On April 7, 2021 Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo) reported the first patient has been dosed in the first-in-human phase 1/2 study of DS-1594, a selective small-molecule menin inhibitor, in adults with relapsed/refractory acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) (Press release, Daiichi Sankyo, APR 7, 2021, https://www.businesswire.com/news/home/20210407005234/en/Phase-12-Trial-Initiated-for-Daiichi-Sankyo%E2%80%99s-Menin-Inhibitor-DS-1594-in-Patients-with-Acute-Myeloid-Leukemia-and-Acute-Lymphoblastic-Leukemia [SID1234577699]). The trial is being conducted by The University of Texas MD Anderson Cancer Center under an existing strategic research collaboration.

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Inhibition of the menin protein is being studied as a novel treatment approach for acute leukemias with MLL rearrangement (MLLr) or NPM1 mutation (NPM1m), two gene alterations that drive cancer development and growth.1 MLLr occurs in approximately 5 to 10% of acute leukemia patients and is associated with aggressive disease, reduced treatment response and poor prognosis.2 NPM1m occurs in about 30% of patients with AML.3 There are currently no medicines specifically approved for MLLr or NPM1m leukemias and no approved menin inhibitors.

"Research has shown that the menin protein, which binds to MLL, plays a critical role in the development and growth of leukemias with MLL rearrangement," said Arnaud Lesegretain, Vice President, Oncology R&D and Head, Alpha Portfolio, Daiichi Sankyo. "Our scientists designed DS-1594 to inhibit the menin-MLL interaction and disrupt the intracellular activity implicated in leukemogenesis. Together with MD Anderson, we will evaluate DS-1594 as a potential therapeutic option for patients with AML or ALL who have exhausted standard treatments."

The collaboration with MD Anderson is focused on accelerating development of Daiichi Sankyo pipeline therapies for AML, including phase 1 and 2 clinical trials to evaluate single and combination regimens, translational research to explore novel biomarkers, and pre-clinical studies aimed at identifying resistance mechanisms.

About the Study

MD Anderson will sponsor and lead an open-label, non-randomized, multi-arm phase 1/2 study to evaluate DS-1594 in single and combination regimens for patients with relapsed/refractory AML and ALL.

The primary objective of the phase 1 part of the study is to determine the maximum tolerated dose and recommended phase 2 dose of DS-1594 in up to 54 patients with AML or ALL regardless of mutation status. Primary endpoints include dose-limiting toxicities, recommended phase 2 dose and safety profile. Secondary endpoints include complete remission rate (CR) and CR with partial hematologic recovery rate (CRh).

In the phase 2 part of the study, DS-1594 will be further evaluated at the established dose in four expansion cohorts of patients with specific genetic markers. Patients with relapsed/refractory AML with MLLr or NPM1m will receive DS-1594 as monotherapy (Cohorts A and B) or in combination with azacitidine and venetoclax (Cohort C), and patients with ALL with MLLr will receive DS-1594 in combination with a mini-HCVD regimen (Cohort D). The primary endpoints are safety, CR/CRh rates for the AML cohorts, and CR/CR with incomplete hematologic recovery rates (CRi) for patients in the ALL cohort.

A number of secondary efficacy and pharmacokinetic endpoints along with exploratory pharmacodynamic and biomarker endpoints will also be evaluated. Up to 170 patients will be enrolled in the study, which will initially be conducted only at MD Anderson with global expansion planned for phase 2. For more information, visit Clinicaltrials.gov.

About Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.4 In the U.S., there were approximately 60,530 new cases of leukemia and 23,100 deaths in 2020.5

AML is the most common form of acute leukemia in adults, accounting for about 33% of all new cases.6 An aggressive and heterogenous cancer originating in bone marrow, AML is characterized by a five-year survival rate of 28.7%, the lowest by far among the major leukemia subtypes.7 Standard chemotherapy remains the main treatment option for most patients with AML with or without targeted therapy. Newer treatments for genetically defined AML subtypes have increased options and improved response rates and outcomes for some patients, but primary and secondary resistance remain a challenge and new types of therapies continue to be researched.8

ALL is a less common form of leukemia with 6,150 new cases estimated in the U.S. in 2020.9 The overall five-year survival rate for ALL is 68.8% among patients of all ages but significantly lower for adults.10 ALL is typically treated with standard chemotherapy-based regimens with or without targeted therapy.9

About MLL, NPM1 and Menin

The MLL (mixed-lineage leukemia) gene, also known as KMT2A, is important in sustaining hematopoietic stem cells and is known to undergo chromosomal translocations or epigenetic changes resulting in the expression of MLL fusion proteins that ultimately drive formation and growth of leukemia.11 Approximately 5 to 10% of acute leukemias harbor the MLL rearrangement, with a five-year overall survival rate of about 35%.11

