On December 8, 2020 Amgen (NASDAQ: AMGN) reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for its investigational KRASG12C inhibitor, sotorasib, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy (Press release, Amgen, DEC 8, 2020, View Source [SID1234572464]).

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"For more than 40 years, scientists have been trying to target KRAS. Today’s news is a welcome update for the many non-small cell lung cancer patients with the KRAS G12C mutation, who currently have no targeted therapies," said Bonnie J. Addario, cofounder and board chair of the GO2 Foundation for Lung Cancer. "We are pleased that the FDA and Amgen recognize the unmet need for these patients and are working to make new treatment options available as quickly as possible."

KRAS G12C is the most common KRAS mutation in NSCLC.1,2 In the U.S., about 13% of patients with NSCLC adenocarcinoma harbor the KRAS G12C mutation3 and each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated NSCLC.4 Unmet need remains high and options are limited for NSCLC patients with the KRAS G12C mutation that have failed first-line treatment. The outcomes with current therapies are suboptimal with response rates of approximately 9-18% and a median progression-free survival of approximately 4 months for second-line NSCLC.5,6,7

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research8 by developing sotorasib. Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across 4 continents. In just over two years, the sotorasib clinical program has also established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

"Breakthrough Therapy designation and Real-Time Oncology Review bring Amgen closer to potentially providing a targeted therapy to patients with a KRAS G12C mutation and establishing sotorasib as the foundational therapy in KRAS G12C-driven cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to receive these regulatory designations and plan to submit a new drug application by end of year as we rapidly work to get sotorasib to the patients who need it."

A Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.9 The Real-Time Oncology Review (RTOR) pilot program aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.10

The designation and RTOR are supported by positive Phase 2 results in patients with advanced NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.11

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

On December 8, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it will release financial results for its fiscal 2020 fourth quarter ended September 30, 2020 after market close on Thursday, December 17, 2020 (Press release, Applied DNA Sciences, DEC 8, 2020, View Source [SID1234572434]). In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Standard Time that will also be broadcast live over the Internet.

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What: Applied DNA’s Fiscal 2020 Fourth Quarter Financial Results Conference Call
When: Thursday, December 17, 2020, at 4:30 p.m. Eastern Standard Time
Where: Via phone by dialing +1-844-887-9402 (U.S toll free) or +1-412-317-6798 (international dialers) or via live webcast.

A telephonic replay of the conference call will be available for one week and may be accessed by calling +1-877-344-7529 (U.S. toll) or +1-412-317-0088 (international dialers) with the passcode 10149831. An archive of the webcast will be available for a period of one year on the ‘IR Calendar’ page of the Investor Relations section of the Company’s website starting within two hours from the conclusion of the live call.

On December 8, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that first-in-human data from the first dose cohort of the Phase 1 portion of the Actimab-A venetoclax Phase 1/2 combination trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) were presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (Press release, Actinium Pharmaceuticals, DEC 8, 2020, View Source [SID1234572450]). The poster presentation highlighted results from the first three patients treated with the initial subtherapeutic dose level of 0.5 μCi/kg of Actimab-A and venetoclax.

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The enrolled patients had a median of 2 prior therapies (range 2-3) and a median bone marrow blast percentage of 30% (range 20 – >60). All 3 patients had poor risk disease with adverse cytogenetics, and each patient had an additional high-risk marker (FLT3-ITD+, antecedent JAK2+ myelofibrosis, or TP53 mutation). One patient who had multiple genetic mutations including IDH2, RUNX1, TP53 and others, achieved a complete remission with incomplete blood count recovery (CRi) after the first cycle of Actimab-A and venetoclax. Next generation sequencing at the end of the first cycle showed that patient was negative for the known IDH2 and RUNX1 mutations. This patient has continued treatment receiving the second cycle and their bone marrow remains normocellular with no excess blasts. In addition, another patient achieved a partial response after one cycle of Actimab-A and venetoclax. There were no Actimab-A related dose limiting toxicities or nonhematologic Grade 3 or greater related AEs reported in the first cohort. The trial has advanced to the second dose cohort of 1.0 μCi/kg of Actimab-A and venetoclax with patient enrollment ongoing.

