On November 5, 2024 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the third quarter of 2024 and provided an update on recent business progress (Press release, Nuvectis Pharma, NOV 5, 2024, View Source [SID1234647735]).

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!

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "In the third quarter we continued to advance the development programs of NXP800 and NXP900. For NXP800, we anticipate the upcoming clinical data update from the Phase 1b study in platinum-resistant, ARID1a-mutated ovarian cancer this month. In addition, we obtained a second Orphan Drug Designation for NXP800 from the FDA, for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers." Mr. Bentsur continued, "For NXP900, we have cleared 4 cohorts in the dose escalation Phase 1 study so far with no reports of dose limiting toxicities, and the dose escalation continues. In parallel, we are solidifying our plans for the next stage of development with both single agent and combination approaches to unlock the full therapeutic potential of NXP900, especially in non-small cell lung cancer in combination with currently approved targeted therapies to overcome acquired resistance to such therapies". Mr. Bentsur concluded, "Finally, we continue to be responsible and efficient with our financial resources and believe that our current cash position will allow us to meet important milestones for both clinical programs and provide working capital well into 2026."

Third Quarter 2024 Financial Results

Cash, cash equivalents, and short-term investments were $17.2 million as of September 30, 2024, compared to $19.1 million as of December 31, 2023. The decrease of approximately $2.0 million was primarily a result of the operating expenses for the quarter, partially offset by the utilization of the at-the-market facility.

The Company’s net loss was $4.2 million for the three months ended September 30, 2024, compared to $5.9 million for the three months ended September 30, 2023. The net loss for the three months ended September 30, 2024, included $1.2 million in non-cash expenses related to stock-based compensation, and $0.5 million in one-time development costs in connection with NXP800 and NXP900.

Research and development expenses were $2.8 million for the three months ended September 30, 2024, compared to $4.5 million for the three months ended September 30, 2023.

General and administrative expenses were $1.5 million for the three months ended September 30, 2024, compared to $1.7 million for the three months ended September 30, 2023.

On November 5, 2024 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized neoantigen cancer immunotherapies, reported further promising data from the fully enrolled Phase 1b/2 study evaluating NOUS-209 for its potential to ‘intercept’ cancer in Lynch Syndrome (LS) carriers (Press release, NousCom, NOV 5, 2024, View Source;utm_medium=rss&utm_campaign=nouscoms-off-the-shelf-neoantigen-immunotherapy-nous-209-continues-to-elicit-potent-and-durable-immune-responses-in-lynch-syndrome-carriers-highlighting-its-potential-to-intercept [SID1234647734]).

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!

These updated data demonstrate that NOUS-209 monotherapy induces potent, broad and durable immune responses in all LS carriers evaluated and continues to be well-tolerated with no treatment-related serious adverse events reported. The new data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Houston, TX, USA on Saturday 9th November 2024.

NOUS-209 is an off-the-shelf immunotherapy encoding 209 neoantigens that are shared across both sporadic and hereditary deficient Mismatch Repair (dMMR) / Microsatellite Instable (MSI) tumors. LS carriers have a high-risk, genetic predisposition to developing MSI tumors such as colorectal cancer (CRC) and other types of life-threatening cancers, including endometrial, gastric and ovarian. Once diagnosed, people with LS undergo intensive and invasive surveillance programs that may include pre-emptive surgery but otherwise have no approved treatment options available.

In the ongoing Phase 1b/2 trial evaluating NOUS-209 as a monotherapy (NCT05078866), immune responses were evaluated in 23 LS carriers. NOUS-209 monotherapy continued to be safe, well tolerated and to generate potent immunogenic CD4 and CD8 T cell responses in all 23 participants. T cell responses were shown to be potent, broad and durable against multiple neoantigens encoded within NOUS-209. These data continue to support future clinical development of NOUS-209 as a valuable intervention for intercepting cancer in LS carriers.

Final data from the Phase 1b/2 study are expected to be available in mid-2025 and discussions with regulators regarding the future clinical development of NOUS-209 in LS carriers are underway.

