On December 12, 2023 Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, reported that it will host a virtual KOL event on December 19, 2023 at 11:00 AM ET, led by Suji Jeong PhD (Founding Partner, The SJR Group), featuring Phil Nicklin (Senior Analyst, LifeSci Consulting) and Dr. Ashley Mishoe, PharmD (Vice President of Regulatory Affairs and Quality Assurance, PharmaLogic) (Press release, Nusano, DEC 12, 2023, View Source [SID1234638497]). They will discuss emerging trends in the radiotherapeutics landscape, a market that is projected to have a $30 billion potential in the next five years, a prospect that is capturing the attention of investors and companies alike. To register, click here.

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The event will highlight the isotopes that are the next frontier in radiotherapeutics development, exploring alternatives to industry staples like Lutetium-177 and Actinium-225. Additionally, the discussions will delve into supply chain complexities, the role of CDMOs in bringing radiotherapeutics to patients, and the optimal timing for commercial-scale product development.

Nusano’s production platform enables the creation of rare and hard-to-produce medical radioisotopes in quantities needed for commercial-stage diagnostics and therapeutics. A reliable supply of radioisotopes is an important requirement for drugmakers developing and manufacturing next-generation pharmaceuticals needed to advance the fight against cancer.

A live question and answer session will follow the moderated panel discussion.

Emerging Trends in Radiotherapeutics: Beyond Lu-177 and Ac-225
Format: Panel Discussion
Date: Tuesday, December 19, 2023
Time: 11:00 AM ET
Location: Virtual Event

On December 12, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta, will present live at the Life Science Investor Forum, hosted by VirtualInvestorConferences.com, on December 14th, 2023 (Press release, Kineta, DEC 12, 2023, View Source;utm_medium=rss&utm_campaign=kineta-to-present-at-the-life-sciences-investor-forum-december-14th [SID1234638496]). Dr. Iadonato will engage in a "CEO Chat" session with John Vandermosten, Senior Biotechnology Analyst with Zacks Small-Cap Research.

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DATE: December 14th , 2023
TIME: 11:30 A.M. Eastern
LINK: https://bit.ly/3FgGsBt
Available for 1×1 meetings: December 14th, 15th, 18th and 19th

This will be a live, interactive online event with Dr. Iadonato and John and investors will be given the opportunity to ask Dr. Iadonato and John questions at the end of the session. If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.

It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.

Learn more about the event at www.virtualinvestorconferences.com.

On December 12, 2023 ISA reported positive anti-tumor response data with ISA101b, an HPV16 directed therapeutic cancer vaccine given in combination with Libtayo, an anti-PD1 checkpoint inhibitor (CPI) (Press release, ISA Pharmaceuticals, DEC 12, 2023, View Source [SID1234638495]). The data were generated in the OpcemISA trial, a large scale randomized double blind study that is ongoing in patients with advanced oropharyngeal cancer (OPC), a type of head and neck cancer. It is the first time that the combination of a tumor-specific therapeutic vaccine and a CPI has generated such high response rates, albeit in a predefined subpopulation of metastatic cancer patients.

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ISA101b is a therapeutic cancer vaccine targeting cancers caused by the human papillomavirus type 16 (HPV16). More than 60 percent of head-and-neck cancers are HPV16-related, and incidence rates are going up. ISA101b elicits a powerful and targeted T-cell immune response to the HPV16 virus.

OPC is a solid cancer with a high unmet medical need that does not always respond to immunotherapy. Best responses in the OpcemISA trial are found in a subcategory of patients with characteristics suitable for immunostimulatory treatments.

Study design & results

A total of 199 first- and second-line patients with recurrent/metastatic HPV16+ OPC were enrolled in the OpcemISA trial. Patients were randomized to receive either ISA101b plus CPI, or placebo plus CPI. The primary endpoint was the objective response rate (ORR) at 6 months, confirmed by independent central review. The secondary endpoints included drug safety, progression free survival (PFS) and overall survival (OS). Further details can be found at clinicaltrials.gov (NCT03669718).