The NPM1 (nucleophosmin 1) mutation causes aberrant expression of the NPM1 protein, which is involved in functions, including cell proliferation. NPM1m is observed in approximately 30% of AML patients with a five-year overall survival rate of about 50%.3

Menin is a scaffold protein that interacts with a multitude of other proteins to regulate gene expression and cell signaling.11 The interaction between menin and MLL proteins is critical to the leukemogenic activity in MLLr leukemia and is also reported to play a key role in development of NPM1m leukemia.1 Scientific evidence supports inhibition of the menin-MLL interaction as a therapeutic approach for acute leukemias.11 There are currently no medicines specifically approved for MLLr or NPM1m leukemias and no approved menin inhibitors.

About DS-1594

DS-1594 is a potent and selective small molecule menin inhibitor in clinical development in the Alpha portfolio of Daiichi Sankyo. DS-1594 was designed to target and disrupt the protein-protein interaction of menin and MLL to inhibit leukemic cell growth and proliferation. In preclinical studies, DS-1594 displayed selective growth inhibition against AML and ALL cells with MLLr and demonstrated robust and durable anti-tumor activity in AML models with an acceptable safety profile.12 DS-1594 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On April 7, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that leading independent proxy advisory firms Institutional Shareholder Services, Inc. ("ISS") and Glass, Lewis & Co., LLC ("Glass Lewis") have both recommended Sesen Bio’s (the "Company") stockholders vote "FOR" the proposal to increase the number of authorized shares of common stock by 200 million ("Proposal 2") which is on the ballot for the Company’s Annual Meeting of Stockholders on May 3, 2021 (the "Annual Meeting") (Press release, Sesen Bio, APR 7, 2021, View Source [SID1234577698]).

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ISS and Glass Lewis are widely recognized as leading independent voting advisory firms. Their impartial analyses and reports are developed with the objective of delivering transparency to help investors make informed investment decisions.

Notably, ISS stated in its report that support for Proposal 2 is warranted given that the proposed increase in the number of authorized shares is reasonable and that there is a specific and severe risk to stockholders if Proposal 2 is not approved.

Glass Lewis also concluded in its report that the proposed increase in the number of authorized shares is reasonable, citing the relatively limited amount of shares currently available to the Company (only 7% of its issued share capital as of March 18, 2021, which is the record date for the Annual Meeting). As part of its methodology, Glass Lewis undertakes an analysis to ensure that the additional shares are truly needed.

"The ISS and Glass Lewis recommendations are consistent with our view that an increase in the number of authorized shares is both needed and in the best interest of our stockholders," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We have not requested an increase since going public in 2014, and we believe the requested increase will allow us to execute on our strategy as we transition into a commercial, revenue generating company. We are committed to issue shares to support our strategic initiatives which we believe drive value for stockholders, such as the planned commercialization of Vicineum and advancing our promising pipeline."

Since the proposed increase to the number of authorized shares of common stock will not affect the number of shares outstanding, it will not by itself have a dilutive effect on the Company’s current stockholders. Sesen Bio believes this increase will be enough to achieve corporate profitability, and therefore the Company is hopeful this may be the last time it needs to request additional shares.

Sesen Bio’s stockholders are encouraged to vote as ISS and Glass Lewis recommend by voting "FOR" the proposed increase in authorized shares. Voting will be open through the conclusion of the Annual Meeting on May 3, 2021 at 8:00 a.m. EDT. Stockholders with questions about how to vote may contact the Company’s proxy solicitor, Okapi Partners, at (888) 785-6709 or [email protected].

Stockholders who have already voted and want to change their vote can update their vote at any time – Sesen Bio will count your vote in accordance with the last instruction received prior to the closing of the polls.

ISS and Glass Lewis are independent proxy advisory firms and do not have any business relationship with Sesen Bio. Sesen Bio did not engage or compensate either firm for their analysis or recommendations.

Where to Find Additional Information

On March 25, 2021, the Company filed a definitive proxy statement with the SEC in connection with the Annual Meeting (such proxy statement and any supplements or amendments thereto, "the Annual Meeting Proxy Materials"). The Annual Meeting Proxy Materials contain important information about the Annual Meeting. Stockholders are urged to read the Annual Meeting Proxy Materials carefully. Stockholders are able to obtain free copies of the Annual Meeting Proxy Materials and other documents filed with the SEC by the Company through the web site maintained by the SEC at www.sec.gov and at View Source The Company, its directors and executive officers may be deemed participants in the solicitation of proxies from stockholders in respect of the Annual Meeting. Detailed information regarding the identity of participants, and their respective interests in the Company by security holdings or otherwise, are set forth in the definitive proxy statement for the Annual Meeting.

