On November 18, 2022 DELBERT Laboratories reported the acquisition from Noventia Pharma Srl of the European MA of CEPLENE 0.5mg/0.5ml, solution for injection (histamine dihydrochloride) on September 12, 2022, and strengthens its commitment in hematology-oncology in Europe (Press release, Laboratoires DELBERT, NOV 18, 2022, View Source [SID1234624251]).

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Ceplene demonstrated a clinical interest in maintenance treatment of acute myeloid leukemia (AML) in patients below 60 years of age in first "complete remission" (symptom-free period of disease after initial treatment) in a clinical study published in Blood in 2006 and received orphan drug designation in 2005 1,2,3.

Acute myeloid leukemias are rare genetic diseases. In Europe, the incidence is estimated at 3.7/100,000 new cases per year. The prognosis for AML is unfavourable with a 5-year relative survival rate of 19%4.

DELBERT Laboratories (View Source) is a French pharmaceutical company specialized in the "renewal of essential medicines" frequently affected by marketing termination, stock shortages, particularly in times of crisis.

"We are focused on keeping essential medicines available to patients in 3 therapeutic areas (Antiinfectives, CNS and Oncology), with the mission of maintaining the therapeutic arsenal of doctors and preventing well-balanced patients from changing treatments.The acquisition of Ceplene’s MA in Europe is part of this strategy to maintain essential medicines and make available medicines with clinical benefit in rare diseases," said Eric Fidelin (Head of Strategy & Global Development).

With this acquisition, DELBERT Laboratories strengthens its presence in hematological oncology.

On November 18, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) reported that it has reached an agreement in principal with FutureChem based in Seoul, South Korea, a radiopharmaceutical company, for the clinical supply of radioisotope, Lu-177 n.c.a. (Lutetium-177 non-carrier-added), to support FutureChem’s Investigational New Drug IND-enabling Phase 2 clinical trial with Ludotadipep, 177Lu-FC705 to assess the efficacy and safety for repeated administration of the recommended Ludotadipep dose in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Eczacıbaşı-Monrol Nuclear Products, NOV 18, 2022, View Source [SID1234624250]). Clinical supply contract signed by two parties on 18th of Oct 2022 in Barcelona. A new supply contract between Monrol and FutureChem will be signed following the commercialization of the product in South Korea and US.

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Monrol General Manager Aydın Küçük, added: "We are delighted to be working with FutureChem to have a clinical supply agreement to support clinical development program of an innovative radiopharmaceutical product Ludotadipep, 177Lu-FC705 to assess the efficacy and safety in patients with metastatic castration resistant prostate cancer (mCRPC). Collaboration with FutureChem is another example of we continue our mission to improve quality of life for cancer patients and transform patient care for the future."

Dae Yoon Chi, Chief Executive Officer, FutureChem said: "FutureChem is thrilled to be partnering with Monrol, a company with a broad set of offerings to support our development programs and pipeline. We look forward to rolling out the supply of high-quality radioisotopes to our Phase 2a clinical trial patients in US soon. We have a future prospect to expand this partnership, supply of radioisotope, Lu-177 n.c.a. by Monrol for the commercialization of the Ludotadipep, 177Lu-FC705".

On November 18, 2022 Delphinus Medical Technologies reported that it will host demonstrations of the commercially available SoftVue 3D Whole Breast Ultrasound Tomography System (SoftVue) in Booth #2969 in the South Hall of McCormick Place at the annual meeting of the Radiological Society of North America (RSNA) in Chicago Nov. 27 to Dec. 1, 2022 (Press release, Delphinus Medical Technologies, NOV 18, 2022, View Source [SID1234624249]). SoftVue, a 3D whole breast ultrasound tomography system for screening dense breasts, was approved by the U.S. Food & Drug Administration (FDA) in October 2021 and may be paired with a mammography screening at the same visit.

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When paired with the screening mammogram, SoftVue has been shown to identify up to 20 percent more cancers in women with dense breasts while also reducing false positives and decreasing unnecessary call-backs and biopsies.