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer, commented, "This ASH (Free ASH Whitepaper) meeting, we are excited to highlight the promising data emerging from both our combination trials with Actimab-A in the R/R AML setting, namely the Actimab-A venetoclax and Actimab-A CLAG-M trials. Particularly compelling is the complete response reported in a patient with complex mutations like TP53 with Actimab-A and venetoclax and the high MRD negativity rate with Actimab-A and CLAG-M. The results clearly demonstrate that a superior clinical effect without adding meaningful toxicity is achievable using Ac-225 ARC’s to precisely deliver powerful internal radiation and elicit a potentiating and synergistic treatment effect with chemotherapy and targeted agents. With this clinical validation in hand, we look forward to expanding our ARC combinations with other therapeutic modalities in AML and into additional indications to further establish our leadership position in the field by leveraging our enhanced R&D capabilities including new research facilities and key hires."

Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "We were thrilled to report a complete response in the Actimab-A venetoclax combination trial, in addition to the partial response previously highlighted in the abstract. Both responses occurred after just one cycle of a subtherapeutic dose of Actimab-A. These initial results, the one complete response and safety profile to date, support the potential mechanistic synergy of Actimab-A with venetoclax. As a single agent, venetoclax has produced low response rates of 19% in patients with R/R AML1 so we are pleased with the results seen in our first dose cohort. In addition, the clinical data from Actimab-A and Iomab-B presented at this year’s ASH (Free ASH Whitepaper) demonstrates our strong commitment to addressing the unmet needs of patients with R/R AML with our ARCs as best in class therapeutics, bridge to transplant and targeted conditioning for potentially curable bone marrow transplant. With this in mind, we look forward to guidance on Iomab-B expected from the ad-hoc DMC meeting before year-end."

This Phase 1/2 trial is a multicenter, open label trial of Actimab-A (lintuzumab-Ac225) added to venetoclax for patients with CD33 positive R/R AML. A Phase 2 trial studying Actimab-A as a single agent produced a 69% overall response rate in older unfit patients with newly diagnosed AML. In a poster presentation at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Actimab-A was shown to be synergistic with venetoclax in venetoclax resistant cell lines, by depleting MCL-1, a protein shown to mediate resistance to venetoclax. Further, the induction of direct AML cell death via double-stranded DNA breaks by Actimab-A provides a second mechanism for enhancing synergistic potency with venetoclax. Venetoclax is a B-Cell Lymphoma 2 (BCL-2) inhibitor that is jointly developed and marketed by AbbVie and Genentech and is approved for patients with AML, Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Leukemia (SLL). Despite its approval in AML, venetoclax has produced low response rates of 19% as a single agent in R/R AML.1 This is due in part to the type of AML, risk factors, and cytogenetics of this patient population. The Phase 2 trial results, together with a synergistic mechanism of action with venetoclax demonstrated in pre-clinical studies, are driving this combination trial with an initial focus on the high unmet needs of R/R patients including those who have relapsed or do not respond to treatment with venetoclax based regimens.

1 Aldosset al. Efficacy of the combination of venetoclax and hypomethylating agents in relapsed/refractory acute myeloid leukemia. Haematologica2018.1888094.

About Actinium’s CD33 Program

Actinium’s CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant. Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

On December 8, 2020 Imaging Endpoints reported that the U.S. Patent and Trademark Office has issued Patent No. 10,854,338 – "PREDICTING BREAST CANCER RESPONSIVENESS TO HORMONE TREATMENT USING QUANTITATIVE TEXTURAL ANALYSIS" to Imaging Endpoints’ and its inventor, Chief Medical Officer, Ron Korn, M.D., PhD (Press release, Imaging Endpoints, DEC 8, 2020, View Source [SID1234572465]).

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This breakthrough radiomic evaluation tool provides a biomarker for predicting tumor aggressiveness in breast cancer patients, and thus the ability to determine whether less invasive treatment (e.g., hormone therapy) or more invasive treatment (e.g., chemotherapy) is warranted.

Breakthrough radiomic evaluation tool provides biomarker signature for predicting breast cancer tumor aggressiveness.

The technology enables a real-time evaluation that is otherwise available only through an invasive biopsy and avoids the time involved in obtaining and processing the biopsied tissue. Imaging Endpoints is excited to share with the market this new technology that may provide patients and physicians the advantage of faster, less invasive information that is critical to treatment decisions and patient outcomes.

"A reliable imaging signature for guiding treatment decisions based on Luminal vs Basilar type cancer has remained elusive until now," said Ronald Korn, MD, PhD. "The Imaging Endpoints’ invention provides a biomarker for evaluating the treatment options that are most likely to be effective. The signature is derived from aggregate breast tumor imaging data in conjunction with quantitative textural analysis. Imaging Endpoints believes that its technology offers a real-time advantage with rapid results over tests such as Oncotype DX, however additional studies are needed to further validate the correlation of the signature with pathologic variables."

