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Takeda Agrees to Divest Select OTC and Non-core Assets to Acino for Over $200 Million USD

On October 15, 2019 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it has entered into an agreement to divest a portfolio of select over-the-counter (OTC) and prescription pharmaceutical assets in a number of Near East, Middle East and Africa (NEMEA) countries within its Growth and Emerging Markets Business Unit to Acino for a total value in excess of $200 million USD (Press release, Takeda, OCT 15, 2019, View Source [SID1234542269]). This is the third transaction in FY19 that furthers Takeda’s strategy to focus on business areas core to its long-term growth and facilitate rapid deleveraging following its acquisition of Shire.

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"The divestment of non-core assets sold in NEMEA represents the continued execution of our strategy to optimize our portfolio, invest in the defined core business areas, and accelerate our progress toward reaching our target leverage ratio," said Costa Saroukos, Chief Financial Officer, Takeda.

While these products continue to play important roles in meeting patient needs, they are primarily outside of Takeda’s chosen business areas – Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience – core to its global long-term growth.

"Takeda remains committed to this region, as we continue our work in accelerating access to our life-changing portfolio of innovative products to meet the needs of patients. We will do this via our commercial activities and Takeda’s Access to Medicines program," said Ricardo Marek, President, Growth and Emerging Markets Business Unit, Takeda. "We are confident that Acino is best positioned to provide uninterrupted access and supply of the divested products to patients."

Takeda intends to use the proceeds from this divestiture to reduce debt and continue to deleverage towards its target of 2.0x net debt/adjusted EBITDA over the next three to five years. Takeda is committed to rapid deleveraging driven by strong cash flow and divestiture proceeds, while also simplifying its portfolio.

Transaction Details

Takeda has agreed to sell a portfolio of approximately 30 select prescription pharmaceutical and OTC products sold in the NEMEA region to Acino, a Swiss pharmaceutical company headquartered in Zurich, with a clear focus on selected markets in the Middle East, Africa, the CIS Region, and Latin America. The following key countries are included in the agreement: Egypt, Saudi Arabia, South Africa, Turkey, Ukraine and United Arab Emirates, as well as other countries.

Under the terms of the agreement, Acino will acquire the rights, title, and interest to the products in the portfolio exclusive to these countries. It is anticipated that primarily sales and marketing professionals supporting the portfolio will transition to Acino at closing of the transaction. The parties will also enter into a multi-year manufacturing and supply agreement, under which Takeda will continue to manufacture the products on behalf of Acino.

The transaction is expected to close in Q4 FY19 (January – March 2020), subject to the satisfaction of customary closing conditions including receipt of applicable antitrust approvals. Until then, these products will continue to be made available by Takeda.

Takeda is being advised by BofA Securities (financial advisor), White & Case (legal advisor), and Deloitte (financial consultant) in this transaction.

CohBar to Present at the 2019 BIO Investor Forum

On October 15, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat age-related diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present at the 2019 BIO Investor Forum, which is being held October 22-23 at the Westin St. Francis Hotel in San Francisco, CA (Press release, CohBar, OCT 15, 2019, View Source [SID1234542268]). The BIO Investor Forum explores investment trends and opportunities in life sciences, with a focus on venture-stage growth and emerging public companies as well as those poised to join the growth "watch list" in 2020.

Presentation details:
Wednesday, October 23rd 11:15 AM PT
Westin St. Francis Hotel, Yorkshire conference room

Webcast: The presentation may be accessed via webcast at the scheduled time, or after the presentation, using the following link: CohBar Presentation.

OncoSec Announces New Peer-Reviewed Data for TAVO™ in Virus-Associated Skin Cancer Published in Clinical Cancer Research

On October 15, 2019 OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported the publication of new data in Clinical Cancer Research which highlighted TAVO (intratumoral plasmid IL-12 with electroporation) as a safe, feasibility and clinically meaningful therapy in patients with Merkel cell carcinoma (MCC), an aggressive form of skin cancer (Press release, OncoSec Medical, OCT 15, 2019, View Source [SID1234542267]).

"These data demonstrate that intratumoral delivery of plasmid interleukin-12 with electroporation (TAVO) as a monotherapy has the potential to have a durable impact on skin cancers such as Merkel cell carcinoma. I’m encouraged by these initial findings and believe that TAVO is a treatment approach that merits further exploration in MCC," commented Shailender Bhatia, M.D., associate professor, medical oncology, Department of Medicine, University of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington and lead investigator and author of the study.

The single-arm, open label pilot study evaluated 15 patients with MCC receiving TAVO intratumorally in two cohorts (Cohort A N=3 and Cohort B N=12). Cohort A patients had locoregional MCC and received one treatment cycle prior to a definitive surgery. Cohort B patients had metastatic MCC and received four cycles of TAVO. Results showed that 25% of Cohort B patients experienced an overall response, with two patients receiving durable effect over 16 and 55+ months, respectively. Two Cohort A patients (one with pathologic complete remission) were recurrence-free at 44+ and 75+ months.

"We continue to explore the broad therapeutic potential of TAVO across various cancer types and believe this study underscores the power of TAVO monotherapy in solid tumors such as MCC," said Daniel J. O’Connor, president and chief executive officer of OncoSec. "We remain encouraged by the growing body of clinical evidence for TAVO in multiple cancer indications both as a monotherapy and in combination with leading checkpoint inhibitors. We look forward to providing further data updates as we continue to advance our ongoing pivotal clinical trial with TAVO in metastatic melanoma and our phase 2 trial in triple negative breast cancer."

