On June 15, 2021 Actinium Pharmaceuticals reported data from its pivotal Phase 3 SIERRA trial for Iomab-B in an oral presentation at the 2021 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, which is to be held virtually from June 11th – 14th (Press release, Actinium Pharmaceuticals, JUN 15, 2021, View Source [SID1234584091]). Iomab-B is radiotherapy that targets cells expressing CD45, a protein found only on blood cancer cells and immune cells including bone marrow stem cells, with the radioisotope iodine-131 and is intended to be a targeted conditioning agent to enable potentially curative bone marrow transplant (BMT). The SIERRA trial is the only randomized Phase 3 trial to offer potentially curative BMT as an option for patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above, a patient population not considered eligible for BMT with standard non-targeted conditioning regimens.

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Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "Our enthusiasm for Iomab-B continues to grow at every safety and feasibility update from the pivotal Phase 3 SIERRA trial. With consistently strong engraftment data through 75% of patient enrollment, we believe Iomab-B has the potential to unlock a paradigm shift in the treatment of patients with relapsed and refractory AML. Despite 9 approved drugs for patients with AML since 2017, many of which are targeted agents, AML remains one of the most difficult to treat blood cancers with the lowest 5-year survival rate. In developing Iomab-B our goal is to improve patient outcomes by enabling potentially curative BMT for a large portion of the AML patient population."

SNMMI Presentation Title: Relationship of Marrow Radiation Dose and Timing of Engraftment for Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia

Presenter: Susan Passalaqua, MD, Banner MD Anderson Cancer Center

SNMMI Presentation Highlights:

100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician’s choice of salvage therapy on the control arm
79% of all patients enrolled on SIERRA were able to proceed to BMT despite being a patient population not considered eligible for BMT with standard approaches
Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events

About Iomab-B
Iomab-B (I-131 apamistamab) is an Antibody Radiation Conjugate (ARC) that is intended to condition or prepare patients for a potentially curative bone marrow transplant (BMT) in a targeted manner with the goal of reducing adverse events and increasing patent access to BMT. Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once its attached to its target cells, it emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company’s Phase 3 clinical trial in R/R can be found at www.sierratrial.com.

On June 15, 2021 Actinium Pharmaceuticals reported safety data from its ongoing pivotal Phase 3 SIERRA trial of Iomab-B in patients with relapsed or refractory Acute Myeloid Leukemia (r/r AML) were presented at the 2021 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting which was held virtually June 11th – 14th (Press release, Actinium Pharmaceuticals, JUN 15, 2021, View Source [SID1234584090]). The presentation highlighted Iomab-B’s targeting ability and corresponding safety data from 113 patients, representing 75% of patient enrollment on the SIERRA trial.
Iomab-B targets CD45, an antigen expressed on leukemia and lymphoma cancer cells and immune cells including bone marrow stem cells but not on cells outside of the blood forming or hematopoietic system. This allows high amounts of radiation to be delivered to the bone marrow via Iomab-B while sparing critical organs. As a result, statistically significant lower rates of sepsis were reported as well as lower rates of febrile neutropenia, mucositis and non-relapse transplant related mortality in patients receiving Iomab-B and bone marrow transplant (BMT) compared to patients that received salvage therapy and a BMT. In addition, patients who crossed over to receive Iomab-B and went to BMT after receiving salvage therapy but not achieving a complete response also had lower rates of sepsis, febrile neutropenia, mucositis and non-relapse transplant related mortality.
Dr. Mark Berger, Actinium’s Chief Medical Officer, commented, "Relapsed and refractory AML in older patients is a particularly challenging disease to treat. Patients are heavily pretreated making their disease resistant to most standard therapies and often have comorbidities that limit treatment options, particularly bone marrow transplant. It is highly encouraging to us that in the SIERRA trial thus far, Iomab-B has enabled all patients receiving a therapeutic dose to proceed to BMT, the only curative treatment option for this patient population. Importantly, Iomab-B has been well tolerated and we are elated with the safety data from 75% of patient enrollment in the SIERRA trial. Given the targeted nature of Iomab-B, we can spare non-targeted organs like GI tract and deliver higher amounts of radiation to the bone marrow, the target organ. We are thrilled to be able to highlight results of the SIERRA trial through 75% of patient enrollment at SNMMI and look forward to future opportunities to present topline data from the full study."

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About Iomab-B
Iomab-B (I-131 apamistamab) is an Antibody Radiation Conjugate (ARC) that is intended to condition or prepare patients for a potentially curative bone marrow transplant (BMT) in a targeted manner with the goal of reducing adverse events and increasing patent access to BMT. Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once its attached to its target cells, it emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company’s Phase 3 clinical trial in R/R can be found at www.sierratrial.com.