Imaging Endpoints is a pioneer and global leader in analyzing diagnostic images to identify imaging patterns linked to tumor biology. The Company currently offers its advanced imaging technologies through its imaging CRO services for clinical trials, and is actively seeking partners to help commercialize its technologies for routine patient care.

On December 8, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data on its investigational T-cell engaging bispecific antibodies, mosunetuzumab, glofitamab and cevostamab, were presented at the all-virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, from 5-8 December 2020, showing encouraging activity across multiple types of blood cancer (Press release, Hoffmann-La Roche, DEC 8, 2020, View Source [SID1234572399]). These antibodies work by binding to two different targets, on two different cells, simultaneously: one on the surface of cancer cells and one on the surface of immune cells called T-cells. This dual targeting approach activates a patient’s existing T-cells to engage and eliminate target cancer cells, offering an innovative approach for the treatment of blood cancers including non-Hodgkin lymphoma (NHL) and multiple myeloma (MM); diseases where treatment options are currently limited, and resistance to, or relapse following, treatment is common. These bispecifics are just one of the novel ‘off-the-shelf’ technologies Roche is exploring, in its quest to improve patient outcomes.

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"The data suggest that our novel bispecific antibodies have potential across multiple types of blood cancers, and supports broad exploration of these new immunotherapy approaches across different patient populations and treatment lines," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Lymphoma and multiple myeloma are challenging cancers to treat, especially when patients present with aggressive subtypes or experience multiple relapses, but ‘off-the-shelf’ therapies like these could provide new options that may potentially enable patients to be treated quickly."

Promising responses with mosunetuzumab and glofitamab in non-Hodgkin lymphoma
To date in clinical trials, Roche’s two CD20xCD3 T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, have shown promising responses across multiple types of NHL, including relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). This is reinforced by the latest results from the phase I/Ib GO29781 study in R/R FL, which show that 51.6% of patients (n=32/62) achieved a complete response (CR) when treated with mosunetuzumab.1 High response rates also continue to be seen with glofitamab. For example, new data from the phase I/Ib NP30179 study in R/R NHL show a CR rate of 53.6% in aggressive NHL (n=15/28).2 Additionally, both bispecific antibodies have proven to have manageable safety profiles. One of the most common adverse events (AEs) observed with bispecific antibodies is cytokine release syndrome (CRS), which involves the over activation of immune cells, and is a known risk associated with immunotherapies that activate the body’s own immune system.3 Based on studies so far, CRS events with mosunetuzumab and glofitamab are largely low-grade (mainly Grade 1-2), occur in early treatment cycles, and are mostly reversible.1,2

Beyond the R/R setting, mosunetuzumab and glofitamab are also being investigated in earlier treatment lines, including first-line DLBCL. Initial data with single-agent mosunetuzumab in the phase I/II GO40554 study, show a CR rate of 45.5% (n=10/22) in elderly or unfit patients who are unable to tolerate full-dose immunochemotherapy. Additionally, when mosunetuzumab was combined with chemotherapy in the phase Ib/II GO40515 study, the CR rate was 79.4% (n=27/34). These are the first bispecific antibody studies in 1L DLBCL to report data, and while early, these results support the potential for mosunetuzumab to provide a new, much-needed treatment option for these patients.4,5

Robust development programmes are ongoing for mosunetuzumab and glofitamab, investigating the treatments as monotherapies and in combination with other molecules, as well as more convenient forms of administration such as subcutaneous administration, with several phase III trials planned in the near future.

Encouraging activity with cevostamab in heavily pre-treated patients with multiple myeloma
The third of Roche’s bispecific antibodies in malignant haematology, and latest addition to its pipeline, is cevostamab, a first-of-its kind FcRH5xCD3 bispecific antibody targeting FcRH5 on myeloma cells and CD3 on T-cells. FcRH5 is a unique and differentiated target and is expressed on nearly 100% of myeloma cells. Cevostamab is currently being investigated in the ongoing phase I GO39775 dose-escalation and expansion study in heavily pre-treated patients with MM (with a median of six prior lines of therapy); a population for whom new treatment options are urgently needed.