The study is led by researchers at The University of Texas MD Anderson Cancer Center, in collaboration with the Cancer Prevention Clinical Trials Network and sponsored by the National Cancer Institute (grant # UG1CA242609).

"Lynch Syndrome affects about one in 300 people, making it one of the most common hereditary cancer syndromes. Vaccine development is a significant step forward for the LS community, which currently relies on routine screening tools for cancer prevention", said the study’s principal investigator, Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Clinical Cancer Prevention at MD Anderson. "The updated data further suggest that cancer interception may be possible and that NOUS-209 has the potential to become an important intervention for people with LS, who face an elevated risk of developing life-threatening cancers, such as colorectal, gastric, and endometrial."

Dr. Elisa Scarselli, Chief Scientific Officer of Nouscom, added: "These exciting data substantially reinforce those first presented in a late-breaking oral abstract presentation at SITC (Free SITC Whitepaper) last year1, and further highlight the ability of NOUS-209 monotherapy to safely and effectively induce long-lasting immune responses in Lynch Syndrome carriers. This strengthens our belief that the immune system can be primed to intercept pre-malignant lesions and prevent the development of MSI tumors. We greatly appreciate the contribution and dedication of our collaborators at the US National Cancer Institute, clinical investigators and LS carriers who participated in this trial, all of whom share our commitment to intercept cancer."

Dr. Marina Udier, Chief Executive Officer of Nouscom, commented: "The data we are seeing from the Phase 1b/2 trial with NOUS-209 as a monotherapy in Lynch Syndrome carriers are extremely encouraging. Together with the previously published positive Phase 1 data of NOUS-209 in combination with pembrolizumab in dMMR/MSI cancers, and our ongoing randomized Phase 2 trial of NOUS-209, also in combination with pembrolizumab in dMMR/MSI metastatic CRC, NOUS-209 has demonstrated induction of powerful neoantigen-specific immune responses. These responses could lead to clinical benefits and highlight the transformative potential of NOUS-209, from cancer interception to treatment of metastatic disease2,3.

"Primary data read-outs from both the randomized Phase 2 trial in MSI mCRC and the Phase 1b/2 trial in LS are expected by mid-2025. We are excited to plan the future clinical development for NOUS-209 including a path towards registration."

Details of the poster presented at SITC (Free SITC Whitepaper) 2024 are as follows:

Title: Nous-209 vaccine induces shared neoantigen immunogenicity for cancer interception in healthy Lynch Syndrome carriers: results from Phase Ib/II trial
Number: 638
Date: Saturday, 9th November 2024
Session: Clinical Trials in Progress
Presenter: Dr. Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Clinical Cancer Prevention at MD Anderson

The abstract can be viewed on SITC (Free SITC Whitepaper)’s website.

On November 5, 2024 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and announced financial results for the quarter ended September 30, 2024 (Press release, MacroGenics, NOV 5, 2024, View Source [SID1234647733]).

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 pending MARGENZA transaction as well as the recently received milestone payment from Incyte further solidify our financial position, enabling us to remain focused on advancing our pipeline of innovative product candidates. In that regard, we are pleased to have submitted the IND for MGC028, our next topoisomerase I inhibitor-based ADC, and look forward to commencing the dose escalation study in the coming months," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "The advancement of our expanding clinical portfolio continues to create data read-out opportunities in the near future."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation.

•The TAMARACK Phase 2 study of vobra duo is being conducted in patients with metastatic castration-resistant prostate cancer (mCRPC). While study participants are no longer being dosed in the study, participants continue to be monitored for adverse events, disease progression and survival.

•The Company presented interim results from the TAMARACK study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024 and expects to have mature median radiographic progression-free survival (rPFS) data in hand no later than early 2025.

•Assessment of future development alternatives for vobra duo will be based on several factors, including the final TAMARACK safety and efficacy data in mCRPC, a review of the competitive treatment landscape for mCRPC, resource allocation across the Company’s clinical portfolio as well as potential partnering opportunities for vobra duo. Until MacroGenics completes its assessment of the monotherapy development opportunity for vobra duo in mCRPC, the Company has paused its other development efforts in alternative tumor types as well as the Phase 1/2 dose combination study of vobra duo plus lorigerlimab.

