On June 22, 2023 CEL-SCI Corporation (NYSE American: CVM) reported that it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in Montreal, Canada (Press release, Cel-Sci, JUN 22, 2023, View Source [SID1234632859]).

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"This data to be presented at AHNS, in our view and also in the view of our clinical consultants, is quite remarkable and has the potential to help many more people than just the study population in our recently concluded Phase 3 clinical trial," stated CEL-SCI CEO, Geert Kersten. "In fact, these findings are so novel that we are currently preparing to file a new patent application. Details will be announced once the presentation has been given."

CEL-SCI’s IT-MATTERS pivotal Phase 3 study reported a statistically significant 14.1% absolute 5-year overall survival (OS) benefit in the intent to treat (ITT) subjects who received Multikine followed by surgery and radiotherapy, as compared to control subjects who received only standard of care (SOC) (surgery plus radiotherapy). The Company is pursuing marketing approval for Multikine in the treatment of head and neck cancer in the U.S., Canada and the European Union.

On June 22, 2023 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a first reported case of a uveal melanoma (UM) patient who was treated with single agent darovasertib as neoadjuvant therapy and was spared enucleation in an Investigator Sponsored Trial (IST) (Press release, Ideaya Biosciences, JUN 22, 2023, View Source [SID1234632858]).

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"We are very excited to explore the potential of darovasertib as neoadjuvant and adjuvant therapy for patients with ocular melanoma. This case suggests that treatment with darovasertib as monotherapy can preserve the eye and may have vision-sparing utility as well as quality of life benefits," said Professor Anthony Joshua, MBBS, PhD, FRACP, Head Department of Medical Oncology, Kinghorn Cancer Centre, St. Vincent’s Hospital in Sydney, a principal investigator in the IST. The IST, captioned as "Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma" (NADOM), also includes participating sites of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne.

"Avoiding enucleations with darovasertib is a very promising development in the field of ocular oncology. We are looking forward to further research and trials using this approach," said Dr. William Glasson, MBBS, FRANZCO, Terrace Eye Center, Brisbane, Australia, who was the treating ophthalmologist for the first reported case of spared enucleation on darovasertib monotherapy.

In the reported case, the UM patient observed a 24% reduction in tumor size following four months of neoadjuvant treatment with darovasertib as monotherapy. The reduction in tumor size enabled plaque brachytherapy as a primary interventional treatment rather than originally planned enucleation. This UM patient shared his experience in an exclusive interview and report by medical reporter Gabriella Rogers of Television 9 News Channel station in Sydney Australia on June 21, 2023. See link: View Source

The eye preservation was observed in the first UM patient treated under the amended protocol of the NADOM study. Pursuant to the protocol, uveal melanoma patients who would otherwise undergo enucleation are instead treated with single agent darovasertib as neoadjuvant treatment for up to six months or maximum benefit – reflecting an increase in potential treatment duration versus the initial approach of one month neoadjuvant therapy. Multiple additional UM patients are also enrolled in the Phase 1 NADOM study under the amended protocol.

IDEAYA is initiating clinical sites to support a company-sponsored Phase 2 clinical trial, designated as IDE196-009 (NCT05907954), to evaluate darovasertib as monotherapy in (neo)adjuvant uveal melanoma with potential near-term clinical endpoints such as organ preservation (avoiding enucleation) for large ocular tumors and reduction in radiation dose and/or vision preservation for small or medium ocular tumors. The Phase 2 clinical trial plans to enroll patients in U.S., Europe and Australia.

IDEAYA previously reported preliminary clinical activity observed in primary uveal melanoma, including tumor shrinkage in 9 of 9 patients following therapy with darovasertib as monotherapy or in combination with crizotinib, and an initial reported patient who was spared an enucleation following neoadjuvant treatment with the combination under a compassionate use protocol.

