On May 29, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported initial data from the Phase 1 MINOTAUR study evaluating lunresertib (RP-6306) in combination with FOLFIRI for the treatment of advanced solid tumors has been selected for a poster presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal (GI) Cancers Congress 2024, being held June 26-29 in Munich, Germany (Press release, Repare Therapeutics, MAY 29, 2024, View Source [SID1234643831]).

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!

Details for the poster presentation are as follows:

Title: Phase 1 Study of the PKMYT1 Inhibitor Lunresertib (Lunre) in Combination with FOLFIRI in Advanced Gastrointestinal (GI) Cancers (MINOTAUR Study)
Speaker: Zev A. Wainberg, David Geffen School of Medicine at UCLA
Presentation Number: 504P
Date and Time: June 27, 2024 at 3:35 PM CEST

On May 29, 2024 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, reported that at a special meeting of its shareholders (the "Shareholders"), held virtually earlier today, the Shareholders voted in favour of the resolution to approve the previously announced plan of arrangement with a wholly-owned subsidiary of AstraZeneca under the Canada Business Corporations Act pursuant to which AstraZeneca will acquire all of the issued and outstanding shares of Fusion (the "Arrangement") (Press release, Fusion Pharmaceuticals, MAY 29, 2024, View Source [SID1234643782]).

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!

As of the close of business on April 16, 2024, the record date of the special meeting, there were approximately 84,965,608 shares issued and outstanding and entitled to vote. A total of 68,678,602 shares were voted at the special meeting representing approximately 80.83% of the issued and outstanding shares as of the record date.

The Arrangement was approved, receiving the required affirmative vote of (i) 99.92% of the votes cast by the Shareholders, voting as a single class, present in person or represented by proxy and entitled to vote at the special meeting and (ii) 99.92% of the votes cast by the Shareholders, present in person or represented by proxy and entitled to vote at the special meeting, after excluding the votes of those Shareholders whose votes are required to be excluded under Multilateral Instrument 61-101—Protection of Minority Security Holders in Special Transactions.

The formal report on voting results with respect to all matters voted upon at the meeting will be filed under Fusion’s profile on SEDAR+ at www.sedarplus.com.

The arrangement is subject to court approval, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the transaction is expected to be completed in the second quarter of 2024.

On May 29, 2024 Scorpius Holdings, Inc (NYSE American: SCPX) (‘Scorpius" or "the Company"), an integrated contract development and manufacturing organization ("CDMO"), reported strategic, financial, and operational updates for the first quarter ended March 31, 2024 (Press release, Scorpius BioManufacturing, MAY 29, 2024, View Source [SID1234643799]).

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!

Jeff Wolf, CEO of Scorpius Holdings, Inc., stated, "We are successfully executing our strategy to enhance revenue and reduce costs as we seek to become cash flow positive in the near future. This quarter is indicative of this goal as we achieved a 359% increase in revenue while reducing operating expenses by 34% over the same period last year. We believe this performance reinforces the growing demand for our services and our prudent financial management. Moreover, we have built a highly scalable business model poised to generate meaningful cash flow as we continue to grow our sales and increase utilization of our state-of-the-art San Antonio campus, which we anticipate will allow us to achieve meaningful operating leverage. We are very confident that the future for Scorpius is brighter than ever, with significant industry-wide capacity shortages, and our growing revenue backlog, which stood at $10.8 million as of March 31, 2024."

2023 Financial Results

For the three months ended March 31, 2024, the Company recognized $3.5 million of revenue from process development. For the three months ended March 31, 2023, the Company recognized $0.7 million of process development revenue and $0.1 million of license revenue. The increase in process development revenue was attributable to the expanded biomanufacturing operations and service offerings of the CDMO.

Cost of revenues were $0.9 million and $0.6 million for the three months ended March 31, 2024, and 2023, respectively, and primarily consisted of the direct cost of labor, overhead and material costs at Scorpius. The increase in cost of revenues was due to the expanded service offerings and completed milestone work on multiple CDMO contracts.

Research and development expenses were $3.9 million for the three months ended March 31, 2024, compared to $6.3 million for the three months ended March 31, 2023.

Selling, general and administrative expenses were $5.0 million and $6.5 million for the three months ended March 31, 2024, and 2023, respectively. The decrease of $1.5 million was primarily due to decreases in marketing expense of $0.5 million, consultant labor of $0.5 million, and stock-based compensation of $0.5 million.

For the three months ended March 31, 2024, the change in fair value of contingent earn-out receivable, related party, was $1.0 million. This change was primarily due to an increase in expected value of the earn-out due to a new contract received by Elusys Therapeutics.

Total non-operating income was $0.7 million for the three months ended March 31, 2024, which primarily consisted of $1.0 million from the sale of an intellectual property license, partially offset by $0.2 million of interest expense on finance leases, and $0.1 million change in fair value of convertible promissory note, related party. Total non-operating income was $0.1 million for the three months ended March 31, 2023, which primarily consisted of $0.2 million of interest income, $0.1 million of unrealized gain on short-term investment balances, partially offset by $0.2 million of interest expense on finance leases and other expense.

