1stOncology™: Cancer Intelligence Service – Page 5946 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Odimma partners with myNEO for the clinical development of its personalized DNA-based cancer immunotherapy

On February 13, 2023 Odimma Therapeutics (Strasbourg, France), a biopharmaceutical company developing an innovative immunotherapy platform dedicated to the treatment of cancer and myNEO (Ghent, Belgium), a data-driven neoantigen discovery company, reported that they are expanding their existing collaboration into a clinical trial collaboration agreement (Press release, myNEO Therapeutics , FEB 13, 2023, View Source [SID1234640210]). The agreement combines Odimma’s synthetic DNA vaccine technology with myNEO’s data analysis platform for fast and accurate per-patient identification and selection of neoantigen targets predicted to elicit strong immune responses. The agreement covers a phase I and phase II clinical trial in solid tumors.

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!

After combining Odimma’s DNA vaccine technology with neoantigens identified by myNEO and achieving promising preclinical results in mice last year, both companies decided to continue the successful collaboration into a clinical-stage program. myNEO will utilize its proprietary, best-in-class machine learning algorithms to screen the mutational profile of individual patients to investigate personalized highly immunogenic neoantigens. For this, myNEO will explore the complete genomic profile of the tumor to find more and novel sets of highly immunogenic neoantigenic sources.

"We strongly believe that the accurate prediction of immunodominant neoantigens along with the potency of the immunization platform are the two key drivers for the success of personalized immunotherapy," said Dr Jean-Marc Limacher, Chairman of the board and co-founder of Odimma. "We are very confident that the Artificial Intelligence solution developed by myNEO will give each patient the best chances of response to immunotherapy."

Odimma will manufacture the vaccine for each patient individually using its ODI-2001 candidate. The synthetic DNA vector vaccine will encode for up to 20 patient-specific tumor neoantigens, selected by myNEO, aiming to induce a potent and precise immune response against the patient’s unique tumor. The proven enhanced efficacy results in mice – compared to other vaccines targeting the same neoantigen – together with the rapid manufacturing process Odimma has developed, highlight the potential of the technology in a personalized setting.

"The myNEO project team is excited to have Odimma as our newest partner, and to be able to enter the field of DNA cancer vaccines," said Cedric Bogaert, Chief Executive Officer and co-founder of myNEO. "We are fully convinced that a more patient-centric approach of evaluating and targeting the tumor will be an essential part of the future, and different parallel revolutions have enabled to incorporate it in a cost-efficient and logistically feasible process. The Odimma technology provides an innovative new avenue to bring the breakthroughs of personalized tumor targeting models to the patients."

The clinical phase I aims to test the personalized synthetic DNA vaccine as monotherapy in solid tumors and will be conducted in France. The trial is expected to be initiated in Q4 2023 to primarily assess feasibility and safety but also to collect early signs of efficacy. A program of translational research is closely associated to this first clinical trial.

LegoChemBio Signs License Agreement to Acquire First-in-class Antibody From Elthera

On February 13, 2023 LegoChem Biosciences reported a license agreement with Elthera AG, a biotechnology company in Switzerland, to develop and commercialize a novel antibody-drug conjugate (ADC) therapy using a monoclonal antibody developed by Elthera (Press release, LegoChem Biosciences, FEB 13, 2023, View Source [SID1234638675]).

The licensed asset is a monoclonal antibody with a target expressed in a variety of solid tumors including pancreatic, ovarian, breast, lung, and colorectal cancer. Under the terms of the agreement, LegoChemBio will be responsible for the future development and commercialization of any products incorporating this antibody.

Elthera will receive an upfront payment and is eligible to receive progress-dependent development and regulatory milestone payments as well as cumulative commercial milestone payments. Elthera will additionally receive royalties on net product sales.

"We are very pleased to enter into this license agreement with LegoChemBio, a global ADC company with industry-leading ADC technology," said Anne Schmidt, CEO of Elthera. "This agreement is the result of a fruitful collaboration with LegoChemBio, demonstrating the outstanding quality and therapeutic potential of our antibody. The combination with LegoChemBio’s ConjuAll technology generates a well-differentiated first-in class ADC with a wide therapeutic window that has the potential to provide new treatment options for a large number of solid tumors."

"We are pleased to enter this agreement with Elthera as we continue to expand our toolbox to maximize the value of our ADC platform. We look forward to bringing this innovative ADC drug into the clinic as LCB’s fifth ADC," said Dr. Yong-Zu Kim, CEO of LegoChemBio.