First clinical safety and efficacy data presented at ASH (Free ASH Whitepaper), showed an encouraging overall response rate of 53% (n=18/34) at active doses. Notably, responses were seen in high-risk patients, including those refractory to five different classes of drug (penta-drug refractory) and those with prior exposure to anti-BCMA therapy. Safety of cevostamab was manageable with the most common treatment-related AE being CRS (76%). The majority of CRS events were Grade 1–2 (Grade 1; 34% and Grade 2; 40%) and occurred in cycle 1. One patient experienced Grade 3 CRS (2%) and no Grade 4 or 5 CRS events were observed.6 Additional biomarker analyses presented at the congress are also helping to further understand the potential of cevostamab in MM and inform its future development, including strategies to mitigate the risk of CRS.7

Roche is excited about the ongoing development of its three bispecific antibodies in malignant haematology and eager to understand their full potential in patients with blood cancers.

About Roche’s CD20xCD3 bispecific antibodies
Roche is currently developing two T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and re-directs a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. Mosunetuzumab and glofitamab differ in their structures, and both are being developed by Roche as part of our ongoing haematology research and development strategy to explore multiple bispecific formats, to identify those that may maximise clinical benefits for patients. Mosunetuzumab has a structure similar to that of a natural human antibody in that it has two ‘Fab’ regions, but is different from naturally-occurring antibodies in that one ‘Fab’ region targets CD20 and the other ‘Fab’ region targets CD3. Glofitamab is based on a novel structural format which we call ‘2:1’, which refers to the structure of the antibody. It is engineered to have two ‘Fab’ regions which bind to CD20, and one ‘Fab’ region which binds to CD3. The clinical development programmes for mosunetuzumab and glofitamab include ongoing investigations of these molecules as monotherapies and in combination with other medicines, for the treatment of people with CD20-positive B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and follicular lymphoma, and other blood cancers.

About cevostamab (FcRH5xCD3 bispecific antibody)
Cevostamab (BFCR4350A) is an FcRH5xCD3 T-cell engaging bispecific antibody designed to target FcRH5 on myeloma cells and CD3 on T-cells. FcRH5 is a unique and differentiated target, expressed on nearly 100% of myeloma cells.8 Cevostamab has a structure similar to that of a natural human antibody in that it has two ‘Fab’ regions, but is different from naturally-occurring antibodies in that one ‘Fab’ region targets FcRH5 and the other ‘Fab’ region targets CD3. This dual targeting activates and re-directs a patient’s existing T-cells to engage and eliminate target FcRH5-expressing myeloma cells by releasing cytotoxic proteins into the myeloma cells.

About the GO29781 study
The GO29781 study [NCT02500407] is a phase I/Ib, multicentre, open-label, dose-escalation study evaluating the safety and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include best objective response rate by revised International Working Group criteria, maximum tolerated dose and tolerability.

About the GO40554 study
The GO40554 study [NCT03677154] is a phase I/II, multicentre, open-label, randomised study evaluating the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy, or in participants with previously untreated DLBCL who are unable to tolerate full-dose, first-line immunochemotherapy. Primary objectives include complete response rate at time of primary response assessment, as measured by PET-CT, according to Lugano 2014 Response Criteria, and safety. Secondary objectives include assessment of pharmacokinetics, objective response rate, duration of response and progression-free survival.

About the NP30179 study
The NP30179 study [NCT03075696] is a phase I/Ib, multicentre, open-label, dose-escalation study, evaluating the efficacy, safety, tolerability and pharmacokinetics of glofitamab. In this study, glofitamab is assessed as a single-agent and in combination with Gazyva/Gazyvaro (obinutuzumab), following pre-treatment with a one-time, fixed-dose of Gazyva/Gazyvaro, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include overall response rate, complete response rate per Lugano 2014 criteria, maximum tolerated dose and tolerability.

About the GO39775 study
The GO39775 study [NCT03275103] is a phase I, multicentre trial evaluating the safety and activity of cevostamab (BFCR4350A) monotherapy in adult patients with relapsed or refractory multiple myeloma for which no established therapies are available, appropriate or tolerable. Prior exposure to CAR T-cells, T-cell engaging bispecific antibodies, bispecific T-cell engagers (BiTEs) and antibody-drug conjugates, including those targeting BCMA, is allowed. Primary objectives are to evaluate safety (including the maximum tolerated dose and dose-limiting toxicities) and to identify a recommended phase II dose. Secondary objectives include assessment of pharmacokinetics, activity, immunogenicity and pharmacodynamic biomarkers.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1; and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.
(Press release, Hoffmann-La Roche, DEC 8, 2020, View Source [SID1234572399])