On June 12, 2025 Bristol Myers Squibb (NYSE: BMY) reported the presentation of new data from its targeted protein degradation platform during the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress being held from June 12-15 in Milan, Italy (Press release, Bristol-Myers Squibb, JUN 12, 2025, View Source [SID1234653840]). Presentations feature updated clinical findings on the company’s investigational oral CELMoD agents mezigdomide and iberdomide in multiple myeloma, and golcadomide in non-Hodgkin lymphoma, as well as the first results evaluating the company’s first-in-class, oral BCL6 ligand-directed degrader (LDD) (BMS-986458) in non-Hodgkin lymphoma.

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The latest data presented for the three lead CELMoD agents and BCL6 LDD underscore the potential impact that these therapies may have in addressing significant unmet medical needs in hematologic malignancies. These agents are part of continuing research across targeted protein degradation at Bristol Myers Squibb, which also encompasses additional CELMoD agents, LDDs and degrader antibody conjugates (DACs) across blood cancers and solid tumors, as well as non-malignant hematologic disorders.

Protein degraders, like CELMoD agents and LDDs, are therapies designed to target and degrade specific proteins that drive diseases, including many proteins that are difficult to target through conventional small-molecule inhibitors. These innovative agents have the possibility to enhance the efficacy of existing therapies and overcome resistance in various malignancies, potentially improving patient outcomes.

"As a leader in the field of targeted protein degradation, we are committed to applying our decades of expertise to the development of these next wave of agents. The efficacy and safety data presented at the EHA (Free EHA Whitepaper) Annual Meeting this year is promising and reinforces the potential of CELMoD agents in combination with other standard treatments," said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy for Bristol Myers Squibb. "These analyses also add to the body of evidence for these programs as we continue pivotal studies for each of the agents that we anticipate reading out in the next year and onwards."

Key targeted protein degradation data being presented by Bristol Myers Squibb at the EHA (Free EHA Whitepaper) Annual Congress include:

Mezigdomide (MEZI):

Abstract #4160130: Updated results were presented from the dose-escalation phase of the MM-002 study for the combinations of mezigdomide, dexamethasone, and bortezomib (Cohort A MeziVd; n=28), and mezigdomide, dexamethasone, and carfilzomib (Cohort C MeziKd; n=27) in patients with relapsed/refractory multiple myeloma (RRMM) who had received 2–4 prior therapies:

Overall response rate (ORR) was 75.0% for Cohort A and 85.2% for Cohort C, respectively.
Median (95% CI) duration of response (DOR) for Cohort A and Cohort C was 10.9 (8.8–18.7) and 11.9 (6.4–35.9) months, respectively.
Median (95% CI) progression-free survival (PFS) for Cohort A and Cohort C was 12.3 and 13.5 months, respectively.
Results from the dose-expansion cohort (Cohort D) of the study were also presented for the MeziVd combination (n=49) in patients with RRMM who had received 1–3 prior therapies:

ORR was 85.7%
Median (95% CI) DOR was 19.4 months (9.7-NA)
Median PFS (95% CI) was 17.5 months
The most common grade 3/4 treatment-emergent adverse event (TEAE) across arms was neutropenia and was managed with G-CSF and dose modifications.

Abstract #4160802: New data was presented evaluating mezigdomide in all-oral triplet combinations with other oral novel agents in RRMM.

Results showed that the ORR was:
50% for mezigdomide plus EZH2 inhibitor tazemetostat and dexamethasone (n=16)
35% for mezigdomide plus BET inhibitor BMS-986158 and dexamethasone (n=20)
80% for mezigdomide plus MEK inhibitor trametinib and dexamethasone (n=20)
The most frequent grade 3/4 TEAE was neutropenia, and grade 3/4 nonhematologic TEAEs were low.
A separate analysis(Abstract #4160749) showed that these combinations lead to the activation and proliferation of NK and T cells, including in patients previously treated with T cell-redirecting therapies.
Iberdomide (IBER):

Abstract #4160144: Updated results were presented from MM-001, evaluating the combination of iberdomide, bortezomib, and dexamethasone (IberVd) in patients with transplant-ineligible, newly diagnosed multiple myeloma (NDMM), confirming durable, deep responses in the study.