"SoftVue is a game-changer that will transform clinical practice with a new and highly impactful whole breast ultrasound adjunctive screening modality that will help save lives by identifying cancer sooner for women with dense breasts," said Mark J. Forchette, president and chief executive officer at Delphinus. "We are seeing significant interest and enthusiasm from leading health centers across the country for SoftVue, who see the value of our technology can bring to delivering the best care for patients. To date, SoftVue has been installed at Detroit’s Barbara Ann Karmanos Cancer Institute, and at the East Alabama Medical Center. We are thrilled to be at RSNA this year and look forward to demonstrating SoftVue to radiologists attending the conference."

Also at the RSNA meeting, Dr. Mary Yamashita of the University of Southern California’s Keck School of Medicine will present the results of a study, "Density Awareness: Do Patients Know About Breast Density," showing that a large number of women are not aware of their breast density. Dr. Yamashita’s presentation is scheduled for Nov. 28 at 12:15 p.m. at the McCormick Place exhibition center.

Dense breast tissue (fibrous tissue that can hide cancerous lesions on mammogram) is common, affecting 40 percent of women and making them four times more likely to develop breast cancer. Compounding the increased risk, dense breast tissue, like cancer, typically appears white on a mammogram, making it more challenging to detect cancer early.

SoftVue was developed to address the unmet clinical need for early breast cancer detection in individuals with dense breast tissue and provides a new annual screening solution for this population. The system identifies more cancers, with fewer callbacks, using a proprietary TriAD (Triple Acoustic Detection) technology that effectively characterizes tissue by recording reflection, speed and direction of sound waves moving through breast tissue, unlike traditional ultrasound which utilizes only reflection.

On November 18, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that clinical and translational data from the final analyses of the pivotal SPEARHEAD-1 trial (Cohort 1) with afamitresgene autoleucel (afami-cel) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) at the Connective Tissue Oncology Society (CTOS) annual meeting taking place this week in Vancouver, BC (Press release, Adaptimmune, NOV 18, 2022, View Source [SID1234624248]). The data will be shared in an oral presentation by SPEARHEAD-1 investigator, Brian A. Van Tine, MD, PhD, Washington University School of Medicine in St. Louis, on Friday, November 18th, during Session 9: Immunology & Immunotherapy at 4:39 p.m. UTC/ 7:30 p.m. EST (Paper 61).​

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"With these results, we continue our excitement and optimism about the clear potential of afami-cel to address synovial sarcoma- a difficult-to-treat cancer with high unmet need," said Elliot Norry, Chief Medical Officer, Adaptimmune. "These data reaffirm our commitment to this therapy, and we are very pleased to be able to include these data in our upcoming BLA submission."

Data reinforce clinical efficacy and acceptable safety profile of Adaptimmune’s novel T-cell therapy, afami-cel (August 29, 2022 data cut)

Data continue to support BLA submission for afami-cel in heavily pre-treated patients with synovial sarcoma with an overall response rate of 38.6% by independent review (N=44)
Responses are durable with a median duration of 50 weeks (range: 11.7-122 weeks)
Toxicities include cytokine release syndrome and reversible hematologic toxicities, in line with previous findings indicating an acceptable safety profile
Responses were observed across all evaluated subpopulations​ with higher response rates observed in female patients and those who had higher MAGE-A4 expression, had lower disease burden at baseline, or did not require bridging therapy. Data are consistent with those presented earlier this year as ASCO (Free ASCO Whitepaper)
Translational data indicate that afami-cel drives tumor infiltration of activated and proliferative cytotoxic ("killer") T-cells, shifting the balance from immune-suppressive to a pro-immune in the tumor microenvironment which likely contributes to antitumor response
"We are on the cusp of an exciting and important time for people impacted by synovial sarcoma, a cancer that for much too long has not seen innovative treatment options," said Dr. Brian A. Van Tine, Professor of Medicine and Pediatrics at Washington University School of Medicine in St. Louis. "The SPEARHEAD-1 Trial results provide us a reason to be very optimistic about the game-changing potential to treat more people with this difficult cancer in the very near future."

