New Data for Precision Biologics, Inc. PB-223 ADC against novel tumor-specific target on human cancers revealed at SITC 2026

On November 6, 2026 Precision Biologics, Inc. CEO Philip M. Arlen, MD reported presentation of new data describing in-vivo efficacy of its novel tumor-specific antibody-drug-conjugate PB-223 ADC. Recent tumor killing data showing specific non-toxic anti-tumor activity in human cancer expressing truncated core 2 O-glycans will be reported in "In vivo efficacy of the antibody-drug conjugate (ADC) PB-vcMMAE-5 in an ovarian cancer patient-derived xenograft (PDX) model expressing truncated core 2 O-glycans", at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2026, November 7th, 2026, Phoenix Convention Center, Phoenix, AZ.

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"This highly sensitive and specific monoclonal antibody (mAb) PB-223 that internalizes into cancer cells expressing its target enables the opportunity for a high degree of anti-tumor response to our ADC with minimal toxicity in preclinical animal studies. The unique target is found on a broad variety of human solid tumors but not on healthy tissue, suggesting a strong rationale to move this drug into clinical development," said Dr. Arlen.

"We’re excited to further discuss PB-223 ADC with the scientific community, to share for the first time new compelling preclinical data showing ovarian cancer patient-derived xenograph human tumor models (PDX) treated with PB-223 ADC resulted in complete tumor eradication, with minimal toxicity observed in blood and healthy tissue," he went on to say.

Here are details of the presentation:

Title:

"In vivo efficacy of the antibody-drug conjugate (ADC) PB-vcMMAE-5 in an ovarian cancer patient-derived xenograft (PDX) model expressing truncated core 2 O-glycans"

Date/Time:

Saturday, November 7th, 12:30pm – 1:30pm – Day 2 –

Place:

SITC 2026, (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting),

Phoenix Convention Center – North Building, Lower Level – Exhibition Halls 4 – 6

Primary Category:
Immuno-Conjugates and Chimeric Molecules, Poster no. #888

Link to poster:

View Source

(Press release, Precision Biologics, NOV 6, 2026, View Source [SID1234674414])

U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme’s ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer

On November 6, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) (Halozyme) reported that Johnson & Johnson was granted accelerated approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE, as a single agent for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication does not include patients with oropharyngeal squamous cell carcinoma that is HPV-associated. It is the first approval of a dual-targeted therapy in this setting, simultaneously targeting epidermal growth factor receptor (EGFR)- and mesenchymal-epithelial transition (MET).

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"This approval will further expand the reach of RYBREVANT FASPRO in a high unmet need population," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "We are pleased that our ENHANZE technology is helping bring a new subcutaneous treatment option to patients with advanced head and neck cancer."

For more information on this approval, please view Johnson & Johnson’s press release issued on November 5, 2026.

(Press release, Halozyme, NOV 6, 2026, View Source [SID1234674413])

Inimmune Presents Late-Breaking Phase 1 INI-4001 Results Demonstrating On-Target Immune Activation in Advanced Solid Tumors at SITC 2026

On November 6, 2026 Inimmune, a clinical-stage biotechnology company developing novel immunotherapies, vaccine adjuvants and other immune-modulating technologies, reported Phase 1 results for INI-4001, an investigational small-molecule TLR7/8 agonist, in heavily pretreated patients with advanced solid tumors (NCT06302426). The study demonstrated no dose-limiting toxicities (DLTs) and dose-responsive cytokine production consistent with on-target immune activation. The data are being presented today by Shannon Miller, Ph.D., Vice President at Inimmune, in a late-breaking poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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"The Phase 1 data provide encouraging evidence that INI-4001 can activate the TLR7/8 pathway as intended, supporting its potential as a novel approach to cancer immunotherapy," said David Burkhart, Ph.D., Chief Executive Officer of Inimmune. "Despite advances in cancer treatments, many patients do not respond to existing therapies. We believe INI-4001 may help address this challenge by stimulating innate immune activity and making tumors more responsive to immunotherapy. These findings support continued clinical development of INI-4001 as a potential monotherapy, while we also look to explore its use in combination with other cancer treatments."

