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Helix Biopharma Corp. Provides Corporate Update

On April 2, 2020-Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported a corporate update (Press release, Helix BioPharma, APR 2, 2020, View Source [SID1234556099]).

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COVID-19
As countries across the globe face an unprecedented public health crisis due to COVID-19, Helix has taken various measures to protect the health and well-being of our staff while maintaining business continuity.

The office and laboratory of Helix in Canada have been following the recommendations of federal, provincial and regional authorities. This includes operating a safe and clean working environment, providing work at home facility and observing latest public health guidance such as ‘social distancing’. Except for a limited number of staff at the laboratory to maintain critical infrastructure operation, all Helix personnel are working from remote locations.

Clinical Development initiatives The Company’s U.S. Phase I L-DOS47 lung cancer study in combination with pemetrexed and carboplatin (LDOS001) has completed patient recruitment. Study reports are being compiled and an abstract has been submitted to a conference. As previously reported in the Company’s recently filed Q2 fiscal 2020 filings, the Company’s European Phase II L-DOS47 lung cancer study in Poland and Ukraine (LDOS003) no longer requires patient enrollment. The Company indicated that the first stage of the study related to dose escalation would be concluded and progression to the second stage of the study would only proceed if a third-party was willing to partner with the Company on the study and upon a confirmatory medical review.

The Company’s U.S. Phase 1b/II pancreatic study of L-DOS47 in combination with doxorubicin (LDOS006) continues to enroll patients and has dosed two patients. Given the COVID-19 crisis however, the Company expects patient enrollment will be impacted. Helix is working closely with the clinical trial site and the hospital to ensure best care is being provided to patients while ensuring Helix complies with their COVID-19 protocols.

Corporate initiatives COVID-19 has created significant uncertainty and has materially impacted equity markets globally at a time when the Company was in the planning process of up-listing to the U.S. and raising additional capital. Nevertheless, the Company continues to engage both U.S. and Canadian investment bankers and is preparing for a capital raise in combination with an up-listing on the NASDAQ. Though the Company previously expected to conduct road shows and face-to-face meetings with potential investors during the month of April 2020, COVID-19 has made it impossible to do so. Instead, the Company expects to conduct online meetings and conference calls.

The Company recently closed a $6,000,000 private placement which included the disposition of a 15.5% stake in the Company’s Polish subsidiary, Helix Immuno-oncology S.A. ("HIO"). As previously disclosed, the Company intends to fully divest its remaining 51.0% interest in HIO to raise additional capital to further fund the Company’s clinical development programs while retaining a licensing arrangement for future royalties and milestone payments.

As a result of the recent private placement the Company is in a sound financial position allowing management to operate as normally as possible, in light of COVID-19. Given that the duration and magnitude of the impact on the economy and the Company’s business from COVID-19 is unknown, the Company has implemented a review of 2 operations in order to reduce or defer spending where possible, while maintaining key clinical and business program priorities.

The Company thanks all its staff who responded quickly and professionally as well as all our stakeholders who continue to support our Company during these challenging times.

Kite Licenses Antibodies and Establishes Collaboration With Teneobio in Multiple Myeloma

On April 2, 2020 Kite, a Gilead Company (Nasdaq: GILD), and Teneobio, Inc. reported the companies have entered into a license and collaboration agreement through which Kite will receive exclusive rights to certain antibodies directed to B-cell maturation antigen (BCMA) (Press release, Kite Pharma, APR 2, 2020, View Source [SID1234556098]). The fully human variable heavy chain of one such antibody is currently undergoing clinical evaluation in a chimeric antigen receptor (CAR) format for the treatment of patients with multiple myeloma in a Phase 1 clinical trial at the National Cancer Institute. Kite and Teneobio will also collaborate on the discovery of antibodies directed to four additional targets, using Teneobio’s proprietary Human Heavy-Chain Antibodies (UniAb) platform, to be used in CAR T cell therapies for multiple myeloma and other cancers.

This press release features multimedia. View the full release here: View Source

CARs traditionally utilize an antigen-recognition domain made up of a single chain variable fragment (scFv). The binding domain derived from Teneobio’s BCMA antibody has key potential benefits, including minimal potential for immunogenicity due to its lack of murine elements, and its small size, which may allow for the creation of dual-targeting CAR T therapies.

"Kite is committed to pursuing novel CAR T therapies that have the potential to be meaningfully differentiated treatment options for people living with multiple myeloma," said Peter Emtage, PhD, Senior Vice President of Research at Kite. "Based on encouraging early clinical signals and unique attributes of the binding domain from Teneobio, this exciting collaboration will be central to our strategy of developing next-generation CAR T therapies with the potential to overcome the tumor microenvironment."

"We are pleased that Kite, a leader in cell therapy, has recognized the potential of Teneobio’s UniAb platform to enable differentiated CAR T cell therapies in treating multiple myeloma and other cancers," said Roland Buelow, PhD, CEO of Teneobio. "We look forward to working with Kite to advance our uniquely differentiated cancer-targeting UniAbs on behalf of patients in need of novel therapies."

Under the terms of the agreement, Teneobio will receive an upfront payment and will be eligible to receive additional payments based on achievement of certain clinical and regulatory milestones, as well as royalties on future potential sales.

The Anti-BCMA CAR T cell therapy using Teneobio’s UniAb platform is investigational and not yet approved by any regulatory authority. Its efficacy and safety have not been established.