An online version of the publication is available here: View Source

CRISPR Therapeutics and KSQ Therapeutics Announce License Agreement to Advance Companies’ Respective Cell Therapy Programs in Oncology

On October 15, 2019 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and KSQ Therapeutics, a biotechnology company using CRISPR technology to enable the company’s powerful drug discovery engine to achieve higher probabilities of success in drug development, reported a license agreement whereby CRISPR Therapeutics will gain access to KSQ intellectual property (IP) for editing certain novel gene targets in its allogeneic oncology cell therapy programs, and KSQ will gain access to CRISPR Therapeutics’ IP for editing novel gene targets identified by KSQ as part of its current and future eTIL (engineered tumor infiltrating lymphocyte) cell programs (Press release, CRISPR Therapeutics, OCT 15, 2019, View Source [SID1234542266]). The financial terms of the agreement are not being disclosed.

"We are thrilled to gain access to CRISPR Therapeutics’ foundational IP estate through this agreement," said David Meeker, M.D., Chief Executive Officer at KSQ Therapeutics. "Our eTIL programs involve editing gene targets in human TILs that were discovered at KSQ by applying our proprietary CRISPRomics approach to immune cells in multiple in vivo models. This agreement clears an important path for us to be able to bring these programs through development and commercialization, leveraging CRISPR Therapeutics’ proprietary editing technology."

The gene targets within the scope of the license agreement were identified using KSQ’s proprietary CRISPRomics drug discovery engine, which allows genome-scale, in vivo validated, unbiased drug discovery. These specific targets were uncovered in screens to identify genetic edits that could enhance the functionality and quality of adoptive cell therapies in oncology.

"KSQ has built an industry-leading platform to screen for novel gene targets using its technology, and has identified a group of targets that could help unlock the full potential of adoptive cell therapy in oncology," said Samarth Kulkarni, Ph.D., Chief Executive Officer at CRISPR Therapeutics. "As a result of this license agreement, CRISPR Therapeutics will have the opportunity to bring these novel targets into our leading allogeneic CAR-T development platform to further strengthen our future programs in this important therapeutic area."

Affimed Reports Progress on Key Clinical Development Programs

On October 15, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a first-in-human Phase 1/2a study of AFM24 (Press release, Affimed, OCT 15, 2019, View Source [SID1234542265]). The initial goal of the study is to determine the maximum tolerated dose and recommended Phase 2 dose of AFM24, as well as to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with advanced cancers known to express the epidermal growth factor receptor, EGFR. The second part of the study will evaluate the preliminary efficacy of AFM24 in patients with select solid tumor subtypes.

Affimed also announced that the FDA has cleared an IND application for a Phase 1 study to evaluate a stable complex of AFM13, its lead innate cell engager, pre-mixed with cord blood-derived allogeneic NK cells (cbNK cells) as an investigational treatment for patients with relapsed/refractory CD30-positive lymphoid malignancies. In addition, the registration-directed study of AFM13 as monotherapy in relapsed/refractory peripheral T cell lymphoma (pTCL), where patients have very few treatment options, is on track to initiate this year.

AFM24: Potential to Address Current Treatment Limitations in Solid Tumors
"Our goal at Affimed is to develop medicines that activate the innate immune system, the body’s first line of defense, as a powerful way to treat patients living with cancer," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "The IND filing is an important step toward the development of AFM24, our innate cell engager designed to target EGFR-expressing cancers, including those with resistance to existing EGFR-targeted therapies."

AFM24, a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager from Affimed’s fit-for-purpose ROCK platform, is designed to address limitations associated with other EGFR-targeted therapies, such as toxicities or resistance, by using a new mechanism of action to target EGFR-expressing solid tumors through activation of innate immunity rather than inhibition of EGFR-mediated signal transduction.

AFM24 has the potential to provide meaningful benefit to patients with certain mutations that cannot be addressed by existing EGFR-targeted therapies. According to internal market research, leading clinical experts across multiple cancer indications see a tremendous need for novel immuno-oncology approaches for the treatment of solid tumors. Preclinical data showed AFM24’s ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines and induce cell lysis through antibody-dependent cellular cytotoxicity (ADCC), independent of RAS mutational status, and antibody-dependent cellular phagocytosis (ADCP). In addition, AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapeutics.

AFM13: Lead Innate Cell Engager, Targeting CD30-positive Lymphomas
"We also continue to progress our lead innate cell engager, AFM13," said Dr. Hoess. "The clearance of the IND for AFM13 pre-mixed with cord blood-derived NK cells is a significant milestone in our overall clinical development plan. The planned clinical study will investigate the potential for adoptive cellular therapy together with our AFM13 innate cell engager to overcome a patient’s dysfunctional immune system to treat cancer."

AFM13 binds to CD16A on NK cells with high affinity, which enables the formation of a stable complex of AFM13 and cbNK cells that results in pre-mixed AFM13 with cbNK cells. This will be investigated in CD30-positive lymphoma patients and the study will be conducted by The University of Texas MD Anderson Cancer Center (MDACC) as an investigator-sponsored study. It builds upon encouraging in vitro and in vivo data that showed a significant enhancement of antitumor activity of pre-mixed AFM13 with cbNK cells versus cbNK cells alone.

Enrollment is ongoing for a Phase 1b/2a study of AFM13 led by Columbia University, with 13 patients now recruited. Previously reported data from this investigator-sponsored translational study in patients with relapsed/refractory CD30-positive lymphoma with cutaneous manifestation confirmed single-agent activity of AFM13, with an objective response rate of 50% (5 out of 10 patients). Patients who responded showed increased infiltration of NK cells, as well as NK cell-mediated killing in the patients’ tumors. These encouraging data supported Affimed’s rationale to study AFM13 in patients with relapsed/refractory CD30-positive pTCL and the registration-directed Phase 2 study of AFM13 is on track to enroll patients this quarter.