Uveal melanoma is a rare, lethal form of melanoma that arises from melanocytes of the iris, the ciliary body, or most commonly the choroid, with an annual potential incidence of approximately 8,700 patients aggregate and an estimated prevalence of ~100,000 patients aggregate in the U.S. and Europe. UM has no approved systemic neoadjuvant or adjuvant therapies. Current approaches for treatment of primary UM includes radiotherapy (plaque brachytherapy or stereotactic radiosurgery) and, for larger tumors, enucleation of the eye, with consequential patient impact including reduced vision, decreased depth perception, diminished social functioning and unsatisfactory cosmesis.

Darovasertib (IDE196) is a potent, selective small molecule inhibitor of protein kinase C (PKC). The FDA has designated darovasertib as an Orphan Drug in Uveal Melanoma, including primary and metastatic disease under 21 C.F.R Part 316. IDEAYA owns or controls all commercial rights in darovasertib in UM, subject to certain economic obligations pursuant to its exclusive, worldwide license with Novartis.

On June 22, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported presentations from the Company’s investigational prostate (prostate specific-membrane antigen, or PSMA-targeting) and renal (carbonic anhydrase IX, or CAIX-targeting) diagnostic and therapeutic programs at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting being held in Chicago from June 24 – 27 (Press release, Telix Pharmaceuticals, JUN 22, 2023, View Source [SID1234632857]).

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Further data from Telix’s completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be delivered by Jeremie Calais, MD in an oral presentation.

In addition, Andrew M. Scott, MD will present a preclinical evaluation of Telix’s CAIX-targeting radionuclide therapy candidate TLX250 (177Lu-DOTA-girentuximab) in combination with a Merck KGaA DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib.

SNMMI 2023 will also feature presentations on Telix’s lutetium-based, antibody-directed prostate cancer therapy program, ProstACT, and the Company’s FDA-approved, gallium-based prostate cancer imaging agent, Illuccix, where PSMA imaging with positron emission tomography (PSMA-PET) continues to be a focus for the nuclear medicine and molecular imaging community.

Telix Chief Medical Officer, Dr. Colin Hayward said, "It is fantastic to have such broad representation at this year’s SNMMI annual meeting, the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging worldwide. Alongside further data from the highly successful Phase III ZIRCON study in kidney cancer imaging, we are excited to present latest updates from our ProstACT SELECT and TARGET studies as this program builds momentum into the ProstACT GLOBAL study.

"Preclinical data from a study of Telix’s CAIX-targeting therapy candidate TLX250 with an investigational DNA damage response inhibitor will also be presented as this combination prepares to move into the clinic. And last – but by no means least – our approved prostate cancer imaging agent, Illuccix, will feature on the program as part of lifecycle management. Drop by our booth number 4015 to meet with the team, to learn about Telix’s deep theranostic pipeline, and to discuss how recent guideline updates for prostate cancer imaging could impact clinical decision making and patient management."

SNMMI oral presentation details are as follows:

Session: Focus on Clinical Studies – New Insights
Title: 177Lu-TLX591 safety, biodistribution and dosimetry study (ProstACT SELECT)
Date and Time: 24-Jun-2023, 3:45 – 3:55 PM
Presenter: Nat Lenzo, MD (GenesisCare)
Abstract ID: P1145

Session: Urologic Malignancies – Integrated Session
Title: 89Zr-DFO-girentuximab PET/CT imaging can accurately detect clear cell renal cell carcinoma (ccRCC) primary and secondary lesions in patients with renal masses at conventional imaging, results from ZIRCON Phase III study
Date and Time: 26-Jun-2023, 10:55 – 11:05 AM
Presenter: Jeremie Calais, MD (UCLA)
Abstract ID: P1113

Session: Imaging and Therapy in Preclinical Oncology Models – Session 2
Title: Addition of DNA dependent protein kinase (DNA-PK) inhibitor peposertib enhances efficacy of 177Lu-based radioimmunotherapy in pre-clinical models of prostate and renal cell carcinoma
Date and Time: 26-Jun-2023, 11:05 – 11:15 AM
Presenter: Andrew M. Scott, MD (Olivia Newton-John Cancer Research Institute, and La Trobe University)
Abstract ID: P1271

SNMMI poster presentations:

