On May 12, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will participate in a virtual fireside chat at the 2021 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 19, 2021 at 1:20 p.m. ET / 10:20 a.m. PT (Press release, Xencor, MAY 12, 2021, View Source [SID1234579823]).

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A live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Following the webcast, a replay will be archived on the website for at least 30 days.

On May 12, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that 15 abstracts have been accepted at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper)’s (EHA) (Free EHA Whitepaper) 2021 Virtual Congress, including new and updated data from the CARTITUDE clinical development program being led by Janssen Research & Development, LLC (Janssen) for the investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel) (Press release, Legend Biotech, MAY 12, 2021, View Source [SID1234579822]).

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"The Legend Biotech team, together with our collaborator Janssen, look forward to sharing the updated efficacy and longer-term safety data for cilta-cel," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "These exciting data and a wide range of other abstracts highlight our continued commitment and efforts to developing innovative treatments that will make a difference in the lives of those living with multiple myeloma."

Longer-term follow-up efficacy and safety results from the Phase 1b/2 CARTITUDE-1 study of cilta-cel in patients with relapsed/refractory multiple myeloma (Abstract #8005) will be featured in an oral presentation at the 2021 ASCO (Free ASCO Whitepaper) Meeting and as a poster presentation at EHA (Free EHA Whitepaper) (Abstract #EP964). Results from this study supported recent U.S. and European regulatory filings submitted by Legend Biotech’s collaborator, Janssen.

For the first time, data from Cohort A of the CARTITUDE-2 study evaluating the safety and efficacy of cilta-cel in patients with progressive multiple myeloma who have received 1-3 prior lines of therapy, will be presented, being featured as a poster presentation at ASCO (Free ASCO Whitepaper) (Abstract #8013) and in an oral presentation at EHA (Free EHA Whitepaper) (Abstract # S190). Poster presentations at both meetings will provide additional efficacy and safety information with cilta-cel in comparison to standard of care therapies and neurological adverse event mitigation measures.

Select abstracts from both Congresses are below.

ASCO Presentations (June 4-8, 2021)

Abstract No.

Title

Date/ Time

Abstract #8005

Oral Presentation

Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1​

Tuesday, June 8th 8:00-11:00 AM EDT

Abstract #8013

Poster Discussion

CARTITUDE-2: Efficacy and safety of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR T-cell therapy, in patients with progressive multiple myeloma (MM) after 1–3 prior lines of therapy​

Friday, June 4th @ 9:00AM EDT

Abstract #8028

Poster Presentation

Incidence, mitigation, and management of neurologic adverse events in patients with multiple myeloma (MM) treated with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-2​

Friday, June 4th @ 9:00 AM EDT

Abstract #8045

Poster Presentation

Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 vs real-world standard of care (RW SOC) for patients (pts) with triple-class exposed relapsed/refractory multiple myeloma (RRMM)

Friday, June 4th @ 9:00 AM EDT

Abstract #8030

Poster Presentation

Cilta-cel vs. conventional treatment in patients with relapse/refractory multiple myeloma​

Friday, June 4th @ 9:00 AM EDT

Abstract #8041

Poster Presentation

LocoMMotion: A prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma (RRMM) receiving ≥3 prior lines of therapy.

Friday, June 4th @ 9:00 AM EDT

The abstracts will be released on ASCO (Free ASCO Whitepaper) Meeting Library on May 19th, 2021 at 5:00 PM EDT.

EHA Presentations (June 9-17, 2021)

Abstract No.

Title

Date/ Time

Abstract #S190

Oral​

Efficacy and safety of the BCMA-directed CAR-T cell therapy, ciltacabtagene autoleucel, in patients with progressive multiple myeloma (MM) after 1–3 prior lines of therapy: Initial results from CARTITUDE-2

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP964

EPoster​

Updated CARTITUDE-1 results of ciltacabtagene autoleucel, a B-cell maturation antigen–directed chimeric antigen receptor T cell therapy, in relapsed/refractory multiple myeloma

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP1003

EPoster​

Incidence, mitigation, and management of neurologic adverse events in the phase 2 CARTITUDE-2 study of ciltacabtagene autoleucel in patients with multiple myeloma

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP987

EPoster​

A prospective, non-interventional, multinational study of real-life standard of care in patients with relapsed/refractory multiple myeloma receiving ≥3 prior lines of therapy: Interim data from LocoMMotion

