On November 19, 2024 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in the Evercore 7th Annual HealthCONx Conference (Press release, Cidara Therapeutics, NOV 19, 2024, https://www.cidara.com/news/cidara-therapeutics-to-participate-in-evercore-7th-annual-healthconx-conference/ [SID1234648498]).

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Details are as follows:

Event: Evercore 7th Annual HealthCONx Conference
Date: Tuesday, December 3, 2024
Time: 7:55 AM ET
Format: Fireside chat
Webcast: View Source

A replay of the presentation will be available in the Investors section on the Company’s website at www.cidara.com. The replay of the presentation will be available for 90 days.

Cidara will also participate in one-on-one investor meetings during this event. Investors interested in meeting with Cidara at the conference should contact their Evercore representative directly.

On November 19, 2024 Curium, a world leader in nuclear medicine, reported that it has completed enrollment of its Phase 3 SOLAR-RECUR clinical trial (Press release, Curium Pharma, NOV 19, 2024, View Source [SID1234648499]). The trial is a multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer after radical prostatectomy or radiation therapy. The additional Phase 3 trial, SOLAR-STAGE, a multicenter, open-label study to evaluate the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in staging of men with newly diagnosed unfavorable intermediate-risk, high-risk or very-high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection continues to enroll patients at sites in the U.S. and will soon open locations in Europe.

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Sakir Mutevelic, MD, Curium’s Chief Medical Officer said: "The completion of enrollment of the SOLAR-RECUR trial is yet another significant milestone for Curium. Cu 64 PSMA I&T represents an important pillar in the development of our theranostic program for prostate cancer patients and the healthcare professionals treating them. Curium is very thankful to the hundreds of healthcare professionals from over 30 sites across the U.S. who have enrolled their patients in this pivotal trial."

Amy Bartalotta, Vice President of Clinical Operations added: "Curium is working to expand its Cu 64 diagnostic imaging platform. If successful, this will allow greater PSMA PET access to healthcare providers and patients across the country. SOLAR-RECUR enrollment completion is tangible evidence of Curium’s commitment to increasing availability of PET imaging for physicians and patients. We are especially thankful for all of the patients who enrolled in this important study."

On November 18, 2024 AstraZeneca reported that Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (CRT) (Press release, AstraZeneca, NOV 18, 2024, View Source [SID1234648466]).

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

Results showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio [HR] 0.16; 95% confidence interval [CI] 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.

Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Each year in Europe, there are more than 450,000 people diagnosed with lung cancer.1 Among those with NSCLC, the most common form of lung cancer, about 10-15% of patients in Europe have tumours with an EGFR mutation.2,3 Additionally, nearly one in five people with NSCLC has an unresectable tumour.4

Manuel Cobo, MD, Specialist Physician of the Medical Oncology Service at the Carlos Haya University Hospital, Malaga, Spain, and investigator for the trial, said: "The LAURA results build on the established efficacy of osimertinib and support the approval of the first targeted therapy for patients with unresectable, EGFR-mutated lung cancer. Today’s positive recommendation marks an important step towards offering patients in Europe a targeted treatment option that can extend the time before their disease progresses by more than three years."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Today’s news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting. Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives."

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

Tagrisso following CRT was recently approved for the treatment of adult patients with unresectable, Stage III EGFRm NSCLC in the US. Regulatory applications are also currently under review in China, Japan and several other countries based on the LAURA trial.

Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan. Approved indications include 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. Tagrisso is also approved in combination with chemotherapy in the US, China and several other countries for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

Notes

Lung cancer
Each year, an estimated 2.4 million people are diagnosed with lung cancer globally.5 Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.5 Lung cancer is broadly split into NSCLC and small cell lung cancer.3 The majority of all NSCLC patients are diagnosed with advanced disease.6

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.7-9 Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells.10

LAURA
LAURA is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were offered treatment with Tagrisso.

The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including in the US, Europe, South America and Asia. The primary endpoint is PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso as standard of care in EGFRm NSCLC. Tagrisso improved patient outcomes in early-stage disease in the ADAURA Phase III trial, Stage III, unresectable disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial.

