On November 30, 2018 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported the injection of the first patient in the Phase 1 alloSHRINK trial evaluating the Company’s non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable metastatic colorectal cancer (mCRC) (Press release, Celyad, NOV 30, 2018, View Source [SID1234531747]).

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"The initiation of the alloSHRINK trial marks a critical milestone for our organization," said Dr. Christian Homsy, CEO of Celyad. "CYAD-101 represents a potential first-in-class approach to allogeneic CAR-T therapy and continues to build up Celyad’s leadership position in the allogeneic field, which is anchored by the Company’s robust allogeneic patent estate in the United States and complemented by our novel shRNA-based non-gene edited platform."

Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, "CYAD-101 represents Celyad’s second oncology program to enter the clinic for the treatment of metastatic colorectal cancer and balances the Company’s autologous clinical candidate CYAD-01, which has demonstrated encouraging preliminary results in the Phase 1 SHRINK trial. We believe investigating CYAD-101 in the alloSHRINK trial will leverage our clinical experience to date in the treatment of metastatic colorectal cancer as we look to develop novel therapies for this devastating disease."

Celyad also announced that ONO Pharmaceutical Co., Ltd. has given notice to the Company that it will no longer pursue development of CYAD-101 in Japan, Korea and Taiwan. Celyad and ONO Pharmaceutical entered into an exclusive license agreement for the development and commercialization of CYAD-101 in these specified territories in July 2016. Based on the agreement, ONO Pharmaceutical was required to exercise an option following the initiation of the Phase 1 trial for CYAD-101. The agreement has now expired and Celyad controls worldwide development and commercialization rights to CYAD-101.

Press Release

30 November 2018

07:00 am CET

CYAD-101 and alloSHRINK Trial Design

CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). TCR signaling is responsible for Graft versus Host Disease (GvHD). The expression of TIM reduces signaling of the TCR complex and could therefore reduce or eliminate GvHD in patients treated with CYAD-101.

The alloSHRINK trial (NCT03692429) is an open-label, dose-escalation trial that will assess the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC. Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks 48 hours after the initiation of chemotherapy cycles one, two and three. The three dose levels to be evaluated are 100 million, 300 million and 1 billion cells per injection, respectively.

On November 30, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported presentations of clinical and scientific data related to Peripheral T-cell Lymphoma (PTCL) and EVOMELA (melphalan) at the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) being held in San Diego, California, from December 1-4, 2018 (Press release, Spectrum Pharmaceuticals, NOV 30, 2018, View Source [SID1234531743]).

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For more information about the ASH (Free ASH Whitepaper) annual meeting and for a complete list of abstracts, please refer to the conference website at View Source

The following posters will be presented at the ASH (Free ASH Whitepaper) meeting:

Management of Mucositis with Use of Leucovorin as Adjunct to Pralatrexate in Treatment of Patients with Hematological Malignancies including of Peripheral and Cutaneous T-Cell Lymphomas-Results from a Prospective Multicenter Phase 2 Clinical Trial. Poster 2910; Presented on Sunday, Dec 2, 6:00 PM-8:00 PM, Hall GH
Role of Single Agent and Combination Chemotherapy Strategies in Relapsed/Refractory Peripheral T-Cell Lymphoma: Results from the Complete Registry. Poster 2926; Presented on Sunday, Dec 2, 6:00 PM-8:00 PM, Hall GH
Safety and Efficacy of Evomela in Myeloma Autotransplants; Poster 3446; Presented on Sunday, Dec 2, 6:00 PM-8:00 PM, Hall GH

On November 30, 2018 IGEM Therapeutics (IGEM or "the Company"), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer, reported it has secured an additional £3 million to close its Series A round at £5 million (Press release, IGEM Therapeutics, NOV 30, 2018, View Source [SID1234531742]). Two new investors, Alsa Holdings and UCL Technology Fund (co-managed by Albion Capital and UCLB, UCL’s commercialisation company) have joined initial investor Epidarex Capital who also committed further capital in this second close.

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The funding will enable IGEM to further develop its portfolio of IgE antibody candidates against a variety of cancers. The epsilon constant region of IgE has evolved to fight complex, multicellular parasitic organisms resident in tissue by recruiting powerful immune effector cells such as macrophages, basophils and monocytes. IGEM believes that potent immune responses arising from IgE are suited to the destruction of solid tumours which also reside in tissue. Pre-clinical proof of concept data repeatedly shows superior efficacy for IgE versus cognate IgG antibodies in a range of cancer models.

Alek Safarian, Chief Executive Officer of Alsa Holdings, commented: "We are excited by the promise that IGEM’s technology holds for major therapeutic advances in a host of oncology indications, and are looking forward to working with the management team to help bring new options to oncology patients in the future."

Dr Christoph Ruedig, Partner at Albion Capital commented: "The UCL Technology Fund strives to back innovative early stage companies that are seeking to translate ground-breaking research into commercial and societal impact. The pioneering work of Dr Sophia Karagiannis and her collaborators, which includes significant clinical development by clinical academics from UCL, highlight the profound potential of IgE antibody technology in cancer therapeutics. We are delighted to invest alongside Epidarex and Alsa and look forward to working with IGEM’s accomplished executive team."

