On February 3, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, reported the successful completion of an oversubscribed US$112 million Series C financing (Press release, Advancell, FEB 3, 2025, View Source [SID1234650011]). This milestone funding round was co-led by SV Health Investors, Sanofi Ventures, Abingworth, and SymBiosis. Additional support came from existing investor Morningside, alongside new investors Tenmile, Brandon Capital, and others.

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Since its founding in June 2019, AdvanCell has grown from a belief in the potential of Targeted Alpha Therapy into a global organisation with 60 passionate team members, a 40,000-square-foot manufacturing facility, world-class pre-clinical infrastructure, a potentially best-in-class drug for prostate cancer that is in trials, and a deep and developing pipeline of assets.

This investment will fuel AdvanCell’s ongoing efforts to expand its manufacturing capacity, accelerate the clinical development of its pipeline of radionuclide therapies, and advance its mission of delivering life-changing treatments to cancer patients worldwide.

AdvanCell is currently enrolling patients for the highest dose cohort of its multi-center TheraPb Ph I/II dose escalation clinical trial of ADVC001 for metastatic prostate cancer, a potentially best-in-class Targeted Alpha Therapy. The trial aims to demonstrate the safety and efficacy of Pb-212-based radionuclide treatment.

As part of the financing, Jamil M. Beg from SV Health Investors, Christopher Gagliardi from Sanofi Ventures, and Bali Muralidhar from Abingworth have joined the AdvanCell Board of Directors. They bring extensive industry expertise to support the company’s growth and join existing directors Bill Ferris AC, Anthony Aiudi, Kevin Cameron, and Andrew Adamovich.

Jamil M. Beg, Partner at SV Health Investors, commented:

"We are delighted to support AdvanCell’s growth and play a role in its remarkable journey through leading this oversubscribed Series C. We have looked long and deep at the field of radionuclide therapies and are confident that AdvanCell stands out with a first-in-class Pb-212-PSMA program and a best-in-class manufacturing platform. The company’s exceptional team, technologies, robust infrastructure, collaborations with some of the world’s largest pharma companies and ability to consistently execute, position it to truly change outcomes for patients. We are excited to help AdvanCell realize its potential in transforming cancer care globally."

AdvanCell was founded on the belief that Targeted Alpha Therapies could change the course of cancer treatment and that the scalable supply of isotopes would enable the development of multiple practice-changing drugs. Radionuclide therapies for prostate cancer and gastroenteropancreatic neuroendocrine tumours have transformed patient care. Pb-212 Targeted Alpha Therapy has the potential to further advance this progress by leveraging the radiobiological and physical attributes of Pb-212 to make life-changing treatments for patients.

"This successful Series C round demonstrates strong confidence in our vision and capabilities," said Andrew Adamovich, CEO of AdvanCell. "We are grateful for the continued support from our existing investors, particularly the long-term support from Morningside and are excited to welcome new partners who share our commitment to transforming cancer care. With this funding, AdvanCell is well-positioned to scale our manufacturing operations and progress our cutting-edge therapies towards commercialization."

The Series C funding represents a significant step in AdvanCell’s journey to become a global leader in radionuclide-based cancer therapeutics.

On February 3, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported it has initiated an Expanded Access Program (EAP) for taletrectinib in the U.S. for the treatment of patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) when no comparable or satisfactory alternative therapy options are available (Press release, Nuvation Bio, FEB 3, 2025, View Source [SID1234650010]).

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"We are committed to working with the ROS1-positive NSCLC community, and the healthcare providers who serve them, to ensure this EAP provides eligible patients in the U.S. with efficient access to taletrectinib outside of our clinical trials."

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"This EAP reflects our unwavering dedication to patients with ROS1-positive NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are committed to working with the ROS1-positive NSCLC community, and the healthcare providers who serve them, to ensure this EAP provides eligible patients in the U.S. with efficient access to taletrectinib outside of our clinical trials."

The EAP, as authorized by the U.S. Food and Drug Administration (FDA), allows patients with serious or immediately life-threatening ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal Phase 2 TRUST-II study.

"ROS1-positive NSCLC is a rare form of lung cancer with a unique patient journey to navigate," said Janet Freeman-Daily, Co-Founder and President of The ROS1ders. "At The ROS1ders, we are constantly working toward our goal of improving survival and quality of life for the ROS1-positive cancer community by encouraging the research, development, and commercialization of effective treatments. Despite recent progress, there are times when approved therapies have not provided sufficient benefit or when patients are not eligible for a clinical trial. EAPs represent an opportunity for patients and their families to access investigational drugs that would not have otherwise been available to them."

