On September 12, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) with Halozyme’s ENHANZE drug delivery technology (Press release, Halozyme, SEP 12, 2024, View Source [SID1234646540]). Tecentriq Hybreza can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab). The treatment will be available in the U.S. for all approved adult indications of intravenous Tecentriq, including certain types of lung, liver, skin and soft tissue cancer.

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!

Tecentriq Hybreza is a subcutaneous product combination of atezolizumab, a monoclonal antibody that targets PD-(L)1 aiming to prevent cancer immune evasion, and Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20.

"We are delighted that Tecentriq Hybreza has been approved in the U.S. for all approved adult indications of the IV treatment," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval represents another opportunity for our ENHANZE technology to provide patients and physicians with greater flexibility and a new option for how treatment is administered."

The FDA approval is based on pivotal data from Roche’s Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.

On September 12, 2024 Xencor, Inc. ("Xencor") (Nasdaq: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, reported the closing of its previously announced underwritten public offering of 8,093,712 shares of its common stock at a price to the public of $18.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 1,458,600 additional shares of common stock, and pre-funded warrants to purchase up to an aggregate of 3,088,888 shares of common stock at a price to the public of $17.99 per pre-funded warrant (Press release, Xencor, SEP 12, 2024, View Source [SID1234646539]). The pre-funded warrants are immediately exercisable and have an exercise price of $0.01 per share. The gross proceeds to Xencor from this offering were approximately $201.3 million, before deducting underwriting discounts and commissions and offering expenses.

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!

Leerink Partners, Raymond James and RBC Capital Markets acted as joint book-running managers for the offering. Wedbush PacGrow acted as a co-manager for the offering.

Xencor currently intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, capital expenditures, working capital and general and administrative expenses.

The public offering was made pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-270030), previously filed with the Securities and Exchange Commission (the "SEC") on February 27, 2023, and which automatically became effective upon filing. The securities were offered only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by email at [email protected]; or from RBC Capital Markets, LLC, Attention: Equity Capital Markets, Brookfield Place, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

On September 12, 2024 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported that Raul Rodriguez, the company’s president and CEO, will present a company overview at the Cantor Global Healthcare Conference on Thursday, September 19, at 9:10 am ET in New York, NY (Press release, Rigel, SEP 12, 2024, View Source [SID1234646538]).

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!

To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

On September 12, 2024 Oncternal Therapeutics, Inc. (Nasdaq: ONCT) (the "Company") reported its decision to discontinue its clinical trials evaluating ONCT-534, its dual action androgen receptor inhibitor for the treatment of patients with metastatic castration resistant cancer, and ONCT-808, its ROR1-targeting autologous CAR T program for the treatment of patients with aggressive B-cell lymphoma, and to explore strategic alternatives (Press release, Oncternal Therapeutics, SEP 12, 2024, View Source [SID1234646537]).

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!

In the current study, interim Phase 1 results of ONCT-534 did not show clinically meaningful improvements of disease, including prostate-specific antigen (PSA) levels, in the 20 patients treated in eight dosing cohorts with various doses and schedules of administration of ONCT-534. ONCT-534 was generally well tolerated, with dose limiting toxicity observed in 2 of 3 patients at the highest dose tested, 1200 mg given orally once per day.

The results with ONCT-808 at an interim Phase 1 analysis showed anti-tumor activity at every dose tested, including a complete metabolic response lasting eight months and long-term persistence of the CAR-T cells, with expected treatment emergent adverse events for a CAR-T therapy, and one death due to complications of shock at the highest dose tested.

Based on the available clinical data and capital requirements for continued development, the Company has decided to terminate these studies. The Company will focus on exploring strategic alternatives with the goal of maximizing value for its stockholders, which may include asset sales, licensing or other strategic transactions relating to the Company’s development programs or a merger, reverse merger, acquisition, or other business combination involving the Company. While this strategic exploration is ongoing, the Company will discontinue all product development activities and will take other steps to reduce costs, including a reduction in its workforce to preserve cash resources.

"The early results during dose escalation in the Phase 1/2 studies of ONCT-534 in heavily pretreated patients are disappointing, as the study was supported by extensive preclinical data and was designed to address important unmet medical needs for patients with advanced prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "In light of these data and the challenging financing environment, we intend to explore strategic options with the hope of advancing and realizing value from our pipeline including ONCT-534, ONCT-808, zilovertamab and ONCT-216."

