On March 20, 2025 Aptevo Therapeutics ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported two additional frontline AML patients have achieved remission* within 30 days of treatment in the Company’s RAINIER dose optimization trial evaluating mipletamig in combination with standard of care for patients unfit for intensive chemotherapy (Press release, Aptevo Therapeutics, MAR 20, 2025, View Source [SID1234651323]). In total, 9 of 10 frontline patients across two trials achieved remission* when receiving the triplet combination of mipletamig + venetoclax + azacitidine (ven/aza). Notably, no CRS has been reported in the RAINIER trial to date.

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The data builds on previously reported favorable outcomes from RAINIER’s Cohort 1 and the completed dose expansion trial where 100% of frontline patients achieved remission. Together with the addition of these interim Cohort 2 results, mipletamig has achieved a compelling overall remission rate of 90% among frontline patients. This outperforms the doublet remission* rate from a venetoclax + azacitidine only study, of 66%. Additionally, the frontline patient triplet therapy CR rate of 70% outperforms the CR rate from a venetoclax + azacitidine only study of 36% (Viale-A Pivotal trial).Thus far, all RAINIER patients who achieved remission remain in remission.

Cohort 2 will include six patients, dosed at the 18mcg level, the same dose used in combination with ven/aza in the completed expansion trial.

Three patients evaluable for efficacy achieved the following outcomes:

Two patients achieved remission withing 30 days of being dosed

One patient progressed after the first cycle and passed away for reasons unrelated to study drugs

Cohort 2 enrollment is nearing completion

"We’re now past the halfway mark in Cohort 2 of the RAINIER trial and are thrilled by the continued, highly favorable remission results," said Dirk Huebner, MD, Chief Medical Officer of Aptevo. " This emerging pattern further supports mipletamig’s impact on treatment outcomes in frontline AML patients who are not fit for intensive chemotherapy and who would otherwise receive ven/aza as the standard of care. One of our primary goals with the RAINIER trial is to demonstrate the contribution of mipletamig’s unique mechanism of action when used in combination with venetoclax and azacitidine. By targeting AML this way, our approach has the potential to improve outcomes, particularly for elderly patients who have limited treatment options."

Mipletamig, a differentiated by design CD3 x CD123 bispecific antibody built on Aptevo’s ADAPTIR platform and driven by a unique CRIS-7 derived binding domain, is being investigated as frontline therapy in combination with venetoclax and azacitidine, the current standard of care for AML patients who are unfit for intensive chemotherapy. These latest results further reinforce mipletamig’s potential as a transformative treatment, supported by impressive efficacy, safety, and tolerability data from two prior clinical trials involving almost 100 patients.

*Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi).

About RAINIER
RAINIER, a frontline AML study, is a Phase 1b/2 dose optimization, multi-center, multi-cohort, open label study of up to 39 patients who are being treated across five dose levels ranging from 9 mcg – 140 mcg in combination with venetoclax and azacitidine (ven/aza). Subjects will be adults aged 18 or older, newly diagnosed with AML who are not eligible for intensive induction chemotherapy. Phase 1b consists of 28-day cycles of treatment in five sequential cohorts. Aptevo has partnered with Prometrika (View Source), a premier contract research organization for the trial. RAINIER will be conducted in two parts. First, a Phase 1b dose optimization study in frontline AML patients followed by a Phase 2 study.

Cohort 1 included 3 patients, dosed at the 9mcg level.

All patients achieved remission* within 30 days

Thus far, all patients who achieved remission remain in remission.

One CR patient had no minimal residual disease (MRD-negative status) and was positive for the TP53 genetic mutation, which is generally associated with poor prognosis due to chemotherapy resistance, genetic instability, and overall treatment challenges

About Mipletamig
Aptevo’s wholly owned lead proprietary drug candidate, mipletamig, targeting AML, MDS and other leukemias, 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 a unique CD3 derived from CRIS-7 vs. the CD3 used by other competitors. Mipletamig has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act. Mipletamig has been evaluated in almost 100 patients over three trials to date. RAINIER, Aptevo’s Phase 1b/2 frontline AML program, was initiated in 3Q24.

