On June 11, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported a poster presentation with positive, updated data from a Phase 1/2a trial of the tetraspecific T-cell engager MP0533 in relapsed/refractory acute myeloid leukemia (AML), at the 30th EHA (Free EHA Whitepaper) (European Hematology Association) Congress, taking place in Milan on June 12–15, 2025 (Press release, Molecular Partners, JUN 11, 2025, View Source [SID1234653818]).

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The poster, Updated Results from the Ongoing Phase 1/2a Study of MP0533, a Tetra-Specific Designed Ankyrin Repeat Protein (DARPin; CD33 x CD123 x CD70 x CD3), in Patients with Relapsed/Refractory AML or MDS/AML, outlines the impact of accelerated step-up dosing regimen (steeper and faster) of MP0533 on exposure and clinical responses in cohort 8, providing the rationale for further optimization to the dosing regimen implemented in the ongoing cohort 9.

Data from cohort 8 show that 3 of 8 evaluable patients (> 30%) achieved a clinical response after the first cycle, with one patient achieving a complete response and two patients a complete response with partial hematologic recovery as best overall response. Two patients maintained a response for more than 3 months and one patient remains on treatment, maintaining a response beyond 6 months at the time of data cutoff (14 April 2025). Cohort 8 implemented a higher starting dose than cohorts 1-7, and the inclusion of an additional day of dosing, reaching the target dose by day 12, as opposed to day 15 previously.

Cohort 8 data indicate that patients maintained exposure to MP0533 for a longer period of time within the predicted therapeutic range through the accelerated step-up dosing scheme, within the first cycle. Data show that patients reached over 4 days of relevant exposure, with 5 out of 8 patients displaying > 50% blast reduction. MP0533 shows an acceptable safety profile after adjustment of the target dose in cohort 8.

"I am encouraged by the number and level of responses observed in the most recent cohort and have started to include patients with the new ‘dense administration’ schedule aiming to establish the full potential of this product for our R/R AML patients," said Pierre Bories, MD, PhD, Principal Investigator at Institut Universitaire du Cancer Toulouse – Oncopole, France.

In cohorts 1-7, where step-up dosing reached target dose by day 15, exposure to predicted therapeutic doses was limited to roughly 2 days in the first cycle, most likely due to target-mediated-drug deposition. This prior treatment protocol, despite demonstrating initial blast reductions in ~30% of patients, resulted in limited responses.

Based on the encouraging antitumor activity observed in cohort 8, the amended protocol for cohort 9 and beyond includes further acceleration of the step-up dosing to reach therapeutically-relevant doses faster, increased frequency of dosing for higher cumulative MP0533 exposure, and the introduction of anti-CD20 premedication to mitigate loss of exposure, with the objective to further increase the depth and duration of responses in patients.

Cohort 9 is currently dosing patients and initial data from the amended dosing scheme are expected in H2 2025. Additionally, future study cohorts will evaluate the combination of azacitidine/venetoclax with MP0533.

Details of the presentation:

Updated Results from the Ongoing Phase 1/2a Study of MP0533, a Tetra-Specific
Designed Ankyrin Repeat Protein (DARPin; CD33 x CD123 x CD70 x CD3), in Patients with
Relapsed/Refractory AML or MDS/AML
Time: June 13, 18:30 – 19:30 CEST (Poster Session 1)

On June 11, 2025 ADC Therapeutics SA (the "Company") reported to have entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $100 million private placement (Press release, ADC Therapeutics, JUN 11, 2025, View Source [SID1234653834]). In the private placement, the Company will sell 13,031,161 common shares at $3.53 per share, which is the last reported sale price of the common shares on the New York Stock Exchange on June 11, 2025, and pre-funded warrants to purchase 15,734,267 common shares at $3.432 per pre-funded warrant, which is the price per common share in the private placement minus the exercise price per pre-funded warrant. The private placement is expected to close on June 16, 2025, subject to customary closing conditions.

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The purchase agreements provide certain registration rights, pursuant to which the Company has agreed to file a registration statement within 30 business days to register the resale of the common shares sold in the private placement and the common shares issuable upon exercise of the pre-funded warrants sold in the private placement.

The private placement is exempt from the registration requirements of the Securities Act under Section 4(a)(2) of the Securities Act in that the private placement is between an issuer and sophisticated investors not involving any public offering. The Company is relying on this exemption from registration based in part on representations made in the purchase agreements for the private placement, a form of which is attached to this Current Report on Form 8-K as Exhibit 10.1.