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: Analysis of bone lesions on 68Ga-PSMA-11 PET/CT in a randomized controlled trial of men with biochemical recurrence of prostate cancer post prostatectomy
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: David Schuster, MD (Emory University)
Abstract ID: P968

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: External beam therapy with theranostic radioligand therapy for oligometastatic prostate cancer (ProstACT TARGET)
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: Nat Lenzo, MD (GenesisCare)
Abstract ID: P1178

Session: Meet the Author: Oncology: Clinical Therapy & Diagnosis – Group A
Title: 30-second acquisition for Ga-68 PSMA-11 total-body PET/CT impacts prostate cancer management
Date and Time: 26-Jun-2023, 11:15 – 11:45 AM
Presenter: Harshad Kulkarni, MD (BAMF Health)
Abstract ID: P1408

On June 22, 2023 Tagworks Pharmaceuticals BV ("Tagworks"), the pioneer of Click-to-Release chemistry designed to deliver more effective and safer systemic therapies, reported a $65 million Series A financing led by Ysios Capital and Gilde Healthcare with participation from Novartis Venture Fund, New Enterprise Associates (NEA), and Lightstone Ventures (Press release, Tagworks Pharmaceuticals, JUN 22, 2023, View Source [SID1234632856]). They join existing investors including Meneldor and Oost NL. In conjunction with the financing, Thomas Harth (Ysios Capital), Edwin de Graaf (Gilde Healthcare), Marianne Uteng, Ph.D. (Novartis Venture Fund), Michele Park, Ph.D. (NEA) and Christina Isacson, Ph.D. (Lightstone Ventures) joined the Board of Directors.

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The financing will support the advancement of TGW101, Tagworks’ lead click-cleavable ADC program, and the company’s proprietary Click-to-Release platform.

Tagworks’ platform enables controlled drug release induced by an in vivo click reaction with a trigger molecule. When applied to ADCs the triggered on-target release expands the scope to non-internalizing targets, affording a high bystander effect for the killing of tumors with heterogenous target expression. The platform also enables the on-target activation of immunomodulators, and the off-target deactivation of radiopharmaceuticals, enhancing their safety and therapeutic index.

Marc Robillard, Ph.D., is co-founder and CEO of Tagworks. He initiated and led the team working on Tagworks’ in vivo chemistry within Philips Healthcare, leading its spinout into Tagworks, where the click-to-release approach and other in vivo click-mediated therapeutic applications were further developed.

He commented: "Our Click-to-Release approach is poised to change the standard of care for patients with solid tumors. The limitation of today’s conventional ADCs is that they rely on suitable internalizing targets, which are not necessarily expressed by every cancer type and cancer cell. Our ADC therapy, however, does not depend on internalizing targets as it is based on chemically controlled release of the payload in the tumor micro-environment, thereby killing heterogenous tumors where not every cancer cell expresses the target. Accordingly, Tagworks has the potential to enhance efficacy in a safe manner through controlled payload release, and so, boost the therapeutic index. Importantly, our unique approach to targeting non-internalizing receptors also offers the opportunity to address a whole new cancer target landscape. This financing is an important step in unlocking the wide range of potential applications for Click-to-Release technology, to treat cancer types not addressed by current therapies."

The company’s lead program, TGW101, is a click-cleavable ADC targeting tumor-associated glycoprotein 72 (TAG72), a clinically validated non-internalizing target widely expressed in solid tumors. TGW101 is designed to enable targeted and controlled drug release and activation in the tumor microenvironment, thus facilitating the killing of tumors with heterogenous target expression, which are difficult to treat with current therapies. The proceeds of the financing will support Tagworks in bringing this program towards initial clinical proof-of-concept, and in advancing the company’s broader pipeline, currently focused on oncology.

Tagworks owns a broad intellectual property estate on in vivo Click-Conjugation and Click-to-Release technology and is initially leveraging its approach to expand the number of ADC targets. In addition to TGW101, the pipeline includes discovery phase programs in ADCs and radiopharmaceuticals. Tagworks’ technology is compatible with small molecules, peptides, and larger biomolecules, such as antibodies and fragments, and covers a wide range of toxin and immunomodulator classes.

