On December 3, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") repoted that four abstracts detailing the Company’s clinical trials for Iomab-B and Actimab-A will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held virtually December 5-8, 2020 (Press release, Actinium Pharmaceuticals, DEC 3, 2020, View Source [SID1234572136]).

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Sandesh Seth, Actinium’s Chairman and CEO said "ASH is always a productive meeting for Actinium and we are excited that this year we have our largest presence ever with three oral presentations and a poster presentation. We are thrilled to have the opportunity to highlight the promising data from the pivotal phase 3 SIERRA trial for Iomab-B and our two Actimab-A combination trials with CLAG-M and venetoclax. Notably, we head into ASH (Free ASH Whitepaper) with a series of milestones expected for year-end and next year in addition to a strong cash position of $48 million at the end of the third quarter that will allow us to meet our development objectives well into 2022. We are also excited by recent developments in R&D and our recent senior hires that will enable us to succeed in achieving our near-term milestones and long-term vision for Actinium."

Mark Berger, Actinium’s Chief Medical officer, said, "We are pleased to present updated data from our Iomab-B pivotal Phase 3 SIERRA trial and Actimab-A combination trials this weekend at ASH (Free ASH Whitepaper). We are excited by the progress we have made across our pipeline and the strong potential our targeted radiotherapy agents have for improving the care of patients with relapsed or refractory AML. The data we will present at this year’s meeting is a reflection of the hard work done by our Actinium team and by our clinical sites to demonstrate the promise of our Antibody Radiation Conjugates. We would like to thank everyone for their contributions to this effort and we look forward to sharing the detailed presentations and updated data at this important meeting."

Iomab-B Oral Presentations Details:

Oral Presentation Title:

Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered

Publication Number:

193

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

1:00 PM PT / 4:00 PM ET

Oral Presentation Title:

High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Publication Number:

135

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

9:30 AM PT / 12:30 PM ET

Actimab-A CLAG-M Oral Presentation Details:

Oral Presentation Title:

A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AML

Publication Number:

165

Session Name:

616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Advances in immunotherapeutics for management of AML

Session Date:

Saturday, December 5, 2020

Presentation Time:

12:00 PM PT / 3:00 PM ET

Actimab-A Venetoclax Poster Presentation Details:

Poster Presentation Title:

Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II Study

Publication Number:

2875

Session Name:

616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II

Session Date:

Monday, December 7, 2020

Presentation Time:

7:00 AM – 3:30 PM PT / 10:00 AM – 6:30 PM ET

On December 3, 2020 Immunocore (or the "Company"), a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that it will present new clinical results on tebentafusp (IMCgp100) at the European Society of Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress on the 12th December (Press release, Immunocore, DEC 3, 2020, View Source [SID1234572135]). These data represent the primary clinical results from a Phase 2 study of tebentafusp in previously treated, metastatic uveal melanoma (mUM) patients.

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The Phase 2 study investigated the overall response rate (ORR), with secondary objectives being overall survival (OS) and safety in 127 patients who had enrolled after progressing on one or more prior therapies. During the session, Dr. Joseph Sacco, Consultant in Medical Oncology, Clatterbridge Cancer Centre, will present the clinical results from the trial.

"In this phase 2 study of previously treated metastatic uveal melanoma, we observed a promising survival that replicates the overall survival benefit we recently reported in our randomized phase 3 study in previously untreated patients," said David Berman, Head of Research and Development at Immunocore. "TCR bispecifics represent a new frontier in IO which will require matching science to clinical observation. Because the proposed mechanism of action includes redirecting T cells into a solid tumor, the survival benefit in patients treated with tebentafusp showed the potential to extend beyond RECIST-defined response rate to also include immune-related responses."

In this Phase 2 study, the overall RECIST-defined response rate (ORR) was 5%, with 45% of patients achieving stable disease. Among patients with evaluable tumours, 44% had reduction in the sum of target lesions, including demonstration of immune-related responses.

Median overall survival (OS) was 16.8 months, with a 12-month OS rate of 62%. The historical 12-month OS rate in previously treated patients is approximately 40%.

Patients who developed a rash, a proposed on-target adverse event (AE), within 7 days of starting tebentafusp had a 12-month OS rate of 77% compared to approximately 40% of those who did not develop a rash. Patients with any reduction in the sum of target lesions, including those with immune-related responses, had a 12-month OS rate of 86%.

Treatment-related AEs were consistent with the proposed mechanism of action, and were generally manageable and decreased in severity after the first three doses; only 3.7% of patients discontinued treatment due to a related AE and there were no fatal treatment-related AEs.

On December 3, 2020 Merck KGaA, Darmstadt, Germany, a leading science and technology company and Artios Pharma Limited (Artios), a leading DNA Damage Response (DDR) company developing a broad pipeline of precision medicines for the treatment of cancer, reported a global three year strategic research collaboration to discover and develop multiple precision oncology drugs (Press release, Merck KGaA, DEC 3, 2020, View Source [SID1234572134]).

