On October 15, 2026 NorthStar Medical Technologies, LLC (NorthStar), the first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron-accelerator technology, reported a strategic partnership with Quarkmed, a Beijing-based contract research organization (CRO) specializing in nuclear medicine and radiopharmaceutical clinical development, with expertise spanning pharmaceutical regulatory affairs, clinical development, and clinical trial operations. Quarkmed will serve as NorthStar’s Registration Agent in China, enabling pharmaceutical and biotechnology companies worldwide to use NorthStar’s n.c.a. Ac-225 in Investigational New Drug (IND) applications submitted to China’s Center for Drug Evaluation (CDE).

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The partnership expands global access to NorthStar’s commercial-scale n.c.a. Ac-225 supply and supports the growing development of targeted alpha therapies in one of the world’s largest pharmaceutical markets. Through Quarkmed’s local regulatory expertise, NorthStar can provide customers with fully translated, eCTD-compliant n.c.a. Ac-225 dossiers for submission alongside customer IND applications, helping streamline regulatory submissions and support efficient clinical development timelines. For sponsors, the result is simplified market entry and expanded access to NorthStar’s commercial-scale n.c.a. Ac-225 for clinical programs in China.

"The future of radiopharmaceutical development is increasingly global," said Dr. Frank Scholz, President and CEO of NorthStar. "By combining NorthStar’s proven U.S.-based Ac-225 manufacturing capabilities with Quarkmed’s regulatory expertise and local market presence, we can help radiopharmaceutical developers worldwide advance clinical programs in China as part of their broader commercialization plans."

NorthStar is currently preparing to support multiple customer IND applications in China utilizing its n.c.a. Ac-225. To expedite the regulatory filing process, NorthStar and Quarkmed have established a collaborative framework that provides customers with the technical and regulatory documentation necessary to support clinical development programs.

Under the partnership, Quarkmed will serve as NorthStar’s Registration Agent, enabling:

Fully translated eCTD-compliant Ac-225 dossiers for submission to China’s CDE.
Efficient support of customer IND applications utilizing NorthStar n.c.a. Ac-225.
Rapid response to regulatory inquiries through local radiopharmaceutical regulatory expertise.
Reduced delays associated with international communication, translation, and time-zone differences.
Alignment of regulatory submissions with customer clinical development timelines.
"As targeted alpha therapy development continues to advance, a dependable supply of no-carrier-added Ac-225 is essential for sponsors in China conducting clinical research. Equally important is aligning access to this isotope with local regulatory requirements. Through our collaboration with NorthStar, Quarkmed will draw on its experience in nuclear medicine and radiopharmaceutical development to provide professional, efficient support for China IND submissions and help sponsors advance their clinical development programs," said Dawei Yuan, Chairman and General Manager of Quarkmed.

The partnership with Quarkmed builds on several important milestones for NorthStar in 2026, as the company builds a global n.c.a. Ac-225 supply platform for radiopharmaceutical developers worldwide. In January, the company became the industry’s first producer of commercial-scale n.c.a. Ac-225 using electron-accelerator technology, which was quickly followed by an expanded partnership with Convergent Therapeutics to support late-stage clinical studies and commercial demand. In April, the U.S. Food & Drug Administration accepted NorthStar’s Drug Master File (DMF) for n.c.a. Ac-225, providing pharmaceutical and biotech companies with a validated pathway to incorporate the isotope into clinical and commercial radiopharmaceutical programs. In September, the company secured up to $185 million in growth financing, led by Hercules Capital, to scale Ac-225 production and radiopharmaceutical manufacturing. Later this year, NorthStar plans to transition to its high-capacity production line of n.c.a. Ac-225 at its integrated Beloit, Wisconsin, campus.

(Press release, NorthStar Medical Radiostopes, OCT 15, 2026, View Source [SID1234673506])

On October 15, 2026 Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, reported that three abstracts, including an oral presentation, will be featured at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 4-8 in Phoenix, AZ.

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The three accepted abstracts focus on preclinical data demonstrating how Ankyra’s anchored immunotherapy platform can be applied to multiple immune-modulating agonists, including CD40, CD28, CD137 (4-1BB), and IL-2/IL-15, to precisely target localized solid tumors and anchor powerful cancer-fighting therapeutics in the tumor microenvironment to minimize side effects and maximize therapeutic effect. These findings build on the company’s ongoing Phase 1 study of tolododekin alfa, a first-in-class IL-12-anchored immunotherapy that has demonstrated durable tumor retention, promising clinical activity, and a favorable safety profile. Together, the data highlight the versatility of Ankyra’s anchored immunotherapy platform and the potential to realize the promise of therapeutics previously shelved due to toxicity concerns.

"We look forward to presenting new data from our anchored immunotherapy platform and pipeline, including our CD40, CD28, CD137, and CD122 (IL-2/15Rβ) multi-agonists," said Howard Kaufman, President and CEO of Ankyra Therapeutics. "Our next-generation local immunotherapies have the potential to completely change the cancer treatment continuum and our priority is now advancing them from the lab to the clinic to help address unmet needs for people with cancer."