Emerging ADC Pipeline

•MGC026 is a clinical B7-H3-targeting ADC that is site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza company). With distinct mechanisms of action and potentially different safety/efficacy profiles, vobra duo and MGC026 may address different cancers, tumor stages, or be used in combination with alternate agents — or potentially with one another — to enhance their clinical utility. A Phase 1 dose escalation study of MGC026 in patients with advanced solid tumors is ongoing.

•MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that incorporates Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease domain 9) is a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment. The Company submitted an IND application for MGC028 to the U.S. Food and Drug Administration (FDA) in October.

Lorigerlimab

•Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule. This bispecific checkpoint molecule is being evaluated in the ongoing LORIKEET trial, a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC patients. The current trial design includes a primary study endpoint of rPFS. A total of 150 patients are planned to be treated in the 2:1 randomized study, with more than 100 study participants enrolled to date. The Company anticipates completing enrollment of the study in late 2024 or early 2025 and providing a clinical update on the study in the first half of 2025.

Partnered Programs

•MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing. MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. Under an October 2022 exclusive option and collaboration agreement, Gilead Sciences, Inc. has the option to license MGD024 at predefined decision points during the Phase 1 study.

•ZYNYZ (retifanlimab-dlwr) is a humanized monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. Incyte announced positive Phase 3 top-line results for its registrational studies of retifanlimab in squamous cell carcinoma of the anal canal and non-small cell lung cancer in July 2024 and continues to conduct global studies of retifanlimab across multiple indications.

During the quarter ended September 30, 2024, MacroGenics announced the achievement of $100.0 million in milestones from Incyte related to development progress of retifanlimab, following an agreement on July 24, 2024, pursuant to which certain milestones were deemed to have been met.

•MARGENZA (margetuximab-cmkb) global rights will be sold to TerSera Therapeutics LLC (TerSera), a privately-held biopharmaceutical company with a focus on oncology and non-opioid pain management, pursuant to an agreement previously announced. TerSera is expected to pay MacroGenics $40.0 million at closing and MacroGenics may receive additional sales milestone payments of up to an aggregate of $35.0 million. The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions. MacroGenics expects to pay an $8.0 million amendment fee to its current commercialization partner during the fourth quarter of 2024. MacroGenics will manufacture MARGENZA drug substance on behalf of TerSera going forward.

Third Quarter 2024 Financial Results
•Cash Position: Cash, cash equivalents and marketable securities balance as of September 30, 2024, was $200.4 million, compared to $229.8 million as of December 31, 2023. The September 30, 2024, balance did not include the $40.0 million upfront payment anticipated from the closing of the MARGENZA transaction.

•Revenue: Total revenue was $110.7 million for the quarter ended September 30, 2024, compared to total revenue of $10.4 million for the quarter ended September 30, 2023. The increase was primarily due to $100.0 million in milestones received under the Incyte License Agreement in August.
•R&D Expenses: Research and development expenses were $40.5 million for the quarter ended September 30, 2024, compared to $30.1 million for the quarter ended September 30, 2023. The increase was primarily due to increased research and development costs related to the Company’s preclinical ADC pipeline, vobra duo and the TAMARACK clinical trial.

•SG&A Expenses: Selling, general and administrative expenses were $14.1 million for the quarter ended September 30, 2024, compared to $12.4 million for the quarter ended September 30, 2023. The increase was primarily due to increased stock-based compensation expense and professional fees.
•Net Income: Net income was $56.3 million for the quarter ended September 30, 2024, compared to net income of $17.6 million for the quarter ended September 30, 2023. Net income for the quarter ended September 30, 2024, included $100.0 million in milestones received from Incyte in August related to retifanlimab. Net income for the quarter ended September 30, 2023, included a $50.0 million milestone payment from Sanofi S.A. related to the previously disclosed achievement of a primary endpoint in a TZIELD clinical study, which was recorded in other income.