On September 12, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, reported the completion of enrollment in NANO-GBM phase Ib/II trial, evaluating the combination of AGuIX nanoparticles with radiotherapy and temozolomide in the treatment of newly diagnosed glioblastoma and the publication of the positive Phase Ib outcomes and MRI-based biodistribution data from this trial in the journal Clinical and Translational Radiation Oncology under the title "NANO-GBM trial of AGuIX nanoparticles with radiotherapy and temozolomide in the treatment of newly diagnosed Glioblastoma: Phase Ib outcomes and MRI-based biodistribution" (Press release, NH TherAguix, SEP 12, 2024, View Source [SID1234646535]).

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!

Glioblastoma progression occurs mainly within the tumor volume after treatment by radiotherapy. To address this challenge, a radiosensitization strategy with intravenous administration of AGuIX nanoparticles is being explored in the NANO-GBM phase Ib/II trial (NCT04881032), which is the firstin-human use of these nanoparticles with radiotherapy and chemotherapy for the treatment of newly diagnosed glioblastoma.

Developed by NH TherAguix, AGuIX is designed to improve tumor targeting and increase radiobiological damage to tumor tissue locally, thanks to its radiation signal amplification capabilities, in the purpose of expanding lifespan of cancer patients

Enrollment completion
Nano-GBM is a multicentric, randomized, open-label and non-comparative Phase Ib/II trial. These patients with unresected or partially resected glioblastoma receive four injections of AGuIX in combination with temozolomide (75 mg/m²/day) and radiotherapy (60 Gy in 30 fractions of 2 Gy), followed by adjuvant temozolomide according to Stupp protocol, as the standard of care.

The aim of the phase IIstudy is to randomize patients within two arms: i) an experimental arm in which patients are treated with AGuIX at a dose of 100 mg/kg in combination with radio chemotherapy (40 patients), and ii) a control arm in which patients are treated with radio chemotherapy alone (20 patients). To date, all patients of the phase II have been successfully enrolled.

The primary endpoint of this phase II study is progression-free survival at 6 months. Secondary endpoints include AGuIX distribution in tumors, progression-free survival, overall survival, overall objective response rate and the safety profile of AGuIX in combination with radiotherapy and temozolomide.

The Phase II final data are expected by mid-2026.
In May 2024, AGuIX has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as a next-generation radio-enhancer for the treatment of malignant gliomas, particularly glioblastoma (GBM). The Company has recently submitted a dossier for a PRIME designation from the European Medical Agency (EMA).

NH TherAguix is also preparing to launch a multicentric, randomized, double-blind pivotal trial in patients with recurrent glioblastoma in 2025.

Publication of the positive Phase Ib outcomes and MRI-based biodistribution
In the Phase Ib part of the NANO-GBM trial, eligible patients were aged 18 to 75 years with newly diagnosed and histologically confirmed glioblastoma with unresected or partially resected glioblastoma. A dose escalation approach was applied to assess 3 dose levels of AGuIX: 50 mg/kg, 75 mg/kg and 100 mg/kg. Patients were treated with radiotherapy (60 Gy), and concomitant and adjuvant temozolomide. Four intravenous injections of AGuIX were delivered during radiotherapy and concomitant temozolomide.

The goal of the phase Ib was to determine the recommended phase II dose (RP2D) by the evaluation of the occurrence of dose-limiting toxicity (DLT), and to evaluate pharmacokinetic and AGuIX biodistribution in glioblastoma on MRI based images.

Eight patients were enrolled and have successfully received four intravenous injections of AGuIX: at 50 mg/kg (1 patient), 75 mg/kg (1 patient), and 100 mg/kg (6 patients). No AGuIX-related DLTs were observed, leading to the determination of the RP2D of AGuIX as 100mg/kg for continuation in the ongoing phase II multicenter randomized trial.

Moreover, the pharmacokinetic data confirmed previous results obtained in the Nanorad study, with AGuIX mean AUC increasing with dose and a mean plasmatic half-life ranging from 0.84 to 1.41 h.

The quantification assessment confirmed the precise and specific biodistribution of AGuIX within the glioblastoma allowing to identify regions with different AGuIX concentration levels, ranging from: moderate (36-123 µM) to high (123-291 µM) and very high (> 291 µM) concentration. These values are in agreement with range of concentration high enough for inducing a radiosensitization effect according to NH TherAguix knowledge and experience.

These results confirm the good safety profile of AGuIX (with no occurrence of severe AGuIX-related toxicity) and the widespread dispersion of nanoparticles throughout glioblastoma. Those outcomes support progression to the multicenter and randomized phase II, utilizing an RP2D of AGuIX of 100mg/kg (4 injections).