On March 20, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that it has elected to discontinue development of EO-3021 (Press release, Elevation Oncology, MAR 20, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-to-discontinue-development-of-eo-3021-advancing-eo-1022-while-evaluating-strategic-options [SID1234651308]). EO-3021 is a Claudin 18.2 antibody-drug conjugate (ADC), which Elevation Oncology was developing for the treatment of advanced, unresectable or metastatic gastric and gastroesophageal junction (GEJ) cancers. Elevation Oncology will continue to advance EO-1022, a HER3 ADC for the treatment of patients with HER3-expressing solid tumors, and, in parallel, is initiating a process to evaluate strategic options to maximize shareholder value.

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The decision to discontinue clinical development of EO-3021 was based on data from the dose escalation and expansion stages of Elevation Oncology’s Phase 1 trial, in which treatment with EO-3021 as a monotherapy demonstrated an objective response rate (ORR) of 22.2% (95% CI: 10, 39; 1 confirmed complete response and 7 confirmed partial responses) and a disease control rate (DCR) of 72.2% (95% CI: 55, 86) among 36 evaluable patients with gastric or GEJ cancer and Claudin 18.2 in ≥20% of tumor cells at IHC 2+/3+. In the safety analysis of all enrolled patients (n=85), treatment with EO-3021 was observed to be generally well-tolerated, with an adverse event profile consistent with previously reported data, including minimal hematological toxicity and hepatotoxicity, and no peripheral neuropathy/hypoesthesia.

"We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to other Claudin 18.2 ADCs in development," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "Based on these data, we have decided to discontinue further development of EO-3021. I want to express my tremendous gratitude to the patients, physicians and site coordinators who participated in the EO-3021 clinical trial."

Mr. Ferra continued, "We are turning our focus to our potentially differentiated HER3 ADC, EO-1022, which incorporates glycan site-specific conjugation and is designed to address significant and emerging unmet needs in many HER3-expressing cancers. We look forward to presenting preclinical data supporting its potential at the AACR (Free AACR Whitepaper) Annual Meeting next month. In parallel, we are initiating efforts to evaluate strategic options for the company. With cash into the second half of 2026 and a disciplined operating strategy, we are well-positioned to advance EO-1022 while working to identify and capitalize on the best opportunities to maximize value for our stakeholders."

Corporate Update:

Elevation Oncology is implementing a workforce reduction of approximately 70%. The total cash payments and costs related to this reduction in force are estimated to be approximately $3 million, with a significant majority of these amounts expected to be paid though the end of June 2025. As part of this reduction, Elevation Oncology’s Chief Medical Officer, Valerie Malyvanh Jansen, M.D., Ph.D., will step down, effective March 31, 2025. Dr. Jansen will continue to support the company in a consulting capacity.

"I want to thank the employees who will be departing as part of this restructuring. Over the past five years, my colleagues have worked tirelessly to advance a novel pipeline of selective medicines, demonstrating a tremendous commitment to making a difference for people living with cancer. I am deeply appreciative of their dedication, support and contributions," added Mr. Ferra.

Based on its current operating plans, Elevation Oncology now expects that its cash, cash equivalents, and marketable securities of $93.2 million as of December 31, 2024, will be sufficient to fund its operations into the second half of 2026.

On March 20, 2025 Akeso Inc. (9926.HK) reported promising phase III safety run-in results from the COMPASSION-18/AK104-305 study, at the 2025 Annual Meeting of the Society of Gynecologic Oncology (SGO) (Press release, Akeso Biopharma, MAR 20, 2025, View Source [SID1234651324]). The study evaluates the global first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab (AK104), in combination with concurrent chemoradiotherapy (CCRT) for the treatment of locally advanced cervical cancer.

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Currently, CCRT is the standard of care for locally advanced cervical cancer, but approximately 30%-40% of patients experience relapse or disease progression within five years. Cadonilimab, with its unique dual-target mechanism, is designed to simultaneously inhibit the PD-1 and CTLA-4 immune checkpoint pathways. It has received approval from the National Medical Products Administration (NMPA) in China for use in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy. The Phase III COMPASSION-16 study further confirmed that cadonilimab, when combined with platinum-based chemotherapy (with or without bevacizumab), significantly improves progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. Based on these compelling results, the supplemental New Drug Application (sNDA) for cadonilimab as a first-line treatment for persistent, recurrent, or metastatic cervical cancer is currently under regulatory review.

At this year’s SGO, data from the COMPASSION-18 study highlighted the exceptional efficacy seen in patients receiving cadonilimab in combination with CCRT during the safety run-in phase. The results demonstrate the considerable therapeutic potential of cadonilimab combined with CCRT for locally advanced cervical cancer. The study included a more challenging patient cohort, with a notably higher proportion of patients having PD-L1 CPS <1 (38.2%) and an ECOG performance status of 1 (52.9%) compared to other similar studies.

