On September 4, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported they have enrolled their first patient with non-small cell lung cancer (NSCLC) in the ongoing Phase 1/2 combination trial of IDE397, a potential first-in-class, small molecule adenosyltransferase 2a (MAT2a) inhibitor, and Trodelvy (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with methylthioadenosine phosphorylase (MTAP)-deletion solid tumors (Press release, Ideaya Biosciences, SEP 4, 2025, View Source [SID1234655778]). IDEAYA is conducting the trial pursuant to a clinical study collaboration and supply agreement with Gilead, where the initial focus was in MTAP-deletion urothelial cancer (UC). In April 2025, the companies announced expansion of the combination trial into MTAP-deletion NSCLC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort. This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion," said Darrin Beaupre, Chief Medical Officer, IDEAYA Biosciences.

"MTAP-deletion is found in up to 20% of non-small cell lung cancer and remains an area with no approved targeted therapies. We’re pleased to expand our collaboration with IDEAYA and explore the potential of this novel combination in a patient population with limited treatment options," said Bilal Piperdi, MD, Vice President, Clinical Development Oncology at Gilead Sciences.

Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor, and Gilead will provide the supply of Trodelvy to IDEAYA.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

The use of Trodelvy in MTAP-deletion NSCLC and UC is investigational, and the safety and efficacy of this use have not been established. IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

On September 4, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported the pricing of a public offering of an aggregate of 5,999,999 of the Company’s American Depositary Shares (ADSs) (or pre-funded warrants in lieu thereof), with each ADS representing 200 ordinary shares, and short-term warrants to purchase up to 11,999,998 ADSs, at a combined public offering price of $1.00 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrants (Press release, Purple Biotech, SEP 4, 2025, View Source;id=363034&p=2399526&I=1206939-c7Z3G6f3m8 [SID1234655773]). The short-term warrants will have an exercise price of $1.00 per ADS, will be exercisable immediately upon issuance and will expire twenty-four months from the date of issuance. The closing of the offering is expected to occur on or about September 5, 2025, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $6 million. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $12 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for development of its oncology therapeutic candidates and for general working capital and corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form F-1 (File No. 333-289927), which was declared effective by the Securities and Exchange Commission (the "SEC") on September 4, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at View Source and may also be obtained by contacting 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 September 4, 2025 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIRTMand ADAPTIR-FLEXTM platform technologies, reported expansion of its anti-cancer pipeline with the filing of two provisional patents for trispecific candidates, APVO452 and APVO451 for prostate cancer and multiple, additional solid tumor types with significant unmet needs (Press release, Aptevo Therapeutics, SEP 4, 2025, View Source [SID1234655771]). These programs build on the Company’s growing suite of CRIS-7-derived, CD3-directed molecules and are supported by compelling clinical validation from lead candidate, mipletamig, which has demonstrated strong clinical safety and efficacy for the treatment of acute myeloid leukemia (AML).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A New Generation of CD3 Therapies

Aptevo’s CD3-engaging portfolio is anchored by mipletamig, a first-in-class CD123 x CD3 bispecific currently being evaluated in RAINIER, a Phase 1b/2 trial for frontline AML. In total, mipletamig has been evaluated in more than 100 patients across three trials, where mipletamig has consistently demonstrated high remission rates and a favorable safety and tolerability profile, with no observed cytokine release syndrome in frontline patients treated to date.

Building on this clinical validation, Aptevo previously expanded the suite with tumor-directed bispecifics APVO442 (prostate, PSMA x CD3) and APVO455 (solid tumors, Nectin-4 x CD3). All share the CRIS-7-derived CD3 binding domain, designed to deliver tumor-specific immune activation with a lower risk of systemic toxicity.

"It’s thrilling to introduce Aptevo’s first two trispecific immune cell engager biologics-and an exciting milestone for our team. Powered by our ADAPTIR-FLEX platform, these molecules are designed with a finely tuned mechanism of action that not only activates T cells in a tumor-specific manner but also modulates the immunosuppressive tumor microenvironment. This achievement reflects the monumental effort and exceptional talent of our highly capable team. Ultimately, we are creating therapeutics with the potential to fight cancer using multiple approaches of attack, but with a single molecule," said Peter Pavlik, PhD, Senior Director of Protein Engineering at Aptevo.