At a median follow-up of 25 months, the ORR in the intent-to-treat (ITT) population (n=18) was 88.9%, with 66.6% having a complete response or better.
44% of patients in CR achieved minimal residual disease (MRD) negativity at a sensitivity of 10-5.
The most common hematologic grade 3/4 TEAE was neutropenia (29.4%); 2 (11.8%) patients had grade 3/4 peripheral neuropathy. Overall, the most common grade 3/4 TEAEs were infections (47.1%).
Golcadomide (GOLCA):

Abstract #4160953: Updated results were presented from a study evaluating golcadomide with or without rituximab for the treatment of R/R follicular lymphoma (FL). Patients with R/R FL who had received ≥2 prior lines of treatment received golcadomide monotherapy in the dose-escalation part of the study (Part A), followed by golcadomide once daily at 0.2 or 0.4 mg with or without rituximab in the expansion part (Part B). Results continued to show promising efficacy with durable responses in heavily pre-treated patients with R/R FL.

In Part A, the ORR was 67%, with a complete response rate (CRR) of 42% for patients treated with golcadomide monotherapy.
In Part B, the ORR was 94% and the CRR was 63% for patients treated with golcadomide 0.4mg + rituximab. The median DOR was 4.8 months at a median follow-up of 5.75 months. Responses were consistent in patients who received prior lenalidomide-based and/or T cell-redirecting therapy.
The most common grade 3/4 treatment-related adverse events across dose levels in Part B (n=60) were neutropenia and anemia, occurring in 60% and 13% of patients, respectively. No patients discontinued therapy due to side effects related to golcadomide. Non-hematologic side effects were infrequent and mostly low-grade.
Abstract #4161005: Updated results were presented from a study evaluating golcadomide with or without rituximab for the treatment of R/R diffuse large b-cell lymphoma (DLBCL). Patients received golcadomide once daily at either 0.2 mg (n=39) or 0.4 mg (n=38). Results continued to show durable responses in heavily pre-treated patients with R/R DLBCL and a consistent safety profile.

For patients treated with golcadomide 0.4mg + rituximab, the ORR was 58% and the CRR was 44%, with a median DOR of 14.5 months. Among patients who had prior T cell–redirecting therapy, the ORR was 56%, and the CRR was 38%.
The most common grade 3/4 treatment-related adverse events across dose levels (n=77) were neutropenia and anemia, occurring in 64% and 20% of patients, respectively. Most adverse events were manageable, with discontinuation due to AE occurring in 7% of patients.
Based on the results of early studies, mezigdomide, iberdomide and golcadomide are being evaluated in multiple phase 3 studies:

SUCCESSOR-1: mezigdomide, bortezomib, and dexamethasone vs. pomalidomide, bortezomib, and dexamethasone in patients with RRMM (projected data in 2026)
SUCCESSOR-2: mezigdomide, carfilzomib, and dexamethasone vs. carfilzomib and dexamethasone in patients with RRMM (projected data in 2026)
EXCALIBER RRMM: iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone in patients with RRMM (projected MRD data in 2025)
EXCALIBER Maintenance: iberdomide maintenance vs. lenalidomide maintenance following autologous stem cell transplant in patients with NDMM (projected data in 2029)
GOLSEEK-1: golcadomide and R-CHOP chemotherapy vs. placebo and R-CHOP in patients with previously untreated high-risk LBCL (projected data in 2028)
GOLSEEK-4: golcadomide and rituximab vs. investigator’s choice in patients with R/R FL who received at least 1 prior systemic therapy (projected data in 2030)
BMS-986458 BCL6 LDD:

Abstract #4160340: First clinical findings were presented from the dose-escalation part of the first-in-human, multicenter, open-label study of BMS-986458 in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Initial results evaluating 31 heavily pre-treated patients treated with BMS-986458 were promising and support continued development for the treatment of NHL.

BMS 986458 was well-tolerated, with the most common treatment-related adverse events (TRAEs) being grade 1/2 arthralgia (19.4%) and fatigue (16.1%); no grade ≥3 treatment-related cytopenias or treatment-related discontinuations were observed.
Rapid and sustained degradation of BCL6 was demonstrated in peripheral blood and in the tumor at all doses evaluated.
Antitumor activity was evident from the first dose level in DLBCL and FL patients. Among 21 efficacy-evaluable patients, the ORR was 81% (N=17), and CRR was 23.8% (N=5).

