On June 3, 2025 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 that the Company granted stock options to 11 new employees to purchase an aggregate of 322,000 shares of the Company’s common stock, effective as of June 2, 2025 (Press release, Olema Oncology, JUN 3, 2025, View Source [SID1234653677]). These awards were approved by the Compensation Committee of Olema’s Board of Directors and granted under the Company’s 2022 Inducement Plan as an inducement material to the new employees entering into employment with Olema, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options vest over four years, with 25 percent vesting on the first anniversary of the vesting commencement date for such employee and the remainder vesting in 36 equal monthly installments over the following three years, subject to the employee being continuously employed by Olema as of such vesting dates. The stock options have a 10-year term and an exercise price of $4.38 per share, equal to the last reported sale price of the Company’s common stock as reported by Nasdaq on June 2, 2025. The stock options are subject to the terms of the Olema Pharmaceuticals, Inc., 2022 Inducement Plan.

Olema is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

On June 3, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the presentation of new results from the CALLA phase 3 study showing for the first time its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test detected cervical cancer progression, up to 16 months ahead of imaging (Press release, Personalis, JUN 3, 2025, View Source [SID1234653693]). The results demonstrate the potential of NeXT Personal to enable earlier detection in a cancer with high recurrence rates.

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The results were presented yesterday by Jyoti Mayadev, MD, from the University of California San Diego, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago in an oral presentation titled "Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses." The results from this study were also simultaneously published in the journal Annals of Oncology.

Samples were analyzed from patients with cervical cancer who had enrolled in the original CALLA clinical trial. In this new study analysis, NeXT Personal was used to look for small traces of ctDNA in blood samples from a cohort of 186 patients with locally advanced cervical cancer. Dr. Mayadev’s team found that overall ctDNA levels after chemoradiotherapy (CRT) treatment were strongly predictive of risk of cervical cancer progression.

"Despite standard chemoradiotherapy, up to half of patients with locally advanced cervical cancer relapse, underscoring the urgent need for better prognostic tools. In the CALLA phase 3 study, ultrasensitive, tumor-informed ctDNA analysis emerged as a powerful predictor of progression and survival—detecting relapse up to ~16 months before imaging. These findings highlight ctDNA’s potential to guide treatment decisions and personalize care in high-risk cervical cancer," said Dr. Mayadev.

Key findings presented:

Detection of ctDNA following CRT was independently prognostic of patient outcomes.
Risk of progression and death were at least 95% lower for patients where ctDNA was not detected ~3 months after completing CRT.
Detection of ctDNA after CRT was associated with high subsequent risk of disease progression, and was detected a median of ~5 months and up to ~16 months earlier than by imaging scans.
High ctDNA levels (≥ median) at baseline was associated with higher risk of progression and death.
"We are excited to see the results presented for NeXT Personal in this large phase 3 study in cervical cancer," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "Cervical cancer is the fourth most common cancer for women globally, resulting in hundreds of thousands of deaths each year. The new results show the strong potential for an ultrasensitive MRD test like NeXT Personal to inform treatment for cervical cancer patients."

On June 3, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that biomarker data from its OPTIMIZE-1 clinical trial were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alligator Bioscience, JUN 3, 2025, View Source [SID1234653629]).

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OPTIMIZE-1 is a Phase 1b/2 trial evaluating mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The study has demonstrated strong clinical outcomes to date, including a ~30% survival rate at 24 months and a median overall survival of 14.9 months.

The biomarker analyses highlighted mitazalimab’s immunological mechanism of action, with immune activation in responding patients and gene signatures associated with clinical benefit and improved survival. These results support continued development of mitazalimab, including a planned confirmatory trial in mPDAC.

"ASCO continues to be a cornerstone event for clinical oncology, and it was a privilege to share our OPTIMIZE-1 data with the international community," said Søren Bregenholt, CEO of Alligator Bioscience. "The high level of engagement and many productive meetings we’ve had during the conference further validate the growing interest in mitazalimab and its potential in pancreatic cancer."
The presentation poster is available on Alligator’s website. Alligator’s participation at ASCO (Free ASCO Whitepaper) is part of its broader commitment to scientific collaboration and strategic business development.

On June 3, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported that it has entered into a definitive securities purchase agreement for the issuance and sale in a private placement of an aggregate of $12.5 million of shares of its common stock, for an aggregate of 4.6 million shares, together with warrants to purchase an equal number shares of common stock at an exercise price of $3.3125 per warrant share (Press release, TuHURA Biosciences, JUN 3, 2025, View Source [SID1234653678]). The securities in the offering were sold at a combined purchase price of $2.65 per share and accompanying warrant, which represents a fifteen percent (15%) discount to the NASDAQ closing price of the Company’s common stock on June 2, 2025.

