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Bold Therapeutics’ Clinical-Stage Anticancer Agent BOLD-100 Demonstrates Neuroprotective Potential when Utilized in Combination with FOLFOX for the Treatment of Advanced Gastrointestinal Cancers

On May 28, 2026 Bold Therapeutics, a clinical-stage biopharmaceutical company founded to develop and commercialize novel metallotherapeutics, reported data to support the neuroprotective potential of BOLD-100 when utilized in combination with FOLFOX for the treatment of patients with advanced gastrointestinal cancers.

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This data is presented in an abstract as part of the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from May 29th to June 2nd.

Abstract title: Neuroprotective potential of BOLD-100 when utilized in combination with FOLFOX for the treatment of advanced gastrointestinal cancers.
Authors: Grainne M. O’Kane, Elena Elimova, Jennifer L. Spratlin, Rachel A. Goodwin, Elaine McWhirter, Petr Kavan, Joel R. Hecht, Dae Won Kim, Do-Youn Oh, Sun Young Rha, Seung Tae Kim, Moon Ki Choi, Dong-Hoe Koo, Mark Bazett, Malcolm Snow, Michelle A. Jones, Jim Pankovich

Abstract #: e15029
View Source

Summary

Results: 109 participants with advanced gastrointestinal cancer were evaluated in the study and all but one had prior chemotherapy in the advanced setting. 95% were previously treated with oxaliplatin (65%) or cisplatin (30%). 45 patients (41%) had prior neuropathy. On study, 24 patients (22%) experienced at least one oxaliplatin-induced peripheral neuropathy (OIPN) adverse event. Lower OIPN incidence was observed across all cohorts relative to benchmarks: mCRC (14% vs. 53%), BTC (32% vs. 68%), GC (19% vs. 63%), and pancreatic cancer (29% vs. 38%). Only 9 patients (8.2%) discontinued oxaliplatin, with only 2 attributed to OIPN. Of 69 dose reductions, 16 (23%) were due to OIPN. Patients at the highest BOLD-100 dose level (625 mg/m2) had the lowest OIPN incidence.

Conclusions: Analysis of safety and dosing data from this study suggests a potential neuroprotective effect of BOLD-100 against oxaliplatin-induced peripheral neuropathy.

Bold Therapeutics is currently advancing BOLD-100 through a global Phase 2 randomized controlled trial across sites in Canada, European Union, and South Korea. This trial is investigating BOLD-100’s anticancer efficacy, but also includes important quality of life questionnaires focused on its neuroprotective potential. Please visit ClinicalTrials.gov for more information (NCT04421820).

(Press release, Bold Therapeutics, MAY 28, 2026, View Source [SID1234666163])

Menarini Group Presents New Data from the Phase 1b/2 ELEVATE Study of Elacestrant in Combination with Capivasertib in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 28, 2026 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, reported it will present safety and preliminary efficacy for the elacestrant and capivasertib combination arm of the Phase 1b/2 ELEVATE study in patients with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC). Additionally, various other trial-in-progress updates will be presented, underscoring elacestrant’s potential as an endocrine therapy (ET) backbone across the spectrum of breast cancer. These data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

The ELEVATE study was designed to evaluate the safety and efficacy of combination treatment options with elacestrant, to overcome different resistance mechanisms observed in ER+/HER2- mBC and improve patient outcomes, irrespective of ESR1 mutation status. The study is composed of six treatment regimens evaluating elacestrant in combination with CDK4/6 inhibitors (palbociclib, abemaciclib and ribociclib) and with inhibitors of the PI3K/AKT/mTOR pathway (everolimus, alpelisib and capivasertib).

ELEVATE results reported at ASCO (Free ASCO Whitepaper) 2026 (abstract 1098)[1] include safety and preliminary efficacy data from the phase 1b elacestrant (258-345 mg) plus capivasertib (320-400 mg) cohorts (n=31), which demonstrate preliminary median progression-free survival (mPFS) benefit in the recommended phase 2 dose (RP2D) cohort. The RP2D was determined in cohort 2 (n=9) to be elacestrant 345 mg plus capivasertib 320 mg BID (4 days on/3 days off).

In RP2D response-evaluable patients, preliminary efficacy showed an 88.9% disease control rate (DCR), a 66.7% clinical benefit rate at 24 weeks (CBR24), and a 33.3% objective response rate (ORR). All patients with ORR had co-existing ESR1 and PIK3CA mutations. The median duration of response (mDOR) has not yet been reached. The preliminary mPFS was 11.3 months in the overall RP2D population, and 10.9 months in patients with co-existing ESR1 and PIK3CA mutations. Additionally, these initial results show that the combination is consistent with the known safety profiles of each targeted therapy plus standard of care endocrine therapy.