On June 12, 2025 GO2 for Lung Cancer (GO2) and the Addario Lung Cancer Medical Institute (ALCMI) reported to have launched SUCCEED, a landmark, remote-participation, observational clinical study in small cell lung cancer (SCLC), one of the deadliest and most under-researched cancers (Press release, Bonnie J Addario Lung Cancer Foundation, JUN 12, 2025, View Source [SID1234653839]).

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Despite comprising up to 15% of all lung cancer cases, SCLC has seen minimal treatment advancements in nearly four decades. Even with the introduction of immunotherapy to standard chemotherapy treatment, survival gains have been modest, extending median overall survival by just two months. With a 5-year survival rate of just 6%, the need for deeper biological understanding and new treatment approaches has never been more urgent.

One of the key innovations of the SUCCEED study is its remote, decentralized design, allowing patients with SCLC across the United States to enroll and participate from home. This inclusive approach is critical, as many SCLC patients are older, live farther from the center where they receive treatment, and face multiple co-morbidities. These reasons, and the fact that SCLC progresses quickly, have historically limited their participation in clinical research.

"The SUCCEED study is an important step forward for people with small cell lung cancer, who have long faced limited treatment options and barriers to participating in research," said GO2 for Lung Cancer President and CEO, Laurie Ambrose. "By bringing the study directly to patients, SUCCEED makes it easier for them to get involved, have their voices heard, and contribute to research that could lead to better treatments and, ultimately, more time with their loved ones."

The SUCCEED study will test whether this remote, direct-to-patient approach works well with this population while collecting blood samples from people with SCLC. The samples will be bio-banked and could potentially support future studies aimed at finding new treatments.

"In order to best serve patients with small cell lung cancer, the SUCCEED study will seek to learn about patient preferences and goals," said Principal Investigator Christine Lovly, MD, PhD, from Vanderbilt University Medical Center. "We will do so in a unique way, bringing the study to the patient so that patients can join while being close to home, hopefully making it easier for them to take part."

"SCLC research has long been left behind," said ALCMI Board Member and Chief Operating Officer Richard Erwin. "The SUCCEED study is designed to change that by harnessing real-world data and samples from patients often excluded from traditional clinical trials."

For information on study eligibility and participation, visit here.

On June 12, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and CureVac N.V. (Nasdaq: CVAC, "CureVac") reported that they have entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on messenger ribonucleic acid ("mRNA") (Press release, BioNTech, JUN 12, 2025, View Source [SID1234653838]). The all-stock transaction will bring together two highly complementary companies based in Germany and will build on BioNTech’s proven track record and established position in the global mRNA industry.

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With the acquisition, BioNTech aims to strengthen the research, development, manufacturing, and commercialization of investigational mRNA-based cancer immunotherapy. The strategic transaction will complement BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. For BioNTech, this transaction marks the next milestone in the execution of its oncology strategy which focuses on two pan-tumor programs, mRNA-based cancer immunotherapy candidates, and BNT327, a PD-L1xVEGF-A bispecific antibody candidate.

Under the terms of the Purchase Agreement, each CureVac share will be exchanged for approx. $5.46 in BioNTech ADSs, resulting in an implied aggregate equity value for CureVac of approx. $1.25 billion (subject to the adjustments described below). The consideration is subject to a collar mechanism, such that if the 10-day volume weighted average price of the BioNTech ADSs ending on the fifth business day prior to the closing of the offer ("VWAP") exceeds $126.55, the exchange ratio would be 0.04318, and if the VWAP is lower than $84.37, the exchange ratio would be 0.06476. Upon closing of the transaction, CureVac shareholders are expected to own between 4% and 6% of BioNTech.

"This transaction is another building block in BioNTech’s oncology strategy and an investment in the future of cancer medicine," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments and establishing new standards of care for various types of cancer in the coming years."

"To me, this transaction is more than a business decision, it represents a shared commitment to leverage the full potential of mRNA as a disruptive technology to develop transformative therapies with greater scale and speed," said Dr. Alexander Zehnder, CEO of CureVac. "For more than two decades, both companies have operated with related ambitions, often tackling challenges from different angles. This transaction aims at combining complementary scientific capabilities, proprietary technologies, and manufacturing expertise in the mRNA field under one roof."