Presentation details:
Title: Anchored immunotherapy with CD137 (4-1BB) and CD122 (IL-2/15Rβ) multi-agonists induce monotherapy anti-tumor immunity and abscopal responses without systemic toxicity

Type: Oral Presentation
Session: Cytokine Engineering and Clinical Translation
Abstract: 1061
Date / time: Friday, November 6, 2026 – 5:15-5:25pm MT
Lead author: Robert G. Newman, PhD, Ankyra Therapeutics
Title: Safety and efficacy of ANK-302, an alum anchored CD28 and IL-2 bi-agonist in preclinical tumor models

Type: Poster Session
Session: Novel Single-Agent Immunotherapies
Abstract: 1067
Date: Friday, November 6, 2026
Lead author: Lisa Sturla, PhD, Ankyra Therapeutics
Title: Alum-anchored CD40–IL-2 multi-agonist (ANK-301) promotes local and abscopal anti-tumor immunity without systemic toxicity

Type: Poster Session
Session: Immuno-Engineering
Abstract: 930
Date: Saturday, November 7, 2026
Lead author: Kanika Jain, PhD, Ankyra Therapeutics

(Press release, Ankyra Therapeutics, OCT 15, 2026, View Source [SID1234673505])

On October 15, 2026 Veramorph LLC (VeraMorph) a specialty pharmaceutical company utilizing its "degradable gel" oral drug delivery platform to develop a pipeline of clinically differentiated orally reformulated drug products reported the lead product is the first effective oral formulation of fulvestrant, which is the potential best in class endocrine therapy for estrogen receptor positive (ER+) metastatic breast cancer (mBC) patients without ESR1 gene mutations.

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The potential clinical benefit of orally administered fulvestrant is to prolong survival and improve compliance, which is typically correlated with better outcomes, and quality of life for ER+ mBC patients. VeraMorph’s degradable gel technology will enable this outcome by maximizing the drug’s oral bioavailability, which has already demonstrated 20 times higher maximum plasma concentrations in preclinical studies relative to the current injectable product without generating severe adverse events. The initial beneficiaries of oral fulvestrant’s improved exposure are the roughly 70% of ER+ mBC patients that retain a wild-type ESR1 gene. Several oral alternatives to fulvestrant have been approved for patients with ESR1 mutations after progression on a prior endocrine therapy (i.e., in the second line setting). In contrast, fulvestrant efficacy is independent of ESR1 mutation status. With this context, an oral fulvestrant product could capture a substantial portion of the estimated $3B to $6B oral selective estrogen receptor degrader (SERD) therapy market.

VeraMorph plans to develop a dosage strength of oral fulvestrant that achieves an equivalent area under the curve (AUC) over 28 days relative to the approved monthly injectable product. The proposed clinical strategy comprises an initial dose range finding study, a PK bridging study, and an additional safety study given the new route of administration and use of a novel excipient. During a pre-IND meeting, the FDA conveyed openness to the proposed clinical strategy that entails generating clinical data from healthy volunteers. Based on this feedback, VeraMorph expects to submit an NDA in 2029.

Using funds from an SBIR Phase I grant sponsored by the NIH, VeraMorph recently replicated results indicating non-inferior efficacy of oral fulvestrant relative to the approved injectable product in orthotopic and metastatic models of ER+ mBC. Based on these positive results, VeraMorph has received a $2.1M NIH SBIR Phase II grant in order to complete remaining IND-enabling studies on oral fulvestrant as well as PDX studies to generate additional preclinical proof of concept data. These studies will enable VeraMorph to bring oral fulvestrant into the clinic in 2027.

VeraMorph has also recently strengthened its leadership team by adding Daniel O’Connor as the company’s CEO, while founder Doug Godfrin has transitioned to President and CTO. Dan is the former chief strategy officer (CSO) of Eagle Pharmaceuticals, where he spearheaded the development of an FDA New Drug Application (NDA) filing of a novel IM injection of fulvestrant. Dan also contributed to Eagle out-licensing and development efforts for several successful drug products in Eagle’s portfolio, including BENDEKA and PEMFEXY. Dan’s experience and expertise across finance, business development, strategy, and commercialization of drug products will ensure VeraMorph’s success in developing a pipeline of clinically differentiated, orally reformulated drug products using its degradable gel platform.

"I’m thrilled to join VeraMorph to help lead our efforts developing oral drug products meant to improve the patient experience and improve outcomes, starting with breast cancer by focusing on fulvestrant, a product that I have several years of experience with. Our recent engagement with the FDA confirms the enthusiasm for novel oral SERDs within the breast cancer community and the long history of fulvestrant provides confidence in the potential for a superior therapy among this patient population," said Dan O’Connor, CEO of VeraMorph. "VeraMorph’s pipeline has the opportunity to improve the duration and quality of life of hundreds of thousands of patients across several indications, which is a mission our whole team is dedicated to and motivated by."