Net loss attributable to Scorpius was approximately $4.4 million, or ($0.16) per basic and diluted share, for the three months ended March 31, 2024, compared to approximately $12.8 million, or ($0.49) per basic and diluted share, for the three months ended March 31, 2023.

As of March 31, 2024, the Company had approximately $1.7 million in cash, cash equivalents, and short-term investments. On May 16, 2024, the Company consummated a public offering resulting in aggregate gross proceeds of approximately $6.0 million, before deducting underwriting discounts and other offering expenses.

On May 29, 2024 Biohaven Ltd. (NYSE: BHVN) (Biohaven), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported the first patient has been dosed in a first-in-human Phase 1/2 study of BHV-1510, a highly differentiated Trophoblast Cell Surface Antigen-2 (Trop-2) directed Antibody Drug Conjugate (ADC), and the lead ADC program to advance into clinical trials in Biohaven’s growing oncology pipeline (Press release, Biohaven Pharmaceutical, MAY 29, 2024, View Source [SID1234643816]).

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 Phase 1/2 study of BHV-1510 is a multicenter, open-label study in subjects with select advanced or metastatic epithelial cell tumors. The trial consists of a dose-escalation phase, followed by a multicohort expansion phase. Additional information can be found at View Source (NCT06384807).

"We are extremely proud to advance our first oncology clinical program with a potentially best in class ADC," said Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven. "With the initiation of this monotherapy study, we are one step closer to providing differentiated and superior treatment options to people living with cancer. We are also excited to work with Regeneron and efficiently explore BHV-1510 in combination with its PD-1 inhibitor Libtayo across a range of tumors."

BHV-1510 is a next-generation, fully optimized ADC that consists of a Trop-2 directed antibody conjugated to a proprietary best-in-class Topoisomerase 1 (TopoIx) payload at a homogeneous drug-antibody ratio (DAR) of 4. BHV-1510 incorporates a unique site-specific conjugation methodology and highly stable and irreversible linker chemistry designed by GeneQuantum Healthcare Co. (Suzhou) Ltd. Preclinically BHV-1510 has shown superior cellular cytotoxicity, bystander killing, and immunogenic cell death resulting in improved efficacy as monotherapy, and synergistic efficacy in combination with anti-PD-1 therapy. In IND-enabling studies, BHV-1510 also showed a broader therapeutic margin relative to more advanced Trop-2 ADCs, including a lack of lung toxicity, that may translate to an improved clinical efficacy and safety profile.

Shiraj Sen M.D., Ph.D., Director of NEXT Oncology-Dallas, commented, "Antibody drug conjugates have shown promising efficacy in solid tumors, but their clinical potential is currently limited by their safety margin. BHV-1510 has compelling and differentiated preclinical data, with the potential to translate to better safety and efficacy in several tumors including those with significant unmet need. We are excited to be working with the Biohaven team on this important clinical trial for patients with advanced epithelial tumors."

Biohaven entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) under which Biohaven will sponsor and fund the planned clinical trial and Regeneron will provide Libtayo. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1).

Brian Lestini, M.D., Ph.D., President of Oncology at Biohaven stated, "Biohaven’s ADC technology and portfolio has the potential to differentiate from current ADCs in the market that use older payloads or maleimide linkers. The advancement of our lead ADC program, BHV-1510, into clinic as both monotherapy and in combination with Regeneron’s anti-PD-1 represents an important first opportunity to show the breadth and differentiation of Biohaven’s extensive ADC pipeline. Coupled with our deep in-house expertise in oncology clinical development, ADC chemistry, and complex manufacturing, we believe our diverse and growing ADC portfolio positions Biohaven for future leadership in oncology."

Biohaven is developing a broad portfolio of highly differentiated ADCs with the potential to broaden therapeutic margin, increase time on treatment, and improve efficacy. Biohaven’s proprietary MATE platform technology focuses on novel, single-step conjugation chemistry, with the potential to be superior to the current industry standard maleimide and lipophilic click chemistry.

On May 29, 2024 Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; "PMV Pharma") reported a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation (Press release, Foundation Medicine, MAY 29, 2024, View Source [SID1234643833]).

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!

Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases.1 Historically, TP53 mutations have been considered undruggable despite its prevalence across cancers.2 TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors.3 PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.

"The innovative science driven by PMV Pharma’s efforts specific to TP53 Y220C has the potential to offer a new therapeutic option for patients in this area of high unmet medical need," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to provide our high-quality tissue-based genomic test, along with real-world data from our Flatiron Health-Foundation Medicine Clinico-Genomic Database, to support PMV Pharma as they develop this exciting new treatment option."

Rezatapopt (PC14586) is an investigational, first-in-class, selective p53 reactivator designed to stabilize p53 Y220C proteins. The TP53 Y220C mutation creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA. Rezatapopt is an orally available small molecule designed to selectively bind to a pocket in the p53 Y220C protein, leading to the restoration of the wild-type p53 tumor suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and is the subject of the ongoing registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial. For more information about the Phase 2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If the CDx and separately the therapy are approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.