On June 10, 2021 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported it has initiated patient enrollment and screening in its Phase 1 imaging study evaluating VMT01 for the treatment of metastatic melanoma (Press release, Viewpoint Molecular Targeting, JUN 10, 2021, https://viewpointmt.com/viewpoint-molecular-targeting-commences-patient-enrollment-in-phase-1-imaging-study-for-vmt01-program-for-metastatic-melanoma/ [SID1234585490]).

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Melanoma is a cancer of the skin and the most aggressive form of skin cancer. While a disease that is identified early (when confined to the outer layers of the skin) can be cured by surgery, melanoma that migrates to distant sites in the body (metastatic melanoma) is difficult to treat. Despite the introduction of new treatments for metastatic melanoma, according to the American Cancer Society, the five-year survival is approximately 25%.

"The start of the VMT01 imaging study represents a significant milestone for the Company. The study tests Viewpoint’s investigational imaging agents in subjects with advanced melanoma to accelerate therapeutic drug development and enable image-guided treatment. We are pleased to be working alongside Mayo Clinic to advance this novel theranostic approach to radiopharmaceutical therapy against metastatic melanoma," commented Frances L. Johnson, MD, Chief Executive Officer and Co-Founder of Viewpoint Molecular Targeting. "Based on the extremely encouraging preclinical data seen to date, we believe that our targeted alpha-particle therapies have the potential to significantly enhance treatment responses in metastatic melanoma."

The Phase 1 first-in-human, crossover design study of Positron Emission Tomography (PET) and Single-Photon Emission Computerized Tomography (SPECT) scanning will enroll approximately 10 subjects with Stage III/IV unresectable melanoma. The primary endpoint of the study is safety and biodistribution. Secondary endpoints of the study are molecular target validation and image quality. The current VMT01 Phase 1 imaging study is being conducted at Mayo Clinic in Rochester, MN, and a future therapy study is planned. Provisional results for the imaging study are targeted for Q4 2021. Following the results of the imaging trial, the Company plans to initiate a multisite Phase 1/2a therapy study of VMT01 for the treatment of metastatic melanoma.

Viewpoint’s VMT01 program is intended to address an unmet clinical need with the use of a new imaging agent to guide Viewpoint’s radiopharmaceutical therapy against metastatic melanoma. This image-guided approach is often referred to as "theranostics." Using information guided by the low-risk medical imaging scan, a treatment plan utilizing the VMT01 ligand is designed to deliver the power of alpha-particle radiation specifically to melanoma tumors, while minimizing risk to unaffected organs and tissues. VMT01 represents a unique way to treat metastatic melanoma that has been vetted as scientifically sound by rigorous peer review and has the potential to be transformative for melanoma patients.

On June 10, 2021 Kurome Therapeutics, a preclinical stage company dedicated to developing novel therapies that target adaptive resistance mechanisms in cancer cells while inhibiting critical disease modifying genes, reported the closing of a $15 million Series A financing (Press release, Kurome Therapeutics, JUN 10, 2021, View Source [SID1234583803]). The round was co-led by Medicxi and Affinity Asset Advisors with participation from founding investor CincyTech, and other existing seed investors.

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"We are excited to have the support of exceptional investors. This financing allows us to expand our R&D program to substantially de-risk compound selection as we identify our first development candidate in advance of IND filing," said Kurome Chief Executive Officer and Chief Scientific Officer Jan Rosenbaum, PhD.

The funding will support the pre-clinical advancement of dual IRAK1/4 and panFLT3 inhibitors to target cancer cells that evade the effects of both targeted therapy and chemotherapy drugs via adaptive resistance mechanisms, having co-opted IRAK1/4-mediated immune signaling pathways to survive. The biology being currently investigated was discovered by Daniel Starczynowski, PhD, who is Principal investigator and Co-Leader, Hematologic Malignancies Program at Cincinnati Children’s Cancer and Blood Diseases Institute, and a leading expert in IRAK 1/4 signaling pathways in cancer. Specifically, these treatments are initially focused on improving outcomes in poor prognosis acute myeloid leukemia (AML) patients but will look to expand its focus across a range of hematopoietic cancers, including pre-leukemic conditions such as myelodysplastic syndromes (MDS), as well as certain solid tumors where dysregulated IRAK1/4 signaling and inflammation may play a pathogenic role in tumorigenesis.

