Tango Therapeutics Announces Combination of Vopimetostat and Daraxonrasib Demonstrated 92% Objective Response Rate in Pancreatic Cancer

On June 8, 2026 Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported positive initial data from its ongoing Phase 1/2 study of vopimetostat, an investigational PRMT5 inhibitor with first- and best-in-class potential, in combination with Revolution Medicines’ RAS(ON) inhibitors in patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC).

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"In the first reported data from the clinical combinations of our PRMT5 inhibitor vopimetostat and RAS(ON) inhibitors, we saw extremely encouraging early results, with 92% of patients with PDAC in the vopimetostat plus daraxonrasib arm achieving an objective response, supporting the preclinical data showing synergistic activity of PRMT5 + RAS inhibition," said Malte Peters, MD, Chief Executive Officer of Tango Therapeutics. "Equally important, we are seeing encouraging signals of durability, with 90% of PDAC patients still progression free at 6 months of follow up. In addition, both combinations were generally well tolerated. Our primary focus is now to bring forward the PRMT5 plus RAS inhibitor combination approach in pancreatic cancer, while also looking toward important upcoming data readouts for vopimetostat single agent in lung cancer and TNG456 in GBM which we believe represents significant long-term opportunity for our company."

Dr. Peters continued, "These compelling results reinforce our belief that a vopimetostat-based combination with RAS inhibitors may be a path to a chemotherapy-free option for patients with MTAP-deleted pancreatic cancer. Given these data, we intend to prioritize advancement of the vopimetostat plus daraxonrasib combination into Phase 3 development in first-line, MTAP- deleted pancreatic cancer."

"Pancreatic cancer remains a largely intractable disease and an area where patients desperately need new therapies," said Brian Wolpin, MD, Director of the Hale Family Center for Pancreatic Cancer Research, Dana-Farber Cancer Institute. "In the front-line setting, chemotherapy has long been the standard of care, yet it presents significant tolerability challenges and overall limited efficacy against this aggressive disease. Building on the monotherapy activity already shown by these investigational PRMT5 and RAS(ON) targeted therapies, these early combination data demonstrated the potential to meaningfully reshape how we treat this disease with a precision-guided, chemotherapy-free approach."

Topline Phase 1/2 Clinical Data Highlights

As of a data cutoff date of May 28, 2026, 59 patients with previously treated MTAP-deleted and RAS-mutant pancreatic ductal adenocarcinoma (PDAC) or non-small cell lung cancer (NSCLC) were treated with a vopimetostat-based combination with either daraxonrasib (n=20 PDAC; n=5 NSCLC) or zoldonrasib (n=34 PDAC). All patients had advanced disease, including 70% with liver metastases in the daraxonrasib PDAC arm and 77% with liver metastases in the zoldonrasib arm, and were generally heavily pre-treated, with more than half receiving the combinations as third-line treatment.

Vopimetostat plus daraxonrasib combination

In the vopimetostat plus daraxonrasib dose escalation arm, patients received either vopimetostat 200 mg or 250 mg once daily (QD) plus daraxonrasib 100 mg QD. As of the data cutoff, 12 patients with PDAC and 3 patients with NSCLC were response evaluable with at least 14 weeks of follow up.

Data highlights include:

PDAC:
92% objective response rate (ORR) (11/12; 9 of 11 responses confirmed)
90% 6-month PFS rate
100% disease control rate (DCR)
NSCLC: 100% ORR, 3 of 3 responses confirmed
The vopimetostat + daraxonrasib was generally well tolerated across all dose levels with no new safety signals observed
Most adverse events were Grade 1 or 2 in severity. The most common treatment-related adverse events (TRAEs) were rash, stomatitis/mucositis and diarrhea.
There were no related Grade 4 or 5 adverse events
There were no dose-limiting toxicities (DLTs) at dose level 1 (vopimetostat 200 mg/daraxonrasib 100 mg). Three DLTs were reported in two patients at dose level 2 (vopimetostat 250 mg/daraxonrasib 100 mg), including one case of Grade 3 rash and one case of Grade 3 stomatitis and fatigue.
There were two dose reductions at dose level 1 and one dose reduction at dose level 2
There were no discontinuations due to adverse events

Development strategy:
Based on these data, Tango intends to rapidly advance this combination approach into Phase 3 development for patients with MTAP-deleted pancreatic cancer. Subject to feedback from regulatory authorities, the Company plans to initiate a Phase 3 randomized-controlled trial in front-line pancreatic cancer and evaluate opportunities to advance the second line combination towards registration phase.

Vopimetostat plus zoldonrasib combination (PDAC with MTAP deletion and KRAS G12D mutation)

In the vopimetostat plus zoldonrasib dose escalation arm, patients with PDAC received vopimetostat 200 mg or 250 mg QD plus zoldonrasib 600 mg or 1200 mg QD. As of the data cutoff date of May 28, 2026, 27 patients were response evaluable with at least 14 weeks of follow-up.