Chris Martin, DPhil, Tagworks’ Chairman of the Board commented: "I am very pleased to join the Tagworks Board as Chair, and to support and guide the team in working to rapidly move their lead ADC program into clinical development. ADCs have long held great promise as powerful, highly targeted cancer therapies, and Tagworks’ platform represents an opportunity to expand both the therapeutic index and reach of these therapies to additional tumor types, and to make a truly transformative impact on cancer patients not served by existing therapies."

Thomas Harth, Principal at Ysios Capital stated: "We are proud to have assembled such a strong, international syndicate of investors around Tagworks. Click-to-Release shows tremendous potential to bring forward a new generation of biologic therapeutics with higher efficacy and improved safety that could be very meaningful for patients. We look for companies with truly differentiated approaches, and thus we are delighted to support Tagworks in its next phase of development."

Edwin de Graaf, managing partner at Gilde Healthcare added: "Tagworks’ cutting-edge technology platform is very promising for the development of first and best in class therapeutics, such as ADCs, immunomodulators and radiopharmaceuticals. The ability to enable on-target activation or off-target deactivation is a potentially game-changing opportunity in the field of drug development. We look forward to working closely with this top-tier team as it advances powerful new treatments for cancer and other diseases."

On June 22, 2023 Kite Pharma, Inc., a Gilead Company (Nasdaq: GILD), reported that the Marketing Authorization in Japan for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc (Press release, Gilead Sciences, JUN 22, 2023, View Source [SID1234632855]).

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This follows the announcement made by Daiichi Sankyo and Kite Pharma, Inc. in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta. With this completion of the Marketing Authorization transfer, the sales and promotion activities of Yescarta in Japan now will be managed by the Kite Cell Therapy Business Unit of Gilead Sciences K.K.

"As the global leader in cell therapy, we appreciate the opportunity and responsibility of bringing this innovative treatment to as many eligible patients as possible who may benefit," said Cindy Perettie, Executive Vice President and Global Head of Kite. "We are pleased that we are able to fully leverage our manufacturing expertise and commercialization capabilities to meet increasing demand and maximize the potential of this important therapy for patients in Japan."

The first Yescarta treatment center in Japan was authorized in December 2021, and there are now a total of six hospitals in Japan authorized to administer the therapy with many more anticipated by the end of the year. Kite’s manufacturing facility in El Segundo, California, U.S. has been approved by Japanese regulatory authorities to manufacture Yescarta for the Japanese market, and commenced its supply of the product earlier this year.

"We are rapidly building a diverse pipeline in oncology, from antibody-drug conjugates and small molecules to cell therapy-based approaches," said Kennet Brysting, General Manager of Gilead Sciences K.K. "We look forward to advancing new treatments in oncology with the potential to positively impact the lives of people with cancer in Japan."

About YESCARTA

Yescarta (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient’s own immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient’s T cells from their blood and engineering them in the lab to express chimeric antigen receptors so that they can recognize and destroy cancer cells when they are infused back into the patient’s body. The CAR T-cell therapy is manufactured specifically for each patient and administered only once.

Axicabtagene ciloleucel received Orphan Drug Designation from the Japan Ministry of Health, Labour, and Welfare in 2018 for the treatment of diffuse large B-cell lymphoma (LBCL), primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma. Yescarta was approved in Japan for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphomas, a type of non-Hodgkin lymphoma, who are previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant, in January 2021. In December 2022, Yescarta was approved for the initial treatment of patients with R/R LBCL in Japan.

Yescarta is approved in more than 20 countries, including the U.S., Canada, Europe, Great Britain, Switzerland, Brazil, Singapore, Israel, Japan, and Australia, for patients with certain types of relapsed or refractory B-cell lymphoma. It is developed and manufactured by Kite and commercialized by Kite in the U.S. and outside the U.S. by the respective Gilead affiliate.

Please see full U.S. Prescribing Information, including BOXED WARNING and Medication Guide.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. (1.1)
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. (1.1)

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2)
For the full European Prescribing Information, please visit: View Source