The Phase 1 study evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of INI-4001 in 10 heavily pretreated patients with advanced solid tumors. INI-4001 was administered intravenously once weekly across five escalating dose levels and was tolerated at doses up to 7.2 µg/kg, with no dose-limiting toxicities reported. Adverse events were primarily transient and consistent with innate immune activation, generally resolving within 24 hours. No concerning pharmacokinetic findings were observed.

Pharmacodynamic analyses demonstrated dose-responsive cytokine production consistent with TLR7/8 activation. At the proposed Phase 2 dose, maximum increases from pre-dose levels included 13.5-fold in IFNγ and 4.15-fold in IP-10, supporting evidence of on-target immune activation. Transient, dose-dependent decreases in circulating lymphocytes were also observed, with levels rebounding within 24 hours, consistent with potential lymphocyte trafficking to tissues and tumors.

Although the study was not designed to evaluate efficacy, two of the 10 patients continue to receive INI-4001 under compassionate use, with no reported disease progression. One patient with a small bowel neuroendocrine tumor has received INI-4001 for 19 months, while a second patient with chondrosarcoma has received treatment for nine months.

Based on these findings, Inimmune is evaluating plans to advance INI-4001 into a Phase 2a clinical study as early as 2027 to further assess its potential as a cancer immunotherapy, subject to securing funding or partnership support.

The late-breaking abstract is published in the Journal for ImmunoTherapy of Cancer and can be accessed through the SITC (Free SITC Whitepaper) 2026 abstract database.

About INI-4001
INI-4001 is an investigational small-molecule Toll-like receptor (TLR) 7/8 agonist being developed by Inimmune as a potential cancer immunotherapy. Designed to stimulate innate immune responses, INI-4001 is being evaluated for its potential to enhance antitumor immunity. Future development may also explore INI-4001 in combination with existing cancer treatments. INI-4001 has completed a Phase 1 clinical study in patients with advanced solid tumors (NCT06302426).

(Press release, Inimmune, NOV 6, 2026, View Source [SID1234674412])

VS Pharmtech Boosts Cancer Treatment Efficacy Without Adding Toxicity

On November 6, 2026 VS Pharmtech reported that cancer drugs keep improving, but their limits remain. When antibody therapies first emerged, only a fraction of patients benefited, and small-molecule anticancer drugs often carry severe toxicity. Rather than developing a new anticancer drug, Park Shin-young, CEO of VS Pharmtech (View Source), has focused on an "anticancer efficacy enhancer" that strengthens existing treatments.

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Park graduated from Seoul National University’s School of Applied Biology and Chemistry. He then worked in planning roles at Daewon Pharmaceutical, SCM Lifescience and CLIPS, a clinical research company. "Whether a new drug can be commercialized is decided in the clinic," Park said. "I was drawn to the fact that you can gauge a drug’s chances of success early, at the clinical stage."

The company grew out of a patent advisory meeting at the Korea Institute of Radiological & Medical Sciences in late 2018. There, Park encountered research on combining an existing drug with radiation therapy to improve its anticancer effect. He suggested that developing the approach into an efficacy enhancer could give it much wider use. He was offered the chance to start a company on the spot and founded VS Pharmtech that November.

A 20-year-old drug at one-fifth the dose

The company’s lead pipeline candidate, VS-101, is a radiosensitizer that makes tumors more responsive to radiation so that more cancer cells die. When radiation damages a cancer cell’s DNA, the cell detects the damage and tries to repair it. VS-101 weakens RAD51, a protein central to that repair process, and drives the cancer cell toward death.

VS-101 is being developed through drug repositioning, which finds new uses for an existing medicine. In this case, the drug has been used for more than 20 years. The company aims to give patients only about 20% of the original dose. "The drug itself doesn’t cause DNA damage or toxicity," Park said. "We designed the dose so that patients receiving other cancer treatments can take it alongside them without strain."