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"Our platform has the potential to revolutionize targeted treatment in cancer and deliver on the promise of precision medicine. This collaboration will leverage the potential of our unique discovery platform of novel DNA repair nuclease inhibitors and targets that we have been developing. The partnership puts us in an exceptional position to focus internal efforts on our leading portfolio of assets which includes a small-molecule ATR inhibitor and a Polθ programme, both in candidate IND evaluation," said Niall Martin, Chief Executive Officer at Artios Pharma.

"Targeting DNA damage response has the potential to provide an important therapeutic option for many patients in need of new treatments. We are excited about working with Artios to develop novel precision oncology medicines as we move towards changing the current paradigm in cancer treatment. This collaboration further strengthens our leadership and expertise in the field and discovery of DDR inhibitors and complements our multiple innovative assets currently being evaluated in several Phase I and Phase II clinical studies," said Andree Blaukat, SVP and Head Translational Innovation Platform Oncology & Immuno-Oncology, at Merck KGaA, Darmstadt, Germany.

Under the terms of the agreement, the companies will leverage Artios’s proprietary nuclease targeting discovery platform to jointly identify multiple synthetic lethal targets for precision oncology drug candidates. During this joint research collaboration, Merck KGaA, Darmstadt, Germany will contribute its significant expertise and resources in the field of DDR and will have exclusive worldwide rights to develop and commercialize selected therapeutics discovered under the collaboration. The collaboration does not include Artios’s lead programmes, Polθ and ATR inhibitors, for which Artios will retain all rights.

Nucleases are critical enzymes involved in the maintenance of genomic integrity. Cancer cells are dependent on nucleases for their survival in response to DNA damage. Also, in certain cancers which exhibit mutations in DNA damage response pathways, inhibiting key nucleases can lead to selective cancer cell killing i.e. synthetic lethality.

As part of the agreement, Artios will receive a payment of US$30 million in the form of an up-front and near-term payments. If Merck KGaA, Darmstadt, Germany chooses to exercise the option, subject to double-digit option fees, Artios will be eligible to receive up to US$860 million per target, in addition to up to double digit royalty payments on net sales of each product commercialized by Merck KGaA, Darmstadt, Germany.

Subject to certain conditions, Artios has opt-in rights for joint development and commercialization with Merck KGaA, Darmstadt, Germany for the programmes.

On December 3, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it will present animal data demonstrating highly improved activity against acute myeloid leukemia ("AML") in combination with the commonly used antileukemic drug Ara-C (also referred to as "cytarabine") versus single agent at the 62nd Annual Meeting & Exposition of the American Society for Hematology ("ASH") under the title: "High Efficacy of Liposomal Annamycin (L-ANN) in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model (Press release, Moleculin, DEC 3, 2020, View Source [SID1234572133])."

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are extremely encouraged by the strong pre-clinical efficacy demonstrated by the combination of Annamycin and Ara-C against AML," commented Walter Klemp, Chairman and CEO of Moleculin. "While we firmly believe in the promise and efficacy Annamycin has demonstrated as a single agent against AML in our two current Phase 1 clinical trials, we believe this discovery warrants further consideration to the potential expansion of its clinical development into clinical trials for the combination of Annamycin with Ara-C ("AnnAraC") against AML."

Mr. Klemp concluded, "The combination of Annamycin with Ara-C is particularly intriguing considering the current first-line therapy for AML patients is "7+3", where Ara-C is administered daily for 7 days in parallel with 3 daily doses of an anthracycline. Substituting a currently used anthracycline such as doxorubicin with Annamycin would be a familiar and well-practiced treatment modality. Furthermore, the combination of Annamycin with Ara-C may offer potential advantages given Annamycin’s demonstrated lack of cardiotoxicity and activity against tumor cells resistant to doxorubicin. We look forward to further discussing the promise of this combination at the 62nd Annual Meeting & Exposition of the American Society for Hematology."

As previously announced, the study was conducted in a highly aggressive AML mouse model where median survival, left untreated, is approximately 13 days. Median survival in animals treated with the combination of Annamycin and Ara-C ranged from 56 to 76 days, expanding median survival by 585%. Notably, several animals in the study were completely cured. The Company believes these experiments support initiation for the clinical development of the combination of Annamycin and Ara-C in AML patients.

On December 3, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will present additional data on its lead partnered asset, monalizumab, at the ESMO (Free ESMO Whitepaper) Immuno-oncology Virtual Congress being held from Dec. 9-12, 2020 (Press release, Innate Pharma, DEC 3, 2020, View Source [SID1234572132]). Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

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The presentation will include updated results from a Phase 2 study investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer (R/M SCCHN) who have been previously treated with a platinum-based chemotherapy and PD-(L)1 inhibitor.

The e-poster presentation (#81P, abstract #235) entitled, "Monalizumab in combination with cetuximab post platinum and anti-PD-(L)1 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Updated results from a phase 2 trial" will be available on Dec. 9th.

As recently announced, AstraZeneca dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in R/M SCCHN patients who have been previously treated with a platinum-based chemotherapy and PD-(L)1 inhibitors.