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 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 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that it has entered into a definitive agreement with a single institutional investor for the purchase and sale in a registered direct offering of 739,000 shares of its common stock (or common stock equivalents), at an offering price of $6.25 per share of common stock (or common stock equivalent) (Press release, Tempest Therapeutics, JUN 11, 2025, View Source [SID1234653817]). The closing of the offering is expected to occur on or about June 12, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $4.6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering primarily for supporting the previously announced strategic alternative process and for working capital and general corporate purposes.

The securities described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333- 280918) that was filed with the Securities and Exchange Commission (the SEC), on July 19, 2024, as amended on January 24, 2025, which was declared effective by the SEC on January 27, 2025. The offering of the securities in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On June 11, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors (Press release, Oncolytics Biotech, JUN 11, 2025, View Source [SID1234653815]).

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Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law.

"Mr. Kelly’s vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of Oncolytics’ Board of Directors and outgoing Interim CEO. "We believe Mr. Kelly’s well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics’ potential to deliver transformative outcomes for patients and exceptional value for investors."

Mr. Kelly added, "Pelareorep’s clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy. I am excited to get to work accelerating development and unlocking significant value for stakeholders."

Pelareorep, an intravenously-administered immunotherapeutic agent, has been granted FDA Fast Track designation by the U.S. Food and Drug Administration (FDA) in metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). It has delivered compelling results in mPDAC, a high-value indication with significant unmet need. In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep has delivered a >60% objective response rate in tumor evaluable patients in the most recent study, which is more than double the benefit observed in historical control trials, and, separately, two-year survival rates 4-6 times those observed in control patients or against the benchmark in prior studies.

In mBC, pelareorep recorded a meaningful survival benefit in two randomized Phase 2 studies of over 100 combined mBC patients, IND-213 and BRACELET-1. Phase 2 objective response rate data in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients continue to exceed historical data for treatment with a checkpoint inhibitor alone. These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships. Pelareorep also has a well-defined and favorable safety profile based on data from >1,100 patients across multiple tumor types.

As a material inducement to Mr. Kelly’s appointment as Chief Executive Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Kelly has been awarded an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares with an exercise price of CAD$0.57, which will vest upon the achievement of certain financing objectives. All stock option grants have a term of 5 years from the date of grant. The Company also granted Mr. Kelly restricted stock units, which will entitle him to receive that number of Common Shares equal to 2% of the Company’s then outstanding common shares upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. Each of these awards is intended to align Mr. Kelly’s long-term incentives with the creation of shareholder value.

On June 11, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported it has secured a debt financing facility of up to $400 million with credit funds managed by SLR Capital Partners, LLC ("SLR") (Press release, Cogent Biosciences, JUN 11, 2025, View Source [SID1234653813]). An initial tranche of $50 million was drawn at closing, with future tranches available based on the achievement of key clinical and commercial milestones aligned with Cogent’s growth strategy.

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"2025 will be a transformative year for Cogent," said Andrew Robbins, the company’s President and Chief Executive Officer. "This strategic financing with SLR provides substantial, non-dilutive capital at very attractive financial terms. It enhances our financial flexibility and enables us to accelerate our bezuclastinib launch planning as we eagerly await the results from SUMMIT, APEX and PEAK pivotal trials this year."

"We’re proud to partner with Cogent in advancing innovative therapies for patients with genetically driven diseases. This investment reflects our ongoing strategy to support high-potential biotech companies as they progress through late-stage development and commercial execution," said Anthony Storino, Partner and Head of Life Science Finance at SLR Capital Partners.

Under the terms of the agreement, Cogent drew $50 million from the facility at closing. An additional $100 million is available during 2025 at Cogent’s discretion, subject to successful top-line data readouts from SUMMIT and PEAK bezuclastinib pivotal trials. An additional $50 million is available upon achievement of early commercial success following bezuclastinib launch. The remaining $200 million is available at mutual agreement of Cogent and SLR.

Cogent remains on track in July to announce top-line results from SUMMIT, a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM. In the second half of 2025, Cogent is on track to release results from APEX, a registration-directed, global, open-label trial in patients with AdvSM. Finally, before the end of 2025, Cogent expects to release results from PEAK, a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant GIST.

Leerink Partners served as the exclusive financial advisor to Cogent on the term loan financing.