Whereas the addition of ISA101b to the CPI led to a doubling of the ORR (from 26.7% to 51.9%) in a large subgroup of patients, the study as a whole did not meet this primary endpoint. Patients in the aforementioned subgroup, predefined based on a validated biomarker, also showed a clear overall survival benefit compared to the placebo arm. ISA101b was well tolerated.

Gerben Moolhuizen, Chief Executive Officer of ISA, said, "Recurrent and/or metastatic head and neck cancer is notoriously difficult to treat. Patients suffering from this terrible disease need new treatment options. In our OpcemISA study, ISA101b shows compelling results in a large, predefined subset of patients. This provides us with a clear development path to make ISA101b a treatment option for these patients."

Phase 3 and beyond

ISA is preparing for a confirmatory Phase 3 trial in this subpopulation of patients. This subgroup represents an important proportion of head and neck cancer patients, and an attractive commercial opportunity. The OpcemISA trial was part of a clinical collaboration between ISA and Regeneron. Regeneron has elected not to exercise its option on the ISA101b asset. ISA is currently in discussions with potential partners with interest in ISA101b and ISA’s technology platform in general.

On December 12, 2023 Immodulon, a late-stage clinical biotechnology company focused on developing a broad spectrum immunomodulator to improve the lives of patients suffering from difficult-to-treat cancers, reported the formation of a new Scientific Advisory Board comprising leading global experts in the field of clinical oncology (Press release, Immodulon Therapeutics, DEC 12, 2023, View Source [SID1234638494]). The new SAB will be chaired by Prof. Dr. med. Thomas Seufferlein, Director, Department of Gastroenterology, University of Ulm, Germany, and will complement the experience of Immodulon’s new management team to support the advancement of IMM-101 into a pivotal trial for pancreatic cancer as well as broader pipeline progress.

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"I am excited about the opportunity to partner with such an esteemed group of scientific advisors who are committed to supporting the development of IMM-101 to treat immunologically cold tumors, including pancreatic cancer," said Josefine Roemmler-Zehrer, MD, Associate Professor, and Immodulon’s Chief Medical Officer. "I am confident that their guidance will be crucial to moving IMM-101 into a pivotal trial for pancreatic cancer, following the completion of a positive Phase 2 trial, and accelerating our efforts to bring its therapeutic potential closer to cancer patients in need."

"I am delighted to chair this board of global experts in pancreatic cancer. My fellow SAB members and I are looking forward to supporting the Immodulon team in their efforts to develop IMM-101 into an effective treatment for patients with metastatic pancreatic cancer," said Prof. Dr. Thomas Seufferlein, Chair of Immodulon’s Scientific Advisory Board.

The new SAB consists of the following members:

Prof. Dr. med. Thomas Seufferlein (Chairman), University of Ulm, Ulm, Germany
Dr. Jean-Pierre Bizzari, MD, Former EVP, Group Head ClinicalDevelopment Oncology at Celgene
Prof. David Chang, MBBS, MS, FRACS, FRCS, PhD, University of Glasgow, Glasgow, UK
Prof. Angus Dalgleish, MD, FRCP, FRACP, FRCPath, St. Georges University Hospital, London, UK
Dr. Andrew Gaya, BSc, MB SC, MRCP, FRCR, MD, Guy’s and St Thomas’ Hospital, London, UK
Prof. Jeeyun Lee, MD, Sungkyunkwan University, Samsung MC,Seoul, ROK
Prof. Andrew MacDonald, BSc, PhD, University of Manchester, Manchester, UK
Dr. Victoria Manax, MD, Managing Partner MRCD Consulting
Prof. Josep Tabernero, MD, PhD, Vall d’Hebron University, Barcelona, Spain
Prof. Dr. Margaret Tempero, MD, USCF, CA, United States
Prof. Dr. Eric Van Cutsem, MD, University of Leuven, Belgium

On December 12, 2023 Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, reported data during three poster presentations at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting and Exposition in San Diego, California (Press release, Ichnos Sciences, DEC 12, 2023, View Source [SID1234638492]).

