- Presentation of interim TAMARACK Part 2 research knowledge: up to date security and preliminary efficacy of vobra duo in mCRPC sufferers
- Convention name scheduled for immediately at 4:30 p.m. ET
ROCKVILLE, Md., Could 09, 2024 (GLOBE NEWSWIRE) — MacroGenics, Inc. MGNX, a biopharmaceutical firm targeted on discovering, growing, manufacturing and commercializing revolutionary antibody-based therapeutics for the therapy of most cancers, immediately supplied an replace on its current company progress and reported monetary outcomes for the quarter ended March 31, 2024.
“We’re very inspired by the interim up to date security and preliminary efficacy knowledge from the TAMARACK research of vobra duo in metastatic castration-resistant prostate most cancers,” stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “We consider this interim knowledge set helps validate our beforehand acknowledged speculation that improved tolerability coupled with compelling organic exercise might be achieved by dose reductions and an extended dosing interval. We consider vobra duo’s organic exercise proven thus far aligns properly with the parameters we outlined on the outset of the research. Primarily based on our analysis of the interim knowledge thus far, we’ve initiated planning actions for a possible Part 3 research that might begin subsequent 12 months. We anticipate sharing ultimate security, efficacy and sturdiness knowledge, together with radiographic progression-free survival knowledge, which is the first endpoint of the research, within the second half of 2024. Moreover, having preliminarily recognized appropriate vobra duo doses in mCRPC within the TAMARACK research, we’ve better confidence within the molecule’s potential to assist sufferers with a broad vary of B7-H3-expressing cancers.”
“The interim security and anti-tumor exercise noticed thus far within the TAMARACK research look very promising for sufferers with metastatic castration-resistant prostate most cancers,” stated Johann DeBono, Regius Professor of Most cancers Analysis and Professor in Experimental Most cancers Drugs at The Institute of Most cancers Analysis, London and The Royal Marsden NHS Basis Belief. “With the restricted therapy choices at the moment obtainable to those sufferers, this novel ADC molecule might probably turn into the primary remedy focusing on B7-H3 in sufferers with prostate most cancers and would characterize an necessary new therapy for this inhabitants.”
Updates on Proprietary Investigational Packages
Latest progress and anticipated occasions associated to MacroGenics’ investigational product candidates are highlighted beneath.
| B7-H3-Directed Therapies |
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| • | Vobramitamab duocarmazine (vobra duo) is an antibody-drug conjugate (ADC) that targets B7-H3, an antigen with broad expression throughout a number of strong tumors and a member of the B7 household of molecules concerned in immune regulation. | |
| • | MacroGenics accomplished enrollment of the TAMARACK Part 2 research of vobra duo in November 2023. TAMARACK is being carried out in sufferers with metastatic castration-resistant prostate most cancers (mCRPC) who had been beforehand handled with one prior androgen receptor axis-targeted remedy (ARAT). Contributors might have acquired as much as one prior taxane-containing routine, however no different chemotherapy brokers. The TAMARACK research is designed to guage vobra duo at two completely different doses: 2.0 mg/kg or 2.7 mg/kg each 4 weeks (q4W). | |
| • | A brand new presentation of TAMARACK interim knowledge, consisting of up to date security and preliminary efficacy knowledge, all based mostly on an information deadline of April 12, 2024, is on the market beneath “Occasions & Shows” within the Investor Relations part of MacroGenics’ web site or instantly by way of this link. Beneath is a high-level abstract of this interim knowledge, which is topic to additional updates: | |
| Vobra Duo 2.0 mg/kg q4W |
Vobra Duo 2.7 mg/kg q4W |
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| Sufferers Enrolled | n=91 | n=90 |
