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]).

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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 Molecular Targeting Technologies, Inc. (MTTI) reported that it will update findings on its proprietary topical near-infrared fluorescent dye, CypH-11 (Cmetglo), at the World Molecular Imaging Conference (WMIC) meeting in Montreal from September 9-13 and at the Peritoneal Surface Oncology Group International (PSOGI) meeting in Lyon from September 26-28, 2024 (Press release, Molecular Targeting Technologies, SEP 12, 2024, View Source [SID1234646553]).

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This convenient fast-acting technology* shows promise as an effective real-time tool for oncologists in fluorescence-guided surgery (FGS). This will allow clinicians to see small tumor residue and achieve a more complete resection of cancer in the abdominal cavity. We expect that Cmetglo may improve patient outcomes by avoiding unnecessary damage to normal tissue and increase progression-free survival of patients with peritoneal surface malignancies (PM).

Dr. Johnny Ong, MD, Associate Professor, Department of Sarcoma, Peritoneal and Rare Tumors, National Cancer Centre Singapore** commented: "One of the limitations of cytoreductive surgery (CRS) is the difficulty in distinguishing tumors from normal and scar tissues. Here, we performed ex vivo validation of patient tissues to evaluate the clinical utility of Cmetglo in detecting PM via topical administration. Preliminary analysis suggests that the best clinical utility of Cmetglo could be in patients with colorectal malignancy, with the possibility of expanding its use to other histological subtypes."

Dr. Brian D Gray, SVP Research and Development noted: "MTTI’s Cmetglo makes the invisible visible. Tumor margins and metastases glow under near-infrared light. It can be a valuable addition to the surgeon’s’ armamentarium to achieve maximal cytoreduction during FGS."

Dr. Seung Koo Lee, Assistant Professor of Cell Biology Research, in Radiology at Weill Cornell Medicine***, commented: "CypH-11 is a sprayable pH-responsive fluorogenic probe that exhibits minimal fluorescence at neutral pH; however, it fluoresces brightly in an acidic environment which is a universal signature of cancer cell proliferation. Its capability of detecting small-sized ovarian tumors was further demonstrated by the spray of CypH-11 in a disseminated high-grade serous ovarian cancer (HGSOC) model."

Chris Pak, President & CEO of MTTI commented: "This groundbreaking molecule builds on MTTI’s innovative legacy in targeted diagnostics and therapeutics. We’re pursuing its use in colorectal, ovarian, and brain cancers, adding value to patients, surgeons, and other stakeholders."

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]).

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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 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported that the companies entered an agreement under which ITM gains the exclusive global license for the clinical and commercial development of the peptide-based, theranostic pair ITM-91/ITM-94D, formerly Debio 0228/0328, targeting the Carbonic Anhydrase IX (CA IX) surface protein (Press release, ITM Isotopen Technologien Munchen, SEP 12, 2024, View Source [SID1234646554]). CA IX plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452) is a Lutetium-177-labeled radioligand therapeutic compound and ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452) is a Gallium-68-labeled imaging agent. The theranostic pair is being investigated in the phase 1/2 GaLuCi(NCT05706129) clinical trial in patients living with locally advanced ccRCC, PDAC and CRC. Further terms and financial details have not been disclosed.

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"Curing patients is our mission. Through this agreement with ITM, we hope to bring breakthrough solutions to patients living with hard-to-treat cancer types. We’re extremely pleased that the trial data generated to-date for our imaging radiotracer have provided high-quality images with high tumor uptake and excellent tumor-to-background ratios. Debio 0328’s outstanding potential as a stand-alone imaging agent has also boosted our confidence for the upcoming evaluation of Debio 0228, the therapeutic agent. As development continues, we are grateful to be able to rely on ITM’s radiopharmaceutical expertise to advance research for patients," said Bertrand Ducrey, CEO of Debiopharm.

Debiopharm is a drug development expert with an evolving radioligand therapy pipeline and strong pre-clinical and clinical competence in this field. Their unique business model allows Debiopharm to continuously bridge the gap between innovative discoveries and leading pharmaceutical companies for commercialization. As the globally leading manufacturer of n.c.a. Lutetium-177 and with a broad pipeline of radiopharmaceutical diagnostic and therapeutic candidates, ITM will use its production capabilities and clinical expertise to advance this theranostic pair.

"Patients with advanced renal cancer often have a long and difficult journey, with recurrence after surgery not infrequent and limited treatment options following immune-oncology or tyrosine kinase inhibitor therapy. I have high hopes for trials like GaLuCi will finally shift the odds defining both a new PET/CT scan and targeted treatment option," said Prof. Michael Hofman, Peter MacCallum Cancer of Melbourne and investigator of the Phase 1/2 GaLuCi study.

"Theranostic approaches are a very exciting treatment modality for patients with hard-to-treat malignancies due to their potential to target specific surface proteins, often regardless of tumor origin. This technique has been shown to improve outcomes for patients with advanced-staged prostate cancer and we are hoping to bring it to the forefront of treatment for kidney cancer," added Darren R. Feldman, MD, Medical Oncologist, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center and investigator of the Phase 1/2 GaLuCi study.

About ITM-91/ ITM-94D (Debio 0228/0328)

ITM-91/ ITM-94D (Debio 0228/0328) is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CA IX. Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), which is designed to deliver targeted radiation to the tumor with the aim to destroy it from the inside.

About the GaLuCi trial

The GaLuCi trial is the first-in-human, multicenter, non-randomized phase 1/2 clinical trial assessing safety and tolerability, imaging characteristics, and the efficacy of the theranostic pair ITM-91/ ITM-94D (Debio 0228/0328) in patients with unresectable, locally advanced, or metastatic solid tumors. This theranostic trial is being carried out in three stages. The ongoing Part A is evaluating the safety and performance of the imaging agent in detecting CA IX-expressing solid tumors. Part B will assess escalating doses of the therapeutic agent, ITM-91 (Debio 0228) in patients, whose tumors show high uptake of imaging tracer. Finally, based on the recommended dose from Part B, Part C of the study will further assess the safety and preliminary efficacy of ITM-91 (Debio 0228) in ccRCC, PDAC and CRC.

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.

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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.