As previously announced, Cohort 1 of the SPEARHEAD-1 trial has completed treatment and met the primary endpoint for efficacy. Data from Cohort 1 will be used to support Adaptimmune’s BLA submission. Cohort 2 of the SPEARHEAD-1 trial is ongoing with treatment 60% complete and an overall response rate nearly identical to Cohort 1. On September 28th, Adaptimmune received the Vision of Hope Award from the Sarcoma Foundation of America at its Annual Stand Up to Sarcoma Gala.

SPEARHEAD-1 trial design
SPEARHEAD-1 is a Phase 2, open-label trial for people with advanced synovial sarcoma or MRCLS to evaluate the efficacy, safety, and tolerability of afami-cel. Afami-cel SPEAR T-cells target MAGE-A4+ tumors. MAGE-A4 is highly expressed in synovial sarcoma and MRCLS in the context of HLA-A*02. Compelling clinical responses in patients with synovial sarcoma were previously reported with afami-cel in a Phase 1 trial (CTOS 2020). Approximately 90 patients are planned to be treated: 45 in Cohort 1 and 45 in Cohort 2. Enrollment in Cohort 1 is complete, and Cohort 2 is currently recruiting. The primary efficacy analysis will be for Cohort 1 only and will be used to support a BLA filing, which is expected to be initiated in Q4 2022.

No formal hypothesis testing is planned for Cohort 2. Cohort 2 will strengthen the efficacy and safety database and will aid in descriptive sub-group analyses. Key eligibility criteria: ECOG performance status of 0 or 1; HLA*02 positive with MAGE-A4 expression in ≥ 30% of tumor cells ≥ 2+ by immunohistochemistry; aged ≥ 16 and ≤ 75 years; and patients must have received either an anthracycline- or ifosfamide-containing regimen. Eligible patients received afami-cel doses between 1-10 × 109 transduced T-cells after receiving lymphodepleting chemotherapy.

On November 18, 2022 Kintara Therapeutics, Inc.(Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported data from three posters that are being presented at the 2022 Society for Neuro-Oncology (SNO) Annual Meeting (Press release, Kintara Therapeutics, NOV 18, 2022, View Source [SID1234624247]). The 2022 SNO Annual Meeting is being held from November 16 through November 20, 2022 in Tampa, Florida.

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Three posters on VAL-083 are being presented as follows:

Phase 2 Study of VAL-083 and Radiotherapy in Newly-Diagnosed, MGMT-unmethylated GBM
Poster Presenter: Zhongping Chen, MD, Ph.D. – Sun Yat-sen University Cancer Center
(Presentation Time: Friday, November 18, 2022 – 7:30 to 9:30 pm ET)

The first poster presented two case reports from the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients conducted at Sun Yat-sen University Cancer Center in China. These two patients, a 32-year-old woman and a 49-year-old man, have remained alive 53 months and 35 months, respectively, as of the October 2022 poster cut-off date.

Recurrent RELA Fusion-Positive Ependymoma Treated with VAL-083 under Expanded Access: A Case Report
Poster Presenter: Carlos Kamiya-Matsuoka, MD – MD Anderson Cancer Center
(Presentation Time: Friday, November 18, 2022 – 7:30 to 9:30 pm ET)

The second poster reported on a patient with recurrent RELA fusion-positive ependymoma who was treated with VAL-083 for 12 cycles under expanded access. Eighteen months after completion of treatment with VAL-083, the patient remains neurologically and radiologically stable with no evidence of disease.

VAL-083 in Patients with Recurrent Glioblastoma Treated under Expanded Access Program
Poster Presenter: Carlos Kamiya-Matsuoka, MD – MD Anderson Cancer Center
(Presentation Time: Friday, November 18, 2022 – 7:30 to 9:30 pm ET)

The third poster presented information on fourteen patients with recurrent GBM who were treated at MD Anderson Cancer Center under expanded access. Eight of these patients received four or more cycles of VAL-083, with one patient receiving 18 cycles. Data was also presented for five patients who received VAL-083 in combination with bevacizumab without any hematological adverse events.