"The combination of elacestrant plus capivasertib is designed to address an unmet need for patients with ER+/HER2- PI3K-pathway altered metastatic breast cancer, particularly when co-existing ESR1 and PIK3CA mutations are present." said Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute. "These encouraging preliminary data suggest the potential for extended clinical benefit with a manageable safety profile, as the combination regimen could simultaneously target ESR1 and PIK3CA mutations, potentially avoiding the need for sequential regimens that address each target individually."

"Building on the data we saw last year at SABCS, we continue to be encouraged by elacestrant’s potential clinical benefit observed across numerous combinations with different agents targeting ER+/HER2- metastatic breast cancer," said Elcin Barker Ergun, CEO of the Menarini Group. "The breadth of our studies, including early breast cancer and various combinations for ER+/HER2- metastatic breast cancer, including with capivasertib, demonstrate our commitment to bringing potentially transformational therapies to cancer patients."

In addition, other elacestrant data will be presented at the ASCO (Free ASCO Whitepaper) congress. See below for a complete list of upcoming presentations:

Presentation Title: Elacestrant in combination with capivasertib in patients with ER+/HER2- advanced breast cancer: Update from ELEVATE, a phase 1b/2 open-label, umbrella study
Abstract Number: 1098
Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CT
Location: Poster Board 212
Presenting Author: Wassim McHayleh

Presentation Title: ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant + everolimus versus elacestrant + placebo in ER+/HER2- advanced breast cancer patients with ESR1-mutated tumors progressing on endocrine therapy + CDK4/6i*#
Abstract Number: TPS1154
Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CT
Location: Poster Board 262b
Presenting Author: Antonio Llombart-Cussac

Presentation Title: ELECTRA: An open-label, multicenter, phase 1b/2 study of elacestrant in combination with abemaciclib in patients with brain metastasis from ER+/HER2- breast cancer
Abstract Number: TPS1155
Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CT
Location: Poster Board 263a
Presenting Author: Nuhad Ibrahim

Presentation Title: CAPELA: A phase II multicenter open-label randomized study of capecitabine in combination with elacestrant versus capecitabine alone in advanced estrogen receptor (ER)–positive breast cancer (TBCRC 070)*
Abstract Number: TPS1156
Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CT
Location: Poster Board 263b
Presenting Author: Kristina Fanucci

Presentation Title: ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study
Abstract Number: TPS1153
Presentation Date & Time: June 1, 2026; 1:30 – 4:30 PM CT
Location: Poster Board 262a
Presenting Author: Aditya Bardia

*Denotes investigator sponsored research or collaborative research

#The ADELA study is a pivotal study co-sponsored with MEDSIR

About The Elacestrant Clinical Development Program

Elacestrant is also being investigated in several company-sponsored clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease.

(Press release, Menarini, MAY 28, 2026, View Source [SID1234666162])

Whitehawk Therapeutics to Present at the Jefferies 2026 Global Healthcare Conference

On May 28, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported Dave Lennon, PhD, President and CEO, will present at the Jefferies 2026 Global Healthcare Conference in New York City, NY on Thursday, June 4 at 8:10 AM ET.

A live webcast of the fireside chat can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, MAY 28, 2026, View Source [SID1234666161])

Innovent Biologics and Pfizer Enter Global Strategic Collaboration to Accelerate Development of Innovative Oncology Medicines

On May 28, 2026 Innovent Biologics, Inc. (01801.HK) and Pfizer Inc. (NYSE: PFE), reported the companies have entered into a strategic global licensing and collaboration agreement for the research and development of 12 promising new breakthrough early-stage and de novo cancer medicines. The partnership includes licensing, co-development, and co-commercialization opportunities across a diverse portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies with differentiated immune-engaging features and unique designs.

The strategic collaboration brings together Innovent’s scientific discovery and clinical capabilities in oncology innovation with Pfizer’s deep scientific expertise, global clinical development capabilities, regulatory leadership and commercial scale, which are highly complementary to each company’s core areas of interest.

The agreement spans a portfolio of 12 programs comprising eight Innovent-originated early-stage programs and four Pfizer-proposed discovery programs. The companies will co-develop and share costs for select programs as they advance these programs through clinical development.

"This agreement brings together best-in-industry expertise of Pfizer and Innovent to advance novel cancer medicines to patients at a global scale," said Dr. Hui Zhou, Chief R&D Officer (Oncology Pipeline) of Innovent. "By leveraging both companies’ complementary resources, we can develop our early-stage oncology pipeline with greater speed and impact to help bring innovative therapies to patients more efficiently worldwide. Furthermore, co-developing and co-commercializing key projects in the U.S. and Europe expands Innovent’s global reach. At Innovent, we are laying the foundation for a truly global oncology platform that can deliver meaningful and lasting benefits for patients around the world."