The pre-funded warrants are exercisable at any time after their original issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the pre-funded warrant for, and the Company will issue, a new pre-funded warrant for the number of common shares then remaining under the pre-funded warrant. The pre-funded warrants will be exercisable, at the option of each holder, in whole or in part (but not for less than a common share) by delivering to the Company a duly executed exercise notice and by payment of the aggregate exercise price; provided that any exercise of the pre-funded warrants must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the pre-funded warrants). A holder will not be entitled to exercise any portion of any pre-funded warrants that, upon giving effect to such exercise, would cause the aggregate number of the Company’s common shares beneficially owned by the holder (together with its affiliates and certain attribution parties) to exceed 9.99% (or, 61 days after a written notice from such holder, any other percentage not in excess of 19.99%) of the number of the Company’s common shares outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the pre-funded warrants. The exercise price per common share purchasable upon the exercise of the pre-funded warrants is CHF 0.08 per share, subject to customary adjustments. In lieu of making cash payment of the aggregate exercise price, a holder may elect to exercise the pre-funded warrants on a cashless basis. However, if the Company, at the time of receipt of an exercise notice electing cashless exercise, (i) does not, or has reason to believe that the Company does not, have a sufficient amount of freely distributable equity to fund the nominal value of the number of common shares the Company would be required to deliver upon such cashless exercise, and (ii) (x) holds common shares representing more than 2% of its share capital registered in the commercial register at that time (the "Minimum Stock") in treasury, then the Company will not be obligated to (but may) deliver more than such number of common shares to the holder as exceeds the Minimum Stock or (y) holds up to the Minimum Stock in treasury, then the Company will not be obligated to deliver any common shares to the holder. The exercise notice will be deemed to be null and void to the extent the holder receives fewer common shares than to which such exercise notice relates. In the event of (i) a sale, lease or other transfer of all or substantially all of the Company’s assets, (ii) a merger or consolidation involving the Company in which the Company is not the surviving entity or in which the Company’s outstanding share capital is converted into or exchanged for shares of capital stock or other securities or property of another entity, or (iii) any sale by holders of the Company’s outstanding voting equity securities in a single transaction or series of related transactions of shares constituting a majority of the Company’s outstanding combined voting power, and (x) if the consideration received by the Company’s shareholders consists solely of cash and/or marketable securities, then holders of the pre-funded warrants will be deemed to have exercised their pre-funded warrants (without regard to the exercise limitations described above) immediately prior to the closing date of such transaction or (y) if the consideration received by the Company’s shareholders does not consist solely of cash and/or marketable securities, then the Company will cause the successor or surviving entity to assume the pre-funded warrants. Subject to applicable laws, the pre-funded warrants may be offered for sale, sold, transferred or assigned without the Company’s consent. The pre-funded warrants are governed by the laws of Switzerland. The foregoing description of the pre-funded warrants does not purport to be complete and is qualified in its entirety by reference to the form of pre-funded warrant, which is attached to this Current Report on Form 8-K as Exhibit 10.2.

On June 11, 2025 Monopar Therapeutics Inc. ("Monopar," the "Company," "us" and "our") (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, in collaboration with Excel Diagnostics and Nuclear Oncology Center ("EDNOC"), a premier diagnostic medical imaging and therapeutic nuclear medicine center, reported that the physician-sponsored Expanded Access Program ("EAP") for the investigational imaging agent MNPR-101-Zr and investigational therapeutic agent MNPR-101-Lu has received authorization to proceed from the U.S. Food and Drug Administration ("FDA") (Press release, Monopar Therapeutics, JUN 11, 2025, View Source [SID1234653819]).

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The MNPR-101 EAP is now open for enrollment to patients with advanced solid tumors at EDNOC in Houston, Texas. EDNOC is among the first private outpatient facilities in the U.S. to be designated as a Radiopharmaceutical Therapy Center of Excellence by the Society of Nuclear Medicine and Molecular Imaging ("SNMMI"). Patients will be treated under the supervision of renowned investigator Ebrahim S. Delpassand, MD, founder and medical director of EDNOC.

"We are pleased to provide patients in the United States with access to MNPR-101-Zr and MNPR-101-Lu, which were developed to target aggressive cancers, such as triple-negative breast, pancreatic, and colorectal cancer," said Andrew Cittadine, Chief Operating Officer of Monopar. "This EAP represents continued progress in our radiopharmaceutical pipeline following last year’s initiation of Phase 1 clinical trials in Australia with MNPR-101-Zr and MNPR-101-Lu. We are grateful for the opportunity to work with Dr. Delpassand to make these therapies available to patients on a compassionate use basis," added Mr. Cittadine.