Fate Therapeutics Announces Worldwide Collaboration with Janssen for Novel iPSC-derived Cell-based Cancer Immunotherapies

On April 2, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported a global collaboration and option agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, Fate Therapeutics, APR 2, 2020, View Source [SID1234556097]).

Under the multi-year collaboration agreement, Janssen will contribute proprietary antigen binding domains for up to four tumor-associated antigen targets. The Company will apply its iPSC product platform to research and preclinically develop new iPSC-derived chimeric antigen receptor (CAR) NK and CAR T-cell product candidates. The Company will receive $50 million in cash and $50 million from the purchase by Johnson & Johnson Innovation – JJDC, Inc. of newly issued shares of the Company’s common stock at a price per share of $31.00. Janssen will also reimburse the Company for all activities conducted under the collaboration.

"We are delighted to enter this strategic collaboration, which brings together Janssen’s scientific and global commercialization leadership, deep domain expertise in oncology and proprietary technologies for targeting and binding certain tumors and our industry-leading iPSC product platform to develop novel off-the-shelf CAR NK and T-cell cancer immunotherapies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The collaboration strengthens our financial and operating position through a focused effort of developing cell-based cancer immunotherapies utilizing Janssen’s proprietary antigen binding domains, while enabling us to continue to exploit our deep pipeline of wholly-owned product candidates and further develop our off-the-shelf, iPSC-derived cell-based immunotherapies."

The Company will advance candidates under the collaboration to the filing of an Investigational New Drug (IND) application, after which Janssen will have the right to exercise its option for an exclusive license for the development and commercialization of collaboration candidates targeting the tumor-associated antigens. The Company will be primarily responsible for the manufacture of collaboration candidates, the cost of which will be paid for by Janssen. The Company is eligible to receive payments of up to $1.8 billion upon the achievement of development and regulatory milestones and up to $1.2 billion upon the achievement of commercial milestones, plus double-digit royalties on worldwide commercial sales of products targeting the antigens. In addition, the Company has the right to elect to co-commercialize each collaboration candidate in the U.S. and share equally in profits and losses in the U.S., subject to its payment of certain clinical development costs and adjustments in milestone and royalty payments.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 250 issued patents and 150 pending patent applications.

Fate Therapeutics Announces First Patient Treated in First-in-human Clinical Trial of FT596 and Provides Corporate Update

On April 2, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the first patient has been treated in the Company’s first-in-human Phase 1 clinical trial evaluating FT596, the first cell therapy product candidate engineered with three active anti-tumor modalities, in patients with B-cell malignancies and chronic lymphocytic leukemia (Press release, Fate Therapeutics, APR 2, 2020, View Source [SID1234556096]). FT596 is an off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a proprietary CD19-targeting CAR, a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, and a unique interleukin-15 receptor fusion (IL-15RF). The hnCD16 Fc receptor enables coincident targeting of additional tumor-associated antigens expressed on cancer cells to overcome antigen escape, and IL-15RF is a potent cytokine complex that promotes survival, proliferation and trans-activation of NK cells and CD8 T cells without the need for systemic cytokine support.

"We are pleased to have worked with the Masonic Cancer Center, University of Minnesota to treat the first patient with FT596," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The COVID-19 pandemic presents unprecedented challenges for clinical trial conduct worldwide, and we anticipate there will be delays across our studies. We are committed to the health and safety of our employees and partners, and have implemented a remote work program to the greatest extent possible while continuing certain activities that can only be completed on-site. We are also working closely with our clinical sites and principal investigators so that we are well positioned to accelerate clinical trial execution when pressures on the health system ease."

In response to the global COVID-19 pandemic, the Company is providing a business update on the conduct of its operations.

The Company has taken steps in line with guidance from the U.S. Centers for Disease Control and Prevention (CDC) and the State of California to protect the health and safety of its employees and the community. In particular, the Company has implemented a work from home policy, and restricted on-site activities to certain manufacturing, laboratory and related support activities. The Company is continuing to assess the impact of COVID-19 pandemic to best mitigate risk and continue the operations of its business.
The Company is working closely with its clinical sites, physician partners and the patient community to monitor the potential impact of the evolving COVID-19 pandemic. The Company remains committed to its clinical programs and development plans, but expects that the timelines of its ongoing clinical trials will be impacted including by potential delays or disruptions in patient enrollment and site initiation.
The Company continues to engage the U.S. Food and Drug Administration (FDA), and remains on-track to submit Investigational New Drug applications to the FDA for FT538, the Company’s off-the-shelf, iPSC-derived NK cell product candidate for multiple myeloma, and for FT819, the Company’s first off-the-shelf, iPSC-derived CAR T-cell product candidate for B-cell malignancies, in the second quarter of 2020.
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About FT596
FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology, which contains a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3-zeta signaling domain, that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors, in combination with IL-15RF signaling, convey synergistic anti-tumor activity. Increased degranulation and cytokine release were observed upon dual receptor activation in lymphoma cancer cells as compared to activation of each receptor alone, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in an open-label Phase 1 clinical trial as a monotherapy, and in combination with rituximab, for the treatment of advanced B-cell lymphoma and in combination with obinutuzumab for the treatment of chronic lymphocytic leukemia (NCT04245722).

AbbVie to Host First-Quarter 2020 Earnings Conference Call

On April 2, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its first-quarter 2020 financial results on Friday, May 1, 2020, before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (Press release, AbbVie, APR 2, 2020, View Source [SID1234556092]). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.