| PSA Discount Abstract: | ||
| PSA Evaluable Sufferers | n=82 | n=71 |
| Any PSA Discount ≥50% | 41 (50.0%) | 36 (50.7%) |
| Confirmed PSA Discount ≥50% | 36 (43.9%) | 26 (36.6%) |
| Tumor Response Abstract: | ||
| RECIST Evaluable Sufferers with Measurable Illness at Baseline | n=45 | n=32 |
| Illness Management Charge (CR+PR+SD) | 41 (91.1%) | 28 (87.5%) |
| General Response Charge (CR+PR, confirmed solely) | 8 (17.8%) | 8 (25.0%) |
| General Response Charge (CR+PR, together with unconfirmed) | 11 (24.4%) | 14 (43.8%) |
| Security Abstract: | ||
| Security Inhabitants | n=90 | n=86 |
| Remedy-Emergent Adversarial Occasions All Grade | 89 (98.9%) | 86 (100.0%) |
| Remedy- Emergent Adversarial Occasions Grade ≥3 | 49 (54.4%) | 44 (51.2%) |
| TEAE Resulting in Examine Drug Discontinuation | 10 (11.1%) | 13 (15.1%) |
| TEAE Resulting in Examine Drug Dose Discount | 39 (43.3%) | 44 (51.2%) |
| TEAE Resulting in Examine Drug Dose Interruption | 38 (42.2%) | 48 (55.8%) |
| 5 Most Frequent TEAE All Grade | Asthenia (46.7%) Nausea (35.6%) Oedema peripheral (32.2%) Decreased urge for food (28.9%) Fatigue (25.6%) |
Asthenia (58.1%) Decreased urge for food (37.2%) Oedema peripheral (36.0%) Nausea (30.2%) Pleural effusion (29.1%) |
| Pleural Effusions | Grade 1=8.9% Grade 2=8.9% No Grade ≥ 3 occasion |
Grade 1=14.0% Grade 2=14.0% Grade 3=1.2% |
| Palmar-plantar Erythrodysaesthesia Syndrome | Grade 1=11.1% Grade 2=4.4% No Grade ≥ 3 occasion |
Grade 1=12.8% Grade 2=9.3% Grade 3=1.2% |
| • | The median variety of cycles of vobra duo administered was 5 (vary of 1-10). | ||
| • | A complete of 5 occasions with deadly consequence occurred as follows: one Grade 5 occasion within the 2.0 mg/kg dosing cohort: acute myocardial infarction (thought-about unrelated to check drug by the investigator); three Grade 5 occasions within the 2.7 mg/kg dosing cohort: one cardiac arrest (thought-about unrelated to check drug by the investigator) and two occasions of pneumonitis. As well as, a affected person within the 2.7 mg/kg dosing cohort had a Grade 3 pleural effusion that’s recorded as having a deadly consequence. The latter three deaths are being investigated, as follow-up is incomplete on this ongoing trial. | ||
| • | Further knowledge is supplied within the presentation on the Firm’s web site and as filed with the Securities and Trade Fee. | ||
| • | Primarily based on a present analysis of this interim knowledge, the Firm is endeavor the preliminary steps mandatory to arrange for the potential initiation of a Part 3 research in mCRPC in 2025. The ultimate resolution to pursue such a Part 3 research shall be based mostly on an evaluation of the ultimate knowledge set, together with rPFS, when obtainable. | ||
| • | The Firm intends to share ultimate security, efficacy, and sturdiness knowledge, together with the first endpoint of radiographic progression-free survival, from the TAMARACK trial within the second half of 2024. | ||
| • | MacroGenics plans to broaden the TAMARACK research of vobra duo by enrolling sufferers with non-small cell lung most cancers (NSCLC), small cell lung most cancers (SCLC), melanoma, squamous cell carcinoma of the top and neck (SCCHN) and anal most cancers. The Firm expects to provoke dosing in these further cohorts in mid-2024. | ||
| • | MacroGenics continues to enroll a Part 1/2 dose escalation research of vobra duo together with lorigerlimab in sufferers with numerous superior strong tumors. The Firm anticipates commencing a dose enlargement research of this mixture in mCRPC and not less than one further indication in 2024. | ||
| • | MGC026 is a scientific B7-H3-targeting ADC that’s site-specifically conjugated to exatecan, a topoisomerase I inhibitor payload developed by Synaffix (a Lonza firm). With distinct mechanisms of motion, vobra duo and MGC026 might tackle completely different cancers, tumor levels, or be utilized in mixture with alternate brokers — or probably with each other — to reinforce their scientific utility. A Part 1 dose escalation research of MGC026 in sufferers with superior strong tumors is ongoing.
