On March 26, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that it presented data from its PRECISION 1 and AMPECT trials in two posters at the Society of Gynecological Oncology (SGO) Annual Meeting 2023, taking place March 25-28, 2023, in Tampa, FL (Press release, Aadi Bioscience, MAR 26, 2023, View Source [SID1234629340]).

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!

"We are pleased to present additional data with nab-sirolimus from our AMPECT trial and highlight our PRECISION 1 trial at SGO 2023, which is the premier medical meeting focused on advancing research for gynecologic cancer," said Loretta Itri, MD., Chief Medical Officer of Aadi Bioscience.

The details of the poster presentations are below:

Title: "Phase 2, multicenter, open-label basket trial of nab-sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes (PRECISION I)"
Date and Time: Sunday, 3/26/2023, 2:00-3:00 PM
Session: Poster Session 1
Poster Number: 401

Title: "Response to treatment with nab-sirolimus among patients with primary uterine PEComa: A sub analysis from AMPECT"
Date and Time: Sunday, 3/26/2023, 2:00-3:00 PM
Session: Poster Session 1
Poster Number: 327

The Society of Gynecological Oncology Annual Meeting on Women’s Cancer is the premier educational and scientific event for those who treat and care for women with gynecologic cancer. Abstracts and full session details are available through the SGO Annual Meeting planner: Annual Meeting on Women’s Cancer | SGO.

The SGO posters are available on the investor relations page of the Aadi website at www.aadibio.com

On March 25, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported final overall survival data and an evaluation of sequence of therapy in the pivotal SORAYA trial of mirvetuximab soravtansine in patients with folate receptor alpha-high platinum-resistant ovarian cancer who had been previously treated with bevacizumab will be presented by Dr. Robert Coleman in a plenary session on Saturday, March 25, at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting in Tampa, Florida (Press release, ImmunoGen, MAR 25, 2023, View Source [SID1234629338]).

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!

Oral Presentation Details
Title: Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer with High Folate Receptor Alpha Expression: Evaluation of Sequence of Therapy on Anti-Tumor Activity in the SORAYA Study
Session: Scientific Plenary I: Progress: Therapeutics Innovations
Session Date: Saturday, March 25, 2023
Session Time: 9:00 am to 10:30 am ET

Additional information can be found at www.sgo.org.

On March 24, 2023 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel (Press release, Iovance Biotherapeutics, MAR 24, 2023, View Source [SID1234629381]). Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.

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!

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options."

The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting with the FDA, Iovance is pursuing accelerated approval in this indication. Iovance also reached agreement with the FDA regarding the registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting. Startup activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for lifileucel in advanced post-anti-PD-1 melanoma.

Marc Hurlbert, Ph.D., CEO of the Melanoma Research Alliance (MRA), said, "MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people with advanced melanoma who have progressed following prior treatments. We hope for an FDA approval as quickly as possible for patients with significant unmet need who have no approved treatment options."

Following receipt of the complete rolling BLA submission for lifileucel, the FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA to the FDA on an ongoing basis, enabling the FDA to begin review as early as possible as documents were received. The rolling BLA submission and eligibility for priority review are benefits available under the FDA’s guidance on expedited programs for serious conditions, which allow for an expedited six-month review from the time of BLA acceptance. In addition, the FDA previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.

On March 24, 2023 NuCana plc (NASDAQ: NCNA) reported that, following a hearing on March 24, 2023, the Technical Board of Appeal (the "TBA") of the European Patent Office (the "EPO") issued an oral judgement that NuCana’s European Patent 2955190 (the "’190 patent") is not valid (Press release, Nucana BioPharmaceuticals, MAR 24, 2023, View Source [SID1234629346]).

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 TBA reversed the previous decisions of the EPO’s Examination Division which issued NuCana’s ‘190 patent and of the EPO’s Opposition Division which upheld this patent in 2021. In July 2022, the Regional Court of Dusseldorf issued a judgement that fully endorsed the decision of the EPO’s Opposition Division.

The TBA considered a part of Claim 1 of the ‘190 patent to lack an inventive step and did not allow NuCana to overcome this finding by an appropriate amendment of the claims in line with established case law of the EPO. "This aspect of the decision is particularly disappointing," said Dr. Thorsten Bausch, Senior Partner at Hoffmann Eitle, who represented NuCana at the hearing.

This follows on from the judgement of the Patents Court of England and Wales handed down on March 21, 2023 which held that the ‘190 patent was invalid in the UK.

Neither of these decisions affect the patent protection on any of NuCana’s anti-cancer ProTides, which are covered by separate patents that were not involved in this litigation.

Hugh S. Griffith, NuCana’s Founder and CEO, said: "While we are disappointed by these decisions, they do not impact our core business of developing innovative new medicines for the treatment of patients with cancer. NuCana is well-capitalized, all of our clinical programs remain on track and we expect multiple data announcements in 2023."

On March 24, 2023 Mersana Therapeutics, Inc. (the "Company") reported that it has entered into a Fourth Amendment to Loan and Security Agreement (the "Fourth Amendment"), by and among the Company, Oxford Finance LLC, in its capacity as collateral agent (in such capacity, the "Agent") and a lender, Silicon Valley Bridge Bank, N.A. (as the successor in interest to Silicon Valley Bank) as a lender ("SVB"), and the other parties thereto as lenders (collectively, the "Lenders") (Filing, 8-K, Mersana Therapeutics, MAR 24, 2023, View Source [SID1234629345]). The Fourth Amendment further amended that certain Loan and Security Agreement dated as of October 29, 2021 by and among the Company, the Lenders and the Agent (as amended by the First Amendment to Loan and Security Agreement dated as of February 17, 2022, the Second Amendment to Loan and Security Agreement dated as of October 17, 2022 and the Third Amendment to Loan Agreement dated as of December 27, 2022, the "Loan Agreement").

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 Fourth Amendment modified the covenant applicable to the Company’s obligation to maintain Collateral Accounts (as defined in the Loan Agreement) at SVB, which may be a securities account invested in money market mutual funds. Pursuant to the Fourth Amendment, the Company is permitted to conduct its banking activities, including, without limitation, cash management, letters of credit and business credit cards, with financial institutions which are not SVB or SVB’s affiliates. In addition, the Fourth Amendment reduced the minimum amounts that the Company is obligated to maintain in Collateral Accounts at SVB to be the lesser of (i) one hundred five percent (105.00%) of the outstanding principal amount of the Term Loans (as defined in the Loan Agreement) advanced solely by SVB (and for purposes of clarity, no other Lender) and (ii) the dollar value of all Collateral Accounts of the Company and certain of its subsidiaries at all financial institutions.

As of the Amendment Date, this obligation requires the Company to maintain a Collateral Account at SVB with 105% of the $12.5 million borrowed from SVB under the Loan Agreement. The Company did not pay any fees to Lenders in connection with the Fourth Amendment, and the Fourth Amendment did not otherwise modify the Company’s obligations under the Loan Agreement.

The foregoing description of the Fourth Amendment does not purport to be complete and is qualified in its entirety by reference to the Fourth Amendment, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ending March 31, 2023.