MacroGenics Announces Preliminary Clinical Results from Single Arm Study of Lorigerlimab in Patients with Metastatic Castration-Resistant Prostate Cancer to be Presented at ASCO Genitourinary Cancers Symposium

On February 13, 2023 MacroGenics Inc, a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported preliminary safety and anti-tumor activity data from the dose expansion phase of the Company’s ongoing Phase 1 clinical trial of lorigerlimab, a bispecific, tetravalent PD-1 × CTLA-4 DART molecule (Press release, MacroGenics, FEB 13, 2023, View Source [SID1234636050]). This investigational molecule was designed to block PD-1 with enhanced CTLA-4 blockade on dual PD-1/CTLA-4-expressing cells, such as tumor-infiltrating lymphocytes (TILs), while maintaining maximal PD-1 blockade on all PD-1-expressing cells. The preliminary data is being presented in a poster titled "Lorigerlimab, a Bispecific PD-1 × CTLA-4 DART Molecule in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase 1 Expansion Cohort" (Poster #155) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO-GU) Cancers Symposium taking place February 16-18, 2023, in San Francisco, CA.

Cohort Expansion Results Update

The ASCO (Free ASCO Whitepaper)-GU abstract included data as of September 10, 2022; updated data as of a December 12, 2022 cut-off are included below and will be presented at ASCO (Free ASCO Whitepaper)-GU.

As of the December 12, 2022 data cut-off, 118 patients with mCRPC, melanoma, non-small cell lung cancer or microsatellite-stable colorectal cancer were enrolled in the cohort expansion phase of the lorigerlimab Phase 1 study at the dose of 6.0 mg/kg, administered intravenously every three weeks (Q3W). Confirmed objective responses were observed across the histology-specific cohorts; preliminary efficacy results for mCRPC are presented in the poster and below.

Preliminary Safety Results

The safety analysis is based on 127 patients who received lorigerlimab at a dose of 6 mg/kg Q3W, including 118 enrolled in the four dose expansion cohorts plus nine patients from dose escalation. Median exposure was 14.4 weeks (range: 1.9 – 100.1 weeks) with a median of four infusions administered per patient. Twenty-four patients remained on lorigerlimab as of the December 12, 2022 data cut-off; 103 discontinued for the following reasons: progressive disease (PD) (n=66), adverse events (AE) (n=31), patient/physician decision (n=5), or death due to PD (n=1).

The results demonstrated a manageable overall safety profile. Treatment-related AEs (TRAEs) occurred in 86.6% of patients, with the most common among them (≥15%) being fatigue, rash, pruritus, hypothyroidism, and pyrexia. Rates of grade ≥3 TRAEs and immune-related AEs were 34.6% and 7.9%, respectively. AEs resulted in treatment discontinuation in 24.4% of patients. There were no fatal AEs related to lorigerlimab.

Preliminary Anti-tumor Activity in mCRPC Cohort

As of the December 12, 2022 data cut-off, 42 patients had been enrolled in the mCRPC expansion cohort. Patients had previously received a median of two prior therapies (range: 1 – 9) for advanced disease, with 35 patients (83.3%) having received docetaxel and 34 patients (81.0%) having received androgen receptor antagonist therapy. The median exposure to lorigerlimab was 19.2 weeks (range: 3.3 – 55.1 weeks), with a median of five infusions administered per patient.

A total of 35 patients with mCRPC had measurable soft tissue disease per RECIST v1.1 at study entry. Nine of the 35 patients (25.7%) achieved confirmed partial responses (cPR). The median duration of response for these nine patients was 4.6 months (range: 2.8 – 8.6+ months), with four patients remaining on lorigerlimab as of data cut-off. Among the other five patients who had achieved cPR, four discontinued due to unrelated adverse events, and one patient discontinued due to physician decision.

Reductions in PSA levels of ≥ 50% were observed in 12 of 42 patients (28.6%), and 9 of the 12 maintained PSA50 response ≥ 3 months. Nine of 42 patients (21.4%), including the nine who achieved cPR, had reductions in their PSA levels of ≥ 90% as of the data cut-off.

"To date, checkpoint inhibition has not fared well in the treatment of patients with late-stage mCRPC. Previously, anti-CTLA-4 therapy, whether alone or in combination with an anti-PD-1 agent, resulted in increased risk for immune-related toxicity with very modest anti-tumor activity," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We designed lorigerlimab to have preferential blockade on dual PD-1/CTLA-4-expressing cells such as TILs, which are most abundant in the tumor microenvironment. As part of this study, biomarker analyses indicated that lorigerlimab was shown to induce T-cell activation as evidenced by an increased frequency of circulating Ki67+ and ICOS+ T cells. We believe we are seeing the benefit of lorigerlimab’s design and are very encouraged by this latest data set from our ongoing Phase 1 study. Looking forward, we plan to initiate a Phase 2 study of lorigerlimab in patients with mCRPC later this year and anticipate providing an update on the proposed study later this quarter."