Data highlights include:

52% ORR (14/27; 10 of 14 responses confirmed)
74% 6-month PFS rate
96% DCR
The vopimetostat plus zoldonrasib combination was generally well tolerated at all dose levels with no new safety signals observed
Most adverse events were Grade 1 or 2. The most common TRAEs were nausea and vomiting.
There were no related Grade 4 or 5 adverse events
There were no DLTs
There was one dose reduction
There were no discontinuations due to adverse events

Upcoming Anticipated Milestones

Finalize design of Phase 3 randomized-controlled trial of the combination approach in front-line pancreatic cancer in 2H 2026
Disclose vopimetostat lung cancer monotherapy data in 2H 2026
Release initial TNG456 glioblastoma data 2H 2026
Present 2/3L PDAC vopimetostat + RAS(ON) inhibitors combination data at a scientific conference 2H 2026
Initiate Phase 1/2 vopimetostat + ERAS-0015 combination study 2H 2026

Investor Webcast and Conference Call Information
The Company will host a conference call to discuss these data at 8:00 a.m. ET today, June 8, 2026. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.tangotx.com. The webcast will be available for replay for at least 30 days on the company website. Analysts who wish to join the teleconference and participate in Q&A should register here.

About Vopimetostat
Vopimetostat is a potentially best-in-class oral, once-daily, MTA-cooperative PRMT5 inhibitor that works selectively in cancer cells with MTAP (methylthioadenosine phosphorylase) deletion. MTAP deletions occur in 10-15% of all human cancers, including approximately 40% of pancreatic cancer and 15% of lung cancer. Vopimetostat is being evaluated as monotherapy and in combination clinical studies. In ongoing clinical studies, vopimetostat has demonstrated a favorable safety and tolerability profile to date and shown durable activity in multiple tumor types.

(Press release, Tango Therapeutics, JUN 8, 2026, View Source [SID1234666500])

Tango Therapeutics Announces Proposed $500 Million Public Offering

On June 8, 2026 Tango Therapeutics, Inc. ("Tango") (Nasdaq: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported the launch of an underwritten public offering (the "Offering") of $500 million of its common stock. All shares of common stock to be sold in the Offering will be offered by Tango. Tango also intends to grant the underwriters a 30-day option to purchase up to an additional $75,000,000 of shares of its common stock offered in the Offering under the same terms and conditions. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or the actual size or terms of the Offering.

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J.P. Morgan, Leerink Partners, Cantor and Stifel are acting as joint bookrunning managers for the offering.

The Offering is being made pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The prospectus supplement, accompanying prospectus and any free writing prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement, accompanying prospectus and any free writing prospectus relating to the Offering may also be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109; by telephone at (800) 808-7525 ext. 6105; or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by e-mail at [email protected]; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected].

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.

(Press release, Tango Therapeutics, JUN 8, 2026, View Source [SID1234666499])

Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector

On June 8, 2026 The European Commission reported it has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications for Sarclisa intravenous (IV) formulation. Sarclisa is the first anticancer therapy in the EU to be administered through an on-body injector (OBI) and manual SC administration and can provide the flexibility of administration at patients’ homes and in the outpatient setting.

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"Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them. There has been a need for innovative approaches to ease this aspect of the treatment journey," said Mohamad Mohty, MD, PhD, Professor of Hematology at the Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department at the Saint-Antoine Hospital, Paris, France. "The ability to administer a therapy through an on-body injector, particularly an anti-CD38 monoclonal antibody with well-established efficacy, either in the clinic or at home represents a meaningful step forward. With this new option now approved, we have an opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care."

Since launching in 2020, Sarclisa has been prescribed to patients worldwide. Sarclisa IV is currently approved across four indications in the EU, including in combination with bortezomib, lenalidomide, and dexamethasone in both transplant-ineligible newly diagnosed MM (NDMM, TI) and transplant-eligible NDMM (NDMM, TE). In relapsed and/or refractory (R/R) MM, Sarclisa is approved in combination with pomalidomide and dexamethasone (Pd) or with carfilzomib and dexamethasone. The approval of Sarclisa SC, which follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, is based on the results from the pivotal IRAKLIA phase 3 study in R/R MM (NCT05405166), which demonstrated non-inferiority of the SC formulation compared to IV, as well as additional studies.

"Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered," said Olivier Nataf, Global Head of Oncology at Sanofi. "Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the multiple myeloma care continuum. With today’s EU approval, we’re combining that foundation with the added convenience, flexibility, and accessibility of the CirCLIQ on-body injector, which could offer a meaningful difference in the treatment experience."