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP990

EPoster​

Comparison of ciltacabtagene autoleucel versus conventional treatment in patients with relapsed/refractory multiple myeloma

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP1049

EPoster​

Ciltacabtagene autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥3 lines of prior therapy: A matching adjusted indirect comparison

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP978

EPoster​

Matching adjusted indirect comparison of ciltacabtagene autoleucel versus belantamab mafodotin in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥3 lines of prior therapy

Available starting Friday, June 11th @ 9:00AM CEST

Abstract #EP977

EPoster​

Comparison of outcomes with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 versus standard of care in triple-class exposed multiple myeloma patients in clinical trials of daratumumab

Available starting Friday, June 11th @ 9:00AM CEST

Abstract # EP972

EPoster​

Ciltacabtagene autoleucel for triple-class exposed multiple myeloma: Adjusted comparison of CARTITUDE-1 outcomes versus real world clinical practice observed in German registry

Available starting Friday, June 11th @ 9:00AM CEST

The abstracts are available on the EHA (Free EHA Whitepaper) website at: View Source

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

About CARTITUDE-2

CARTITUDE-2 (NCT04133636) is an ongoing Phase 2 multicohort study evaluating the safety and efficacy of cilta-cel in various clinical settings. Cohort A included patients who had progressive multiple myeloma after 1–3 prior lines of therapy, including PI and IMiD, were lenalidomide refractory, and had no prior exposure to BCMA-targeting agents. The primary objective was percentage of patients with negative minimal residual disease (MRD).2

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections. 8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9

About Cilta-cel

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.

On May 12, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that it will participate in the 7th Annual Immuno-Oncology Innovation Forum organized by Sachs Associates taking place from May 18 to May 20, 2021 (Press release, NOXXON, MAY 12, 2021, View Source [SID1234579821]).

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Aram Mangasarian, CEO of NOXXON, will present the latest developments in NOXXON’s lead compound NOX-A12 in glioblastoma and pancreatic cancer to investors and potential partners.

Aram Mangasarian will also be on a panel on May 18, 2021 at 01.10 p.m. EDT (07.10 p.m. CEST) to discuss the Development Strategies for Current Times, co-chaired by Esteban Pombo-Villar, CEO of TargImmune Therapeutics AG and Matthias Müllenbeck, SVP, Head Global BD & Alliance Management at Merck KGaA.

On May 12, 2021 Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, reported the presentation of data from preclinical studies of XTX101, its tumor-selective anti-CTLA-4 antibody, demonstrating combination potential with anti-PD-1 therapy, as well as enhanced preclinical activity and improved tolerability compared to ipilimumab, an anti-CTLA-4 antibody therapeutic approved by the U.S. Food and Drug Administration (Press release, Xilio Therapeutics, MAY 12, 2021, View Source [SID1234579820]). The findings will be reported today in a poster presentation at The New York Academy of Sciences’ Frontiers in Cancer Immunotherapy 2021 Virtual Symposium.

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Xilio is leveraging its proprietary platform to engineer novel molecules that are designed to be activated in the tumor microenvironment and have the potential to result in localized clinical activity without dose-limiting toxicities. XTX101 is specifically designed to target the anti-CTLA-4 effect geographically within the tumor and to minimize off-tumor peripheral effects. XTX101 is activated in a protease-dependent manner with high binding affinity to CTLA-4, potentially enabling it to overcome CTLA-4 inhibition of T cell activation and freeing T cells to attack cancer.

"The broad clinical benefit of CTLA-4 blockade, as with ipilimumab, for the treatment of cancer is well-established; however, challenging toxicities arising from systemic immune activation have limited use of these agents as both monotherapy and in combination, including with anti-PD-1 agents," said Rónán O’Hagan, Ph.D., chief scientific officer of Xilio. "XTX101 has been engineered to overcome the tolerability and potency limitations associated with other anti-CTLA-4 antibodies by applying our proprietary masking technology to the antibody and engineering enhanced binding to target receptors. We believe these data validate our approach, and we observed that XTX101 induces tumor-selective biological activity and robust tumor growth inhibition, with favorable tolerability, in preclinical studies. We look forward to advancing XTX101 into a planned Phase 1 clinical trial in the second half of 2021."