Trispecifics Designed to Modulate the Tumor Microenvironment

Expansion into trispecific molecule development represents a potentially profound emerging treatment option with the potential to unlock deeper, more durable anti-tumor responses by simultaneously engaging multiple immune pathways while limiting systemic toxicity. Solid tumors remain difficult to treat because the tumor microenvironment (TME) actively suppresses immune responses, limiting the efficacy of current therapies. To address this, Aptevo is advancing a new class of trispecific engagers that unite tumor targeting, T cell activation, and immune costimulation in a single molecule. This design has the potential to be delivered safely while harnessing the body’s own immune system to fight tumors locally in the tumor microenvironment.

APVO452 targeting PSMA, CD3, and CD40, is designed to address prostate cancers via PSMA targeting. This molecule works like a three-in-one tool: One-part locks onto the tumor, another part activates the body’s T cells to fight, and the third part reprograms other immune cells that normally protect the tumor. In preclinical studies, this trispecific approach was able to effectively kill tumor cells and, importantly, only switched on the immune system when tumor cells were present

APVO451 similarly incorporates trispecific design principles, targeting Nectin-4, CD3, and CD40, and is intended for a broad range of solid tumors. Early data indicate potent, anti-cancer activity that attacks cancer in multiple ways, increasing the opportunity to address critical unmet needs by offering treatment options for multiple solid tumors

"Beyond ramping up immune cell activity, there is a need for cancer treatments that achieve the true goal of immunotherapy in oncology: to restore balance to the immune system so it can kill tumor cells, while avoiding dangerous side effects. Tumor cells don’t exist in isolation. There is a complex tumor environment that includes other types of cells and structures-that signal to each other, increasing tumor growth and progression, and suppressing the body from fighting back. It’s not one single barrier; it’s a whole network of barriers working together," said Lynn Bonham, PhD, Senior Director of Translational Pharmacology at Aptevo. Bonham continued, "Our new trispecific molecules, APVO452 and APVO451, are built to tackle tumors on several fronts at once. They lock onto the tumor itself, activate T cells to attack it, and reprogram suppressive immune cells so they help the fight instead of holding it back."

Looking Ahead

With the addition of APVO452 and APVO451, Aptevo now has eight bispecific and trispecific therapeutic candidates, including five molecules that employ the CRIS-7-derived CD3 pathway. This dual strategy positions the Company at the forefront of next-generation T cell engagers, with a pipeline purposefully designed to address both hematologic and solid tumor cancers such as AML, lung and breast cancers and multiple other solid tumor types.

On September 4, 2025 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the H.C. Wainwright 27th Annual Global Investment Conference, being held in New York, NY on September 8 – 10, 2025 (Press release, TG Therapeutics, SEP 4, 2025, View Source [SID1234655770]). The fireside chat is scheduled to take place on Monday, September 8, 2025, at 10:30am ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On September 4, 2025 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, reported management will participate at the following conferences in September (Press release, Immunocore, SEP 4, 2025, View Source [SID1234655768]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cantor Global Healthcare Conference
Fireside Chat: Friday, September 5, 2025, at 8:35 a.m. EDT

H.C. Wainwright 27th Annual Global Investment Conference
1×1 and small group meetings: Monday, September 8, 2025

Baird 2025 Global Healthcare Conference
Fireside Chat: Tuesday, September 9, 2025, at 10:15 a.m. EDT

Morgan Stanley 23rd Annual Global Healthcare Conference
Fireside Chat: Wednesday, September 10, 2025, at 1:50 p.m. EDT

Where relevant, the presentations will be webcast live and can be accessed by visiting ‘Events & Presentations’, under ‘Events’, via the ‘Investors’ section of Immunocore’s website at www.immunocore.com. Following the event, a replay of the presentations will be made available for a limited time.