On April 6, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulating payloads reported a strategic partnership with WuXi XDC, a global leader in ADC development and manufacturing, to accelerate the development of Akari’s novel PH1 payload.

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"This strategic partnership with WuXi XDC represents a major milestone for Akari and a powerful validation of our novel PH1 payload technology," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "WuXi XDC is widely recognized as a global leader in ADC innovation, and with this partnership, we believe Akari can rapidly advance and further validate our PH1 payload on AKTX-101 in future clinical studies."

WuXi XDC’s CEO, Jimmy Li, Ph.D., added, "We are pleased to work with Akari to advance the novel PH1 payload into more advanced studies. WuXi XDC has a proven record of advancing novel ADC payloads and strives to remain at the forefront of ADC innovation. We believe we are the trusted and best partner to help Akari advance this first-in-kind RNA splicing modulating ADC payload for its use in its lead program, as well as other future ADC molecules. There is a strong need for ADC payload innovation to improve on current therapies, and WuXi XDC wants to be at the forefront working with partners like Akari to bring novel ADCs to cancer patients."

Akari’s lead program AKTX-101 is initially targeting metastatic urothelial cancer, where there continues to be significant unmet medical need particularly in the second-line treatment setting. Patients with metastatic disease that progress following first-line therapies often have limited options beyond standard chemotherapy, which offers only modest clinical benefit in this setting. The Company believes that AKTX-101 with its novel PH1 payload may provide a promising new therapeutic approach for urothelial cancer patients, while also demonstrating the broader potential of Akari’s PH1 payload platform.

AKTX-101 features Akari’s proprietary PH1 payload, a novel spliceosome modulator designed to disrupt RNA splicing in cancer cells. By targeting RNA splicing, PH1 represents a new direction for next-generation ADC therapies. Unlike traditional ADC payloads that are microtubule inhibitors or DNA-damaging agents, PH1 offers a differentiated mechanism of direct cytotoxicity as well as the unique activation of the innate and adaptive immune systems to attack cancer. In preclinical studies, AKTX-101 has demonstrated superior anti-tumor regression and complete remissions relative to other ADCs. Akari believes this differentiated mechanism positions PH1 as part of a new wave of ADC payload innovation aimed at significantly improving the therapeutic potential of antibody-drug conjugates.

Akari is working to advance its lead program, AKTX-101, into a Phase 1 clinical trial expected to initiate in late 2026 or early 2027 subject to regulatory clearance. This key clinical milestone reinforces Akari’s ongoing progress to advance its novel payload and execute its strategy to develop ADC therapies with novel payloads that have the potential to improve outcomes for cancer patients.

(Press release, Akari Therapeutics, APR 6, 2026, View Source [SID1234664179])

On April 6, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported the publication of two abstracts that will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22, 2026, in San Diego, California.

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The Company will present previously undisclosed data demonstrating the expanding potential of its Ac-225 radiotherapy platform across both solid tumors and hematologic malignancies. Both presentations will occur on April 21, 2026 in the session Radiopharmaceutical Platforms for Theranostic Precision Oncology.

Sandesh Seth, Actinium’s Chairman and CEO, said, "These new data further validate the strength and versatility of our Ac-225 radiotherapy platform. ATNM-400 continues to show compelling pan-tumor activity, including activity in tumors resistant to current targeted therapies, supporting its potential as a first-in-class asset in large solid tumor indications. In parallel, Actimab-A’s newly identified mechanism of transcriptional reprogramming provides important insight into its mutation-agnostic activity and ability to enhance standard-of-care therapies. Together, these findings reinforce our strategy to build a differentiated pipeline with multiple value-driving opportunities."

ATNM-400 AACR (Free AACR Whitepaper) 2026 Presentation Details

Poster Number: 5824

Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology

Date & Time: April 21, 2026 – 2:00 PM – 5:00 PM PT | Poster Section 16, Board #18

Actimab-A AACR (Free AACR Whitepaper) 2026 Presentation Details

Poster Number: 5827

Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology

Date & Time: April 21, 2026 – 2:00 PM – 5:00 PM PT | Poster Section 16, Board #21

(Press release, Actinium Pharmaceuticals, APR 6, 2026, View Source [SID1234664178])

On April 6, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company. The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On March 31, 2026, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to four individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 8,400 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the grant date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.

(Press release, Abeona Therapeutics, APR 6, 2026, View Source [SID1234664177])

On April 3, 2026 Bristol-Myers Squibb Company (Headquarters: Tokyo, Japan) today received approval for a partial amendment to the manufacturing and marketing authorization for its CD19-targeted CAR T-cell therapy, "Breyangi Injection" (generic name: lysokabutagen maralucell, hereinafter "Breyangi"), for the treatment of relapsed or refractory marginal zone lymphoma (hereinafter, MZL) and relapsed or refractory mantle cell lymphoma (hereinafter, MCL). This approval will allow Breyanzi to be offered as a treatment option for relapsed or refractory MCL regardless of the number of prior treatment lines, and for relapsed or refractory MZL from the third line of treatment onward.
This adds a new option to these disease areas where there remains a high level of unmet medical need.

