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).

On June 12, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported that the patent office of Canada has granted a patent (CA 2975644) protecting the composition of matter of AB8939, and closely related compounds, until 2036 (Press release, AB Science, JUN 12, 2025, View Source [SID1234653833]). This patent also covers the use of AB8939 in the treatment of hematological disorders and/or proliferative disorders and provides a strong overall protection for the AB8939 clinical development program, including the treatment of acute myeloid leukemia (AML).

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Issuance of this patent also completes the IP coverage for AB8939 and AML across all key geographic areas where AB8939 could be marketed, including Europe (patent EP 3253749), USA (US 10,570,122), Canada (CA 2975644), China (CN 107531685), South Korea (KR 10-2544132), Japan (JP 6713000), Hong Kong (HK 1243700), Israel (IL 253779), Australia (AU 2016214283), Russia (RU 2758259), Brazil BR (112017016883-9), Mexico (MX 377742), India (IN 480996), and South-Africa (ZA 2017/05537). AB8939 is a novel microtubule destabilizer, currently evaluated in early phase clinical trials for the treatment of AML. The phase 1 clinical trial of AB8939 has completed its first steps, consisting in determining the maximum tolerated dose following 3 consecutive days and then 14 consecutive days of AB8939 treatment. The next step will be to determine the maximum tolerated dose in the combination of AB8939 with Vidaza (azacitidine). In addition to patent protection, AB8939 is also eligible for regulatory data protection in Canada, preventing generic competition for a period of 8 years following initial approval.

AB8939 has also received orphan drug designation for AML from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation provides 10 and 7 years of market exclusivity in Europe and the United States, respectively, after product approval. A separate secondary medical use patent application was filed to protect the use of AB8939 for the treatment of AML with certain chromosomal abnormalities, which if granted, would extend AB8939 protection until 2044 in these sub-populations of AML patients.

About AB8939

AB8939 is a new synthetic molecule which jointly targets cancer cells, by destabilizing the microtubules essential for cell division, and cancer stem cells, by inhibiting enzymes (ALDH1A1 and ALDH2) essential for maintaining their physiological state and survival. The molecule ‘1-{4-[2-(5-ethoxymethyl-2-methylphenylamino)-oxazol-5-yl]phenyl}imidazolidin-2-one’ is the chemical name of AB8939. The intellectual property of AB8939 is 100% owned by AB Science.

On June 12, 2025 Scenic Biotech reported the extension of its research collaboration with Bristol Myers Squibb (Press release, Scenic Biotech, JUN 12, 2025, View Source [SID1234653832]). The growth of this partnership highlights the unique power of our Cell-Seq platform, which unlocks the underlying genetic interactions of cellular pathways for novel drug targets.

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Together, we are working to identify target biology for indication selection, and expansion, driving progress towards novel treatments for severe diseases. It’s a testament to the productive collaboration and shared vision between our teams.

In parallel to advancing our proprietary pipeline in neuro- and metabolic diseases, we remain committed to supporting our partners in shaping the future of medicine and improving patient outcomes. We look forward to the continued progress we’ll make together!