treatment, reported the completion of a €38 million Series C financing round.

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The Series C round was led by new investor V-Bio Ventures, a Ghent-based life sciences venture capital fund, with participation from existing investors Pontifax, Bpifrance, Kurma Partners, Hadean Ventures, Sunstone Life Science Ventures and Inserm Transfert Initiative.

The financing will enable Step Pharma to continue advancing its ‘pipeline in a product’ strategy for dencatistat, a first-in-class, highly selective, orally bioavailable CTPS1 inhibitor currently in development for the treatment of cancers and blood disorders. All cancers appear to be highly reliant on CTPS1, a key component of the pyrimidine synthesis pathway, for DNA synthesis and cell proliferation.

Dencatistat is being evaluated in a phase 1/2 clinical trial for adult patients with relapsed/refractory T or B cell lymphoma, and received orphan drug designation for the treatment of T cell lymphoma in May 2025. The Company is also evaluating dencatistat in a phase 1 trial in solid tumour patients, with expansion cohorts in CTPS2-null ovarian, endometrial and lung cancer planned.

Clinical trials of dencatistat in lymphoma demonstrated that continual administration results in a dose dependent and reversible lowering of the platelet count. This led to the initiation of Step Pharma’s third clinical programme for dencatistat, in essential thrombocythaemia, a rare clonal blood disorder in which the bone marrow produces too many platelets.

Andrew Parker, Chief Executive Officer, Step Pharma, commented:

"This Series C financing will allow us to build upon the significant clinical progress we have made with dencatistat, with three clinical programmes underpinning our ‘pipeline in a product’ strategy. These funds will enable us to expand our clinical dataset, complete all ongoing phase 1 studies, and further derisk dencatistat as we enter phase 2 and explore its potential to improve patient outcomes through CTPS1 inhibition. I’d like to thank V-Bio Ventures for joining our investor syndicate and leading this round, and our existing investors for their continued participation and support."

Ward Capoen, Partner, V-Bio Ventures, said:

"We are delighted to support Step Pharma in its next phase of growth through this Series C financing. The Company’s approach to inhibiting CTPS1 to selectively block the proliferation of cancer cells is highly promising, and the team has followed the data into essential thrombocythaemia after observing dencatistat’s effect on platelet levels. This multi-pronged clinical plan has further derisked dencatistat and positions Step Pharma to provide new therapeutic options for patients."

(Press release, Step Pharma, OCT 15, 2025, View Source [SID1234656649])

On October 15, 2025 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., a registrational Phase 2 clinical trial has been initiated in Japan for 64Cu-PSMA-I&T – a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*1), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

*1: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 trial SOLAR RECUR and SOLAR STAGE – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and177Lu-PSMA-I&T and in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, Curium Pharma, OCT 15, 2025, View Source [SID1234656636])

On October 14, 2025 Aanastra, Inc., a biotechnology company leveraging its proprietary targeted peptide delivery technology (PEP-NP) to advance in vivo targeting and reprogramming of cells with RNA therapeutics, reported multiple presentations showcasing preclinical data in its lead programs for anti-CD19 in vivo CAR-T (AAN-14x) and for in vivo P53 rescue in P53 mutant tumors (AAN-53x), at upcoming conferences.

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"Among the broad applications of the PEP-NP technology, we are particularly excited by the preclinical data in our in vivo CAR-T program as well as our ability to target wide-ranging P53 driver mutations in our P53 program for which no therapy exists today ," said Neil Desai Ph.D., Founder and CEO at Aanastra. "These preclinical data highlight the remarkable versatility of the PEP-NP targeted peptide RNA delivery technology, from in vivo reprogramming of immune cells to cause B cell depletion, to in vivo restoration of mutant tumor suppressor function directly in tumors, all with a mRNA approach. Importantly the PEP-NP system can completely bypass the liver, without immunogenicity or safety issues upon repeat administration, uses no lipid, viral or protein components, and is fully owned by Aanastra."

Featured Presentations and Conferences:

Advancing Cell and Gene Therapies for Cancer Conference, Philadelphia, PA, Oct 15-16, 2025

Poster presentation title: In Vivo CAR-T generation of anti-CD19 CAR-T-cells using CAR mRNA delivered with the PEP-NP peptide-based (non-lipid, non-viral) delivery system targeted to CD3/CD5+ T-cells
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

Poster presentation title: P53 mutant tumor regression across P53 mutations with AAN-53x, a P53 mRNA delivered with the PEP-NP tumor-targeted peptide (non-lipid) delivery system
Presenter: Gilles Divita, Ph.D
Date and time: Oct 15, 2025, 5:00 p.m. – 6.30 p.m. ET

mRNA Vaccines and Therapeutics Summit, Barcelona, Spain, Oct 23-24, 2025

Oral Presentation Title: A novel peptide-based nanoparticle platform for systemic targeted delivery of therapeutic mRNA : invivo CAR-T cell engineering and Tumor selectivity
Presenter: Gilles Divita, Ph.D.
Date and Time: Oct 23, 2025, 4.40 pm – 5.20pm. CET

About P53
Known as the "Guardian of the Genome," P53 is a crucial tumor suppressor that preserves DNA integrity by regulating DNA repair and cell division. Loss of functional p53 causes DNA damage to accumulate, driving uncontrolled cell growth and tumor development. It is mutated or inactivated in over 50% of cancers, affecting 400,000 new U.S. patients annually and over 10 million globally. Mutations span hundreds of variants, making broad therapies difficult. These mutations are markers of poor prognosis and key cancer drivers. No existing treatments restore p53 function across this spectrum, leaving a significant unmet need. Aanastra’s RNA-based approach using its targeted PEP-NP delivery offers a promising strategy to broadly restore p53 function, potentially transforming outcomes for aggressive, treatment-resistant cancers.

About In vivo CAR-T
In vivo CAR-T therapy engineers a patient’s T cells inside the body to target and destroy cancer cells, avoiding the costly, complex ex vivo CAR-T process that today is available to less than 20% of eligible patients in the US. Current lentiviral methods for in vivo CAR-T allow only single treatments due to immune responses against viral components. Lipid nanoparticle (LNP)-based mRNA delivery enables transient CAR expression that could be repeated but is limited by liver toxicity and immune related side effects like inflammation. These safety and dosing challenges can restrict sustained treatment effects. Aanastra’s PEP-NP system efficiently targets CAR RNA to T cells for safe, repeat dosing without these toxicities, potentially overcoming current limitations and expanding access for hematological cancers and autoimmune diseases.

About PEP-NP
Aanastra’s PEP-NP technology is based on short, amphipathic peptides that form stable nanoparticles with RNA for efficient delivery. These peptides are designed with distinct hydrophobic and hydrophilic regions, adopting α-helical conformations facilitating membrane interaction and cellular entry. Importantly, PEP-NP peptides can include specific receptor-targeting domains, enabling precise cell and tissue targeting without using antibodies or other large proteins. This antibody-free targeting allows rapid design flexibility and avoids immunogenicity associated with protein-based ligands. PEP-NP nanoparticles can enter cells though a non-endosomal mechanism, enhancing RNA release into the cytoplasm for effective therapeutic action. Together, these features make PEP-NP a highly versatile, scalable, and safe platform for delivering diverse RNA payloads for treating cancer, autoimmune, and genetic diseases.

(Press release, AANASTRA, OCT 14, 2025, View Source [SID1234662316])