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Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines to Further Expand Inflammation Pipeline

On June 4, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) and Lakefront Biotherapeutics NV (Euronext & Nasdaq: LKFT) reported the successful completion of the previously announced acquisition of Ouro Medicines to advance T cell engager therapies for autoimmune diseases.

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The acquisition adds gamgertamig (OM336), a clinical-stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio and will be the foundation of Lakefront’s clinical development pipeline. Gamgertamig is designed to enable rapid and deep plasma cell and B cell depletion following a limited subcutaneously administered treatment course with the potential to induce durable disease control in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.

The addition of gamgertamig builds on Gilead’s long-term strategy to invest in differentiated science and accelerate the development of therapies that address significant unmet need. Combined with existing expertise in immunology and cell therapy, this approach supports the company’s ambition to shift treatment paradigms from chronic disease management toward the potential for durable immune reset.

Under the terms of the agreement, Gilead acquired all the outstanding equity of Ouro Medicines for $1,675 million and up to $500 million in contingent milestone payments. Lakefront and Gilead will equally split the upfront payment, subject to customary adjustments, and contingent milestone payments of up to $500 million.

With this transaction, Lakefront has acquired substantially all of Ouro Medicines’ team and operational assets in connection with Gilead’s acquisition of Ouro Medicines and will collaborate with Gilead on the development of gamgertamig. As part of the collaboration, Lakefront is responsible for the ongoing and future Phase 1/2 clinical studies of gamgertamig, with Gilead leading the registrational and later-stage studies. Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories. Lakefront will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.

Lakefront has also in-licensed a preclinical portfolio of three additional autoimmune focused programs originally from Ouro with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million per program.

The transaction provides relief under the Option, License and Collaboration Agreement dated July 14, 2019, between Lakefront and Gilead (the "OLCA") to enable Lakefront to deploy at least $500 million of its available cash independently from Gilead and outside the scope of the OLCA and the Ouro transaction, including up to $150 million for share buybacks.

The Ouro portfolio will be the cornerstone of Lakefront’s R&D pipeline. Following this transaction, Lakefront will continue to have a majority of its cash remaining for additional strategic transactions and other capital allocation priorities. Lakefront’s year-end 2026 cash balance is expected to be approximately €2B.

About Gamgertamig

Gamgertamig is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. Gamgertamig has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA for certain autoimmune diseases. Gamgertamig is currently in Phase 2 studies is expected to enter registrational studies as early as 2027. Gamgertamig is in-licensed from Keymed Biosciences, which owns the rights to develop the program in Greater China.

(Press release, Gilead Sciences, JUN 4, 2026, View Source [SID1234666444])

Xspray Pharma Receives CRL from U.S. FDA for Nilopki™

On June 4, 2026 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a pharmaceutical company leveraging its proprietary HyNap technology platform to develop improved versions of marketed protein kinase inhibitors (PKIs) for cancer treatment, reportd to have received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Nilopki, an optimized formulation of nilotinib. The company will address remaining questions with FDA; long‑term strategy and HyNap platform remain unchanged.

The FDA has determined that they are currently not able to approve the NDA based on three reasons. Firstly, they require that each Tasigna dose level must have a single corresponding Nilopki dose level starting from a dose with an exposure similar to the Tasigna 200 mg. Secondly, the FDA has requested more data to adequately demonstrate commercial manufacturing capability of nilotinib ASD batches. Thirdly, as previously communicated, Xspray’s third-party manufacturer needs to provide satisfactory responses to FDA’s inspection findings and a pre-approval inspection of the facility related to Xspray’s manufacturing may need to be conducted.

Xspray will now carefully analyze the CRL in detail and seek clarification where needed in dialogue with the FDA and industry experts.

Xspray Pharma’s CEO Blake Leitch commented:
"Receiving a CRL is of course not the outcome we were hoping for, especially considering the advanced state of labeling discussions we have had with FDA since March this year, but we will address these product specific issues with the goal of resubmitting as soon as possible," says Blake Leitch, Chief Executive Officer of Xspray Pharma. "Our immediate priority is to fully understand the FDA’s comments, address the remaining questions together with our partners and determine the most efficient path towards launching Nilopki. Although we now believe a launch of Nilopki within this year is unlikely, we remain confident in Nilopki’s profile and in the long‑term value of our HyNap‑based pipeline for patients and shareholders."

Xspray’s broader strategy and pipeline remain unchanged. The Company continues to progress its portfolio of HyNap‑based product candidates targeting established PKI therapies, including Dasynoc, for which the NDA is currently under review with PDUFA-date set to August 25, 2026. The Company will update the market on timing and next regulatory steps for Nilopki once it has completed its review of the CRL and aligned with the FDA on the way forward.

