On October 18, 2023 Patrys reported that data from preclinical studies using PAT-DX1 and PAT-DX3 in animal models of high grade glioma will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Brain Cancer in Minneapolis, Minnesota (Press release, Patrys, OCT 18, 2023, View Source [SID1234636117]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster, titled "A novel lupus-associated antibody that inhibits the growth of aggressive high-grade glioma orthotopic xenografts and enhances radiotherapy via a unique mechanism" describes research conducted by Professor Terrance Johns from the Telethon Kids Cancer Centre in Perth confirming the single agent activity of both PAT-DX1 and PAT-DX3 in animal models of high grade glioma, as well as the significant survival benefits from combining PAT-DX1 with a therapeutic dose of radiation.

Professor Terrence Johns said:

"I am excited to present our findings with PAT-DX1 and PAT-DX3 at the AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Brain Cancer. Through my partnership with Patrys we have demonstrated both antibodies reach and inhibit the growth of intracranial brain cancers in rodent models. Significantly, we have shown that PAT-DX1 dramatically enhances the activity of radiotherapy, which is the standard of care for many forms of brain cancer."

On October 18, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the pricing of its underwritten public offering of 8,333,334 shares of its common stock at a price to the public of $30.00 per share (Press release, Ultragenyx Pharmaceutical, OCT 18, 2023, View Source [SID1234636115]). In addition, in lieu of issuing common stock to certain investors, the company is offering pre-funded warrants to purchase 1,666,722 shares of its common stock at a purchase price of $29.999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant. The aggregate gross proceeds to the company from this offering is expected to be $300 million, before deducting underwriting discounts and commissions and other offering expenses, and excluding the exercise of any pre-funded warrants. In addition, the company has granted the underwriters of the offering an option for a period of 30 days to purchase up to an additional 1,500,000 shares of the company’s common stock at the public offering price, less the underwriting discount.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering is expected to close on or about October 23, 2023, subject to satisfaction of customary closing conditions. J.P. Morgan, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 12, 2021. This offering is being made solely by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at prospectus- [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Securities, NC1-002-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 18, 2023 Supernus Pharmaceuticals presented its corporate presentation (Presentation, Supernus, OCT 18, 2023, View Source [SID1234636114]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 18, 2023 Prescient Therapeutics (ASX:PTX) reported that its abstract for the results of a Phase 1b study in T-cell lymphomas has been accepted for poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December (Press release, RAPT Therapeutics, OCT 18, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-two-flx475-presentations-society [SID1234636112]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The meeting is the largest and most comprehensive hematology conference in the world.

Prescient Therapeutics managing director and CEO, Steven Yatomi-Clarke, said, "It is a huge honour to have our abstract presented at the world’s most prestigious haematology conference. This is a validation of the quality and relevance of the clinical data we are generating in T-cell lymphomas, which is an area of unmet clinical need. It is also a testament to the hard work by the Prescient team and our clinical collaborators.

"Prescient looks forward to presenting this data at ASH (Free ASH Whitepaper) and will release this data to the market concurrently."

On October 18, 2023 PharmaMar (MSE:PHM) reported that it will present new data on lurbinectedin in Small Cell Lung Cancer (SCLC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, being held in Madrid from October 20-24th (Press release, PharmaMar, OCT 18, 2023, View Source [SID1234636111]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Among the most outstanding studies will be an oral presentation by Dr. Antonio Calles, where final data from the LUPER trial of lurbinectedin in combination with pembrolizumab (immunotherapy) in second-line SCLC will be presented. The presentation called "Lurbinectedin (LUR) in combination with pembrolizumab (PBL) in relapsed small cell lung cancer (SCLC): the phase 1/2 LUPER study" concludes that the combination of lurbinectedin and pembrolizumab is an effective second-line treatment for SCLC in patients who did not receive prior immunotherapy, achieving in some cases deep and durable responses, with a manageable safety profile and no new emerging signs of toxicity when combining the two drugs.