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The studies showcased encouraging safety profiles, dose-dependent pharmacokinetics, and efficacy signals, marking significant progress in the fight against relapsed or refractory multiple myeloma.

"The results of these studies are a validating mile marker for our proprietary BEAT1 multispecific platform’s innovative mechanism of action," said Eugene Zhukovsky, Ichnos’ Chief Scientific Officer. "Our platform shows promise to unleash a powerful combination that can specifically target multiple surface proteins of tumor cells. This novel approach means stronger and more specific binding of immune cells to tumor cells, offering a beacon of hope for patients in dire need of treatment options as they face challenging hematologic malignancies."

1. Dose Escalation of ISB 1342, a Novel CD38xCD3 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM):

Safety and tolerance: Demonstrated treatment with ISB 1342 was manageable at higher dose levels evaluated, with mild to moderate CRS, no ICANS, and no increased risk of infection observed.
Dose-dependent pharmacokinetics and biomarkers: Following IV infusion, ISB 1342 showed dose-linear increase in serum exposures across the evaluated dose range. Increases in several T-cell activation-related biomarkers (CD69 by flow, and serum cytokines withing 24hrs, such as IFNg, TNFa, IL-2, IL-6 and IL-10), were consistently observed following ISB 1342 dosing supporting proof of mechanism.
Efficacy signals: Positive results in patient groups at higher dose levels (8 and 16 μg/kg cohorts) align with predicted effectiveness based on a sophisticated preclinical quantitative system pharmacology (QSP) model, supporting the drug’s potential success in treating multiple myeloma.
2. Initial Dose Escalation of ISB 1442, a Novel CD38 Biparatopic x CD47 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM):

Safety and tolerance: Demonstrated treatment with ISB 1442 was well tolerated at the dose levels evaluated, with observed clinical cytokine release syndrome (CRS) events being low grade and potentially related to macrophage activation following ISB 1442 administration.
Dose-dependent pharmacokinetics: Showed dose-linear increase in serum concentration up to DL 3 (60 mg), followed by a super-proportional increase in serum exposure most evident between DL3 (60 mg) and DL4 (150 mg).
Mechanism of action: Increase in macrophage-associated markers are consistent with a potential mechanism of action involving macrophage activation enhanced by the effector function modifications incorporated into the design of ISB 1442.
3. A Phase 1, First-in-Human, Dose Escalation and Dose-Expansion Study of a BCMAxCD38xCD3 Targeting Trispecific Antibody ISB 2001 in Subjects with Relapsed / Refractory Multiple Myeloma (RRMM):

ISB 2001 debut: A BCMAxCD38xCD3 trispecific antibody1 based on Ichnos’ proprietary TREAT2 platform, which promotes strong avidity induction and enables efficient and potent killing of multiple myeloma (MM) cells. Dual TAA targeting with ISB 2001 may overcome escape mechanisms associated with BCMA and CD38 targeted therapies, including approved T cell engagers, ADC or cell therapies.
Study design: Phase 1 study (NCT05862012) employing a subcutaneous dosing strategy with a step-up dosing approach, aiming to confirm efficacy and tolerability in patients with RRMM. The first-in-human dose was derived using advanced preclinical modeling, emphasizing safety with a preemptive step-up dosing strategy.
Future direction: The study is currently open for enrollment. Part 2 aims to confirm safety, select the recommended Phase 2 dose (RP2D), and explore secondary and exploratory endpoints.
All three of Ichnos’ presentations and corresponding data are available for review on the Ichnos website. More information about the three oncology assets highlighted at the meeting, and the rest of Ichnos’ pipeline can be found at this link.