ESGO

Mersana Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 28, 2024

Mersana plans to initiate tumor-specific expansion cohorts in the second quarter of 2024 and expects to share initial dose escalation and backfill cohort data in mid-2024.

Key Points: 
  • Mersana plans to initiate tumor-specific expansion cohorts in the second quarter of 2024 and expects to share initial dose escalation and backfill cohort data in mid-2024.
  • Collaboration revenue for the fourth quarter of 2023 was $10.7 million, compared to $14.7 million for the same period in 2022.
  • Included in the fourth quarter of 2023 G&A expenses were $1.9 million in non-cash stock-based compensation expenses.
  • ET to discuss business updates and its financial results for the fourth quarter and full year of 2023.

Zai Lab to Present Final Overall Survival (OS) Data from Phase 3 NORA Study of ZEJULA (niraparib) in Platinum-Sensitive Recurrent Ovarian Cancer (PSROC)

Retrieved on: 
Wednesday, March 6, 2024

“Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.

Key Points: 
  • “Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.
  • “We look forward to sharing the final OS findings from this study at both the 2024 ESGO and SGO conferences.
  • The final OS analysis was conducted after ≥ 50% of OS events occurred in the intent-to-treat population.
  • No new safety signals were identified during the long-term follow up period subsequent to the primary analysis.

BioNTech and DualityBio Receive FDA Breakthrough Therapy Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Endometrial Cancer

Retrieved on: 
Thursday, December 21, 2023

The designation is based on encouraging topline data from a Phase 1/2 study ( NCT05150691 ) with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.

Key Points: 
  • The designation is based on encouraging topline data from a Phase 1/2 study ( NCT05150691 ) with BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.
  • Endometrial or uterine cancer is the second most common gynecologic cancer globally, with over 400,000 cases occurring each year1,2 and both incidence and mortality are increasing3,4.
  • “The Breakthrough Therapy designation for BNT323/DB-1303 shows the potential of our ADC candidate to address current treatment challenges for patients with advanced HER2-expressing endometrial cancer who progressed under several lines of systemic therapy.
  • The BNT323/DB-1303 program received FDA Fast Track designation for the treatment of endometrial cancer in January 2023.

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023

ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended September 30, 2023.
  • We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα.
  • Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022.
  • Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively.

Oncoinvent Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for Radspherin® in Ovarian Cancer Patients

Retrieved on: 
Tuesday, October 31, 2023

This represents the second U.S. FDA IND clearance for Radspherin®, as last week, the company also announced an IND acceptance for Radspherin® in patients with peritoneal carcinomatosis from colorectal cancer.

Key Points: 
  • This represents the second U.S. FDA IND clearance for Radspherin®, as last week, the company also announced an IND acceptance for Radspherin® in patients with peritoneal carcinomatosis from colorectal cancer.
  • “We are thrilled to announce the IND clearance for this phase 2b study of Radspherin®, allowing for inclusion of patients in the first-line treatment setting of ovarian cancer,” said Anders Månsson, Chief Executive Officer of Oncoinvent.
  • “This IND clearance comes in succession to the IND clearance of Radspherin® in colorectal cancer patients, announced recently.
  • It is a randomized controlled phase 2b trial, assessing efficacy and safety of Radspherin® in patients with peritoneal metastasis from ovarian cancer.

Oncoinvent To Present Initial Safety Data from the Phase 1 Trial of Radspherin® in Ovarian Cancer Patients at the 24th Congress of the European Society of Gynaecological Oncology (ESGO)

Retrieved on: 
Thursday, September 28, 2023

"Oncoinvent is proud to present safety data from our lead candidate, Radspherin® at a major congress of the global gynecological cancer community.

Key Points: 
  • "Oncoinvent is proud to present safety data from our lead candidate, Radspherin® at a major congress of the global gynecological cancer community.
  • We believe this is an important first step as we advance the development of Radspherin® as a new treatment for patients with advanced ovarian cancer,” says CEO Anders Månsson.
  • The safety interim analysis after completion of the dose-limiting toxicity (DLT) period demonstrated that Radspherin® was well tolerated.
  • The highest dose of 7 MBq was recommended following the completion of dose escalation of 1-2-4-7 MBq, as no DLT was observed.

ELAHERE® Shows Overall and Progression-Free Survival Benefit Regardless of Prior PARPi Exposure or Prior Lines of Therapy in FRα-Positive Platinum-Resistant Ovarian Cancer

Retrieved on: 
Thursday, September 28, 2023

Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%).

Key Points: 
  • Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%).
  • 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.
  • Key secondary endpoints include objective response rate (ORR), overall survival (OS), and patient-reported outcomes (PROs).
  • ELAHERE demonstrated clinically meaningful improvements in PFS and ORR by investigator assessment and in OS compared to IC chemotherapy, regardless of prior lines of therapy (PLOT).

ImmunoGen Reports Recent Progress and Second Quarter 2023 Financial Results

Retrieved on: 
Monday, July 31, 2023

(Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.

Key Points: 
  • (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported financial results for the quarter ended June 30, 2023.
  • Research and development expenses were $50.1 million for the quarter ended June 30, 2023 compared to $51.4 million for the quarter ended June 30, 2022.
  • Selling, general and administrative expenses were $36.4 million for the quarter ended June 30, 2023 compared to $23.8 million for the quarter ended June 30, 2022.
  • Net loss for the second quarter of 2023 was $4.2 million, or $0.02 per share, compared to a net loss of $62.0 million, or $0.24 per share, for the second quarter of 2022.

Pixium Vision announces the agreement to extend the maturity date of the outstanding notes associated with the terminated ESGO financing facility

Retrieved on: 
Tuesday, July 11, 2023

On February 13, 2023, Pixium Vision announced the termination of the convertible note financing agreement signed with ESGO on July 13, 2022, for a maximum total frame of €30 million.

Key Points: 
  • On February 13, 2023, Pixium Vision announced the termination of the convertible note financing agreement signed with ESGO on July 13, 2022, for a maximum total frame of €30 million.
  • Pixium Vision drew a first tranche of 550 notes amounting to €5.5 million on July 13, 2022 with a maturity of one year.
  • To date, 125 notes amounting to €1.25 million remain outstanding to be converted by ESGO or repaid by Pixium Vision for their nominal value if not converted by ESGO before their maturity date.
  • Pixium Vision and ESGO mutually agreed to extend the maturity date of these outstanding notes to January 13, 2024.

Pixium Vision announces receipt of € 1.8 million from the French Government as Research Tax Credit

Retrieved on: 
Thursday, June 8, 2023

This cash injection will help extend the company’s cash runway until the end of September 2023, providing more flexibility to pursue its longer-term funding needs to support its strategic ambitions.

Key Points: 
  • This cash injection will help extend the company’s cash runway until the end of September 2023, providing more flexibility to pursue its longer-term funding needs to support its strategic ambitions.
  • Furthermore, Pixium Vision announces participation at the Octane Ophthalmology Tech Forum.
  • Lloyd Diamond, Chief Executive Officer of Pixium Vision, will give an in-person presentation - Registration for the conference is open here .
  • In May 2023 Edision published an updated investment research report after the announcement of the annual report of Pixium Vision for 2022, the receipt of the Breakthrough Device Designation in the US and the subsequent conversion of ESGO, valuing Pixium Vision at €140 million.