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Under the definitive agreement, approximately $9.0 million of the total offering amount will be purchased in four equal tranches based on the Company’s achievement of certain milestones (the "Initial Funding Amount"), and the remaining $3.5 million is required to be purchased and funded by December 31, 2025. One-fourth of the Initial Funding Amount will be purchased and funded at the initial closing of the offering, which is anticipated to be held on June 4, 2025 (subject to customary closing conditions), with the remaining three tranches of the Initial Funding Amount to be purchased and funded based on the achievement of the following three milestones (the "Funding Milestones") if and when the applicable milestone is achieved:

One-fourth of the Initial Funding Amount will be purchased and funded after the Company is notified by the Food and Drug Administration (FDA) that the Company is no longer subject to the partial clinical hold set forth in the FDA’s Partial Clinical Hold letter dated January 24, 2024, with respect to the Company’s planned Phase 3 trial of IFx-2.0;
One-fourth of the Initial Funding Amount will be purchased and funded after the Company’s Phase 3 trial for IFx-Hu2.0 has been initiated; and
One-fourth of the Initial Funding Amount will be purchased and funded immediately prior to the closing of the Company’s proposed merger transaction with Kineta, Inc. (the "Kineta Merger").
The Company currently anticipates that all of the Funding Milestones will be achieved by the end of July 2025.

The warrants issued in the offering will expire on the fifth (5th) anniversary of the initial exercise date, with the initial exercise date being the later of (i) six months from the date of the definitive securities purchase agreement or (ii) the amendment of the Company’s articles of incorporation to increase the number of authorized shares of common stock. The exercise price of the warrants is subject to proportional adjustment for stock splits, reverse stock splits, and similar transactions.

The Company currently plans to use the net proceeds from the offering to fund cash requirements for the closing the proposed merger with Kineta, Inc., to fund the initiation of the Phase 3 Trial for IFx-2.0, to fund the advancement of Kineta’s KVA12123 novel VISTA-inhibiting antibody to a Phase 2 trial, and for other working capital needs.

Paulson Investment Company, LLC acted as exclusive placement agent for the offering, and Brookline Capital Markets, a division of Arcadia Securities, provided equity market advisory services to the Company.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. Accordingly, the shares of the securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement to register the resale of the shares of common stock issuable and shares of common stock underlying the warrants no later than 60 calendar days following the date of the initial closing and to use reasonable efforts to cause such registration statement to become effective within 120 calendar days following the date of the initial closing.

In addition to the offering, the Company secured $3.0 million in additional cash proceeds from the previously disclosed February 2025 cash exercise of approximately 1.0 million warrants to purchase shares of Company common stock. The Company currently expects that the proceeds from the offering, in addition to the cash proceeds from the warrant exercises, will be sufficient to fund the Company’s cash needs for completion of the Company’s proposed merger with Kineta, Inc. contingent on the satisfaction of the Funding Milestones and the satisfaction of all other closing conditions and requirements relating to the completion of the merger.

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

On June 3, 2025 Incyte (Nasdaq:INCY) reported that data from numerous programs in its hematology/oncology portfolio will be presented at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) congress, held June 12 – 15, 2025, in Milan (Press release, Incyte, JUN 3, 2025, View Source [SID1234653694]).

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"We’re looking forward to presenting new data from across our hematology/oncology portfolio at the 2025 EHA (Free EHA Whitepaper) Congress, including late-breaking data for our first in class, mutCALR-directed monoclonal antibody, INCA033989," said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. "We believe the data that will be presented at the late-breaking session demonstrate the impact of the novel mechanism of action of this monoclonal antibody against mutCALR-driven essential thrombocythemia (ET), and support its potential to be a disease modifying agent and thus transform the treatment of patients with myeloproliferative neoplasms (MPNs) like essential thrombocythemia (ET)."

Key Incyte abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Late-Breaking Oral Presentation

INCA033989 (mutCALR)

INCA33989 is a Novel, First in Class, Mutant Calreticulin-Specific Monoclonal Antibody That Demonstrates Safety and Efficacy in Patients with Essential Thrombocythemia (ET)
(Session Title: Late-Breaking Oral Session. June 15, 3:15 – 4:45 a.m. EDT [9:15-10:45 a.m. CEST]. Abstract #LB4002.)

Oral Presentations

INCA035784 (mutCALR)

INCA035784, a Novel, Equipotent T Cell Redirecting Antibody for Patients with Myeloproliferative Neoplasms Carrying Different Types of Calreticulin Mutations
(Session Title: Novel and Experimental Approaches to Study and Treat MPN. June 15, 5:30 – 5:45 a.m. EDT [11:30 – 11:45 a.m. CEST]. Abstract #S212.)