Overall Response Rate (ORR): The evaluable patients achieved a remarkable ORR of 100%, with a complete response (CR) rate of 84.8% and a partial response (PR) rate of 15.2%, which significantly outperformed data from other comparable studies. The median duration of response (DoR) has yet to be reached.
Progression-Free Survival (PFS): While the median PFS has not been reached, the 12-month PFS rate was 74.9%.
Subgroup Analysis: Patients with PD-L1 CPS ≥1, ECOG 0, and those not infected with COVID-19 derived even greater benefit from the treatment, with 12-month PFS rates of 85%, 87.5%, and 81.3%, respectively.
Safety Profile: Cadonilimab combined with CCRT exhibited a favorable safety profile, demonstrating good tolerability and manageable adverse events. Notably, there were no treatment-related deaths (TRAE) and no new safety concerns were identified.
Cadonilimab is making significant progress in treating both recurrent/metastatic and locally advanced cervical cancer, establishing a comprehensive therapeutic approach. The positive results from the COMPASSION-18 study reinforce its potential in a broader patient population. As clinical development continues, cadonilimab is set to redefine cervical cancer treatment, offering long-term survival benefits to more patients.

On March 20, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business updates (Press release, Immuneering, MAR 20, 2025, View Source [SID1234651309]).

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"We were delighted to report updates from our ongoing Phase 2a trial of IMM-1-104 in January 2025 demonstrating excellent response rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients. Highlights of these data included an observed ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) and an observed ORR of 50% for IMM-1-104 in combination with modified FOLFIRINOX (mFFX). Historic benchmarks for either chemotherapy agent alone are 23% ORR and 32% ORR, respectively. IMM-1-104 in combination with each of mGnP and mFFX was observed to be generally well tolerated. Based on these promising results, we have begun planning for a potential IMM-1-104 global pivotal trial in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer, as we aim to get this exciting potential new treatment option to patients as quickly as possible," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering.

"Importantly, the results demonstrated with IMM-1-104 to date point to its potential combinability, set to continue with our recently announced plans to study IMM-1-104 in combination with a BRAF inhibitor in melanoma, with a G12C inhibitor in non-small cell lung cancer, and with a PD-1 inhibitor in both melanoma and non-small cell lung cancer. We subsequently announced a clinical trial supply agreement with Regeneron for Libtayo in combination with IMM-1-104 in patients with non-small cell lung cancer and aim to get these new trials up and running this year. In support of these plans, we were pleased to announce that Dr. Igor Matushansky has joined Immuneering as Chief Medical Officer to oversee clinical activities, including medical and operational leadership for our development programs."

Zeskind concluded: "As we look ahead to the rest of the year – with our cash balance recently fortified – we expect multiple data events, beginning with an update from our IMM-1-104 Phase 2a trial in the second quarter of 2025. We are continuing to build a growing data set that we believe positions our lead asset with the potential to offer an improved profile in comparison to current MEK inhibitors, which currently represents an existing approximately $2.4 billion annual global opportunity in the aggregate."

Corporate Highlights

Phase 1 Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: Today, Immuneering provided a case study update for a Phase 1 pancreatic cancer patient in the third-line setting who has been receiving IMM-1-104 monotherapy for over 13 months so far. The patient – who previously progressed on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on IMM-1-104 monotherapy at 240 mg once daily. As of the most recent available scan, the patient has maintained stable disease with a RECIST SLD change of -24.2%. In addition to a 91% reduction in peak CA 19-9 levels, IMM-1-104 has been well tolerated by the patient, who has reported improved quality of life and approximately 12% weight gain.
Named Dr. Igor Matushansky as Chief Medical Officer: In March, Immuneering announced that Igor Matushansky, MD, PhD, joined the company as Chief Medical Officer. In this role, Dr. Matushansky will direct Immuneering’s clinical activities, providing medical and operational leadership for the company’s development programs including the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer.
Announced Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo (cemiplimab): In February, Immuneering announced a clinical trial supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo. The agreement supports the intended evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC).
Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104: In January, Immuneering announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include additional combination arms.
Launched Pancreatic Cancer Advisory Board: In December, Immuneering announced the formation of its Pancreatic Cancer Advisory Board. The advisory board, which comprises world-renowned oncology clinical researchers, will provide strategic medical and clinical guidance to the company as its pipeline, including lead clinical program IMM-1-104, continues to advance.
FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma: In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors.
FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer: In October 2024, the FDA granted Orphan Drug designation to IMM-1-104 in the treatment of pancreatic cancer.
Near-Term Milestone Expectations
IMM-1-104