MGC026 preclinical knowledge was introduced just lately on the American Affiliation for Most cancers Analysis (AACR) Annual Assembly. In preclinical research, MGC026 was proven to have better efficiency than B7-H3-directed antibodies conjugated to deruxtecan, or DXd, a topoisomerase-based payload utilized in different ADCs. As well as, the MGC026 payload has been proven to be much less vulnerable to multi-drug resistance (MDR) mechanisms than DXd and SN-38. |
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| • | Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. The HEAT research, an investigator-sponsored, randomized Part 2 scientific trial being carried out by MacroGenics’ educational collaborators, is ongoing. This research is being carried out to guage the exercise of neoadjuvant enoblituzumab given previous to radical prostatectomy in as much as 219 males with high-risk localized prostate most cancers. | ||
| Lorigerlimab | |||
| • | Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART® molecule. Along with the continuing research of lorigerlimab together with vobra duo talked about above, MacroGenics is enrolling LORIKEET, a randomized Part 2 research of lorigerlimab together with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve mCRPC sufferers. A complete of 150 sufferers are deliberate to be handled within the 2:1 randomized research. The present trial design features a major research endpoint of radiographic progression-free survival (rPFS). The Firm anticipates finishing enrollment of the research in 2024 and offering a scientific replace within the first half of 2025. | ||
| Rising ADC Pipeline | |||
| • | MGC028 is a preclinical ADC incorporating an ADAM9-targeting antibody and represents the second MacroGenics ADC molecule that includes Synaffix’s novel site-specific linker and topoisomerase I inhibitor-based cytotoxic payload. ADAM9 (a disintegrin and metalloprotease area 9) is a member of the ADAM household of multifunctional sort 1 transmembrane proteins that play a task in tumorigenesis and most cancers development and is overexpressed in a number of cancers, making it a horny goal for most cancers therapy. The Firm at the moment anticipates submitting an investigational new drug (IND) utility for MGC028 by the tip of 2024.
MGC028 preclinical knowledge was introduced just lately on the AACR Annual Assembly. In preclinical research, MGC028 demonstrated particular antitumor exercise in in vivo fashions representing gastric, lung, pancreatic, colorectal most cancers, SCCHN and cholangiocarcinoma. As well as, in a non-human primate research, MGC028 was properly tolerated at excessive dose ranges, with gentle, reversible unwanted side effects and no ocular toxicity, which is usually a priority with tubulin-inhibitor-based ADCs. These promising preclinical outcomes assist the continued investigation of MGC028 as a therapeutic choice for treating ADAM9-expressing strong cancers. |
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| Partnered Program | |||
| • | MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to attenuate cytokine-release syndrome, whereas sustaining anti-tumor cytolytic exercise, and allowing intermittent dosing. MacroGenics continues to enroll sufferers in a Part 1 dose-escalation research of MGD024 in sufferers with CD123-positive neoplasms, together with acute myeloid leukemia and myelodysplastic syndromes. Underneath an October 2022 unique choice and collaboration settlement, Gilead Sciences, Inc. has the choice to license MGD024 at predefined resolution factors throughout the Part 1 research. | ||
| First Quarter 2024 Monetary Outcomes | |||
| • | Money Place: Money, money equivalents and marketable securities stability as of March 31, 2024, was $184.2 million, in comparison with $229.8 million as of December 31, 2023. | ||
| • | Income: Whole income was $9.1 million for the quarter ended March 31, 2024, in comparison with whole income of $24.5 million for the quarter ended March 31, 2023. The lower was primarily resulting from a lower in income from collaborative and different agreements, together with a $15.0 million milestone acquired from Incyte within the quarter ended March 31, 2023. | ||