Data reported in a poster entitled, "Tumor-Activated Anti-CTLA-4 Monoclonal Antibody, XTX101, Demonstrates Monotherapy and Anti-PD-1 Combination Benefit in Preclinical Models," include:

In a colon cancer model, the combination of XTX101 with an anti-PD-1 antibody showed robust tumor growth inhibition, including two complete responses (CRs) (n=8), where treatment with XTX101 or the anti-PD-1 agent as a monotherapy achieved only modest tumor growth inhibition and no CRs.
No significant body weight loss was observed in animals treated with either XTX101 or anti-PD-1 as a monotherapy or the combination regimen, suggesting that XTX101 can be effectively combined with anti-PD-1 without enhanced toxicity.
In a bladder cancer model, XTX101 monotherapy demonstrated tumor growth inhibition superior to ipilimumab, while a dose of 3 mg/kg of ipilimumab was required to achieve similar activity of XTX101 at 0.3 mg/kg, suggesting XTX101 has 10-fold higher potency than ipilimumab.
XTX101 as a monotherapy induced an increase in CD8+ T cells within the tumor, and a decrease in T regulatory cells in the tumor compared to ipilimumab. In addition, XTX101 achieved CRs without increasing CD4+ T cells in the blood.

On May 12, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell discovery engine platform to discover and develop first-in-class antibody therapeutics, reported financial results for the first quarter ended March 31, 2021 and provided a corporate update (Press release, Immunome, MAY 12, 2021, View Source [SID1234579819]).

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First Quarter and Subsequent Highlights

IMM-BCP-001: In February 2021, Immunome announced that it discovered antibodies capable of neutralizing multiple SARS-CoV-2 variants, including the South African Variant, in pseudovirus testing. In April 2021, the company announced antibody selection for its IMM-BCP-01 cocktail and shared data showing that IMM-BCP-01 neutralizes CDC SARS-CoV-2 "Variants of Concern" in preclinical testing. The cocktail was efficacious in Syrian hamsters infected with SARS-CoV-2 (USA-WA1/2020) in both prophylactic and treatment schedules. Further, the cocktail neutralized South Africa and UK variants in live virus testing and Brazil and California variants in pseudovirus testing. An Investigational New Drug (IND) filing for IMM-BCP-001 is planned for late 2Q/early 3Q 2021.
IMM-ONC-001: In March 2021, Immunome announced its proprietary antibody against IL-38 advanced into IND-enabling studies. Based on Immunome’s research findings, IL-38 functions as a novel innate immune checkpoint that inhibits infiltration and pro-inflammatory activity of innate immune cells. The company’s analysis also suggests that IL-38 is over-expressed in certain tumors and is potentially linked to reduced infiltration of innate immune cells. Immunome anticipates filing an IND for this product candidate in 2H 2021.
Appointed Dr. Dennis Giesing as Chief Development Officer and Corleen Roche as Chief Financial Officer. In March 2021, the company announced the appointment of Dennis Giesing, Ph.D. to the role of Chief Development Officer. Dr. Giesing brings more than 35 years of pharmaceutical industry experience to Immunome and will be responsible for driving Immunome’s programs into clinical development. In April 2021, Immunome announced that it appointed Corleen Roche as its Chief Financial Officer. Ms. Roche is a highly accomplished CFO with over 30 years of industry experience to lead the company’s finance and corporate strategy functions.
Completed a $27 million private placement. In April 2021, the company announced a private placement of its common stock for gross proceeds to Immunome of approximately $27 million, before deducting placement agent commissions and other offering expenses. The company currently expects the proceeds from this private placement, together with its cash on hand, will be sufficient to fund its operations through fiscal year 2022.
"I am thrilled with the significant progress that Immunome has made in the development of our product pipeline," said Purnanand Sarma, Ph.D., President and CEO of Immunome. "We are excited to welcome Dr. Giesing and Ms. Roche to the Immunome team as we move towards becoming a clinical stage biopharmaceutical company."

Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended March 31, 2021 were $2.0 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2021 were $1.9 million.
Net loss: Net loss for the three months ended 2021 was $3.9 million.
Cash and cash equivalents: As of March 31, 2021, cash and cash equivalents totaled $36.3 million (excluding $27.0 million in proceeds from the private placement in April 2021).