ASCO-GU Poster Presentation

MacroGenics’ lorigerlimab poster presentation will be available for on-demand viewing on the ASCO (Free ASCO Whitepaper)-GU website and on the "Events & Presentations" page on MacroGenics’ website at View Source

About Lorigerlimab

Lorigerlimab (previously known as MGD019) is an investigational, bispecific IgG4-based, Fc-bearing DART molecule that was designed to enhance blockade on PD-1 and CTLA-4 dual-expressing, tumor-infiltrating lymphocytes, while maintaining maximal PD-1 blockade on all circulating PD-1-expressing cells. In addition to the study described above and presented in the poster, MacroGenics is also evaluating the activity of lorigerlimab in combination with vobramitamab duocarmazine (previously known as MGC018, an investigational B7-H3-directed antibody-drug conjugate) in a study in patients with advanced solid tumors.

Biocity receives IND approval from FDA for its FIC ADC BC3195

On February 13, 2023 Biocity Biopharma reported that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for the investigational drug BC3195 (CDH3 ADC) (Press release, Biocity Biopharmaceutics, FEB 13, 2023, View Source [SID1234633307]). The approval enables Biocity Biopharma to conduct the phase 1 study of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors in the United States. This is the second US IND approval in the past few months, which is another important milestone for Biocity Biopharma in its effort to extend product development globally.

BC3195 is a novel ADC targeting CDH3/P-cadherin, a calcium-dependent cell-cell adhesion glycoprotein expressed in a variety of malignancies, including lung, breast, gastric, ovarian, colorectal, and pancreatic cancers.
CDH3 is highly expressed in malignant tumors with low or no expression in normal tissues, which makes it an ideal target to develop anticancer treatment, particularly for the development of ADCs.
In preclinical study, BC3195 binds to cell surface CDH3 and is efficiently internalized. In different animal models, BC3195 demonstrated good safety profile and strong antitumor activities with tumor growth inhibition reaching up to 100%.
BC3195 a first-in-class new generation ADC designed with a clinically validated linker and payload (MMAE) that has bystander effect.
Currently, BC3195 is the only ADC targeting CDH3 in clinical development globally.Biocity Biopharma believes that BC3195 may hold the promise of becoming a novel treatment for patients with advanced cancers where high unmet medical needs still exist.

IMV Inc. Presents Positive Initial Results From The MVP-S Phase 2B VITALIZE Trial

On March 13, 2023 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported positive preliminary data from the VITALIZE Phase 2B trial evaluating its lead DPX product, maveropepimut-S ("MVP-S"), in combination with pembrolizumab in patients with relapsed, refractory Diffuse Large B Cell Lymphoma ("r/r DLBCL") (Press release, IMV, FEB 13, 2023, View Source [SID1234628586]).

Key initial findings from the ongoing VITALIZE trial:

8 Patients with an ECOG1 score of 0-1 have been enrolled in arm 1 of the study. Of these, 6 have so far been evaluable for efficacy;
Of these 6 evaluable patients, 3 patients showed confirmed complete responses, 1 patient was assessed with stable disease as best response and 2 patients were assessed with progressive disease as best response; and
2 patients with poor level of baseline functionality (ECOG ≥ 2) failed to stay on study through to the first scan and therefore could not be evaluated.
Overall Response Rate ("ORR") will be communicated when the totality of stage one data are available for definitive assessment.

"VITALIZE is our most advanced and rigorous trial to date, and we are encouraged by the way the data for MVP-S are trending. This is the most refractory population of patients we have treated so far, and to show complete, confirmed clinical responses is notable. These positive initial results, combined with the accelerating recruitment of the AVALON study in platinum resistant ovarian cancer add, we believe, to the growing industry enthusiasm about the potential for MVP-S in multiple tumor settings," said Andrew Hall, CEO of IMV.

About the VITALIZE Study

The VITALIZE Phase 2B trial is a randomized, parallel group, Simon two-stage study designed to assess IMV’s lead candidate, MVP-S, in combination with pembrolizumab with (arm 1) or without (arm 2) cyclophosphamide. Across the arms of this study, the combination will be evaluated in up to 30 patients in stage one (two arms of 15) with the option to expand to up to a total of 102 subjects in stage two with r/r DLBCL who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.

About the AVALON study

The AVALON study is an open label, company-sponsored phase 2b, single arm trial evaluating the efficacy and safety of MVP-S and intermittent low-dose cyclophosphamide (CPA) in patients with platinum-resistant ovarian cancer. The study is a Simon two-stage design where up to 41 subjects will be evaluated in stage one, with the option to expand to up to a total of 73 patients in stage two. Patients participating in the trial will receive two doses of subcutaneous MVP-S once every three weeks, followed by an MVP-S dose once every eight weeks, plus low-dose oral CPA on a repeating cycle of one week on/one week off.