Ruxolitinib

Clinical Outcomes in Patients with Myelofibrosis Treated with Ruxolitinib and Anemia Supporting Medications
(Session Title: Assessment of Risk and Survival in MPN. June 13, 11:45 a.m. – 12:00 p.m. EDT [5:45 – 6:00 p.m. CEST]. Abstract #S218.)

Tafasitamab

Tafasitamab (tafa) Plus Lenalidomide (len) and Rituximab (R) for Patients with Relapsed or Refractory Follicular Lymphoma (R/R FL): Results from the Phase 3 inMIND Study
(Session: Indolent and Mantle-Cell Non-Hodgkin Lymphoma – Clinical. June 14, 11:00 – 11:15 a.m. EDT [5:00 – 5:15 p.m. CEST]. Abstract #S230.)

Poster Presentations

Axatilimab

Trial in Progress: A Randomized, Open-Label, Phase 3 Study of Axatilimab Versus Best Available Therapy in Patients with Chronic Graft-Versus-Host Disease After ≥2 Prior Lines of Systemic Therapy
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1090.)

Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease: Analysis from the AGAVE-201 Study
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1035.)

Correlations of Clinician-Reported Responses with Other Response Measures in Patients with Chronic Graft-Versus-Host Disease: An Analysis From the AGAVE-201 Trial
(Session: Poster Session 1. June 13 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1041.)

The Effects of Prior Lines of Therapy on Clinical Outcomes for Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab: A Post Hoc Analysis of AGAVE-201
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS2029).

INCB057643 (BET)

Bromodomain and Extra-Terminal (BET) Protein Inhibitor, INCB057643, Improves Bone Marrow Function and Shifts Megakaryopoiesis to Erythropoiesis in Patients with Myeloproliferative Neoplasms (MPNs)
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF801.)

INCB057643, a Bromodomain and Extra-Terminal Protein Inhibitor, Has Novel Roles in Myeloid Cell Regulation and Immunosuppressive Tumour Environment Remodelling in Myelofibrosis
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1805.)

Safety and Efficacy of Bromodomain and Extra-Terminal (BET) Inhibitor INCB057643 in Patients (pts) with Relapsed or Refractory Myelofibrosis (MF) and Other Advanced Myeloid Neoplasms: A Phase 1 Study
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1822.)

Ponatinib

Impact of Ponatinib Treatment on Pregnancy Outcomes
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1598.)

Ruxolitinib

JAK2 V617F VAF and Presence of Copy Neutral-LOH at Chromosome 9p (chr9p) Predicts Transformation to Myelofibrosis (MF) in Patients with Polycythemia Vera (PV) Enrolled in REVEAL
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF819.)

Clinical and Gene Expression Patterns Associated with Disease Progression in Patients with Low-Risk Myelofibrosis Enrolled in the Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1808.)

Tafasitamab

CD19 Expression is Retained in Patients with Relapsed/Refractory Follicular or Marginal Zone Lymphoma After Receiving Tafasitamab, Lenalidomide and Rituximab in the inMIND Study
(Session: Poster Session 1. June 13, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PF1006.)

Tafasitamab plus Lenalidomide and Rituximab in Relapsed or Refractory Follicular Lymphoma: A Post Hoc Analysis of Outcomes by POD24 Status from the inMIND Study
(Session: Poster Session 2. June 14, 12:30 – 1:30 p.m. EDT [6:30 – 7:30 p.m. CEST]. Abstract #PS1877.)

More information regarding the 2025 EHA (Free EHA Whitepaper) Congress can be found at: View Source

Conference Call and Webcast

Incyte will host an in-person analyst and investor event on Sunday, June 15, 2025 from 6:00 – 7:30 a.m. ET (12:00 – 1:30 p.m. CEST) to discuss key mutCALR data being presented at EHA (Free EHA Whitepaper).

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

About Mutations in Calreticulin (mutCALR)

Calreticulin (CALR) is a protein involved in the regulation of cellular calcium levels and normal protein production. Somatic, or non-inherited, DNA mutations in the CALR gene (mutCALR) can result in abnormal protein function and lead to the development of myeloproliferative neoplasms (MPNs),1 a closely related group of clonal blood cancers in which the bone marrow functions abnormally, overproducing blood cells.2,3 Among two types of MPNs, essential thrombocythemia (ET) and myelofibrosis (MF), mutCALR drives 25-35% of all cases.2,3

Incyte is at the forefront of developing novel therapies for patients with mutCALR ET or MF that target only malignant cells, sparing normal cells, including INCA033989, a first-in-class, mutCALR-specific therapy.

About Jakafi (ruxolitinib)

Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Tafasitamab (Monjuvi)

Tafasitamab (Monjuvi) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

In the United States, Monjuvi (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.

XmAb is a registered trademark of Xencor, Inc.

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.

About Niktimvo (axatilimab-csfr)

Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Iclusig (ponatinib) tablets

Iclusig (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.