On December 2, 2024 Lixte Biotechnology Holdings, Inc. (the "Company") reported to have amended a Development Collaboration Agreement (the "Collaboration Agreement") with the Netherlands Cancer Institute, Amsterdam (NKI), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (Filing, 8-K, Lixte Biotechnology, DEC 2, 2024, View Source [SID1234648720]).

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On November 29, 2024, the parties signed an amendment ("Amendment 3") to the Collaboration Agreement. This Amendment provides for a pause in the ongoing study activities and any payments thereunder until the initiation of a Phase 1b clinical trial combining LB-100 with a WEE1 inhibitor in metastatic colorectal cancer patients. The collaboration will resume upon dosing of the first patient in this clinical trial (the "Effective Date"), with the termination date revised to be one (1) year from the dosing date of the first patient.

Under Amendment 3, the parties will seek to study translational data derived from patient samples in clinical trials at NKI. Amendment 3 provides for a reduced annual budget of €100,000, invoiced quarterly, for one year from the Effective Date as compered to the initial budget of €250,000. The foregoing description of Amendment 3 does not purport to be complete and is subject to and qualified in its entirety by the full text of Amendment 3, a copy of which is filed hereto as Exhibit 10.1.

On December 2, 2024 Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), reported that an overview of the company’s ongoing first-in-human study with its next generation Type II JAK2 inhibitor, AJ1-11095, has been selected for presentation in a poster session on December 8, 2024 at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego (Press release, Ajax Therapeutics, DEC 2, 2024, View Source [SID1234648737]).

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The poster, entitled "A Multicenter, Open-Label, Phase 1 Clinical Trial of AJ1-11095 Administered As Oral Monotherapy in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed By a Type I JAK2 Inhibitor (JAK2i)," will be presented by John Mascarenhas, MD, Professor of Medicine, Icahn School of Medicine at Mt. Sinai and Director, Center of Excellence in Blood Cancers and Myeloid Disorders at Tisch Cancer Institute and principal investigator of the Phase 1 Study. Further details about the study can be found at www.clinicaltrials.gov under the NCT identifier: NCT06343805.

Details of the poster session are as follows:

Session Name: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II
Session Date and Time: Sunday, December 8, 2024, 6:00 – 8:00 p.m. PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 3147.1

About AJ1-11095

AJ1-11095 was designed by Ajax Therapeutics, through an exclusive collaboration with Schrödinger, using structure-based drug design and computational methods at scale to selectively bind the Type II conformation of the JAK2 kinase in order to provide greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, including ruxolitinib, which bind the Type I conformation of JAK2. AJ1-11095 has been shown in preclinical studies to reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells that become resistant to chronic Type I JAK2 inhibition.

About Myelofibrosis

Myelofibrosis (MF) is a rare blood cancer that affects approximately 20,000 patients in the United States. The disease is characterized by spleen enlargement, scarring (fibrosis) in the bone marrow, progressive anemia, and debilitating symptoms, such as fatigue, night sweats, itching, and abdominal discomfort, which can impair a patient’s quality of life. The most widely used treatment for MF patients are Type I JAK2 inhibitors which can reduce spleen size and provide symptomatic improvement but have little effect on the underlying cause of disease. Over time, most MF patients stop Type I JAK2 inhibitor therapy. The most common causes for treatment discontinuation include a lack of benefit or loss of response, adverse events, and disease progression, leaving significant unmet treatment needs for these patients.

On December 2, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics) and Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company with a focus in hematology and oncology, reported they have entered into an agreement in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno) for the treatment of NRG1 fusion-positive (NRG1+) cancer in the United States (U.S.).

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"We are thrilled to work with the seasoned team at PTx to advance our mission to bring Zeno to patients with NRG1+ cancer," said Shannon Campbell, Chief Commercial Officer of Merus. "We believe PTx is an ideal partner to support Zeno given their oncology commercialization expertise and executive team’s deep understanding and experience with NRG1+ cancer."

"Zeno has the potential to be the first and only targeted therapy for patients with NRG1+ non-small cell lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies," said Sarah Kurz, President and Chief Operating Officer of PTx. " We are grateful to Merus for their development of Zeno, which has the potential to fill an unmet medical need for these patients."

Under the terms of the agreement, following a specified transition period, PTx will assume full rights to U.S. commercialization of Zeno for the treatment of NRG1+ cancer. In exchange for the rights granted under the license agreement, Merus will receive an upfront payment and is eligible to receive milestones and high single digit to low double-digit royalty payments based on the annual net sales of Zeno in NRG1+ cancer in the U.S. for any potential future sales.

A Biologics License Application for Zeno is currently under review by the U.S. Food and Drug Administration for the treatment of patients with previously treated NRG1+ non-small cell lung cancer and pancreatic cancer.

(Press release, Merus, DEC 2, 2024, View Source [SID1234661244])

On December 2, 2024 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported a new clinical trial collaboration and supply agreement with Novartis in frontline metastatic breast cancer (Press release, Olema Oncology, DEC 2, 2024, View Source [SID1234648721]). Olema has also entered into a securities purchase agreement for the private placement of approximately $250.0 million of common stock and pre-funded warrants to purchase common stock with new and existing institutional and accredited investors (the "Private Placement").