Dr Peter Finan, Partner at Epidarex Capital, commented: "IGEM continues to make great progress on this disruptive platform. We look forward to working closely with Alsa and Albion to maximise IGEM’s potential"

Dr Tim Wilson, Chief Executive Officer of IGEM, commented: "This new financing will allow IGEM to continue to pioneer the development of IgE therapeutic antibodies for the treatment of cancer. We are very pleased to have attracted new investors of the calibre of Alsa Holdings and UCL Technology/Albion to IGEM as well as receiving further investment from initial investor Epidarex Capital."

On November 30, 2018 Karolinska Development (Nasdaq Stockholm: KDEV) reported that an investment consortium, including Redmile Group, invests SEK 512 million (EUR 50 million) in Aprea Therapeutics (Press release, Karolinska Development, NOV 30, 2018, View Source [SID1234531741]). Based on the investment, Karolinska Development has decided to increase the book value for its holding of Aprea. As a consequence, a positive effect on earnings by approximately SEK 60 million will be reported in the income statement for the fourth quarter 2018, to be published on 14 February 2019.

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An investment consortium, with Redmile Group in the lead, invests SEK 512 million (EUR 50 million) in Aprea Therapeutics. Redmile Group, which is a US venture capitalist firm focused on health care, will appoint a representative to Aprea Therapeutic’s Board of Directors.

The investment consortium also includes Rock Spring Capital, who like Redmile Group enters as a new owner, and 5AM Ventures, Versant Ventures, HealthCap, Sectoral Asset Management and Karolinska Development AB who all are previous owners of Aprea Therapeutics.

Aprea’s drug candidate APR-246 has shown initial positive results in a combination study with standard care azacitidine in patients with TP53 mutant myelodysplastic syndromes (MDS). Proceeds from the financing will be used to advance the clinical development of APR-246. Aprea is planning to begin a Phase III clinical study in myelodysplastic syndrome (MDS) and is nearing completion of a Phase Ib/II clinical trial in p53 mutated high-risk myelodysplastic syndromes (MDS) and oligoblastic acute myeloid leukemia (AML). The Phase II part of the study is ongoing, with updated data to be presented at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, 1-4 December 2018.

"The engagement from well-renowned international investors is based on the clear advances in Aprea’s development of its drug candidate APR-246 and confirms the quality of the project," says Viktor Drvota, CEO of Karolinska Development.

For more information, please visit www.aprea.com

For further information, please contact:

Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: [email protected]

Fredrik Järrsten, CFO, Karolinska Development AB
Phone: +46 70 496 46 28, e-mail: [email protected]

On November 29, 2018 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into an agreement with PharmaEssentia Corporation (Taipei Exchange:6446) to license the rights to develop and commercialize Athenex’s Oradoxel in Taiwan, Singapore and Vietnam (Press release, Athenex, NOV 29, 2018, View Source [SID1234531900]). The existing licensing agreement for Oraxol (oral paclitaxel) and Oratecan (oral irinotecan) with PharmaEssentia is being expanded to account for additional considerations, including milestone payments, for Oradoxel (oral docetaxel). In December 2013, Athenex and PharmaEssentia entered into a license agreement, pursuant to which PharmaEssentia was granted a license to develop and commercialize Oraxol and Oratecan in Taiwan and Singapore. The agreement was amended in December 2016 to also include Vietnam in the territories covered by the license.

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Under the terms of the expanded agreement, which includes Oradoxel, Athenex will receive a cash payment as well as the potential to receive additional milestone payments for certain development and regulatory milestones of Oradoxel in the territories. PharmaEssentia will be responsible for all activities and expenses relating to clinical development, regulatory approval, and commercialization of Oradoxel in the territories.

Docetaxel is an anti-cancer chemotherapeutic agent that is used widely in the treatment of breast, prostate, gastric, head and neck, and lung cancers. Oradoxel is an oral formulation of Docetaxel combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Oradoxel is currently in Phase I clinical studies in the U.S. and New Zealand, and is ready to advance to Phase II with studies expected to begin in the first half of 2019.

Dr. Kochung Lin, Chief Executive Officer of PharmaEssentia, commented, "We are excited with the encouraging results so far from clinical trials of Athenex’s Orascovery drug candidates, particularly Oraxol. The potential of oral chemotherapy drugs to improve efficacy and safety, and improve patients’ quality of life, cannot be overstated. Athenex has generated promising Phase I data with both Oratecan and Oradoxel, and we are pleased to participate in the development of these exciting products in Taiwan, Singapore and Vietnam to help realize the full potential of this platform. We have been impressed by the Athenex team in their execution and are delighted to continue and expand our excellent partnership with the addition of Oradoxel."

Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, stated, "This agreement builds on our longstanding relationship with PharmaEssentia. PharmaEssentia has demonstrated strong commitment to cancer drug research and development, and we are confident they have the capabilities for successfully delivering Oradoxel to patients in the licensed territories."

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.