In December 2024, the U.S. FDA accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. The NDA is based on the pooled results from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib, which were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024.

About Expanded Access to Taletrectinib

EAPs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical treatment outside of clinical trials and before it is approved by the U.S. FDA. The EAP for taletrectinib may be available for patients with locally advanced or metastatic ROS1+ NSCLC who, in the opinion of the treating clinician, are not appropriate candidates for approved ROS1 targeted therapies and ongoing taletrectinib clinical studies. For additional information on Nuvation Bio’s clinical trials and EAP, please visit View Source or contact [email protected].

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted for Priority Review Nuvation Bio’s NDA for taletrectinib for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

About ROS1+ NSCLC

Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. Up to 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.

On February 3, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI), a biomedical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies and its investigational immunotherapy, reported that it has requested a drawdown of $10 million under its previously announced $50 million credit agreement with OrbiMed, a healthcare investment firm (Press release, TriSalus Life Sciences, FEB 3, 2025, View Source [SID1234650009]).

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Pursuant to the to the Agreement, OrbiMed agreed to provide a term loan facility in an aggregate principal amount of $50 million. The $10 million drawdown became available to TriSalus upon achievement of product revenue-based milestone of $30 million for the trailing 12-months ending on January 31, 2025. With the closing of the $10 million tranche, the company has drawn a total of $35 million under the credit agreement with OrbiMed.

On February 3, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy (Press release, Halozyme, FEB 3, 2025, View Source [SID1234650008]).

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"We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in Europe," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The data that support the recommendation could represent a very compelling proposition for patients with the approximate five-minute administration time and five-fold reduction in infusion related reactions."

The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For more information on the study and its findings, please view Johnson & Johnson’s press release issued today.

Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO (Free ASCO Whitepaper) Journal of Clinical Oncology. 2024;42(3):3593-3605.

2 Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.

3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). View Source Accessed January 2025.

On February 3, 2025 AstraZeneca reported that Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT) (Press release, AstraZeneca, FEB 3, 2025, View Source [SID1234650007]).

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the ADRIATIC Phase III trial, which were published in The New England Journal of Medicine.

Results showed Imfinzi reduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.

Imfinzi also reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo.

SCLC is a highly aggressive form of lung cancer.1 LS-SCLC typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy.2-3 The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients will be alive five years after diagnosis.4

Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, said: "ADRIATIC was the first Phase III trial in decades to demonstrate a survival benefit in limited-stage small cell lung cancer, reducing the risk of death by 27 per cent in patients treated with durvalumab versus placebo. Today’s positive recommendation from the CHMP means that our patients in Europe are one step closer to gaining access to this practice-changing treatment regimen."

Susan Galbraith, Executive Vice President, Oncology Haematology, R&D, AstraZeneca, said: "With 57 per cent of patients still alive at three years in the ADRIATIC trial, Imfinzi has the potential to transform treatment for people with limited-stage small cell lung cancer. If approved, these patients will have access to immunotherapy for the first time, redefining expectations of survival outcomes in this setting."

The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed.

Imfinzi is approved in the US and several other countries in this setting based on the ADRIATIC results. Regulatory applications are currently under review in Japan and several other countries in this indication.

Notes

Small cell lung cancer
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.5-6 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% of cases classified as SCLC.7

LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung or one side of the chest.8 LS-SCLC accounts for approximately 30% of SCLC diagnoses, with an estimated 8,000 people treated for LS-SCLC across the five major European countries each year.9-10 The prognosis for patients with LS-SCLC remains poor despite curative-intent treatment with standard-of-care concurrent CRT (cCRT).9

ADRIATIC
The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of Imfinzi with or without Imjudo 75mg every four weeks for up to four doses/cycles each, followed by Imfinzi every four weeks for up to 24 months.

The dual primary endpoints were PFS and OS for Imfinzi monotherapy versus placebo. Key secondary endpoints included OS and PFS for Imfinzi plus Imjudo versus placebo, safety and quality of life measures. The trial included 164 centres in 19 countries across North and South America, Europe and Asia.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to its indication in LS-SCLC, Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after CRT. Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC; in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC; and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.

Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

Imfinzi is also approved in combination with chemotherapy (carboplatin and paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in the US. In the EU, Imfinzi plus chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer, and Imfinzi plus chemotherapy followed by Imfinzi alone is approved for patients with dMMR disease. In Japan, Imfinzi plus chemotherapy followed by Imfinzi monotherapy has also been approved as 1st-line treatment in primary advanced or recurrent endometrial cancer, and Imfinzi plus chemotherapy followed by Imfinzi and Lynparza has been approved for patients with pMMR disease.

Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.