On May 9, 2025 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and biologics, reported that its self-developed BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (FUCASO), has been granted Orphan Drug Designation (ODD) by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent (Press release, IASO Biotherapeutics, MAY 9, 2025, View Source [SID1234652832]).

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 ODD is a special regulatory incentive established by the Saudi SFDA to encourage the development of therapies for rare diseases. Drugs receiving this designation are eligible for expedited regulatory review and assistance with product development. With the ODD approval, Equecabtagene Autoleucel can now directly submit a New Drug Application (NDA) in Saudi Arabia, which is expected to shorten the approval process and enable earlier access for patients in the Middle East region.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Biotherapeutics, stated: "We are delighted that equecabtagene autoleucel has been grated the Orphan Drug Designation by the SFDA. This once again demonstrates international regulatory recognition of the clinical value of this innovative therapy. Saudi Arabia serves not only as a crucial starting point for our extension into the Middle East market, but also represents a significant step in our steady strategy of "Go Global". We will work closely with local regulatory authorities, medical institutions and partners to advance the approval processes of Equecabtagene Autoleucel in Saudi Arabia, with the goal of delivering clinical benefits to patients in these regions."

About Multiple Myeloma（MM)

Multiple myeloma (MM) is the second most common hematological malignancy globally. According to Globocan data, the global incidence of multiple myeloma in 2022 was 1.8 per 100,000 people, with a 5-year prevalence of 6.8 per 100,000. Despite progress in current anti-myeloma treatments, MM remains largely incurable with multiple relapses and tendency to develop refractoriness to several drug classes, presenting a major therapeutic challenge. Thus, there is an unmet need for new treatment options beyond these current anti-myeloma therapies for the treatment of relapsed or refractory MM, capable of achieving deep and durable responses.

About Equecabtagene Autoleucel

Equecabtagene Autoleucel is an innovative fully human anti-BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully human scFv, CD8a hinge and transmembrane domain, and 4-1BB co-stimulatory molecule and CD3ζactivation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, FUCASO demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve deep and durable remission,providing continuous protection and care for patients with multiple myeloma.

On May 9, 2025 Minghui Pharmaceutical ("Minghui"), a late-stage clinical biopharmaceutical company, reported an exclusive licensing and collaboration agreement with Qilu Pharmaceutical ("Qilu") for the development, manufacturing, and commercialization of its B7-H3 ADC (MHB088C) in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) (Press release, Minghui Pharmaceutical, MAY 9, 2025, View Source [SID1234652831]).

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!

Under the agreement, Qilu will obtain exclusive rights to MHB088C in the region, while Minghui will be eligible for total payments of up to 1.345 billion RMB, including: 280 million RMB upfront and a near-term milestone payment, 1.065 billion RMB in development, regulatory and sales milestone payments, and up to double-digit royalties on net product sales. Minghui will retain global rights to MHB088C outside Greater China and continue advancing its development in these regions.

MHB088C is an innovative B7-H3-targeted antibody-drug conjugate (ADC) developed using Minghui’s proprietary SuperTopoi ADC platform. It is distinguished by its potent anti-tumor activity and superior safety profile, significantly expanding the therapeutic window.

In ongoing Phase Ⅰ/Ⅱ clinical trials, MHB088C has been evaluated in over 300 patients with advanced or metastatic solid tumors, demonstrating a favorable safety profile and promising efficacy. Subgroup analyses in small cell lung cancer (SCLC) and metastatic castration-resistant prostate cancer (mCRPC) will be presented at the ASCO (Free ASCO Whitepaper) 2025 Annual Meeting as oral and poster presentations, respectively. A Phase Ⅲ trial in relapsed SCLC has been officially initiated in China, with the first patient being enrolled in a couple of weeks.

"Our collaboration with Qilu marks a significant milestone in Minghui’s commitment to advancing innovative cancer therapies," said Dr. Guoqing Cao, CEO of Minghui. "MHB088C has demonstrated robust efficacy with great safety profiles, with no major hematological toxicity or ILD, positioning the program as a best-in-class B7-H3 ADC. With Qilu’s leadership and resources, we are confident that MHB088C will serve patients in need and contribute to the advancement of precision oncology in China."