The IRAKLIA and IZALCO studies suggest the use of an OBI may be associated with greater simplicity, flexibility, convenience and patient satisfaction compared to IV, and that patients and healthcare providers (HCPs) prefer the OBI compared to manual SC administration. In the IRAKLIA phase 3 study, 70% of patients treated with Sarclisa SC administered via an OBI reported being satisfied or very satisfied with their injection compared to 53.4% patients receiving Sarclisa IV (OR 2.036; 95% CI: 1.425-2.908; p=0.0001). In the IZALCO phase 2 study, after experiencing both administration methods, 74.5% of patients preferred Sarclisa SC administered via an OBI over manual injection, compared with only 17% who preferred manual injection and 8.5% with no preference (p=0.0004; binomial test against the null hypothesis of <50% rate), reinforcing strong patient preference for simplified, hands-free administration.

Sarclisa will be used in conjunction with Enable Injections’ CirCLIQ OBI, an automated injector developed using the enFuse platform, designed to subcutaneously deliver Sarclisa with the push of a button in either outpatient or home settings. Sarclisa SC administered via the CirCLIQ OBI uses a hidden retractable needle that is shorter and thinner compared to the needles commonly used for large-volume subcutaneous injections.

In the IRAKLIA study, the first phase 3 study to incorporate the use of an OBI in the treatment of MM, Sarclisa SC administered via an OBI in combination with Pd resulted in a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio [RR]: 1.008; 95% confidence interval [CI]: 0.903-1.126; p=0.0006), in adult patients with R/R MM who have received at least one prior line of treatment.

The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced systemic infusion reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) that occurred in .4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2.

The most common grade ≥3 nonhematologic adverse events (AEs) were pneumonia (14.8% OBI, 15.5% IV), COVID-19 (2.7%, 1.9%), and upper respiratory tract infection (1.5% both arms). The most common grade ≥3 hematologic laboratory abnormalities were neutropenia (84.7% OBI, 74.3% IV), thrombocytopenia (26.1%, 23%) and anemia (17.6%, 19.5%).

In patients from countries where at-home administration was permissible, median injection duration with Sarclisa SC via an OBI was the same between clinic and at-home administration (13 minutes). Home administration was well tolerated with no new safety signals and all injections were completed.

About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee (IRC), and observed Sarclisa SC mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa SC plasma concentrations.

About the IZALCO study
IZALCO (clinical study identifier: NCT05704049) was a two-part randomized, open-label phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via an OBI or by manual push, in combination with Kd, for the treatment of patients with R/R MM who have received one to three prior lines of therapy. The primary objective was ORR, as assessed by IRC. The secondary objectives were patient and healthcare provider preference for the OBI versus manual administration of Sarclisa SC.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit www.enableinjections.com.

About Sarclisa
Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM.

Sarclisa-based regimens have been prescribed to treat nearly 70,000 patients worldwide.

Sarclisa subcutaneous is approved in the EU in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in the EU. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration. Additional regulatory submissions for Sarclisa subcutaneous are currently under review with regulatory authorities worldwide, including in the United States, China, and Japan.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

(Press release, Sanofi, JUN 8, 2026, View Source [SID1234666498])

AdvanCell Strengthens Executive Leadership to Accelerate U.S. Expansion and Scale its Global Targeted Alpha Therapy Platform

On June 8, 2026 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported the appointment of Justyna Kelly as Chief Technology Officer (CTO) and François Gaudet as Chief Scientific Officer (CSO), expanding the company’s executive leadership team in the U.S. as it continues to scale its U.S. capabilities, and advance its growing pipeline of innovative targeted alpha therapies.

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Justyna Kelly will lead AdvanCell’s global technical operations strategy, including CMC, GMP production and clinical supply, the company’s global manufacturing network, supply chain, and preparation for commercial readiness. Her focus will include further developing U.S. manufacturing capabilities to support the next phase of development for ADVC001. Ms. Kelly brings 16 years of radiopharmaceutical manufacturing and operations experience, most recently serving as Vice President and Site Head of Eli Lilly and Company’s Indianapolis radioligand therapy manufacturing site. She previously served as Chief Operating Officer at POINT Biopharma prior to its acquisition by Lilly and has held leadership roles of increasing responsibility, including Chief Executive Officer, at the Centre for Probe Development and Commercialization. She holds an MSc in Biochemistry from McMaster University.

"AdvanCell has built a differentiated Lead-212 platform with the potential to meaningfully impact patients with cancer," said Justyna Kelly, CTO of AdvanCell. "I am excited to join the team and help execute a holistic strategy to scale our Lead-212 manufacturing infrastructure for Phase 3 and commercial readiness, while ensuring the quality, reliability, and operational excellence needed to deliver these therapies to patients."