"We are excited to be aligned with the leading experts in the IRAK1/4 signaling pathway and are impressed with the level of development and data generated by Kurome to date," said Daniel Heller, General Partner and Chief Investment Officer at Affinity Asset Advisors.

Launched in 2020, Kurome secured initial seed funding led by CincyTech based on research at Cincinnati Children’s Hospital Medical Center in collaboration with the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS).

"In multi-factorial hematological malignancies like AML, we are excited by the early clinical data of combined IRAK4 and FLT3 inhibition in patients. The Kurome team has generated compelling preclinical data that suggests a differentiated approach with potential advantages over others in this emerging space," said Aaron Kantoff, Venture Partner at Medicxi.

Aaron Kantoff, Venture Partner at Medicxi, and Daniel Heller, General Partner and Chief Investment Officer at Affinity Asset Advisors, will join the Kurome Therapeutics Board of Directors.

On June 10, 2021 Cardinal Health (NYSE: CAH) reported that LYMPHOSEEK (technetium Tc 99m tilmanocept) injection – the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) – has been approved for pediatric use by the U.S. Food and Drug Administration (FDA) (Press release, Cardinal Health, JUN 10, 2021, View Source;Precision-Health-Solutions-Receives-U.S.-Food-and-Drug-Administration-Approval-for-New-LYMPHOSEEK-Pediatric-Indication/default.aspx [SID1234583821]).

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"This new indication opens the door for physicians, oncologists and nuclear medicine specialists to more accurately stage the spread of disease using lymphatic mapping in pediatric cancer patients," said Tiffany Olson, President of Nuclear & Precision Health Solutions at Cardinal Health. "Ultimately, this may help more families to be able to get answers to some of their most concerning questions."

In addition to adult use, this new indication will provide accurate and precise lymph node identification in pediatric patients with melanoma, rhabdomyosarcoma (RMS) or other types of solid tumors. This will offer physicians, oncologists and nuclear medicine specialists an efficient, accurate and safe option to enhance lymphatic mapping and SLNB in pediatric melanoma cases, the most common skin cancer in children, which results in around 500 new cases per year [1].

Approximately the same number of pediatric cases of RMS, a rare type of cancer that forms in soft tissues, such as eyes, occurs each year in the United States. RMS is most often diagnosed in children and teens, with more than half of diagnoses in children younger than 10 years old [2].

LYMPHOSEEK is a radioactive diagnostic agent. A clinical study to evaluate LYMPHOSEEK in pediatric patients has shown that the radiopharmaceutical is safe and effective for patients one month and older. Less than one percent of patients reported injection site irritation and/or pain in clinical trials, with no serious adverse reactions to the drug being reported.

With the largest national pharmacy network and the industry’s most comprehensive portfolio of radiopharmaceuticals – with best-in-class service, accuracy and reliability to deliver on-demand prescriptions across the country – Cardinal Health Nuclear & Precision Health Solutions is helping shape the future of precision healthcare.

On June 10, 2021 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, reported the appointment of Robert (Xiaohua) Xin, M.D., Ph.D., as Chief Medical Officer, reporting to Zhenhai Gao, Ph.D, co-founder, president, and CEO of NiKang (Press release, NiKang Therapeutics, JUN 10, 2021, View Source [SID1234583839]). As a member of the executive leadership team, Dr. Xin will oversee the global clinical development of NiKang’s pipeline and will work closely with the discovery team to prioritize drug targets and formulate strategies.

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"NiKang is on the verge of rapid growth. We are thrilled to welcome Robert at this pivotal time. His successful track record in navigating all stages of clinical development will help us effectively execute our clinical development plans," said Zhenhai Gao. "His in-depth expertise in oncology drug development and strong leadership will be invaluable and instrumental to our patient-focused mission and to the transformation of NiKang into a fully-fledged drug discovery and development company."