"At Pfizer, everything we do starts with patients and the urgency to change what’s possible for people living with cancer," said Jeff Legos, Chief Oncology Officer, Pfizer. "This collaboration brings together two highly complementary engines of innovation with a shared ambition to move faster, go further and deliver truly transformative medicines to patients who are waiting. By combining Innovent’s discovery and early clinical development with Pfizer’s global research and development and commercialization capabilities, we have an opportunity not only to strengthen our pipeline, but to accelerate the delivery of breakthroughs that can redefine standards of care and make a meaningful difference in patients’ lives."

According to the agreement, Innovent will conduct development of these programs through Phase 1, powered by its proprietary discovery engine and robust early clinical capabilities, after which Pfizer will lead future global development. The agreement also sets out the following licensing and commercialization structure:

Innovent and Pfizer will co-develop four programs globally and share the development costs. The companies will co-commercialize in the United States and Europe*, and share the profits. Innovent will retain Greater China rights to these programs.
Pfizer will receive an exclusive license outside Greater China for four programs, and will be responsible for the majority of the development costs; and
Pfizer will receive an exclusive global license for four programs, and will be responsible for the global development costs.
Under the financial terms of the agreement, Innovent will receive a $650 million upfront payment and is eligible for up to $9.85 billion in development, regulatory and commercial milestone payments, bringing the total value of the deal to up to $10.5 billion. Additionally, Innovent will receive up to double-digit royalties on sales of each licensed product if approved. For the ‘co-developed, co-commercialized’ programs, the two companies will share the profits in the U.S. and Europe.

The closing of the transaction is subject to fulfillment of required regulatory approvals.

(Press release, Innovent Biologics, MAY 28, 2026, View Source [SID1234666160])

Phanes Therapeutics Announces Updated Phase 2 Clinical Trial Results of Spevatamig (PT886) in Combination with Chemotherapy in Frontline Treatment of Metastatic PDAC at the 2026 ASCO Annual Meeting

On May 28, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported updated positive Phase 2 results of spevatamig (PT886) in combination with chemotherapy in frontline (1L) treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026 . The full poster presentation will be held on Saturday, May 30 between 9am-12pm CDT during the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Session (Abstract #4192, Poster #175).

The data show spevatamig, an anti-CLDN18.2/CD47 bsAb, in combination with chemotherapy, has the potential to be an effective 1L treatment in patients with metastatic PDAC (mPDAC).

The design of spevatamig with an optimized anti-CD47 arm mitigates hematological toxicity and improves GI tolerability, as evidenced by the results of the spevatamig monotherapy and combination therapy studies where >190 patients have been dosed globally.

Spevatamig + GnP combination is well tolerated in 1L patients with mPDAC, with no significant additive toxicity to GnP.

2 mg/kg QW spevatamig + GnP showed promising efficacy (52.4% ORR, 90.5% DCR) when compared with the GnP arm in pivotal trials in 1L mPDAC; importantly, more than 90% of patients at this dose level had de novo metastatic disease, consistent with the baseline characteristics of the patient populations in pivotal Phase 3 trials.

Median progression-free survival (mPFS) was 7.3 months, and median overall survival (mOS) was 14.7 months in US patients, where the median follow up time is 14.7 months.

The efficacy data for 3 mg/kg spevatamig + GnP is still maturing. 3 mg/kg has the potential to be the dose level for a Phase 3 registrational study.

Overall, the data support further development of spevatamig + GnP in a randomized Phase 3 trial in patients with 1L mPDAC.
Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. Unlike immune checkpoint inhibitors (ICIs) (also known as anti-PD1/anti-PD-L1 drugs) which activate T cells to kill cancer cells, I2Es activate macrophages and dendritic cells to recognize and destroy cancer cells, providing an alternative mechanism to leverage the immune system to attack tumors, especially the so-called "cold tumors" that do not respond to ICIs.

"We are pleased to see the positive results at the first dose level of spevatamig in the 1L PDAC study. This result is significant because PDAC is considered a ‘cold tumor’ to ICIs. Now we have the opportunity to target PDAC with a new class of immunotherapy," said Ming Wang, PhD, MBA, Founder and CEO of Phanes. "The enrollment at the 3 mg/kg dose level is progressing rapidly and we hope to see efficacy data in the second half of 2026. We could be Phase 3 ready shortly after that. Our goal is to advance this exciting I2E aggressively and deliver an innovative immunotherapy for patients with mPDAC."

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the efficacy of spevatamig in combination with chemotherapy in first-line PDAC patients. Spevatamig is a novel immunotherapy which has the potential to become the first innate immunity enhancer (I2E) for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, MAY 28, 2026, View Source [SID1234666159])