•Shares Outstanding: Shares of common stock outstanding as of September 30, 2024 were 62,763,120.
•Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $200.4 million as of September 30, 2024, plus the $40.0 million upfront payment anticipated from TerSera related to the MARGENZA transaction, less an $8.0 million amendment fee to be paid to the Company’s current commercialization partner, in addition to projected and anticipated future payments from partners should support its cash runway into 2026. The Company’s expected funding requirements reflect anticipated expenditures related to the completion of the Phase 2 TAMARACK and LORIKEET clinical trials, as well as MacroGenics’ other ongoing clinical and preclinical studies.
Conference Call Information
To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

On November 5, 2024 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies, reported that an abstract highlighting initial clinical data from the Phase 1-2 study of IMPT-314 in large B-cell lymphoma will be presented by Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in San Diego, CA, December 7 – 10, 2024 (Press release, Lyell Immunopharma, NOV 5, 2024, View Source [SID1234647732]). IMPT-314 is a dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate being developed for patients with aggressive B-cell non-Hodgkin’s lymphoma.

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!

IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory aggressive B-cell lymphoma.

Details of the presentation are below:

First Results of IMPT-314, an Autologous Bispecific CD19/CD20 Chimeric Antigen Receptor (CAR) in Enriched Naive and Central Memory T Cells, for the Treatment of Large B Cell Lymphoma (LBCL)

Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster III
Publication Number: 4824
Presentation Date & Time: Monday, December 9, 2024, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Halls G-H

On November 5, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that two abstracts highlighting clinical data from the KOMET-007 combination trial of ziftomenib, the Company’s potent and selective menin inhibitor, have been accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, to be held in San Diego from December 7-10, 2024 (Press release, Kura Oncology, NOV 5, 2024, View Source [SID1234647731]).

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!

KOMET-007 is a multicenter Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine plus daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data presented at ASH (Free ASH Whitepaper) will be from the Phase 1a dose-escalation portion of the study, which was conducted in newly diagnosed patients with adverse risk in combination with 7+3 and in relapsed/refractory patients with ven/aza. Notably, all four cohorts in the Phase 1a dose-escalation portion of KOMET-007 have cleared the highest dose and have advanced into the Phase 1b expansion study at 600 mg.

"The growing body of clinical data continue to support a potential best-in-class safety and tolerability profile for ziftomenib, as well as robust and durable activity in combination with standards of care," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "In the relapsed/refractory AML setting, ziftomenib combined with ven/aza is well tolerated and continues to demonstrate encouraging activity in R/R patients, including activity in previously ven-exposed NPM1-m and KMT2A-r patients. No DLTs or ziftomenib-induced QTc prolongation were reported, and events of differentiation syndrome were mitigated in combination."

"In the AML frontline population, we are very encouraged by the safety and tolerability profile and high rates of complete response and MRD negativity as of the abstract’s June 21st data cutoff," Dr. Wilson continued. "We are particularly encouraged by the fact that, in the context of the very challenging 7+3 adverse risk AML patient cohorts, 100% (15/15) of the NPM1-m AML patients and 84% (16/19) of the KMT2A-r patients remained on study as of the data cutoff, approximately one year after study start. These preliminary results support the potential for ziftomenib to transform the standard of care in these high-risk patients. We look forward to sharing a more mature dataset from more than 100 patients, including data from the 600 mg cohorts, in the Phase 1a dose-escalation portion of KOMET-007, at the ASH (Free ASH Whitepaper) Annual Meeting next month."

Session titles and information for the two abstracts are listed below and are now available on the ASH (Free ASH Whitepaper) online itinerary planner.

Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Session: 616. AML: Investigational Drug & Cellular Therapies: Menin Inhibitors in AML
Date and Time: Saturday, December 7, 2024; 2:00 – 3:30 PM PT
Oral Presentation Time: 2:45 PM PT
Location: San Diego Convention Center, Ballroom 20CD
Publication Number: 214

Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET 007
Session: 616. AML: Investigational Drug & Cellular Therapies: Poster II
Date and Time: Sunday, December 8, 2024; 6:00 PM – 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 2880

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.