Dr. Xin brings to NiKang more than 20 years of experience with an excellent track record of successfully developing novel oncology therapies including small molecules, therapeutic antibodies, antibody drug conjugates and immunotherapies. Previously, Dr. Xin served as SVP, head of clinical development at Turning Point Therapeutics, where he led early and late stage clinical programs for selective small molecule inhibitors for the treatment of cancer. Before Turning Point, he spent 7 years at Pfizer and had served in positions of increasing responsibilities, most recently as interim VP of oncology early clinical development. Prior to Pfizer, Dr. Xin served for 10 years at Genentech/Roche in senior leadership roles in oncology clinical development. His early career experience includes drug discovery and translational medicine at Chiron, Eli Lilly and Sugen. Dr. Xin obtained his M.D. from Zhejiang University School of Medicine in China and a Ph.D. in Cell and Molecular Physiology from the University of North Carolina at Chapel Hill School of Medicine.

"I am honored to serve as NiKang’s Chief Medical Officer. I have been incredibly impressed with the capability and productivity of NiKang’s extremely talented and passionate drug hunters. They have built an attractive portfolio of novel small molecules against hard-to-drug targets for cancer treatment. It is an exciting time at NiKang as the company is advancing multiple promising drug candidates into clinical development. I look forward to working with the team to accomplish NiKang’s mission of helping cancer patients with unmet medical needs."

On June 10, 2021 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that mOS between 21.9 and 25.0 months from the randomized phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) (Press release, Targovax, JUN 10, 2021, View Source [SID1234583822]).

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The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (or later) line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The trial has now completed the 24-month follow-up.

At the 24-month follow-up, it was determined that the final mOS will be in the range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the randomized group (n=8). This is a clear improvement over the mOS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous MPM clinical trials have reported mOS in the range of 12–16 months for patients receiving the same SoC chemotherapy treatment[1].

Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 36). The tumor tissue analyses revealed broad and powerful ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. Notably, this activity was associated with both tumor responses and survival outcomes, indicating that the immune activation generated by ONCOS-102 is driving the clinical benefit for patients.

Dr. Luis Paz-Ares, Chair of the Medical Oncology Department at the Hospital Doce de Octubre, Madrid and Principal Investigator of the trial, said: "Mesothelioma remains a challenging disease with a generally poor prognosis, and there is a large unmet medical need for new, innovative treatments such as ONCOS-102. Although the number of patients in this trial is small, the overall survial is very encouraging, particularly since the outcomes can be linked to ONCOS-102-induced immuno-modulation. These early results clearly support further clinical development, and we look forward to participating in future trials with ONCOS-102 in mesothelioma."

Recently, the double checkpoint inhibitor (CPI) combination of Opdivo and Yervoy (nivolumab and ipilimumab) was approved by the U.S. Food and Drug Administration (October 2020) and the European Medicines Agency (April 2021) for the first-line treatment of MPM, based on a phase 3 trial showing mOS of 18.1 months compared with 14.1 months in the SoC control group (pemetrexed/cisplatin). The Opdivo/Yervoy combination is seeing rapid uptake among clinicians in both the USA and Europe and is becoming the new preferred first-line Standard of Care. Given the class-leading activity ONCOS-102 has demonstrated in CPI-refractory melanoma (see link here), Targovax believes there is a strong scientific rationale for testing ONCOS-102 in the CPI-refractory setting also in MPM. This opportunity is now being discussed with key opinion leaders.

Øystein Soug, CEO of Targovax, commented: "We are very pleased to see ONCOS-102 generating robust immune activation in a tumor type with low immunogenicity and delivering meaningful survival benefit for patients with high medical need. With the recent approval of the Opdivo/Yervoy combination, the power of immunotherapy is now making its way into mesothelioma and is already improving patient outcomes. ONCOS-102 is ideally positioned for combination with checkpoint inhibitors and, as demonstrated in our melanoma trial, to reactivate checkpoint resistant tumors. Therefore, we are now evaluating the potential opportunity in the emerging checkpoint resistant mesothelioma population, thereby expanding on the demonstrated ability of ONCOS-102 to bring benefit to the majority of patients who still progress after checkpoint inhibitor treatment."

[1] 1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC (Free SITC Whitepaper) 2020 poster