Dr. Antonio Calles, Specialist in Medical Oncology at the Hospital General Universitario Gregorio Marañón, Madrid, Spain, who has led the study, comments "the combination represents an opportunity for those patients with metastatic SCLC, who could not be treated with first-line immunotherapy. The treatment achieved a confirmed response rate of 46.4%, including deep and durable responses that exceeded one year in some patients. Median Progression-Free Survival (PFS) was significantly longer for platinum-sensitive patients compared to platinum-resistant patients, with a PFS of 10 versus3 months, respectively. Currently, the only treatment other than lurbinectedin approved for this indication in the last 2 decades, has a response rate of only ~20% and a PFS of 4 months, in addition to very significant toxicity. However, here we saw no unexpected side effects both drugs could be safely combined at full doses".

Dr. Ali Zeaiter, Vice President and Head of Clinical Development at PharmaMar said: "We are pleased to present new data on the combination of lurbinectedin with immunotherapy. We believe that these data, with the suggested improvements in patients’ outcomes, confirm once again that lurbinectedin is an important treatment option for relapsed SCLC and support the ongoing investigation of lurbinectedin combination with immunotherapy".

In addition to the above presentation, the study entitled "A randomised, multicenter phase-III study comparing doxorubicin (dox) alone versus dox with trabectedin (trab) followed by trab in non-progressive patients (pts) as first-line therapy, in pts with metastatic or unresectable leiomyosarcoma (LMS): Final results of the LMS-04 study" will show the final Overall Survival (OS) data for the combination of doxorubicin and trabectedin of 33.1 months versus 23.8 months for doxorubicin alone. These data confirm that this is the first drug combination that is able to demonstrate benefit in both PFS and OS in a phase III trial in first-line treatment of metastatic leiomyosarcoma. These data have supported further the rationale of also studying lurbinectedin in sarcoma.

Lead investigator, Dr. Patricia Pautier, from the Institut Gustave Roussy in Villejuif, Paris, France, comments "the final results were positive with a median progression-free survival (PFS) statistically improved from 6.2 months with doxorubicin alone to 12.2 months with the combination."

PharmaMar’s abstracts at ESMO (Free ESMO Whitepaper) 2023

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) Lurbinectedin (LUR) in combination with pembrolizumab (PBL) in relapsed small cell lung cancer (SCLC): the phase 1/2 LUPER study Dr. Antonio Calles Mini oral presentation ABSTRACT: 1989MO DATE: Saturday, October 21st, 14:50 – 14:55 CET
Lurbinectedin (LRB) pharmacokinetics (PK) and safety when co-administered with itraconazole (ITZ) in patients with advanced solid tumor Dra. Irene Moreno ABSTRACT: 679P DATE: Monday, October 23rd
Supportive measures to control myelosuppression and costs for patients with SCLC with lurbinectedin, CAV or topotecan with or without trilaciclib: a review on the basis of clinical trials Dr. Manuel Domine ABSTRACT: 2024P DATE: Saturday, October 21st
Yondelis (trabectedin) A randomised, multicenter phase-III study comparing doxorubicin (dox) alone versus dox with trabectedin (trab) followed by trab in non-progressive patients (pts) as first-line therapy, in pts with metastatic or unresectable leiomyosarcoma (LMS): Final results of the LMS-04 study Patricia Pautier Proffered Paper presentation ABSTRACT: #2965 DATE: Sunday, October 22nd, 08:30-10:00 CET
TOMAS2: a randomized phase 2 study from the Italian Sarcoma Group (ISG) of trabectedin plus olaparib (T+O) or trabectedin (T) in advanced, metastatic, or unresectable soft tissue sarcomas (STS) after failure of standard treatments. Lorenzo D’Ambrosio Proffered Paper presentation ABSTRACT: #4076 DATE: Sunday, October 22nd, 08:30-10:00 CET.
Tolerability and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in elderly patients with ovarian cancer (OC) – GEICO 105-O Study María Jesús Rubio ABSTRACT: 770P DATE: Sunday, October 22nd
Trabectedin plus radiotherapy on symptomatic advanced sarcoma patients, results from the SYNERGIAS study: a Spanish group for research in sarcoma (GEIS) phase II study Javier Martin Broto ABSTRACT: 1926P DATE: Monday, October 23rd
Targeting Microenvironment and Cellular Immunity in Sarcomas with Trabectedin Combined With Metronomic Cyclophosphamide: The TARMIC study Cheng-Ming Su ABSTRACT: 1924P DATE: Monday, October 23rd