The first results came from a Phase 1 trial in Korea. Seven patients with stage 1–3 head and neck cancer received VS-101 together with radiation therapy. All seven achieved complete remission, meaning their tumors disappeared, with no dose-limiting toxicities or serious adverse events.

Based on these results, the U.S. Food and Drug Administration (FDA) approved the company’s Phase 2 plans for head and neck cancer, breast cancer and glioblastoma. These trials extend to patients receiving chemotherapy and radiation together, adding VS-101 to cisplatin for head and neck cancer and to temozolomide for glioblastoma. "This means the FDA recognized that VS-101 causes no significant harm when combined with other anticancer drugs," Park said. "We expect approval for a trial in hard-to-treat ovarian cancer, in combination with a PARP inhibitor, in the first half of next year." The current trials, run at U.S. institutions including Yale Cancer Center, add VS-101 to standard chemoradiation for patients with advanced head and neck cancer. The goal is to improve outcomes without additional side effects.

Seeking joint research at Berkeley

VS Pharmtech is pursuing commercialization on two tracks. For VS-101, it plans to discuss global licensing deals based on interim Phase 2 data. For its preclinical candidates, which are covered by new-compound patents, it is negotiating region by region. One option is to supply them as payloads to antibody-drug conjugate (ADC) developers. The company is in talks with firms in the Middle East, Latin America, Japan and China.

The company is also expanding its overseas footprint. It was selected for MARU SF, run by the Asan Nanum Foundation, and then for Bakar Labs, an accelerator program at UC Berkeley. VS Pharmtech is the first Korean company admitted to Bakar Labs. "The first resident company we reached out to was Catena Biosciences, founded by former students of Professor Jennifer Doudna, the 2020 Nobel laureate in chemistry," Park said. "We plan to actively pursue joint R&D with member companies."

Going abroad has not been without difficulties. "Getting FDA approval for a Phase 2 trial doesn’t cost much, but it serves as official recognition that you can run clinical development overseas," Park said. "I hope there will be more government programs, training and patent support that let companies practice this process in advance."

VS Pharmtech has raised a cumulative KRW 18.6 billion (about US$13 million) and is currently raising additional funding. It aims to list on the KOSDAQ in 2027 and has already appointed a lead underwriter to plan its timeline. "The timing of the listing will depend on when we close a licensing deal and how large it is," Park said. "We hope to share good news soon."

The company is also a resident of SVC Seoul, a global startup hub in Seoul’s Hongdae area. The hub was established to connect startups with strong overseas growth potential to companies, universities, and investors in Korea and abroad.

(Press release, VSPharmTech, NOV 6, 2026, View Source [SID1234674411])

CREATE Medicines to Host Investor and Partnering Meetings at the 2026 Jefferies Global Healthcare Conference in London

On November 6, 2026 CREATE Medicines, Inc. ("CREATE"), a clinical-stage biotechnology company pioneering in vivo multi-immune programming, reported that members of its senior management team will host one-on-one meetings with investors and prospective partners at the Jefferies Global Healthcare Conference in London, taking place from November 16–19, 2026, at the Waldorf Hilton and ME London. CREATE will be represented by Daniel Getts, PhD, CEO and Co-Founder, and Matthew Maurer, MD, Chief Medical Officer.

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CREATE is a leader in in vivo CAR therapy, with over 80 patients treated, the largest clinical dataset in the field. The company’s proprietary platform selectively programs immune cells directly inside the body for either transient or stable CAR expression, all from RNA. CREATE’s clinical-stage programs include:

CRT-402, a CD19-targeted in vivo CAR
MT-303, a GPC3-targeted in vivo CAR
MT-302, a TROP2-targeted in vivo CAR
MT-304, a HER2-targeted in vivo CAR
Investors who wish to request a meeting should contact their Jefferies representative. Prospective partners may contact [email protected].

(Press release, Create Medicines, NOV 6, 2026, View Source [SID1234674410])