On May 9, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported that one abstract on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer 2025 Annual Congress taking place May 14 – May 17 in Munich, Germany (Press release, SystImmune, MAY 9, 2025, View Source [SID1234652830]). Iza-bren is being jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license 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!

Data will be presented at the meeting from an ongoing Ph1 clinical trial of iza-bren in patients with locally advanced or metastatic HER2- Breast Cancer. Additional subgroup analysis in previously disclosed data at SABCS 2024 shows encouraging efficacy for iza-bren across all HER2 levels in HER2- Breast Cancer patients including HER2 0 patients. These data highlights continued progress in iza-bren clinical development and builds upon the previously reported clinical data in breast cancer patients at SABCS in 2024.

"These data continue to support our conviction that iza-bren demonstrates strong clinical efficacy across a wide variety of tumors such as breast cancer including HER2 negative breast cancer with a manageable safety profile," said Jonathan Cheng, M.D., CMO of SystImmune. "This positions iza-bren as an important therapeutic option that may address the unmet medical needs of patients with limited treatment options. We are committed to advancing this therapy through clinical trials, exploring its potential not only as a monotherapy but also in combination with other agents, so as to improve outcomes for cancer patients globally."

Details on the presentations at ESMO (Free ESMO Whitepaper) Breast are below:

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Breast Cancer (BC)
Presentation No: 302MO
Session Title: Mini Oral Session 2
Speaker: Yiqun Du (Shanghai, China)
Session Date & Time: Friday, May 16th, 2025, 8:20 AM-10:10 AM CEST

About iza-bren
The company is developing iza-bren, a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent iza-bren has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Iza-bren blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, iza-bren is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induces genotoxic stress activating pathways leading to cancer cell death.

On May 9, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor, reported financial results and provided an update on recent operational highlights for the first quarter ended March 31, 2025 (Press release, Allarity Therapeutics, MAY 9, 2025, View Source [SID1234652829]).

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 start of 2025 marks an important next chapter for Allarity," said Thomas Jensen, CEO of Allarity Therapeutics. "With enrollment about to begin in both our self-funded ovarian cancer trial and the Veterans Administration–funded combination trial in small cell lung cancer, we are focused on generating the data needed to advance stenoparib toward regulatory approval. The continued durability of response observed in ovarian cancer patients is encouraging, and we look forward to sharing updates on both trials in the months ahead."

Clinical and Drug Development Progress

Durable Clinical Benefit as monotherapy dosed twice daily: Multiple patients treated with stenoparib in the ongoing Phase 2 trial for advanced ovarian cancer exceeded 30 weeks on therapy, with two patients still on treatment and receiving benefit more than 19 months, underscoring the drug’s safety profile.
DRP Platform Expansion Beyond Small Molecules: At AACR (Free AACR Whitepaper) 2025, Allarity presented a novel DRP for daratumumab in multiple myeloma, marking the Company’s first DRP developed for a targeted antibody therapy. This milestone expands the versatility of the DRP platform, which was previously focused exclusively on small-molecule drugs.
New Protocol Implemented: Building on compelling data in the ongoing phase 2 ovarian cancer trial, the Company implemented a new Phase 2 protocol focused on platinum-resistant, advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib more aggressively toward regulatory approval.
Combination Trial Launched: Allarity announced a new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration. Allarity’s material contribution is limited to supplying the necessary stenoparib drug product. This novel trial is based upon compelling therapeutic rationale for the combination and could provide a new treatment option for these patients whose options are otherwise limited.
Clinical Data Presented at SGO: The Company presented updated Phase 2 clinical data at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting, demonstrating durable clinical benefit from stenoparib in heavily pre-treated ovarian cancer patients, including those with platinum-resistant, platinum-refractory, and BRCA wild-type disease.
Financial Strengthening and Corporate Development