1This amount is preliminary and is subject to change upon completion of the Company’s financial statements for the quarterly period ended March 31, 2021.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On April 7, 2021 OncoDNA, a theranostic and genomic company specializing in precision medicine, and myNEO, an AI-driven company revolutionizing target identification within immuno-oncology, reported a new collaboration that will revolutionize cancer care (Press release, OncoDNA, APR 7, 2021, View Source [SID1234577697]). The two companies agreed to consolidate their core technologies to enable the production of personalized vaccines for patients who have run out of treatment options.

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With the COVID-19, the field of mRNA therapeutics has been moving faster than ever before. In oncology, personalized vaccines can help fight cancer by selectively boosting the immune system. These vaccines can teach the body to recognize and eliminate tumor-specific neoantigens.

OncoDNA and myNEO will leverage their sequencing and bioinformatics technologies to identify and select the most effective neoantigens to target in a patient. While OncoDNA will perform whole genome and whole transcriptome sequencing, myNEO will handle the advanced interpretation of the sequenced data and design the optimal vaccine construct for maximum clinical benefit.

The project promises to guide patients through a completely personalized journey. The eligible patients would receive tailor-made vaccines as well as personalized follow-up by monitoring circulating tumor DNA after inoculation. With its OncoFOLLOW liquid biopsy, OncoDNA will help monitor the patient response and the evolution of the cancer very closely using personalized next-generation sequencing method.

"OncoDNA is delighted to jump with myNEO into this ambitious project. We stand at the forefront of innovation and the challenges ahead are herculean. Together we will work towards a world where patients with a hard-to-treat disease will have the opportunity to design their personalized elixirs. It may take years before this technology becomes a reality. However, the ongoing pilot tests on patients who do not respond to any therapy are showing promising results", commented Jean-Pol Detiffe, Chief Strategy & Innovation Officer and Founder of OncoDNA.

"Since day 1, myNEO’s mission has been to unlock the promise of immunotherapy via deep genomic and immune profiling of tumors," described Cedric Bogaert, co-founder and CEO of myNEO. "Currently, our technology is used by biopharma partners to design the upcoming breakthrough immuno-oncology therapies. This project takes our ambition one step further in enabling OncoDNA’s vast network of clinicians and patients to directly benefit from this deep genomic and immune profiling. As such, this project holds great potential to make individualized immunotherapies more accessible to patients."

On April 7, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the 20th Annual Needham Virtual Healthcare Conference, taking place April 12-15, 2021 (Press release, Fortress Biotech, APR 7, 2021, View Source [SID1234577696]). The company will present on Monday, April 12, 2021, at 4:30 p.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the presentation.

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On April 7, 2021 Alkermes plc (Nasdaq: ALKS) reported that it has entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc. Kenilworth, NJ, USA) for a planned phase 3 study to evaluate nemvaleukin alfa ("nemvaleukin", formerly referred to as ALKS 4230), Alkermes’ novel investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combination with MSD’s KEYTRUDA (pembrolizumab), in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer (Press release, Alkermes, APR 7, 2021, View Source [SID1234577695]). Under the terms of the agreement, Alkermes is responsible for conducting the phase 3 study, which is planned to initiate in the second half of 2021.

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"We are pleased to collaborate with MSD to evaluate nemvaleukin in combination with KEYTRUDA in patients with platinum-resistant ovarian cancer, a patient population for which there are limited treatment options available and overall survival remains low. Importantly, there are no anti-PD-1 treatments currently approved for this tumor type," said Jessicca Rege, Ph.D., Vice President, Head of Oncology at Alkermes. "Nemvaleukin in combination with KEYTRUDA has demonstrated antitumor activity in heavily pre-treated patients with platinum-resistant ovarian cancer in the ongoing ARTISTRY-1 study, with durable and deepening responses observed. We look forward to initiating this phase 3 study to further evaluate the potential clinical utility of this combination in this tumor type and advancing our interactions with regulatory authorities related to potential registration strategies for the combination in platinum-resistant ovarian cancer."

About nemvaleukin alfa
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven antitumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin in patients with advanced solid tumors.

ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days, followed by an off-treatment period. In the ongoing phase 2 efficacy expansion stage of ARTISTRY-2, nemvaleukin is administered subcutaneously once every seven days.

ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of intravenous nemvaleukin monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors.