On September 12, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported that the Company accepted offers from multiple leading biotech institutional and individual investors to purchase an aggregate of approximately 10.35 million shares of the Company’s common stock at $22.70 per share, the closing price on Wednesday, September 11, 2024, for aggregate gross proceeds to the Company of approximately $235 million. The capital raise was completed without bankers’ fees (Press release, Summit Therapeutics, SEP 12, 2024, View Source [SID1234646552]).

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All of Summit’s Section 16 officers participated in the capital raise. A total of $79 million was raised by insiders, including Robert W. Duggan, Dr. Maky Zanganeh, Manmeet S. Soni, and Bhaskar Anand, as well as Jeff Huber, a member of the Board of Directors, who invested via a controlled entity. The remaining $156 million was raised with multiple leading biopharma institutional investors.

Summit intends to use the net proceeds to advance, in part, the clinical development of ivonescimab, including in non-small cell lung cancer and in settings outside of lung cancer by leveraging the data that will be presented at ESMO (Free ESMO Whitepaper), which may include, but is not limited to, colorectal cancer, and triple-negative breast cancer, in addition to working capital needs and general corporate purposes.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Summit has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock following the closing of the securities purchase agreement.

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

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,800 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, with a plan to initiate HARMONi-7 in early 2025.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

HARMONi-7 is a planned Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS > 50%).

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

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.