About Nilopki
Nilopki is Xspray’s HyNap‑based, improved formulation of nilotinib, developed as an improved version of Tasigna for the treatment of chronic myeloid leukemia. It is designed to address well‑recognized limitations of current nilotinib therapy. Nilopki effectively eliminates the requirement for fasting at dosing that currently forces Tasigna patients to abstain from food for up to six hours per day, one of the biggest challenges for adherence to CML treatment. Nilopki has demonstrated matching bioavailability at 52 percent lower dose, thanks to the improved properties of the HyNap platform.

(Press release, Xspray, JUN 4, 2026, View Source [SID1234666443])

Xenetic Biosciences, Inc. Announces That Its Collaboration Partner Received Approval From the Israeli Ministry of Health to Conduct Exploratory, Investigator Initiated Study of DNase I In Combination With Anti-CD19 CAR T Cells in Large B-Cell Lymphoma

On June 4, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. (PeriNess), has informed the Company that it received formal approval from the Israeli Ministry of Health and the respective Institutional Review Board to conduct an exploratory clinical study of a combination systemic DNase I with anti-CD19 CAR T Cells in large B cell lymphoma (LBCL) patients. This approval follows positive preclinical results that demonstrated significant improvement of CAR T cell expansion and persistence and functionality when combined with DNase I. This combination therapy resulted in improved tumor control, delayed relapse and prolonged survival across multiple preclinical models of leukemia and lymphoma.

Under the approved clinical study protocol, 12 LBCL patients with stable or progressive disease prior to lymphodepletion therapy are intended to be treated with CAR T cells targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) in combination with DNase I (50-ml IV infusion dose, 1.0 mg/kg IV on Days 0,3,6,10 and 15 after CAR T cells infusion). Clinical efficacy is intended to be evaluated by the Objective Response Rate (ORR) at 1 and 3 months post CAR T infusion, duration of response (DOR), disease control rate (DCR) and overall survival (OS) at 12 months post CAR T cells infusion. We believe the study has the potential for a translational component with a complex assessment of biomarker response and analysis of anti-CD19 CAR T expansion and persistence.

Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Sourasky Center, has initiated the study as the principal investigator and all work is intended to be conducted at Sourasky Center in Israel.

"Progression of LBCL is the major obstacle for the success of CAR T therapies, with approximately 50-60% of the patients relapsing in the first year, and approximately 30-45% within 3 months after CAR T infusion, depending on the CAR T product used. While patients with partial or complete response before CAR T infusion have a 1-year progression free survival of approximately 60-80%, those with stable or progressive disease at the time of CAR T infusion have a dismal 1-year progression free survival of approximately 20-30%," commented Dr. Ram "Preclinical data generated over the last few years confirms that accumulation of cell-free chromatin and neutrophil extracellular traps (NETs) within the tumor microenvironment represents a general mechanism of CAR T-cell dysfunction through induction of exhaustion, immunosuppression and impaired expansion and this mechanism is targetable by DNase I. The goal of this clinical study is to improve clinical response by administering DNase I to abrogate the negative effects of cell-free chromatin and NETs on the performance of immune system and CAR T cells."

Alexey Stepanov, PhD, Institute Investigator at The Scripps Research Institute and a member of Xenetic’s Scientific Steering Committee, added, "CAR T cell treatment induces intensive tumor-cell death and inflammation within the tumor over a short period of time, resulting in massive release of cell-free chromatin and neutrophil extracellular traps (NETs) into the tumor microenvironment. This extracellular DNA burden acts as a major stress factor that accelerates CAR T cell dysfunction and exhaustion, creating a potent negative feedback loop that limits durable efficacy. DNase I disrupts this loop by degrading cell-free chromatin and NETs, thereby improving CAR T cell fitness, preserving cytotoxicity and functional persistence and reducing exhaustion markers, including PD-1, LAG-3, and TIM-3. In our preclinical models, these effects were associated with more durable tumor control following repeated tumor re-challenge, with no tumor regrowth observed in DNase I-treated animals under conditions where tumor progression occurred in the control group. Importantly, unlike conventional strategies that seek to improve CAR T cells primarily through additional cell engineering, our approach is designed to improve the battlefield itself by removing key extracellular barriers to CAR T cell function. We believe the planned study at Tel Aviv Sourasky Medical Center is particularly meaningful given the institution’s longstanding leadership in CAR T-cell therapy and immuno-oncology innovation, both in Israel and internationally. As a pioneer in the development, clinical validation and early adoption of advanced cellular therapies, Sourasky Center combines elite clinical expertise, cutting-edge translational research infrastructure and a proven ability to rapidly translate scientific discoveries into innovative patient treatments, making it an ideal institution to lead this exploratory clinical study."