On June 15, 2021 Autolus Therapeutics, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO1 (obecabtagene autoleucel, obe-cel), the company’s CAR T cell therapy being investigated in the ongoing FELIX Phase 1b/2 study in relapsed / refractory (r/r) adult B-cell Acute Lymphocytic Leukemia (ALL) in patients 18 years and older (Press release, Autolus, JUN 15, 2021, View Source [SID1234584088]).

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"The ILAP designation for obe-cel, alongside the recent PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA), is another step forward in accelerating the review process of this promising therapy," said Dr. Christian Itin, chief executive officer of Autolus. "Obe-cel continues to show the potential to be differentiated on efficacy, durability and safety from other CAR T cell products and could change standard of care by offering a potentially curative therapy for r/r ALL."

About ILAP
ILAP was announced in December 2020 and launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).

The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to chart a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.

On June 15, 2021 NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, and the Parker Institute for Cancer Immunotherapy (PICI) reported that they are collaborating on an expansive molecular characterization project for cellular therapies(Press release, NanoString Technologies, JUN 15, 2021, View Source [SID1234584086]). The collaboration will define the characteristics that make a cell therapy effective, providing a standardized approach to developing CAR-T regimens that may improve patient outcomes across all cancer types, especially solid tumors.

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The collaboration will leverage the cell therapy expertise of PICI’s network, including world-class academic research centers, and empower research teams with NanoString’s widely recognized nCounter Analysis System and CAR-T Characterization Panel. The technology utilizes a standardized gene expression panel of 780 genes, which the team will use to profile eight different biological characteristics of existing cell therapies. By analyzing the factors that correlate with optimal cellular therapies, the team will define the characteristics that make a therapy more likely to be effective. The team will also make the findings publicly available to the scientific community through PICI’s Cancer Data and Evidence Library (CANDEL) analysis platform.

CAR-T cell therapy has produced significant advancements in the treatment of hematological malignancies, which has led to an explosion of research aimed at adapting these therapies for solid tumors. Despite this activity, several significant challenges remain. There is a particular need in the field to define key aspects of CAR-T activity, including molecular pathways that regulate effectiveness, toxicity, and persistence. This challenge is compounded by varying strategies used during the design and manufacturing process, and the variability associated with these patient-derived treatments. Overcoming these barriers can help unlock the benefits of cellular therapies for cancer patients currently in need of more effective treatments.

"By working together, NanoString and PICI will generate meaningful information from our scientific community to develop a standardized approach to cell therapy development, allowing us to better understand the attributes that make treatments effective and to ultimately improve patient outcomes," said Joseph Beechem, Ph.D., NanoString’s chief scientific officer and senior vice president of Research and Development.

"PICI’s approach is based on bringing together the brightest minds to solve cancer’s toughest problems," said Lisa Butterfield, Ph.D., PICI’s vice president of Research and Development. "This collaboration provides an important opportunity to deeply examine cell therapies and layout a road map for future development and manufacturing that can overcome the challenges of treating solid tumors."

NanoString and PICI are working together on other collaborative projects in parallel, including a multi-site validation of the GeoMx Digital Spatial Profiler and the GeoMx as a tool to characterize patient response to immunotherapy. Work is underway for both projects, which includes processing nearly 1,000 cell therapy samples from across PICI’s network with nCounter.

The team aims to provide updates on its work to the community through conferences and round table discussions.

On June 15, 2021 RayzeBio which is discovering and developing a broad pipeline of innovative targeted radiopharmaceutical drugs for cancer, reported a $108 million Series C financing led by Venrock Healthcare Capital Partners alongside new investors Perceptive Advisors, Vivo Capital, Acuta Capital Partners, Deerfield Management, and TCG X (Press release, RayzeBio, JUN 15, 2021, View Source [SID1234584085]). Also participating were all of Rayze’s existing investors: venBio Partners, Versant Ventures, Samsara BioCapital, Redmile Group, Viking Global Investors, Cormorant Asset Management, OrbiMed, LifeSci Venture Partners, Logos Capital, Alexandria Venture Investments, and others.
"The targeted radiopharmaceuticals field represents a highly clinically validated modality that, until recently, has been underappreciated," said Ken Song, M.D., president and CEO of RayzeBio. "The interest and confidence from our exceptional group of investors that has funded the company enables us to fully invest in our plans to be the leader in targeted radiopharmaceuticals for a multitude of cancer types."
With over $258 million of capital raised since the company first debuted in the second half of 2020, RayzeBio has rapidly expanded its team, infrastructure, capabilities, and pipeline.

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