| • | R&D Bills: Analysis and improvement bills had been $46.0 million for the quarter ended March 31, 2024, in comparison with $45.9 million for the quarter ended March 31, 2023. | ||
| • | SG&A Bills: Promoting, basic and administrative bills had been $14.7 million for the quarter ended March 31, 2024, in comparison with $13.5 million for the quarter ended March 31, 2023. The rise was primarily associated to elevated stock-based compensation expense and different skilled charges. | ||
| • | Web Loss: Web loss was $52.2 million for the quarter ended March 31, 2024, in comparison with web lack of $38.0 million for the quarter ended March 31, 2023. | ||
| • | Shares Excellent: Shares of widespread inventory excellent as of March 31, 2024 had been 62,560,502. | ||
| • | Money Runway Steerage: MacroGenics anticipates that its money, money equivalents and marketable securities stability of $184.2 million as of March 31, 2024, along with projected and anticipated future funds from companions and product revenues ought to lengthen its money runway into 2026. The Firm’s anticipated funding necessities replicate anticipated expenditures associated to the Part 2 TAMARACK scientific trial, the Part 2 LORIKEET research in addition to MacroGenics’ different ongoing scientific and preclinical research. | ||
Convention Name Data
To take part by way of phone, please register upfront at this link. Upon registration, all phone members will obtain a affirmation e mail detailing learn how to be a part of the convention name, together with the dial-in quantity together with a singular passcode and registrant ID that can be utilized to entry the decision.
The listen-only webcast of the convention name may be accessed beneath “Occasions & Shows” within the Investor Relations part of MacroGenics’ web site at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast shall be obtainable shortly after the conclusion of the decision and archived on MacroGenics’ web site for 30 days following the decision.
| MACROGENICS, INC. | |||||
| SELECTED CONSOLIDATED BALANCE SHEET DATA | |||||
| (Quantities in hundreds) | |||||
| March 31, 2024 | December 31, 2023 | ||||
| (unaudited) | |||||
| Money, money equivalents and marketable securities | $ | 184,237 | $ | 229,805 | |
| Whole belongings | 248,285 | 298,418 | |||
| Deferred income | 79,019 | 80,894 | |||
| Whole stockholders’ fairness | 106,154 | 152,613 | |||
| MACROGENICS, INC. | |||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||
| (Unaudited) | |||||||
| (Quantities in hundreds, besides share and per share knowledge) | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Revenues: | |||||||
| Collaborative and different agreements | $ | 1,449 | $ | 16,686 | |||
| Product gross sales, web | 4,861 | 3,490 | |||||
| Contract manufacturing | 2,276 | 3,615 | |||||
| Royalty income | 160 | 422 | |||||
| Authorities agreements | 358 | 283 | |||||
| Whole revenues | 9,104 | 24,496 | |||||
| Prices and bills: | |||||||
| Price of product gross sales | 270 | 113 | |||||
| Price of producing companies | 1,846 | 3,410 | |||||
| Analysis and improvement | 46,029 | 45,872 | |||||
| Promoting, basic and administrative | 14,709 | 13,527 | |||||
| Whole prices and bills | 62,854 | 62,922 | |||||
| Loss from operations | (53,750 | ) | (38,426 | ) | |||
| Curiosity and different revenue | 2,693 | 1,073 | |||||
| Curiosity and different expense | (1,133 | ) | (656 | ) | |||
| Web loss | (52,190 | ) | (38,009 | ) | |||
| Different complete revenue (loss): | |||||||
| Unrealized achieve (loss) on investments | (29 | ) | 13 | ||||
| Complete loss | $ | (52,219 | ) | $ | (37,996 | ) | |
| Primary and diluted web loss per widespread share | $ | (0.84 | ) | $ | (0.61 | ) | |
| Primary and diluted weighted common widespread shares excellent | 62,290,538 | 61,809,817 | |||||
About MacroGenics, Inc.
