On May 6, 2026 Aptevo Therapeutics Inc. (Nasdaq:APVO) reported new clinical results from its RAINIER frontline acute myeloid leukemia (AML) trial. The Company is on track to complete the Phase 1b dose-optimization trial and select the recommended Phase 2 dose (RP2D) this year. As with the current study, the Phase 2 trial will dose mipletamig in combination with venetoclax and azacitidine.

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!

Across 31 evaluable frontline AML patients treated to date (includes data through RAINIER Cohort 5, plus 4 patients from the previously completed dose expansion trial), mipletamig in combination with venetoclax and azacitidine has demonstrated an 87% clinical benefit rate (CR/CRi/PR) and an 81% remission rate (CR/CRi), with results continuing to reflect a consistent profile of clinical activity and favorable safety as the dataset expands.

With Cohort 5 complete, dosing has progressed through all previously evaluated mipletamig dose levels. The trial has now entered its final stage, which includes:

Two final dose-level cohorts-Cohorts 6 and 7-representing the highest dose levels of mipletamig evaluated. Enrollment in Cohort 6 is nearing completion

Two groups of six additional patients will be enrolled at select dose levels, with the first enrolling concurrently with Cohort 6

These activities will complete the dataset required for RP2D selection and the planned Phase 2 regulatory interaction, with the trial on track for completion this year.

"With the completion of Cohort 5, we have evaluated mipletamig across all previously studied dose levels and have entered the final stage of the RAINIER trial," said Jeff Lamothe, President and Chief Executive Officer of Aptevo Therapeutics. "The data is compelling, the remaining work is clearly defined, and the study is on track for completion this year, with the dataset enabling selection of the Phase 2 dose and our advancement into Phase 2. The strength and consistency of the data as it expands gives us confidence in the path forward."

Among the evaluable frontline patient population treated to date (N=31), including 27 patients from the RAINIER trial through Cohort 5 and 4 patients from the completed dose-expansion trial, mipletamig in combination with venetoclax and azacitidine has demonstrated:

87% clinical benefit rate,*demonstrating broad anti-leukemia activity and blast reduction across response categories

81% achieved CR or CRi (remission), comparing favorably to the historical benchmark**.

65% achieved CR (complete remission), comparing favorably to the historical benchmark**

55% of patients who achieved CR/CRi had blast reductions that reached the important measurable residual disease-negative level, a result that is typically associated with stronger, more durable responses

36% of patients with remissions had the TP53 genetic mutation, a high-risk biomarker typically associated with poor prognosis in AML and for which most treatment options frequently fail

6 patients treated to date have proceeded to allogeneic stem cell transplant, which represents the best possible outcome in AML treatment and is rarely achieved in the older or unfit frontline patient population

No cytokine release syndrome reported

*Clinical benefit rate, including complete remission (CR), complete remission with incomplete hematologic recovery (CRi), and partial remission (PR)

**In the Phase 3 VIALE-A trial evaluating venetoclax plus azacitidine in frontline intent-to-treat AML patients who were ineligible for intensive induction chemotherapy, the reported composite CR/CRi rate was 66.4%, and the CR rate was 37% (DiNardo et al., New England Journal of Medicine, 2020).

Collectively, these data outperform the benchmark** and demonstrate mipletamig’s potential to meaningfully enhance frontline AML treatment in older and/or unfit patients by improving efficacy outcomes without materially increasing toxicity.

"Our results demonstrate a consistent pattern of clinical activity and favorable safety across patients treated to date," said Dirk Huebner, M.D., Chief Medical Officer of Aptevo Therapeutics. "As dose selection progresses, the focus is on identifying a Phase 2 dose that is supported by a complete and well-characterized dataset."

About the RAINIER Trial

RAINIER, a frontline AML study, is a Phase 1b/2 dose-optimization, multi-center, multi-cohort, open-label study. Subjects are adults aged 18 or older, newly diagnosed with AML, who are not eligible for intensive induction chemotherapy. RAINIER will be conducted in two parts: first, a Phase 1b dose-optimization study in frontline AML patients, followed by a Phase 2 study. The Phase 1b trial consists of 28-day cycles of treatment across multiple sequential cohorts.

About Mipletamig

Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, being evaluated for the treatment of AML, is differentiated by design to redirect the immune system of the patient to destroy leukemic cells and leukemic stem cells expressing the target antigen CD123, which is a compelling target for AML due to its overexpression on leukemic stem cells and AML blasts. This antibody-like recombinant protein therapeutic is designed to engage both leukemic cells and T cells of the immune system and bring them closely together to trigger the destruction of leukemic cells.

Mipletamig is purposefully designed to reduce the likelihood and severity of CRS by use of the CRIS-7-derived CD3 binding pathway, an approach that differentiates Aptevo from competitors. Mipletamig has received orphan drug designation ("orphan status") for AML under the Orphan Drug Act. Orphan drug designation provides key advantages-including the opportunity to seek U.S. market exclusivity for a specific period of time upon approval, FDA fee reductions, and access to development and tax credits. Mipletamig has been evaluated in more than 120 patients over three trials to date.

(Press release, Aptevo Therapeutics, MAY 6, 2026, View Source [SID1234665215])

On May 6, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported its participation in the Bank of America Securities 2026 Health Care Conference being held at the Encore Hotel in Las Vegas, Nevada. Management will participate in a fireside chat on Wednesday, May 13, 2026, at 3:00 pm Pacific Time and will also participate in one-on-one investor meetings.

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 live audio webcast of the event will be available online at Erasca.com/events. An archived replay of the event will be available for 30 days following the webcast at Erasca.com/events.