BioNTech will start preparing an integration plan in alignment with BioNTech’s ongoing group-wide transformation. Following the closing of the transaction, CureVac’s operating subsidiary will become a wholly owned subsidiary of BioNTech. As part of this plan, BioNTech will integrate CureVac’s state-of-the-art research and manufacturing site in Tübingen.

BioNTech’s all-stock acquisition of CureVac is expected to create long-term value for shareholders of both companies, building on BioNTech’s proven track record in mRNA research, development, manufacturing, and commercialization, in particular the COVID-19 vaccine, which was developed in collaboration with Pfizer Inc. and marked the first approved mRNA product in the history of medicine. Based on BioNTech’s strong financial position with €15.9 billion in cash, cash equivalents and security investments as of March 31, 2025, its global presence, late-stage clinical pipeline, and sustained investment in mRNA research across a broad range of solid tumor types, the acquisition positions the company to accelerate and broaden the development of mRNA-based medicines for patients in need.

Following the closing of the exchange offer BioNTech and CureVac will effectuate a corporate reorganization of CureVac and its subsidiaries, resulting in BioNTech owning 100% of CureVac’s business and interests in CureVac and its subsidiaries. As part of this corporate reorganization, CureVac shareholders who do not tender their shares in the exchange offer will receive the same consideration received for each CureVac share tendered in the exchange offer (without interest and subject to applicable withholding taxes). An extraordinary general meeting of CureVac’s shareholders will be convened in connection with the exchange offer to adopt, among other things, certain resolutions relating to the transaction.

The transaction was unanimously approved by both BioNTech’s and CureVac’s management and supervisory boards. The transaction, which is expected to close in 2025, is subject to the satisfaction of customary closing conditions, including a minimum acceptance threshold of at least 80% of CureVac’s shares (which threshold may be reduced to 75% unilaterally by BioNTech under certain circumstances) and required regulatory approvals.

Certain shareholders of CureVac representing 36.76% of CureVac’s shares, including dievini Hopp BioTech holding GmbH & Co. KG and certain of its affiliates and all members of CureVac’s management and supervisory boards, have entered into tender and support agreements, pursuant to which they have agreed, among other things, and subject to the terms and conditions of such agreements, to tender their shares in the exchange offer and to vote in favor of the resolutions relating to the transaction at the CureVac extraordinary general meeting to be held in connection with the transaction. In addition, the German Federal government has confirmed to generally have a positive view on the transaction. BioNTech therefore assumes that Kreditanstalt für Wiederaufbau – which holds 13.32% of the shares in CureVac on behalf of the Federal Republic of Germany – will support the transaction by tendering its shares in CureVac. As a result, BioNTech expects to have contractual commitments to support the transaction from shareholders of CureVac representing a total of 50.08% of CureVac shares towards the 80% minimum condition required under the exchange offer.

Covington & Burling LLP, Hengeler Mueller Partnerschaft von Rechtsanwälten mbB and Loyens & Loeff N.V. served as legal counsel to BioNTech. Skadden, Arps, Slate, Meagher & Flom LLP and NautaDutilh N.V. served as legal counsel to CureVac. PJT Partners served as exclusive financial advisor to BioNTech. Goldman Sachs Bank Europe SE served as exclusive financial advisor to CureVac.

On June 12, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, reported data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2025), being held June 12-15, 2025, in Milan, Italy (Press release, Aptose Biosciences, JUN 12, 2025, View Source [SID1234653837]).

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The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine, and an investigator in the TUSCANY study, reported safety and efficacy data from the first two dose cohorts at 40 mg of TUS or 80 mg of TUS in the TUS+VEN+AZA triplet. Dr. Mannis also noted three patients were rapidly enrolled on the third dose cohort of 120 mg TUS in the TUS+VEN+AZA triplet, and that no DLTs have been observed to date.