As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.
The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso plus savolitinib as well as other potential new medicines.

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On November 18, 2024 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University’s Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company’s Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company’s ongoing INVINCIBLE-3 Study design (NCT06263231) (Press release, Intensity Therapeutics, NOV 18, 2024, View Source [SID1234648482]). Dr. Meyer shared the information during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society ("CTOS") on November 16, 2024, at 9 AM PST. The abstract’s lead author was Albiruni Razak, MB BCh, BM BCh, Clinician Investigator, Princess Margaret Cancer Centre at the University Hospital Network in Toronto, Ontario, Canada. Both Drs. Razak and Meyer, enrolled patients in the Phase 1/2 clinical trial. This year’s annual CTOS conference was held in San Diego from November 13 to 16, 2024 at the Grand Hyatt.

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"The data in the Phase 1/2 study has shown that INT230-6 causes cell death leading to tumor necrosis, improved cancer recognition by immune cells, and an ignition of a systemic anti-cancer immune response that results in T-cells entering the tumor microenvironment and has shown a favorable safety profile in soft tissue sarcomas," said Dr. Razak. "Systemically delivered chemotherapies have severe side effects, including cardiotoxicity, and most sarcoma subtypes have only a minimal response to immunotherapies. In addition, most sarcoma patients remain on current therapies for only a few months prior to progression, death or excessive toxicity. Demonstrating statistically significant improvement in median overall survival for the INT230-6 treatment arm compared to the standard of care arm in the INVINCIBLE-3 Study would be a major step forward in treating patients with these deadly soft tissue sarcomas."

Phase 1/2 Study (Sarcoma Subset Data: 15 Patients):

Demographics:

Median (min, max) lines for prior drug therapies: 3 (1.00, 7.00)
Mean (SD) age: 62.8 (8.1) years and ranged from 41.9 to 76.1 years
ECOG performance status at screening was 0, 1 and 2 for 2 (13.3%), 12 (80.0%), and 1 (6.7%) subjects respectively
The sarcoma diagnoses of the Phase 2 patients included liposarcoma, pleomorphic sarcoma, leiomyosarcoma, chondrosarcoma, osteosarcoma (chondroid syringoma), myofibroblastic, osteosarcoma, Kaposi sarcoma and chordoma
Efficacy:

The mOS in the mixed sarcoma population: 21.3 months for INT230-6
The mOS had not been reached with 21.4 months of median follow-up for patients who received a cumulative INT230-6 dose volume that was greater than 40% of their total tumor burden
INT230-6 extended overall survival in refractory sarcoma subjects by nearly 15 months as monotherapy when compared to a synthetic control group based on the Royal Marsden Hospital scoring method
Sarcoma population’s overall disease control rate (DCR): 93.3% (95% CI: 68.1, 99.8) at 2 months
Median duration of response (DOR): 4.0 months (95% CI: 1.7, NA) and 11.3 months (95% CI: 2.8, NA) for subjects who received a cumulative dose of ≥ 40% of the total incoming total tumor burden
INT230-6 demonstrated an increase in T-cells within the tumors
27% of patients had uninjected tumors shrink (abscopal effects), though tumors less than 1 cm were uninjected, untracked and unreported by investigators, so the true abscopal percentage is unknown; further radiomics work is on-going
Safety

INT230-6 demonstrated a favorable safety profile and was well-tolerated
3 subjects (20%) had one or more drug regimen-related Grade ≥ 3 Treatment Emergent Adverse Events (TEAE); all were grade 3 (there were no grade 4 or 5 TEAEs)
INVINCIBLE-3 Study Overview
The INVINCIBLE-3 Study is designed to evaluate INT230-6 administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed standard of care ("SOC") chemotherapy. The study endpoints are overall survival and safety, along with an exploratory quality of life (QoL) assessment using the EORTC-30 survey. This is a global randomized Phase 3 study comparing the efficacy and safety of INT230-6 intratumoral (IT) injection with any of three standard of care therapies (pazopanib, trabectedin, or eribulin) in approximately 333 adult participants with locally recurrent, inoperable, or metastatic soft tissue sarcoma ("STS") patients who had disease progression prior to study enrollment following standard therapies, which must have included an anthracycline-based regimen unless contraindicated. Participants may also have received a maximum of one additional regimen. Randomization will occur after screening and eligibility confirmation. As this is a survival study, there is no crossover allowed between SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) criteria. Participants will be prospectively stratified into 1 of 3 histologically defined STS strata:

leiomyosarcoma
liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic)
undifferentiated pleomorphic sarcoma
The comparator agents used are all U.S., Europe, Canadian and Australian-approved agents for sarcomas: pazopanib tablets, trabectedin, and eribulin mesylate. Authorizations for the INVINCIBLE-3 Study have been obtained from the U.S. FDA, Health Canada, the European Medicines Agency, and Australia’s Therapeutic Goods Administration. Sites will be opened in 8 countries and the study is presently recruiting participants in the U.S., Canada, and Europe.

"The safety and efficacy data of our lead drug candidate, INT230-6, generated for sarcomas was quite encouraging. Many insights were gained from the over 200 patients treated before initiating the INVINCIBLE-3 study and applied to the ongoing study. Our approach uses sophisticated interventional radiology technologies to guide needles into tumors to inject our novel cytotoxic drug, which is highly absorbed by tumors, and showed a potential meaningful impact on lengthening metastatic sarcoma patient lives, reducing toxicities and improving quality of life compared to current treatments in our first clinical trial," said Lewis H. Bender, Intensity’s President and Chief Executive Officer. "Our unique chemistry enables water-based products to diffuse throughout tumors and into cancer cells, causing immunologic cell death."

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

On November 18, 2024 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies for patients, reported it has entered into an exclusive option agreement with VelaVigo for an exclusive license to develop, manufacture and commercialize a potential first-in-class Nectin4/TROP2 bispecific antibody-drug conjugate (ADC), globally (excluding Greater China) (Press release, Avenzo Therapeutics, NOV 18, 2024, View Source [SID1234649419]). Nectin4 and TROP2 are highly co-expressed in multiple solid tumor types, including metastatic urothelial cancer.

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In addition, Avenzo has closed the final tranche of an oversubscribed Series A/A-1 financing, adding three new investors. The prior syndicate of investors, namely OrbiMed, Foresite Capital, SR One, Lilly Asia Ventures, Surveyor Capital (a Citadel company), New Enterprise Associates (NEA), Deep Track Capital, Sofinnova Investments, Sands Capital, INCE Capital, TF Capital, Delos Capital, and Quan Capital participated in this tranche, bringing the total capital raised to approximately $386 million.

"Since the formation of Avenzo, we have focused on building a pipeline of potential best- or first-in-class oncology assets. Today’s announcement brings us one step closer to our goal, and is based on the tremendous work from Scott Lipman, Chief Business Officer, and our entire team over the past 18 months," said Athena Countouriotis, M.D., Co-founder, President and CEO of Avenzo. "We continue to build our team to support our expected multiple clinical stage assets in mid-2025 and are excited to close our Series A/A-1 financing and add three new investors to our syndicate."

Under the terms of the exclusive option agreement, VelaVigo will receive an upfront fee and be entitled to receive upon the option exercise by Avenzo, an option exercise payment and potential development, regulatory, and commercial milestone payments, totaling up to approximately $800 million, as well as tiered royalties on sales in Avenzo’s territory.

An Investigational New Drug application for the Nectin4/TROP2 ADC is planned for submission to the U.S. Food and Drug Administration in mid-2025.

The company also announced the promotion of Scott Lipman, MBA to Chief Business Officer. Mr. Lipman joined Avenzo in March 2023 as Senior Vice President, Corporate Development and has led the company’s business development and strategy functions. Previously, he was on the leadership team at Turning Point Therapeutics and played an integral role in its acquisition by Bristol Myers Squibb for $4.1 billion in 2022. Mr. Lipman also worked in Healthcare Investment Banking at Goldman Sachs and started his career as a management consultant at ZS Associates. He received his B.S. in Chemical Engineering from the University of California, Los Angeles and his M.B.A. from the Kellogg School of Management at Northwestern University.