"Our team at Excel Diagnostics looks forward to providing MNPR-101-Zr and MNPR-101-Lu to patients in need," said Dr. Delpassand. "Targeting uPAR-expressing solid tumors will be another promising frontier in radioligand therapy to help patients with ‘difficult-to-treat’ cancers," continued Dr. Delpassand.

About Expanded Access to MNPR-101-Zr and MNPR-101-Lu

EAPs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product outside of clinical trials preceding FDA approval; this occurs when no comparable or satisfactory alternative treatment is available, and the patient’s situation necessitates accessing an unapproved product outside of clinical trials. Healthcare providers and cancer patients who are interested in learning more about the MNPR-101-Zr and MNPR-101-Lu EAP, including eligibility criteria, can visit www.clinicaltrials.gov using the following links: NCT06980506 and NCT06980519 for the imaging and therapy EAP, respectively.

About MNPR-101-Zr and MNPR-101-Lu

MNPR-101 is Monopar’s proprietary antibody targeting the urokinase plasminogen activator receptor ("uPAR"), which is expressed in numerous tumor types, including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to image tumors and deliver a targeted radiopharmaceutical therapy that kills cancer cells while minimizing damage to healthy tissue. MNPR-101-Zr is MNPR-101 conjugated to zirconium-89 and designed for the imaging of advanced cancers; MNPR-101-Lu is MNPR-101 conjugated to lutetium-177 and designed as an investigational treatment of advanced solid cancers.

On June 11, 2025 Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that Dr. Marnix Bosch, its Chief Technical Officer, will make a presentation on "Next Generation Dendritic Cell Treatments to Improve Anti-Tumor Responses" at the upcoming Frontiers in Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) of the New York Academy of Sciences (Press release, Northwest Biotherapeutics, JUN 11, 2025, View Source [SID1234653820]). Dr. Bosch will address certain factors and combinations of factors that may lead to supercharged dendritic cells with enhanced anti-tumor effects.

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The presentation will take place on Monday, June 16, at 2:50 p.m. The slides will be posted on the Company’s website after the presentation.

On June 11, 2025 TC BioPharm (Holdings) PLC (NASDAQ: TCBP), a clinical-stage biotechnology company pioneering gamma delta T cell therapies for the treatment of cancer, reported the first patient treated in Cohort B, presenting with detectable Minimal Residual Disease (MRD), is now in complete molecular remission following treatment with the lead drug candidate TCB008 (Press release, TC Biopharm, JUN 11, 2025, View Source [SID1234653821]).

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The response was achieved after the patient’s second dose of 250,000,000 gamma delta t-cells, two weeks after treatment began, in total the patient received approximately 500,000,000 gamma delta t-cells over two weeks. The patient received 2 of a possible 4 infusions of TCB008 and continues to be monitored under the care of Dr. Hugues de Lavallade at Guy’s and St. Thomas’ NHS Foundation Trust and remains in remission state two months after treatment.

This data readout represents a major milestone in TC BioPharm’s mission to develop innovative cell therapies that target and eradicate malignant cells with precision and durability. Over 1 million patients are diagnosed with blood cancers globally each year. Patients who initially achieve remission can retain a molecular burden of disease that results in relapse. Multiple factors, including previous treatments, limit treatment options for relapsed patients.

‘This patient experienced molecular relapse while continuing low-intensity chemotherapy," said Dr. Hugues de Lavallade, consultant hematologist at Guy’s and St. Thomas’ NHS Foundation Trust. "NPM1 transcript levels detected the rising MRD on repeated samples, and chemotherapy was stopped. After two doses of the IMP, given post-lymphodepletion, the patient has now achieved a complete molecular response with no detectable NPM1 transcripts."

"This is an encouraging patient response, and our team is invigorated by this important step forward. We believe TCB008 has the potential to become a foundational component of post-remission therapy for patients with blood cancers, helping to extend survival and improve long-term outcomes, as well as newly diagnosed patients where TCB008 can potentially be impactful as a monotherapy to avoid an arduous bone marrow transplant process" said Bryan Kobel, CEO of TC BioPharm. "Treating MRD effectively halts disease progression before it has the chance to return, and TCB008’s targeted immune activity continues to show great promise in this setting. This response to TCB008 heightens our focus on this patient population, where we believe the ability of the gamma deltas to rapidly overwhelm the cancer cells and bring about a high-grade patient response is value-enhancing and commercially impactful."