Immunomic Therapeutics Announces License Agreement With Lineage Cell Therapeutics for Cancer Immunotherapy

On April 20, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported a worldwide license and development collaboration agreement with Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions (Press release, Immunomic Therapeutics, APR 20, 2021, View Source [SID1234578260]). The collaboration will generate a novel product candidate derived from Lineage’s investigational allogeneic VAC cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to an upfront payment of $2 million paid in the first year and development and commercial milestones totaling $67 million across multiple indications. Lineage also will be eligible to receive royalties up to 10% on future product sales.

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"We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM," commented Dr. William Hearl, CEO of ITI. "Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs."

"The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer," stated Brian Culley, Lineage CEO. "This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC."

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain "de novo" or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

Veracyte to Release First Quarter 2021 Financial Results on May 10, 2021

On April 20, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its full financial results for the first quarter of 2021 after the close of market on Monday, May 10 (Press release, Veracyte, APR 20, 2021, View Source [SID1234578245]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following conclusion of the live broadcast and will be accessible on the company’s website at View Source

Autolus Therapeutics Receives Innovation Passport and entry into ILAP for AUTO4 for the treatment of T cell receptor constant region beta chain 1 (TRBC1) positive T cell lymphomas

On April 20, 2021 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO4 being studied in a Phase 1 study in TRBC1 positive Peripheral T Cell Lymphoma (PTCL) (Press release, Autolus, APR 20, 2021, View Source [SID1234578261]).

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"The granting of the Innovation Passport and entry into ILAP comes soon after we received PRIority MEdicines (PRIME) designation from the European Medicines Agency for AUTO1, with both designations accelerating the review of promising therapies targeting unmet medical needs," said Dr. Christian Itin, chairman and chief executive officer of Autolus. "We look forward to working with the MHRA as we progress AUTO4 through the clinic and to providing an interim update on the Phase 1 program later this year."

About ILAP
ILAP was announced in December 2020 and launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).

The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile (TDP) document to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.

Evotec invests into Oxford Cell Therapy Company "OxVax"

On April 20, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that the Company has invested into OxVax, a new immuno-oncology company based on research from Oxford University, which enables the development of the next generation of cancer vaccines with the potential to overcome the limitations of the current approaches (Press release, Evotec, APR 20, 2021, View Source;announcements/press-releases/p/evotec-invests-into-oxford-cell-therapy-company-oxvax-6053 [SID1234578281]).

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OxVax is developing an innovative cancer vaccine platform based on a unique and proprietary population of dendritic cells capable of inducing a potent anti-tumour immune response. The company’s technology allows the bulk manufacture of these cells from donor blood derived stem cells. By ex vivo loading of these cells with tumour antigens, OxVax will be able to create a vaccine which can train the body to target and eliminate tumours.

The research is based on the work of Professor Paul J Fairchild and Tim Davies from the Sir William Dunn School of Pathology at Oxford University. The founders will be joined by Marcelo Bravo as Chief Executive Officer, a serial entrepreneur who has taken two companies public.

Evotec’s investment is co-led by the South Korean-based venture capital company Lead Compass Investment. Financial details were not disclosed.

Dr. Thomas Hanke, Head of Academic Partnerships at Evotec, said: ‘We are excited to work with the Oxford researchers and Lead Compass to support the development of next-generation dendritic cell therapies to treat tumours with a high unmet medical need in the future. This investment fits well with Evotec’s ambition to become a biotech powerhouse in off-the-shelf cell therapy offerings.’

Professor Paul J Fairchild, Associate Professor of the Immunobiology of Stem Cells at Oxford University, said: "Our research has shown how stem cells can be used to create potentially unlimited numbers of a rare cell type of the immune system responsible for orchestrating the immune response to solid tumours. We believe that access to these cells can open the field of cancer vaccination and transform the treatment of some of the most intractable cancers."

Marcelo Bravo, Chief Executive Officer at OxVax, added: "Our platform enables the manufacture at scale of an off-the-shelf highly potent vaccine which addresses the major limitations that have frustrated cancer vaccine development in the past. Our immediate focus will be the definition of the quality profile of the product and the industrialisation of the manufacturing protocol which will put us in a strong position to proceed towards the clinic."

Tae-erk Kim, Chief Executive officer at Lead Compass Investment, added: "We are excited to invest in OxVax’s technology since it addresses the low migration, cross-presentation, and T-cell activation problems of past dendritic cell cancer treatments. Promising results in an oncology setting would further pave the way for OxVax to expand its technology into other therapeutic areas and be the first company to have dendritic cells act as the true control tower of the immune system."

Vincerx Pharma Announces FDA Clearance of IND for Phase 1b Study of VIP152 in Chronic Lymphocytic Leukemia and Richter Syndrome

On April 20, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application to initiate a Phase 1b dose escalation study evaluating VIP152, a highly selective PTEFb/CDK9 inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter syndrome (RS) (Press release, Vincerx Pharma, APR 20, 2021, View Source [SID1234578246]).

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"The IND clearance for VIP152 in CLL is an important milestone for Vincerx, marking our first IND clearance and now second clinical program for what we believe is the most selective CDK9 inhibitor in clinical development," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Preclinical data for VIP152 show highly selective, ATP-independent, inhibition of CDK9 which translates to robust on-target activity across key gene targets. Most importantly, we believe this differentiated profile leads to encouraging early clinical activity, with demonstrated durable single-agent activity in hematologic malignancies and heavily pretreated solid tumors. This new dose-escalation study in CLL and Richter syndrome, expected to initiate before year end, builds upon our planned Phase 1b expansion cohort study in MYC-driven hematologic malignancies and solid tumors, which is on track to begin patient dosing in Q2 2021. We are proud of our rapid progress and look forward to continued execution as we advance VIP152 through our targeted oncology clinical programs to address a broad range of aggressive, resistant cancers."

The Phase 1b dose-escalation study will evaluate VIP152 in patients with relapsed/refractory CLL who have failed a Bruton tyrosine kinase inhibitor (BTKi) and venetoclax. Part 1 of the study will enroll CLL patients treated with ³2 prior regimens including either a BTKi or venetoclax. Part 2 of the study will consist of a CLL Phase 1b expansion which will enroll 20 patients with CLL relapsed/refractory to venetoclax and BTKi, and a RS Phase 1b expansion which will enroll 20 patients with CLL transformed to diffuse large B cell lymphoma (DLBCL) who have relapsed after, or been refractory to, at least 1 prior line of therapy for DLBCL and having MYC overexpression/ amplification/translocation. The Company expects to initiate the Phase 1b dose-escalation study in 2H 2021.

The Phase 1b dose-escalation in CLL and RS builds upon Vincerx’s ongoing first-in-human (FIH) study in patients with advanced cancer. Part 2 of the FIH study is on-track to begin patient dosing in 2Q 2021 and will consist of two expansion arms. Arm 1 will enroll up to 30 patients with relapsed/refractory aggressive lymphoma including DLBCL, transformed follicular lymphoma, or blastoid mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.