On December 2, 2022 Sanofi reported that Data featured at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition from December 10-13, 2022, reinforce Sanofi’s commitment to transforming care for people living with multiple myeloma (MM) and other difficult-to-treat blood cancers (Press release, Sanofi, DEC 2, 2022, View Source [SID1234624747]).

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Peter C. Adamson, MD
Global Head of Oncology Development

"Data to be presented at this year’s ASH (Free ASH Whitepaper) Meeting demonstrate our commitment to improving the outcome for patients with cancer. This includes presentations for Sarclisa, an anti-CD38 antibody of choice for patients with multiple myeloma and a cornerstone of our strategy to broaden our portfolio in hematologic malignancies. We are proud to be advancing knowledge and the treatment of patients with multiple myeloma, by sharing emerging data from our research efforts."

The first Sarclisa oral presentation will detail results from a subgroup analysis of the Phase 3 IKEMA trial, which in May 2022 reported updated median progression-free survival results in combination with carfilzomib and dexamethasone. This new analysis compared patients with early versus late relapse. The second Sarclisa oral presentation highlights updated longer-term efficacy data following subsequent therapy in the pivotal Phase 3 ICARIA-MM trial. It is critical to advance scientific understanding of how individuals who relapse early will respond to subsequent lines of therapy because the earlier a person relapses, the more difficult they can be to treat.

Sanofi is also presenting multiple abstracts from its investigational early pipeline of cutting-edge compounds, such as an open-label, first-in-human, dose-escalation study of Natural Killer Cell Engager (NKCE) SAR443579 as a monotherapy for the treatment of relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high-risk myelodysplasia. Another abstract will highlight the potential of SAR’514, an anti-B cell Maturation Antigen (BCMA) NKCE, for controlling MM tumors in vivo.

Since 2019, Sanofi’s oncology pipeline has doubled, with a dozen next-generation, potential first- or best-in-class compounds entering clinical trials. Much of this growth is a result of an acceleration of in-house research and development capabilities, as well as building external partnerships, particularly in early portfolio, including for MM and other hematologic malignancies.

Abstracts accepted for presentation at ASH (Free ASH Whitepaper) include:

Isatuximab

Isatuximab Plus Pomalidomide/Low-Dose Dexamethasone Versus Pomalidomide/Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (ICARIA-MM): Characterization of Subsequent Antimyeloma Therapies Oral presentation
Abstract #247
Dec. 10, 2-3:30 p.m. CST
Isatuximab Plus Carfilzomib and Dexamethasone in Patients with Early Versus Late Relapsed Multiple Myeloma: IKEMA Subgroup Analysis Oral presentation
Abstract #753
Dec. 12, 10:30 a.m.-12 p.m. CST
Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (Isa-KRd) in Patients with High-Risk Newly Diagnosed Multiple Myeloma: Planned Interim Analysis of the GMMG-Concept Trial Oral presentation by GMMG
Abstract #759
Dec. 12, 10:30 a.m.-12 p.m. CST
Bone Marrow Immune Signatures in Multiple Myeloma Are Linked to Tumor Heterogeneity and Treatment Outcome Oral presentation by GMMG
Abstract #860
Dec. 12, 2:45-4:15 p.m. CST
Subcutaneous Isatuximab Administration by an On-Body Delivery System (OBDS) in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Phase 1b Expansion Study Results Poster
Abstract #1923
Dec. 10, 5:30-7:30 p.m. CST
Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma: IKEMA Subgroup Analysis By Number of Prior Lines of Treatment Poster
Abstract #3176
Dec. 11, 6-8 p.m. CST
Isatuximab in Combination with Lenalidomide and Dexamethasone in Patients with High-Risk Smoldering Multiple Myeloma: Updated Safety Run-in Results from the Randomized Phase 3 ITHACA study Poster
Abstract #3253
Dec. 11, 6-8 p.m. CST
Isatuximab Plus Pomalidomide and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma in Real-Life Context in France: IMAGE Subgroup Analysis Based on Prior Lines of Therapy and Refractory Status Poster
Abstract #4928
Dec. 12, 6-8 p.m. CST
Rasburicase

Fatalities from Tumor Lysis Syndrome (TLS) After Anti-Hyperuricemic Monotherapy – Nationally Representative, Propensity Score Matched, Retrospective Study Comparison of Rasburicase and Allopurinol Poster
Abstract #3632
Dec. 11, 6-8 p.m. CST
Pipeline and other

MAP4K2 Inhibition Reinforces the Iberdomide Sensitivity in MM Cells by Inducing IKZF1 Degradation Through a CRBN Independent Mechanism (Externally Sponsored Collaboration) Poster
Abstract #1838
Dec. 10, 5:30-7:30 p.m. CST
Real-World Multiple Myeloma Risk Factors and Outcomes by Race/Ethnicity in the United States Poster
Abstract #2285
Dec. 10, 5:30-7:30 p.m. CST
High Ex Vivo Response Rates to CD38/CD28xCD3 Trispecific T Cell Engager in Patients Relapsed After Anti-CD38 and Anti-BCMA Targeted Immunotherapies (Externally Sponsored Collaboration) Poster
Abstract #3157
Dec. 11, 6-8 p.m. CST
Real-World Multiple Myeloma Front-Line Treatment and Outcomes by Transplant in the United States Poster
Abstract #3198
Dec. 11, 6-8 p.m. CST