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"We are now fully enabled to initiate our planned pivotal Phase 3 clinical trial, OPERA-02, for palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer. Our new agreement with Novartis, which includes sufficient ribociclib drug supply for the planned approximately 1,000 patient trial, is a major milestone. When combined with our Private Placement of $250.0 million of common stock and pre-funded warrants with high-quality, long-term investors, Olema now expects to have the necessary resources to execute OPERA-02, the Phase 1/2 study of OP-3136, and the ongoing Phase 3 OPERA-01 monotherapy trial," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We remain on track to share topline data from OPERA-01 in 2026 and we are excited to present our latest data from the ongoing Phase 1b/2 study of palazestrant in combination with ribociclib at the San Antonio Breast Cancer Symposium (SABCS) next week."

New Clinical Trial Collaboration and Supply Agreement Enables Phase 3 OPERA-02 Trial

Under the terms of the agreement, Novartis will provide Olema with ribociclib drug supply for the planned, Olema-sponsored, Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in ER+/HER2- frontline advanced or metastatic breast cancer. All clinical data and inventions from the trial will be jointly owned while Olema maintains global commercial and marketing rights to palazestrant.

Private Placement Funds Expanded Clinical Development Activities

The Private Placement is expected to close on or about December 4, 2024, subject to the satisfaction of customary closing conditions. The financing included participation by new and existing investors Adage Capital Partners LP, Bain Capital Life Sciences, BVF Partners L.P., Driehaus Capital Management, Janus Henderson Investors, Paradigm BioCapital Advisors, Wellington Management, Woodline Partners LP, and a large investment manager. Pursuant to the terms of the securities purchase agreement, Olema will issue 19,928,875 shares of common stock at a purchase price of $9.08 per share and pre-funded warrants to purchase up to an aggregate of 7,604,163 shares of common stock at a purchase price of $9.0799 per pre-funded warrant, for gross proceeds of approximately $250.0 million, before deducting placement agent fees and other offering expenses. The pre-funded warrants will have an exercise price of $0.0001 per share of common stock, be immediately exercisable and remain exercisable until exercised in full. The Private Placement is being conducted in accordance with applicable Nasdaq rules and was priced using the average Nasdaq official closing price of Olema’s common stock for the five trading days ended November 27, 2024.

Jefferies is acting as lead placement agent with J.P. Morgan, Citigroup, Goldman Sachs & Co. LLC, LifeSci Capital, Oppenheimer & Co., and H.C. Wainwright & Co. acting as placement agents in the Private Placement.

Olema intends to use the net proceeds from the Private Placement, together with its current cash, cash equivalents and marketable securities, to fund the OPERA-02 trial, the Phase 1/2 study of OP-3136, and its ongoing Phase 3 OPERA-01 monotherapy trial of palazestrant, and for working capital and general corporate purposes.

The securities described above have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state’s securities laws, and are being issued and sold pursuant to an exemption from registration provided for under the Securities Act. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Olema has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued and sold in the Private Placement. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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

About Palazestrant (OP-1250)

Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In preclinical studies, palazestrant completely blocks ER-driven transcriptional activity in both ESR1 wild-type and mutant forms of breast cancer. In Olema’s ongoing clinical trials for advanced or metastatic ER+/HER2- breast cancer, palazestrant has demonstrated anti-tumor activity along with attractive pharmacokinetics and exposure, favorable tolerability, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus).

On December 2, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported a collaboration with Dr. C. Ola Landgren, MD, PhD, head of one of the world’s leading myeloma computational and translational research laboratories (Press release, Mission Bio, DEC 2, 2024, View Source [SID1234648738]). Dr. Landgren’s team, including Dr. David Coffey and Dr. Benjamin Diamond, at the University of Miami’s Sylvester Comprehensive Cancer Center, will work together to generate clinical data sets using Mission Bio’s Tapestri Single-cell DNA Multiple Myeloma Panel to examine Multiple Myeloma (MM) at an unprecedented level of clonal detail, promising to reveal new insights that may potentially improve outcomes for MM patients.

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MM is a challenging and incurable blood cancer that afflicts around 230,000 people worldwide. Relapse is a particular problem for many of these patients — as many as 50% experience relapse within the first year of frontline treatments, and only 20% of relapse victims survive for five years with current standard therapies.

The key to controlling relapse in MM patients lies in better understanding of resistant clones: cells that have developed mutations or alterations that help them evade treatment. However, current tools inadequately profile the disease from the initial emergence of clones to full-blown myeloma. Using clinical samples from University of Miami, the goal of the collaboration is to help predict which patients are at higher risk of relapse, and, in the event of relapse, whether it can inform and guide subsequent treatment decisions. In addition, the project will determine if blood can be used as an alternative sample for patient testing instead of bone marrow samples. The utilization of blood would vastly improve sample accessibility and alleviate the invasive patient experience.

"We recognize that Multiple Myeloma is a genetically complex disease that hasn’t been easy to comprehend fully using existing methods, particularly when it comes to the crucial questions of when patients might experience relapse and what clinicians should do next when relapse occurs," said Dr. Landgren. "Our aim is to utilize Tapestri to better understand Multiple Myeloma disease heterogeneity, which in turn will allow us to detect and treat relapse faster. Ultimately, we hope to demonstrate the clinical feasibility of the Multiple Myeloma assay and to facilitate the establishment of Tapestri to advance outcomes for patients."

"Our partners and customers continue to push the boundaries of single-cell DNA and multiomic analysis in new and inspiring ways," said Brian Kim, CEO of Mission Bio. "The work being done by Dr. Landgren and his team promises to unearth critical insights that will not only be able to help predict relapse in Multiple Myeloma patients, but also inform more effective, personalized treatment strategies in the future."