(Press release, Xenetic Biosciences, JUN 4, 2026, View Source [SID1234666442])

Vycellix to Provide Universal Cell Cancer Therapy Progress Reports at Upcoming Investor & Partnering Meetings

On June 4, 2026 Vycellix, Inc., a biotechnology company developing next-generation allogeneic natural killer (NK) cell-based therapies designed to overcome the risk of immune rejection and redefine functional persistence with durability, reported the Company will attend a series of upcoming investor and partnering meetings to share progress reports on the Company’s universal cell therapy platforms and product candidates targeting multiple myeloma, acute myeloid leukemia and urothelial cancers.

Vycellix is attending:

June 8-9: U.S. Department of Commerce Certified Trade Mission to Norway in Oslo
June 11-14: European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm
June 22-25: BIO International Convention in San Diego (Florida Pavilion, Booth# 1319)
To request a meeting with Vycellix at any of these events, please contact Doug Calder at [email protected].

Vycellix recently announced the successful completion of pre-clinical development for its universal cell engineering platform (VY-UC) with rigorous studies across many donor cell types proving robust immune evasion with functional persistence. The Company is now preparing for first-in-human clinical validation by seeking regulatory approval in Sweden to initiate a Phase 1 study for its lead VY-UC product candidate, a novel, off-the-shelf NK cell therapy (VNK-101) for patients with relapsed or refractory multiple myeloma.

To view VY-UC mechanism-of-action video, please visit:

View Source

The Company has also generated new data in AML and urothelial cancers supporting further development of its VY-GAGE platform and product candidates to engineer persistent allogeneic effector cells capable of delivering multiple disease-targeting payloads directly to tumor sites using logic-gated CARs and proprietary cleavable linkers, which when tumor-activated, deploy potent multi-antigen engagers, CARs and cytokines. This approach is believed to be safer with optimized target engagement and more effective by limiting cytotoxic killing to only occur within the solid tumor microenvironment.

To view VY-GAGE mechanism-of-action video, please visit:

View Source

(Press release, Vycellix, JUN 4, 2026, View Source;utm_medium=rss&utm_campaign=vycellix-to-provide-universal-cell-cancer-therapy-progress-reports-at-upcoming-investor-partnering-meetings [SID1234666440])

Syndax Announces Private Placement of $250.0 Million of Convertible Senior Notes

On June 4, 2026 Syndax Pharmaceuticals, Inc. ("Syndax") (NASDAQ: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, reported to have entered into privately negotiated subscription agreements for the issuance of $250.0 million aggregate principal amount of 2.25% Convertible Senior Notes due 2031 (the "Notes"). The sale of the Notes is expected to close on June 10, 2026, subject to customary closing conditions. J. Wood Capital Advisors LLC is acting as sole placement agent in connection with the private placement of the Notes (the "private placement").

Syndax estimates that the net proceeds from the private placement will be approximately $243 million, after deducting the placement agent’s fees and estimated expenses payable by Syndax. Syndax expects to use the net proceeds from the private placement for general corporate purposes, including working capital, research and development expenditures, commercialization activity expenditures and business development expenditures.

The Notes will be senior unsecured obligations of Syndax and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on December 15, 2026 at a rate of 2.25%. The Notes will mature on June 15, 2031, unless earlier converted, redeemed or repurchased.

Noteholders may convert all or any portion of their Notes at their option at any time prior to the close of business on the business day immediately preceding March 15, 2031, only upon the occurrence of certain circumstances. On or after March 15, 2031, until the close of business on the second scheduled trading day immediately preceding the maturity date, the noteholders may convert all or any portion of their Notes at any time.

Upon conversion, Syndax will pay or deliver, as the case may be, cash, shares of Syndax’s common stock, par value $0.0001 per share (the "common stock"), or a combination of cash and shares of common stock, at Syndax’s election. The conversion rate will initially be 40.3894 shares of common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $24.76 per share of common stock). The initial conversion price of the Notes represents a premium of approximately 35% over the last reported sale price of the common stock on the Nasdaq Global Select Market on June 3, 2026. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date of the Notes or if Syndax delivers a notice of redemption, Syndax will, in certain circumstances, increase the conversion rate for a noteholder who elects to convert its Notes in connection with such a corporate event or notice of redemption, as the case may be.

Syndax may not redeem the Notes prior to June 20, 2029. Syndax may redeem for cash all or any portion of the Notes (subject to certain limitations), at Syndax’s option, on a redemption date on or after June 20, 2029 if the last reported sale price of the common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Syndax provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

If Syndax undergoes a "fundamental change" (as defined in the indenture that will govern the Notes), then, subject to certain conditions and limited exceptions, noteholders may require Syndax to repurchase for cash all or any portion of their Notes at a repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

Neither the Notes, nor the shares of common stock issuable upon conversion of the Notes, if any, have been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state securities laws, and unless so registered, may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer, solicitation or sale of any securities in any state or 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 jurisdiction.

(Press release, Syndax, JUN 4, 2026, View Source [SID1234666439])