On September 12, 2024 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported the presentation of initial clinical data for HST-1011, an investigational oral, selective inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B) (Press release, HotSpot Therapeutics, SEP 12, 2024, View Source [SID1234646542]). Data from the Phase 1 monotherapy dose escalation portion of the study are being shared in a proffered oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024.

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!

"These initial data provide the first comprehensive insight into the clinical experience with a CBL-B inhibitor, a novel immuno-oncology mechanism with the potential to meaningfully transform the treatment paradigm for patients with solid tumors," said Timothy Reilly, Ph.D., Chief Development Officer of HotSpot. "Critically, HST-1011 demonstrated important linkages between drug exposures, target engagement, and proximal and distal measures of pharmacology, and we observed initial signs of clinical benefit, in a heavily pre-treated, advanced solid tumor patient population. We believe these data provide a strong foundation for the continued evaluation of HST-1011 in dedicated patient populations and for the further assessment of HST-1011 in combination with a PD-1 inhibitor, cemiplimab."

The Phase 1/2 study of HST-1011 (NCT05662397) is an open-label clinical study designed to evaluate HST-1011 alone and subsequently in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab), in adult patients with advanced solid tumors that are relapsed on or are refractory to anti-PD(L)-1 or standard of care therapies. The results being presented at ESMO (Free ESMO Whitepaper) include data from 28 patients in the monotherapy dose escalation portion of the study. The presentation describes the following data:

Patients had a diverse range of solid tumor types and were heavily pre-treated, with a median of four prior lines of therapy, including 89% who had been treated previously with immunotherapy.
HST-1011 was generally well tolerated across a range of twice-weekly doses, with no dose-limiting toxicities. The most frequent adverse events were gastrointestinal in nature, which were generally mitigated by the adoption of a prophylactic pre-treatment regimen.
Encouraging linkages were observed between pharmacokinetics (PK), target engagement, pharmacodynamics (PD) and initial signals of clinical activity. Despite the heavily pre-treated, advanced cancer patient population, indications of clinical benefit, including tumor stasis or shrinkage, were observed in 10 of the 28 patients across a range of tumor types and dose levels.
These encouraging data provide support for the ongoing evaluation of HST-1011 (NCT05662397).

Presentation details are as follows:

Title: First-in-Human (FIH) Phase 1 Data of HST-1011, an Oral CBL-B Inhibitor, in Patients with Advanced Solid Tumors
Speaker: Rachel E. Sanborn, M.D., Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR
Session Name: Proffered Paper session: Investigational immunotherapy
Session Date and Time: Fri., Sep. 13, 2024, 16:00-17:30 CEST
Presentation Time: 16:50-17:00 CEST
Location: Burgos Auditorium – Hall 5, Fira Barcelona Gran Via
Presentation Number: 991O

On September 12, 2024 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), reported that it has entered into a multi-target antibody discovery collaboration with Umoja Biopharma, a transformative immunotherapy company creating off-the-shelf treatments that aim to extend the reach and effectiveness of CAR-T cell therapies in oncology and autoimmunity (Press release, Nona Biosciences, SEP 12, 2024, View Source [SID1234646541]). This collaboration leverages Nona’s proprietary fully human heavy chain only antibody (HCAb) technology to produce novel in vivo generated CAR-T cell therapy drug candidates.

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!

Fully human HCAbs have the potential to significantly reduce immunogenicity and offer versatility in CAR design due to their compact size, simplified structure, and precisely calibrated binding properties. This partnership aims to combine Nona’s HCAb Harbour Mice platform and direct CAR-function-based HCAb library screening platform (NonaCarFx) with Umoja’s VivoVec platform to develop novel in vivo CAR-T cell therapies and expand the potential reach of this innovative delivery technology.

Dr. Jingsong Wang, MD, PhD, Chairman of Nona Biosciences, commented, "We are excited to collaborate with Umoja Biopharma, a pioneer in cell and gene therapy. We believe that our HCAb Harbour Mice technology and NonaCarFxTM platform, alongside with our extensive experience in oncology and immunology, will empower Umoja to generate novel CAR-T cell therapies that benefit patients worldwide."

Byoung Ryu, PhD, Umoja’s Executive Vice President of Discovery Research and Vector Biology added, "Nona is a great partner for Umoja as we continue to move the CAR-T cell field towards directly administrated in vivo CAR therapeutics. Nona has demonstrated capabilities for generating highly functional CAR candidates, and we look forward to developing multiple in vivo drug candidates through this partnership and ultimately, helping change outcomes for these patients."

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.