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MZL and MCL are both B-cell lymphomas that fall under the category of non-Hodgkin lymphoma. MZL is a subtype that accounts for about 7% of all non-Hodgkin lymphomas. While many patients achieve remission with initial treatment, relapses are not uncommon, and there has been a need for new treatment options that provide long-term, sustained therapeutic effects. In addition, some cases of MZL can progress to diffuse large B-cell lymphoma, which is a more aggressive form of lymphoma.

MCL is a highly malignant and rare form of non-Hodgkin lymphoma, accounting for approximately 3% of all non-Hodgkin lymphomas. It originates from cells that make up the "mantle zone" of the lymph nodes. The average age at diagnosis is in the mid-60s, and it is more common in the elderly. There is no established standard treatment for MCL that can be expected to cure the disease, and ultimately, disease progression or recurrence occurs. Treatment options for relapsed or refractory MCL are limited.

This approval is based on efficacy and safety results obtained in the MZL cohort of the international collaborative Phase II clinical trial (TRANSCEND FL trial) for patients with relapsed or refractory low-grade B-cell non-Hodgkin lymphoma, and in the MCL cohort of the overseas Phase I clinical trial (TRANSCEND NHL 001 trial) for patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Angela Davis, Head of Research and Development at Bristol-Myers Squibb Company, stated:

"This approval further expands the indications for Breyange as a CD19-targeted CAR T-cell therapy for B-cell malignancies.
This new single-dose CAR T-cell therapy is highly significant for patients with relapsed or refractory MCL and MZL who have received multiple treatments.
Bristol-Myers Squibb will continue to drive the development and delivery of innovative cell therapies worldwide, aiming to bring long-term benefits to patients facing serious illnesses."

About the TRANSCEND FL trial (Marginal Zone Lymphoma (MZL))
The TRANSCEND FL trial is a phase II, open-label, multicenter study evaluating the efficacy and safety of Breyanzi. Cohort 4 (patients with MZL prior to two or more systemic therapies) includes 67 adult patients with relapsed or refractory indolent B-cell NHL (65 non-Japanese patients and 2 Japanese patients).

The primary endpoint is the overall response rate (ORR), while secondary endpoints include the complete response rate (CRR), duration of response (DOR), DOR in patients who achieved complete response (CR), progression-free survival (PFS), overall survival (OS), safety, and cytokinetics, among others.

In the efficacy analysis population of 66 patients (including 2 Japanese patients) treated with Breyanzi, the primary endpoint, the overall response rate (95% CI), was 95.5% (87.3-99.1), which was statistically significant against the threshold of 50% (p<0.0001). Both Japanese patients showed a response. The
safety profile was consistent with previously reported findings, and no new safety signals were observed.

About the TRANSCEND NHL 001 trial (Mantle cell lymphoma (MCL))
The TRANSCEND NHL 001 trial is a phase I, open-label, multicenter study evaluating the efficacy and safety of Breyanzi. The MCL cohort (patients with MCL prior to two or more systemic therapies) includes 88 adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). Patients with one or more prior systemic therapies were also included, although they were not the primary target for the efficacy analysis.

The primary endpoints are safety and overall response rate (ORR), while secondary endpoints include complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), PFS ratio, overall survival (OS), changes in health-related quality of life, and cellular dynamics.

In the primary efficacy analysis population of 74 patients (including only those who received 100 × 10⁶ CAR-expressing live T cells and had received two or more prior systemic therapies, including alkylating agents, Bruton’s tyrosine kinase inhibitors, and rituximab (or other CD20-targeted drugs)), the overall response rate (95% CI), which was the primary endpoint, was 86.5% (76.5–93.3), and the lower limit of the 95% CI was statistically significant against the pre-defined threshold of 40% (p<0.0001). In addition, in the efficacy analysis population of 77 patients (including those who received 100 × 10⁶ CAR-expressing live T cells and had received one or more prior systemic therapies), the ORR (95% CI) was 87.0% (77.4–93.6).
The safety profile was consistent with previously reported findings, and no new safety signals were observed.

(Press release, Bristol-Myers Squibb, APR 3, 2026, View Source [SID1234665483])

On April 3, 2026 GT Biopharma, Inc., a Delaware corporation (the "Company"), reported to have entered into an Investigator Initiated Clinical Trial Agreement (the "Agreement") with the Regents of the University of Minnesota (the "University"), pursuant to which, the University shall sponsor an Investigational New Drug ("IND") application for IND 169118 GTB-5550 (the "Research Program") and shall serve as a sponsor investigator for a phase 1a/1b clinical trial entitled, "GTB-5550, a Camelid Nanobody B7-H3 Tri-Specific Killer Engager (camB7-H3 TriKE), in Select Advanced Solid Tumors That Failed Prior Therapy," designed by University (the "Study"). The Research Program is being conducted for clinical research use. The budget for the Study, including without limitations, funding and resources, provides for up to approximately $3.8 million over the course of three years borne by the Company. The University and the Company will each have the right to publish the Study results. The Agreement may be terminated by the Company or the University at any time upon thirty days’ written notice to the other party, by the University immediately for health, welfare and safety reasons, or by either party if the other party materially breaches the Agreement, provided that the breaching party fails to cure such breach within thirty days.

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The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated by reference into this Item 1.01.

(Filing, GT Biopharma, APR 3, 2026, View Source [SID1234664207])