Fully utilized the Company’s At-the-Market (ATM) offering program initiated in March 2024. With all capacity under the related Form S-3 now exhausted, the current ATM program has concluded.
Authorized a $5 million share repurchase program, reinforcing confidence in long-term shareholder value​.
To date, the Company has repurchased approximately 2 million shares under the authorized buyback program.
Initiated efforts to combat potential illegal short selling, engaging ShareIntel to investigate trading irregularities through enhanced market surveillance and potential legal action.
Ended Q1 2025 with a cash and restricted cash balance of approximately $27 million, further reinforcing the Company’s financial stability and ability to execute on clinical development objectives.
Regulatory and Compliance Resolutions

Finalized settlement with the SEC following receipt of a Wells Notice in July 2024, resolving all outstanding regulatory matters related to past disclosures by prior management regarding FDA interactions on the Dovitinib NDA, which was submitted to the FDA in 2021.
Had class action lawsuit dismissed, closing all related shareholder litigation and further clearing the path for Allarity to focus on clinical and corporate progress.
Anticipated Clinical Milestones in 2025

New Ovarian Cancer Trial Protocol—New Protocol Enrollment: In the first half of 2025, Allarity expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The updated protocol design reflects the compelling, durable clinical benefit observed to date in platinum resistant patients. The protocol aims to provide the definitive foundation for pivotal registration trials for stenoparib in ovarian cancer.​
New Small Cell Lung Cancer Trial—Combination Study: Patient enrollment will initiate in Q2-Q3 2025 in this new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC). The trial, fully funded by the U.S. Veterans Administration, will assess the potential of this novel combination to improve outcomes in recurrent SCLC patients with extremely limited therapeutic opportunities.
First Quarter 2025 Operating Results

Cash Position: As of March 31, 2025, cash, cash equivalents and restricted cash totaled $27.7 million compared to $20.9 million of cash and cash receivables at December 31, 2024.
R&D Expenses: Research and Development (R&D) expenses for the quarter ended March 31, 2025, were $1.4 million, compared to $2.2 million for the quarter ended March 31, 2024.
G&A Expenses: General and Administrative (G&A) expenses for the quarter ended March 31, 2025, were $1.6 million, compared to $2.1 million for the quarter ended March 31, 2024.
Net Loss: Net loss was $2.7 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024.
About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

On May 9, 2025 Turnstone Biologics Corp. ("Turnstone" or the "Company") (Nasdaq-CM: TSBX), a biotechnology company historically focused on the development of a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte ("Selected TIL") therapy, reported financial results for the first quarter ended March 31, 2025, and provided recent corporate updates (Press release, Turnstone Biologics, MAY 9, 2025, View Source [SID1234652828]).

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!

Corporate Updates

In January 2025, Turnstone made the determination to discontinue all TIDAL-01 clinical studies and halted further development of the program. As a result, the Company initiated a process to explore a range of potential strategic alternatives focused on maximizing shareholder value. Turnstone continues to evaluate strategic alternatives and will provide additional updates when it is determined that further disclosure is appropriate or legally required.

In March 2025, Turnstone received approval from the Listing Qualifications Department at the Nasdaq Stock Market ("Nasdaq") to transfer listing of its shares from the Nasdaq Global Market to the Nasdaq Capital Market. This transfer was effective as of the opening of business on March 31, 2025, and the Company’s shares of Common Stock continue to trade under the "TSBX" ticker symbol. The approval by Nasdaq was conditioned upon the Company meeting the applicable market value requirement of publicly held shares for continued listing and all other applicable requirements for listing on the Nasdaq Capital Market.

Financial Highlights

Cash, Cash Equivalents and Short-Term Investments: As of March 31, 2025, cash, cash equivalents and short-term investments were $21.9 million.

Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025, were $4.4 million, compared to $15.8 million for the same period in 2024. The decrease was due primarily to shutting down almost all clinical development activities and the pursuit of strategic alternatives.

General and Administrative (G&A) Expenses: G&A expenses for the three months ended March 31, 2025, were $4.8 million, compared to $4.9 million for the same period in 2024.

Net Loss: Net loss for the three months ended March 31, 2025, was $11.8 million, compared to net loss of $19.6 million for the same period in 2024.