Further IMM-1-104 Phase 2a data expected in the second quarter of 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with Libtayo in NSCLC planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a G12C inhibitor in NSCLC planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a PD-1 inhibitor in melanoma planned for 2025.
Initiation of Phase 2a arm of IMM-1-104 in combination with a BRAF inhibitor in melanoma planned for 2025.
Fourth Quarter and Full Year 2024 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2024, were $36.1 million, compared with $85.7 million as of December 31, 2023. These amounts exclude net proceeds of $13.7 million from the Company’s ATM facility raised in January 2025.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $14.9 million compared with $11.9 million for the fourth quarter of 2023. Full year 2023 R&D expenses were $48.0 million compared to $41.6 million for full year 2023. The increase in fourth quarter and full year 2024 R&D expenses as compared to the same respective periods of 2023 was primarily attributable to higher clinical costs related to the Company’s lead IMM-1-104 program and increased personnel to support ongoing research and development activities.
General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2024 were $3.7 million compared with $4.4 million for the fourth quarter of 2023. Full year 2024 G&A expenses were $16.1 million compared to $16.8 million for full year 2023. The decrease in fourth quarter and full year 2024 G&A expenses as compared to the same respective periods of 2023 was primarily due to lower external professional fees and a reduction in employee-related costs, partially offset by higher stock-based compensation related to the general and administrative functions supporting the business.
Net Loss: Net loss attributable to common stockholders was $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024, compared to $15.1 million, or $0.52 per share, for the quarter ended December 31, 2023. Net loss attributable to common stockholders for full year 2024 was $61.0 million, or $2.04 per share, compared to $53.5 million, or $1.88 per share, for full year 2023.
2025 Financial Guidance

Based on cash and cash equivalents as of December 31, 2024, plus proceeds from the Company’s subsequent utilization of its ATM facility, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.

On March 20, 2025 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported its participation in the 2025 NeauxCancer Conference organized by the Cancer Advocacy Group of Louisiana (CAGLA), being held March 27 – 29, 2025 in New Orleans (Press release, ImmunoGenesis, MAR 20, 2025, View Source [SID1234651325]).

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President and CEO James Barlow will discuss how ImmunoGenesis plans to transform immuno-oncology with its pipeline of products designed to overcome immune resistance. He will provide an update on the active Phase 1a/1b study of their lead compound, IMGS-001, including preliminary data on enrolled subjects. IMGS-001 is a novel dual-specific PD-L1/PD-L2 antibody with killing function designed to treat immune-excluded, cold tumors that are resistant to existing immunotherapy. Mr. Barlow will also discuss the recently initiated phase 2 trial for the company’s second clinical asset, IMGS-101 (evofosfamide), a hypoxia reversal agent being studied in combination with checkpoint inhibition.

Attendees at the conference will include oncologists and other clinicians interested in learning and discussing the latest practices for treating and taking care of cancer patients. The Innovation Track will enable the medical professionals attending the conference, as well as regional investment professionals, to learn about emerging technologies for cancer treatment and prevention.

"We are excited to have ImmunoGenesis as a new presenter in this year’s Innovation Track. The company has recently expanded the Phase 1a/1b clinical trial of its lead candidate, IMGS-001, to Ochsner MD Anderson Cancer Center in southeastern Louisiana. This is an excellent opportunity for clinicians and investors to hear their story."
— Chadwick K. Landry, Portfolio Manager at Poydras Capital Partners and President of CAGLA

Registration and attendance at the conference for investors is complimentary. Investors can register via the link below.

Innovation Track Details:

ImmunoGenesis Presentation

Friday, March 28 2:00PM CST

Conference Registration

View Source

complimentary registrations are available for investors

The 2025 NeauxCancer Conference has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Ochsner Clinic Foundation and CAGLA. The Ochsner Clinic Foundation is accredited by the ACCME to provide continuing medical education for physicians.

About CAGLA
The Cancer Advocacy Group of Louisiana is a nonprofit corporation organized and operated to advocate for state legislation and administration regulations that facilitate cancer research and education, and foster the well-being and care of cancer patients, survivors, and their families.