MacroGenics (the Firm) is a biopharmaceutical firm targeted on discovering, growing, manufacturing and commercializing revolutionary monoclonal antibody-based therapeutics for the therapy of most cancers. The Firm generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based expertise platforms, which have applicability throughout broad therapeutic domains. The mix of MacroGenics’ expertise platforms and protein engineering experience has allowed the Firm to generate promising product candidates and enter into a number of strategic collaborations with world pharmaceutical and biotechnology firms. For extra info, please see the Firm’s web site at www.macrogenics.com. MacroGenics, the MacroGenics emblem, MARGENZA and DART are logos or registered logos of MacroGenics, Inc.
Cautionary Notice on Ahead-Wanting Statements
Any statements on this press launch about future expectations, plans and prospects for MacroGenics (“Firm”), together with statements concerning the Firm’s technique, future operations, scientific improvement of the Firm’s therapeutic candidates, together with initiation and enrollment in scientific trials, anticipated timing of outcomes from scientific trials, discussions with regulatory companies, business prospects of or product revenues from MARGENZA and the Firm’s product candidates, if authorized, manufacturing companies income, milestone or opt-in funds from the Firm’s collaborators, the Firm’s anticipated milestones and future expectations and plans and prospects for the Firm, in addition to future world web gross sales of TZIELD and the Firm’s capability to realize the milestone funds set forth beneath the phrases of the settlement with DRI (or its successors or assigns with respect to such settlement), and different statements containing the phrases “topic to”, “consider”, “anticipate”, “plan”, “anticipate”, “intend”, “estimate”, “potential,” “challenge”, “might”, “will”, “ought to”, “would”, “might”, “can”, the negatives thereof, variations thereon and related expressions, or by discussions of technique represent forward-looking statements inside the that means of Part 27A of the Securities Act of 1933 and Part 21E of the Securities Trade Act of 1934. Precise outcomes might differ materially from these indicated by such forward-looking statements on account of numerous necessary components, together with: dangers that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or another product candidate’s income, bills and prices will not be as anticipated, dangers referring to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or another product candidate’s market acceptance, competitors, reimbursement and regulatory actions; future knowledge updates, particularly with respect to vobramitamab duocarmazine; our capability to supply manufacturing companies to our clients; the uncertainties inherent within the initiation and enrollment of future scientific trials; the supply of financing to fund the interior improvement of our product candidates; expectations of increasing ongoing scientific trials; availability and timing of information from ongoing scientific trials; expectations for the timing and steps required within the regulatory evaluation course of; expectations for regulatory approvals; expectations of future milestone funds; the impression of aggressive merchandise; our capability to enter into agreements with strategic companions and different issues that might have an effect on the supply or business potential of the Firm’s product candidates; enterprise, financial or political disruptions resulting from catastrophes or different occasions, together with pure disasters, terrorist assaults, civil unrest and precise or threatened armed battle, or public well being crises such because the novel coronavirus (known as COVID-19 pandemic); and different dangers described within the Firm’s filings with the Securities and Trade Fee. As well as, the forward-looking statements included on this press launch characterize the Firm’s views solely as of the date hereof. The Firm anticipates that subsequent occasions and developments will trigger the Firm’s views to alter. Nonetheless, whereas the Firm might elect to replace these forward-looking statements sooner or later sooner or later, the Firm particularly disclaims any obligation to take action, besides as could also be required by regulation. These forward-looking statements shouldn’t be relied upon as representing the Firm’s views as of any date subsequent to the date hereof.
CONTACTS:
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
[email protected]