VeraMorph is actively raising a Seed round to finance the upcoming dose ranging study on oral fulvestrant, including the scale-up of production processes for the degradable gel technology and corresponding oral solid dosages to produce clinical trial material. These funds will enable validation of the safety and effectiveness of VeraMorph’s platform technology and the oral fulvestrant product in humans. All of these efforts are aligned with VeraMorph’s mission, which is to improve and prolong the lives of patients across all indications with cost-effective therapies by enabling the full potential of existing therapies.

(Press release, VeraMorph, OCT 15, 2026, View Source [SID1234673504])

On October 15, 2026 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19- and CD22-targeted ARTEMIS T-cell therapies to treat cancers and autoimmune diseases, reported that the first patient who received two infusions, each at 5 × 10⁶ EB103 T cells/kg, three weeks apart, in the dose-expansion phase has tolerated the study drug well in the first month, with no treatment-related serious adverse events (SAEs) reported. STARLIGHT-1 is evaluating EB103, Estrella’s investigational CD19-redirected ARTEMIS T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin’s lymphoma (NHL).

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In the dose-escalation portion of the STARLIGHT-1 trial, EB103 demonstrated a 100% complete response (CR) rate at Month 1 in all evaluable patients in the high-dose cohort. Notably, no treatment-related SAEs have been reported among the nine patients treated with EB103 in the dose-escalation phase, the majority of whom presented with high-risk disease. All evaluable Phase I patients without central nervous system (CNS) involvement who achieved a CR remained in CR at the 9-month assessment.

"Administering two full doses of EB103 within three weeks, with no treatment-related serious adverse events observed to date, is an encouraging start to our expansion phase," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "While this is an early result from a single patient, it supports our rationale for evaluating multiple dosing with the goal of potentially delivering deeper responses in the most difficult-to-treat NHL patients, an approach we believe the safety profile observed with EB103 to date allows us to explore. We look forward to enrolling additional patients and to reporting additional efficacy and safety data from the expansion cohort."

The ongoing expansion phase of the Phase I/II clinical trial for EB103 is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in subjects (≥ 18 years of age) who have R/R B-cell NHL. Estrella expects that data from this expansion cohort will be used to inform the pivotal trial strategy for EB103. As of the date of this press release, active clinical sites for the trial are UC Davis Comprehensive Cancer Center, Baylor Scott & White Research Institute, Oregon Health & Science University, University Hospitals Cleveland Medical Center, and Intermountain Health LDS Hospital. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. (Eureka), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, such as EB103, allows it to be activated and regulated upon engagement with cancer targets through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Immunopharma, OCT 15, 2026, View Source [SID1234673503])

On October 15, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators presented new data showing the critical role of blood-based testing in increasing overall colorectal cancer (CRC) screening and follow-up colonoscopy adherence at the American College of Gastroenterology (ACG) 2026 Annual Meeting in Nashville, Tennessee.

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A modeling study looking at individuals 45 to 75 over a lifetime projected the health outcomes of blood-based testing compared to other non-invasive tests using real-world evidence for follow-up colonoscopy adherence, showing that blood-based screening may increase rather than lower the need for colonoscopy by bringing more patients into the screening pathway. With longitudinal test adherence and real-world follow-up colonoscopy adherence (FU-CY), blood-based screening increased the number of colonoscopies (679 vs. 113 and 326) and also averted more CRC deaths (12 vs. 6 and 9) compared to FIT and mt-sDNA testing per 1,000 simulated individuals during their lifetime.

Building off findings from Guardant Health’s 2025 study in Appalachia, another key study looked at clinical implementation of Shield in two rural health clinics in South Carolina which demonstrated a 99% real-world adherence rate, well above average screening adherence for overall CRC testing which ranges from 28-71%12. The notable findings reiterate the impact of blood-based tests in increasing CRC screening participation and improving outcomes, particularly for medically-underserved communities.

"Today’s research continues to reinforce the data we’ve seen across Guardant’s robust real-world evidence: blood-based screening meaningfully closes gaps in colorectal cancer screening participation with a significant lift in underserved communities that face some of the most persistent access barriers," said Sam Asgarian, Guardant Health’s VP of Clinical Affairs. "For the first time, we’ve been able to correlate the impact of real-world follow-up colonoscopies and screening adherence with the modeling studies of the Shield blood test. We’re proud to present this compelling research with our collaborators at ACG and to continue to demonstrate Shield’s role as a clinically meaningful alternative to traditional screening methods."

Shield was purpose-built to close screening gaps in population health, as the most-clinically validated blood test in market and the first blood test to receive FDA approval as a primary screening option for CRC in average-risk adults 45 and older. With more than 200,000 tests performed in real-world settings, Shield is proven to significantly increase overall CRC screening completion for patients due for CRC screening across practice and health system settings, demonstrating over 90% screening adherence.3

The full abstracts for Guardant Health and a list of all abstracts presented at the ACG Annual Meeting can be found here.

About Shield

Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

(Press release, Guardant Health, OCT 15, 2026, View Source [SID1234673502])