On December 2, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company (Press release, RedHill Biopharma, DEC 2, 2022, View Source [SID1234624749]). The offering consists of 32,000,000 units/pre-funded units consisting of (a) one American Depositary Share ("ADS") (or one pre-funded warrant to purchase one ADS in lieu thereof) and (b) one warrant to purchase one ADS (the "Warrants") at a price to the public of $0.25 per ADS (or $0.249 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 10 of our ordinary shares, par value NIS 0.01 per share. RedHill intends to use the net proceeds of the offering for working capital, acquisitions, and general corporate purposes.

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The offering is expected to close on December 6, 2022, subject to the satisfaction of customary closing conditions.

Aegis Capital Corp. is acting as sole book-running manager for the proposed public offering.

The securities described above are being offered by RedHill pursuant to a shelf registration statement on Form F-3 (No. 333-258259) declared effective by the Securities and Exchange Commission (the "SEC") on August 9, 2021.

The securities may be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering were filed with the SEC and are available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering will be filed with the SEC and, when available, will be available on the SEC’s website at www.sec.gov and may also be obtained from Aegis Capital Corp., Attention: Syndicate Department, 1345 Avenue of the Americas, 27th floor, New York, NY 10105, by email at [email protected], or by telephone at (212) 813-1010.

On December 2, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102 that shows median duration of response (DOR) of 24.4 months for UroGen’s investigational drug UGN-102 currently in Phase 3 development for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) (Press release, UroGen Pharma, DEC 2, 2022, View Source [SID1234624748]). The study (Abstract #193) was presented at SUO on December 2.

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"LG-IR-NMIBC is a challenging disease to treat because of the high recurrence rate managed by repetitive surgeries," says William C. Huang, M.D., FACS, Professor and Vice Chair of Urology at NYU Langone Health and Principal Investigator of the OPTIMA II trial. "The OPTIMA II Phase 2b trial showed significant tumor response benefit for patients using the novel chemoablative therapy UGN-102 for LG-IR-NMIBC and this latest analysis shows that the treatment benefit lasted for more than two years. I look forward to additional data on UGN-102, including evidence from the ENVISION Phase 3 study."

Patients who completed the OPTIMA II study were eligible to participate in this rollover study. Outcomes include DOR in patients who remained in complete response (CR) at the end of OPTIMA II, events of disease recurrence and progression, post-study treatments and death.

At the time of data cut off (February 25, 2022), data were available for 15 of the 25 patients. The median DOR among the 15 patients was 24.4 months (10.1 to 30.7 months). Seven patients remained in CR, six patients had recurrence of LG disease, one patient had progression to high-grade disease and one patient withdrew consent (no longer mobile) but remained in CR at the last evaluation prior to discontinuation. All patients were alive at the last contact, and five patients were known to have had post-study treatment with transurethral resection of the bladder tumors (three patients) or fulguration (two patients).

DOR was calculated as the time from documented CR in OPTIMA II to disease recurrence or death or last adequate disease assessment (for patients who remained in CR). The data cut off for this report is February 25, 2022.

"UGN-102 uses a similar combination with a simpler delivery method to our currently approved chemoablative medicine and has showed a similar durability of response in LG-IR-NMIBC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. UroGen’s proprietary RTGel technology allows medicines to dwell for several hours potentially improving the therapeutic effects of existing medicines. If approved, UGN-102 would be the only primary non-surgical treatment option for patients with LG-IR-NMIBC who often recur within one year of receiving surgery and continue to need repetitive surgeries for the rest of their life."

About the Phase 2b OPTIMA II Trial

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) is an open-label, single-arm, multi-center Phase 2b clinical trial of investigational agent UGN-102 (mitomycin) for intravesical solution to evaluate its safety and efficacy in patients with LG-IR-NMIBC.

Results showed:

65 percent CR at three months
Kaplan-Meier analysis estimated duration of response to be 72.5 percent at 12 months from initiation of therapy (nine months from CR); median duration of response was not reached
Treatment with UGN-102 was generally well tolerated, with mostly mild to moderate adverse events reported
Intermediate risk is defined as one or two of the following: multiple tumors, solitary tumor >3 cm, or recurrence (≥ 1 occurrence of LG-NMIBC within one year of the current diagnosis). Patients were to receive six weekly intravesical instillations of 75 mg UGN-102 in an office setting. The chemoablative effect of UGN-102 was assessed three months after initiation of study treatment with CR defined as a negative endoscopic examination, negative cytology, and when indicated, a negative for-cause biopsy. Patients achieving CR were followed quarterly to 12 months after initiation of study treatment to evaluate safety, efficacy, and durability.

About LG-IR-NMIBC

Approximately 800,000 people are living with bladder cancer in the U.S., of that 80,000 suffer from LG-IR-NMIBC. Patients with LG-IR-NMIBC face a future of recurrence and additional surgeries. Currently, the only primary treatment available is a surgical procedure known as transurethral resection of bladder tumor or TURBT, which requires anesthesia. Every time TURBT is performed it may impose more burden and serious risks on patients, including pain, bleeding, infection and injury (including perforation).

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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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.