An Open-Label, First-in-Human, Dose-Escalation Study of SAR443579 Administered as Single Agent by Intravenous Infusion in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-Cell Acute Lymphoblastic Leukemia (B-ALL) or High-Risk Myelodysplasia (HR-MDS) (Trial in Progress) Poster
Abstract #3329
Dec. 11, 6-8 p.m. CST
The Novel Trifunctional Anti-BCMA NK Cell Engager SAR’514 Has Potent in-Vitro and in-Vivo Anti-Myeloma Effect Through Dual NK Cell Engagement Poster
Abstract #4486
Dec. 12, 6-8 p.m. CST
Pegathor Lymphoma, a Phase 2 Study of SAR444245 as a Monotherapy or in Combination with Pembrolizumab for the Treatment of Adults and Adolescents with Relapsed or Refractory B Cell Lymphoma (Trial in Progress) Online abstract only

On December 2, 2022 Privo Technologies, Inc. reported that it has received IRB approval for its CLN-004 study from WCG IRB (Press release, Privo Technologies, DEC 2, 2022, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-receives-irb-approval-for-prv211-intraoperative-chemotherapy-treatment-for-solid-tumors-s-2-2-2 [SID1234624746]). CLN-004 is a Phase 1/2, open-label, safety and efficacy study accessing the tolerability, anti-tumor effects, systemic exposure, and device technical effects of PRV211 (Cisplatin Intraoperative System) in Subjects with T2-T3 Oral Squamous Cell Carcinoma (OSCC) amenable to surgery. PRV211 is a sterilized derivative of the nano engineered PRV platform intended for intraoperative chemotherapy treatment for all solid tumor surgeries immediately following surgical excision. The goal is to treat the tumor bed locally, eliminating any remaining micro metastases or close margins that are unable to be fully resected while avoiding system circulation.

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This is Privo’s 3rd IRB approval with WCG.

The WCG IRB, formally known as the WIRB Copernicus Group, Inc., is the industry leader in ethical review of clinical trial protocols with over 50 years of experience.

On December 2, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported that it will host a conference call on Monday, December 5, 2022 at 8:00 a.m. ET to review updated clinical data from the ongoing clinical trial of NKX019, its CD19-directed CAR NK cell therapy candidate (Press release, Nkarta, DEC 2, 2022, https://ir.nkartatx.com/news-releases/news-release-details/nkarta-host-conference-call-discuss-updated-clinical-data-nkx019 [SID1234624743]).

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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

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Conference Call and Webcast
To access the conference call, please register through this link:
View Source

Accompanying slides will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

About NKX019
NKX019, a wholly owned program of Nkarta, is an investigational healthy donor-derived CAR NK cell therapy targeting CD19. NKX019 is being investigated in an ongoing Phase 1 single-arm, open label, multi-center, international clinical trial that is designed to assess the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy and combination therapy in patients with relapsed/refractory B cell malignancies.

On December 2, 2022 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that on December 1, 2022, an authorized sub-committee of the Compensation Committee of the Board of Directors of Mersana granted inducement awards, consisting of stock options to purchase an aggregate of 16,425 shares of its common stock and restricted stock unit awards (RSUs) to acquire an aggregate of 14,175 shares of its common stock, to two new employees whose employment commenced in November 2022 (Press release, Mersana Therapeutics, DEC 2, 2022, View Source [SID1234624742]). The awards were granted pursuant to terms and conditions fixed by the Compensation Committee and as an inducement material to each new employee entering employment with Mersana in accordance with Nasdaq Listing Rule 5635(c)(4).

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The option awards have an exercise price of $6.77 per share, which is equal to the closing price of Mersana’s common stock on December 1, 2022. Each option has a 10-year term and will vest over a period of four years, with 25% of the shares vesting on the one-year anniversary of the commencement of the employee’s employment and the remainder vesting in equal quarterly installments over the following three years, subject to the applicable employee’s continued service with Mersana on each such vesting date. The options are subject to the terms and conditions of Mersana’s 2022 Inducement Stock Incentive Plan and the terms and conditions of a stock option agreement covering each grant.

The RSUs will vest in four equal annual installments starting November 15, 2023, subject to the applicable employee’s continued service with Mersana on each such vesting date. The RSUs are subject to the terms and conditions of Mersana’s 2022 Inducement Stock Incentive Plan and the terms and conditions of an RSU agreement covering each grant.

On November 30, 2022 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) reported that it will be presenting at the Planet MicroCap Showcase: VIRTUAL 2022 investor conference Wednesday, December 7, 2022 at 3:30 p.m. EST/12:30 p.m. PST (Press release, Lixte Biotechnology, DEC 2, 2022, View Source [SID1234624741]).

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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

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John S. Kovach, M.D., founder and CEO of LIXTE, will host the presentation. Dr. Kovach, with his team, will be answering questions at the conclusion.

To access the presentation, please use the following information

Planet MicroCap Showcase: VIRTUAL 2022

Date: Wednesday, December 7, 2022
Time: 3:30 p.m. EST/12:30 p.m. PST
Webcast: View Source

LIXTE is a drug discovery company that has a developed unique, proprietary, first in-class protein phosphatase inhibitor, LB-100, as its lead clinical compound. LB-100 has potential widespread use as an anti-cancer agent when used alone and in combination with standard anti-cancer therapies, including cytotoxic drugs, radiation, and immune checkpoint blockers.

To view LIXTE Biotechnology Holdings’ presentation at the Planet MicroCap conference, register in advance at: View Sourcesignup" target="_blank" title="View Sourcesignup" rel="nofollow">View Source

The Planet MicroCap Showcase: VIRTUAL 2022 website is available at View Source

All company presentations as part of the conference will be available directly on the conference event platform on this link under the tab "Agenda" at: View Sourceagenda