The oral presentation at EHA (Free EHA Whitepaper) included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up:
Title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy
Presenter: Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine
Abstract #: S139

Key findings:

To date, ten newly diagnosed AML patients have received the TUS+VEN+AZA combination:
Four received the 40 mg dose of TUS, three received the 80 mg dose of TUS, and three received the 120 mg dose of TUS
At the initial dose of 40 mg TUS (n=4), with patients on longest duration of drug:
Three subjects achieved CRs and were MRD-negative, including
Patient with FLT3-ITD
Patient with FLT3-WT
Patient with TP53/CK
At the 80 mg TUS dose level (n=3):
All three patients (100%) already achieved composite complete remissions (CR and CRi)
A TP53-mutated/CK AML patient achieved an early CRi
Too early in treatment for final MRD assessment
At the 120 mg TUS dose level (n=3):
All three patients at the 120 mg TUS dose level remain on therapy
Too early in treatment for formal response and MRD assessments
Regardless of mutation status, TUS is active in newly diagnosed AML patients
MRD-negative responses achieved across diverse genetic populations, including adverseTP53 mutations and CK
Responses continue to evolve, and the triplet continues to be well tolerated with no DLTs
TUS can be administered safely with standard-of-care dosing of VEN/AZA
TUS PK properties not altered by VEN, AZA, antifungals or food
No prolonged myelosuppression in Cycle 1 in the absence of AML
No treatment-related deaths; all 10 subjects treated to date remain alive
No treatment related QTc prolongation, CPK elevations, differentiation syndrome or non-hematologic SAEs
"The TUSCANY triplet trial is well under way, and we are observing exciting activity with the addition of TUS to the VEN+AZA standard treatment," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "The data presented today reveal complete responses across patients with diverse mutations, including TP53-mutated/CK AML and FLT3-wildtype AML patients. TUS appears to have tremendous opportunity in the largest markets and the most challenging of AML cases."

Abstracts are available on the EHA (Free EHA Whitepaper)2025 website here. The presentation is available on the Aptose website here.

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025. Data will be released as it becomes available.

On June 12, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (OTC Pink: AIMID) ("AIM" or the "Company") reported the United States Patent and Trademark Office has granted U.S. patent No. 12312376, titled "Therapeutic Double Stranded RNA and Methods for Producing the Same (Press release, AIM ImmunoTech, JUN 12, 2025, https://aimimmuno.com/aim-immunotech-granted-u-s-patent-covering-methods-of-manufacturing-therapeutic-dsrna-including-ampligen/ [SID1234653836])." The patent expires January 25, 2041.

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The new patent covers methods involving the manufacture of a range of therapeutic double-stranded RNA (dsRNA) products, of which Ampligen is included. Combined with AIM’s multiple compositions and methods patents involving Ampligen, this manufacturing patent, along with AIM’s other issued patents, further secures the Company’s control over the synthesis and use of the first-in-class drug, and provides patent protection for manufacturing until 2041.

The new patent significantly extends the potential development runway for the drug, securing AIM additional time to safely and confidently develop its drug program as it seeks U.S. Food and Drug Administration ("FDA") approval for Ampligen in any of a series of indications. Ampligen has demonstrated broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.

AIM’s overall intellectual property portfolio covers the manufacture and use of Ampligen. AIM’s patents include Ampligen in the treatment of cancer (U.S. patent 11,813,279, expires August 9, 2039), the Post-COVID condition of fatigue (Netherlands’ patent 2032813, expires August 21, 2042) and endometriosis (U.S. patent 12,102,649, expires October 22, 2040).

AIM CEO Thomas K. Equels commented, "This patent is a significant milestone for AIM as it represents the final step in a multi-year project to strengthen and secure our global patent portfolio surrounding Ampligen. AIM now has extended patent protection for the manufacture of Ampligen, the composition of Ampligen and the way in which Ampligen can be utilized as a therapeutic for a diverse collection of unmet medical needs, from deadly cancers to Post-COVID conditions to endometriosis."

Significantly, AIM’s intellectual property protection for Ampligen also includes multiple Orphan Drug Designations ("ODD") from the FDA and the European Medicines Agency ("EMA"). FDA designation grants seven years of market exclusivity after commercial approval and EMA designation grants 10 years of market exclusivity after such approval. AIM’s orphan drug designations include Metastatic Melanoma (US), Renal Cell Carcinoma (US), Pancreatic Adenocarcinoma (US and EU), Ebola Virus Disease (US and EU), Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (US) and HIV (US).