François Gaudet has commenced the role of CSO and will lead AdvanCell’s discovery and preclinical efforts, with a focus on accelerating the progression of new innovative Lead-212 targeted alpha therapies into clinical development. An accomplished drug hunter, Dr. Gaudet brings 25 years of experience across pharmaceutical and biotechnology companies, including leadership roles of increasing responsibility at Novartis, Johnson & Johnson, and Mnemo Therapeutics where he served as Chief Scientific Officer. He has led research teams responsible for the discovery and development of innovative therapeutic assets through commercialization, including TECVAYLI and TALVEY. He conducted his graduate work in cancer epigenetics at the Massachusetts Institute of Technology and holds a PhD in Biology from Ludwig Maximilians Universität.

"AdvanCell has built an innovative platform of Lead-212 targeted alpha therapies based on its commitment to advance new treatment options for patients in oncology. Lead-212 alpha therapy is a nascent field and ADVC001 represents a validation of the modality," said François Gaudet, CSO at AdvanCell. "I’m excited to have joined the team to continue driving forward the pipeline development and help realize the full potential of the company’s differentiated approach."

Simon Puttick has transitioned from Chief Scientific Officer to the role of Chief Isotope Development Officer. Having played a key role in establishing AdvanCell’s targeted alpha therapy platform, Dr. Puttick, in his new role, will have a dedicated mandate to advance the company’s next-generation isotope production technologies, driving radioisotope process development from concept through to scalable manufacturing, strengthening supply chain security, and further positioning AdvanCell as a leader in this strategically critical capability, supporting the company’s platform expansion. Dr. Puttick will continue to be based at the company’s Australian headquarters in Brisbane.

"These leadership appointments strengthen AdvanCell’s ability to build a category-defining targeted alpha therapy company, accelerating our U.S. expansion and scaling our targeted alpha therapy platform globally," said Philina Lee, CEO of AdvanCell. "Justyna brings deep radiopharmaceutical manufacturing and operations expertise, François brings a proven track record of discovering and advancing innovative oncology therapeutics, and Simon’s dedicated focus on innovative methods for next-generation isotope production reinforces a core strategic advantage for AdvanCell: secure, scalable isotope supply and manufacturing."

TECVAYLI and TALVEY are registered trademarks of Johnson & Johnson or its affiliated companies.

About 212Pb-ADVC001

212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and labelled with Lead-212 (212Pb), an alpha-emitting payload (radionuclide) with a high dose rate, 10.6-hour half-life and simple decay scheme. ADVC001 is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose escalation and expansion study evaluating ADVC001 in metastatic prostate cancer. The completed Phase 1b dose escalation assessed the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2 or 1 week(s) (see press release). The Phase 2 expansion is assessing the efficacy and safety of ADVC001 at two dose levels. The trial utilizes a randomized dose-response design and dose optimization elements to evaluate ADVC001 in PSMA-positive mCRPC and in mHSPC.

(Press release, Advancell, JUN 8, 2026, View Source [SID1234666496])

Johnson & Johnson to Acquire Firefly Bio, Inc. to Expand Oncology Pipeline with Novel Degrader Antibody Conjugate Platform

On June 8, 2026 Johnson & Johnson (NYSE: JNJ) reported it has entered into a definitive agreement to acquire Firefly Bio, Inc., a biotechnology company advancing its proprietary Firelink degrader antibody conjugate (DAC) platform, for $1 billion in cash. The Firelink DAC platform for KRAS-driven tumors bolsters Johnson & Johnson’s oncology pipeline and ambition to develop targeted medicines for the most prevalent and hard-to-treat solid tumors with high unmet need1.

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Antibody therapeutics have revolutionized the treatment of cancer through continuous innovations from monoclonal antibodies, to bi-and multi-specifics, antibody drug conjugates, and other antibody-based approaches. The Firelink DAC platform is a novel, innovative approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.

"KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years," said John Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, Research & Development, Johnson & Johnson. "We believe the proprietary Firelink platform will overcome the limitations of current treatments and diversify our pipeline with preclinical candidates for treating multiple types of solid tumors."

Johnson & Johnson is at the forefront of oncology therapies
For more than three decades, Johnson & Johnson has advanced innovative therapies to address some of the most complex cancers and improve outcomes for patients worldwide. Firefly Bio Inc.’s capabilities in emerging modalities complement Johnson & Johnson’s existing expertise in antibody engineering and accelerates the Company’s pioneering of more effective, durable treatments.

About the agreement
Under the terms of the agreement, Johnson & Johnson will acquire Firefly Bio, Inc. for $1 billion in cash. The closing of the transaction is expected to occur later this year, subject to applicable regulatory approvals and other customary closing conditions. The accounting treatment will be communicated on or before the close of the transaction.

(Press release, Johnson & Johnson, JUN 8, 2026, View Source [SID1234666495])