(Press release, Erasca, MAY 6, 2026, View Source [SID1234665231])

On May 6, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that The New England Journal of Medicine (NEJM) has published a report describing data from the Phase 1/2 clinical trial evaluating daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma (PDAC). The promising Phase 1/2 findings provided important insights supporting initiation of the company’s global, randomized Phase 3 registrational trial, RASolute 302. Revolution Medicines recently announced positive topline results from the RASolute 302 clinical trial showing an unprecedented overall survival benefit with daraxonrasib compared to standard of care cytotoxic chemotherapy, consistent with the Phase 1/2 single-arm observations.

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!

"RAS mutations are a central driver of disease across multiple solid tumors, including particularly pancreatic ductal adenocarcinoma. There is significant room for improvement in outcomes over current standard of care — cytotoxic chemotherapies that are not targeted to these underlying RAS cancer drivers," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "Data from the Phase 1/2 trial show that daraxonrasib demonstrated promising clinical antitumor activity and durable responses, with an acceptable safety and tolerability profile, in patients with previously treated metastatic RAS mutant PDAC. These results, along with those from our Phase 3 trial, RASolute 302, strengthen our confidence in daraxonrasib’s potential to establish an important new treatment option for patients with pancreatic cancer and other RAS-addicted cancers."

The data published in NEJM reflect outcomes in the PDAC cohort from the RMC-6236-001 trial (NCT05379985), an open-label, multicenter Phase 1/2 trial evaluating daraxonrasib monotherapy in patients previously treated for metastatic solid tumors harboring RAS mutations.

In addition to RASolute 302, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC in earlier treatment lines and those with metastatic RAS mutant non-small cell lung cancer.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people are diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most common RAS-addicted malignancy of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.3,4

About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor that is not approved by any regulatory authority, including in the United States or Europe. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. In addition to the RASolute 302 trial, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC and metastatic RAS mutant NSCLC.

Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.

(Press release, Revolution Medicines, MAY 6, 2026, View Source [SID1234665197])

On May 6, 2026 BioOra Limited, a New Zealand-based company pioneering automated, cost-effective CAR T-cell manufacturing, reported the signing of a binding Heads of Terms agreement with Wellington Zhaotai Therapies Limited (Wellington Zhaotai) under which BioOra secures global rights to develop and commercialise Wellington Zhaotai’s novel third-generation anti-CD19 CAR T-cell therapy for the treatment of multiple conditions (WZTL-002), including haematological malignancies and auto-immune diseases.

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!

BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.
BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.
This milestone agreement builds on BioOra’s existing partnership with the Malaghan Institute of Medical Research through which BioOra already holds exclusive rights for commercialisation of WZTL-002 in New Zealand and Australia. The agreement with Wellington Zhaotai will provide BioOra the exclusive rights to commercialise the therapy in all markets outside of China and India, including USA, Europe and the UK.

BioOra have combined the unique CAR-T asset developed by Wellington Zhaotai, with BioOra’s manufacturing and commercialisation expertise to deliver Atla-cel, an autologous CAR T-cell product incorporating patented co-stimulatory domains designed to deliver robust efficacy with a favourable safety profile, including low rates of neurotoxicity. The clinical value of the third-generation design has been demonstrated through New Zealand’s first CAR T-cell clinical trial, sponsored by Malaghan Institute and conducted in collaboration with Wellington Zhaotai (ENABLE-1, NCT04049513). This study also confirmed BioOra’s capabilities in automated manufacturing in a clinical setting. Results from 30 patients showed a complete response rate and fewer serious toxicities than those observed in similar clinical trials of first- and second-generation CAR T-cell therapies1.

Through their partnership, BioOra and the Malaghan Institute are now confirming the safety and efficacy of Atla-cel in patients with relapsed/refractory large B-cell lymphoma in a pivotal Phase 2 study designed to enable registration in New Zealand and Australia (ENABLE-2, NCT06486051)

BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.

John Robson, CEO of BioOra Limited said, "This agreement positions BioOra to expand Atla-cel into high-value global markets and marks an important commercial milestone for the company. At its heart is the opportunity to bring CAR-T to more patients in more markets. Too many people around the world still have limited access to these personalised cell therapies, largely because of cost. Combining Wellington Zhaotai’s innovative science with BioOra’s automated manufacturing expertise creates the pathway to change that. To date, Atla-cel has demonstrated remarkable safety outcomes, which are central to its clinical and commercial potential."

Dr Peter Crabree, Chairman of BioOra Limited said, "CAR T-cell therapy represents one of the most consequential advances in oncology of the past decade, yet access remains profoundly unequal. This agreement with Wellington Zhaotai is a concrete step toward changing that, bringing technology developed through world-class international collaboration, and further advanced here in New Zealand, to patients across the globe. For BioOra, this is about more than commercial expansion; it is about ensuring that patients with blood cancers and B-cell mediated diseases have access to therapies that can genuinely alter the course of their disease".

(Press release, BioOra, MAY 6, 2026, View Source [SID1234665216])

On May 6, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.

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!

"We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+," stated Dr. William V. Williams, BriaCell’s President & CEO. "The unique design of Bria-BRES+ offers the potential for a favorable safety profile and meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options."

As reported in BriaCell’s recent AACR (Free AACR Whitepaper) preclinical poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer.

BriaCell’s Bria-BRES+ builds on its Bria-OTS breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at 2 months, was subsequently confirmed at 4 months, 6 months, and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up.

(Press release, BriaCell Therapeutics, MAY 6, 2026, View Source [SID1234665232])