On July 15, 2019 Boehringer Ingelheim reported its acquisition of all shares of AMAL Therapeutics SA, a private Swiss biotechnology company focused on cancer immunotherapy and advancing first-in-class therapeutic cancer vaccines derived from its technology platform KISIMA (Press release, Boehringer Ingelheim, JUL 15, 2019, View Source [SID1234537524]). AMAL’s lead vaccine ATP128 is currently developed for stage IV colorectal cancer and is slated to begin first-in-human trials later this month. Boehringer Ingelheim plans to develop new therapies by combining assets from its cancer immunology portfolio with AMAL’s proprietary KISIMA immunization platform.

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Michel Pairet
"Acquiring AMAL is part of Boehringer Ingelheim’s long-term strategy to enhance our existing position as an innovator of novel cancer therapies, including immuno-oncology treatments, which leverage cutting-edge scientific discoveries and their applications," said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "We want to pioneer new paradigms of biology-based care for cancer patients, and the technologies and expertise developed at AMAL are critical to our efforts."

The total transaction could amount up to EUR 325 million, and is comprised of an upfront payment as well as contingent clinical, development and regulatory milestones plus up to EUR 100 million if certain commercial milestones are hit.

"I am extremely proud of the hard work of AMAL’s entire team, which is validated by this acquisition, and very excited to further develop the KISIMA technology platform within Boehringer Ingelheim," said Madiha Derouazi, Ph.D., Founder and Chief Executive Officer of AMAL Therapeutics. "Our new relationship with Boehringer Ingelheim will enable us to realize the full potential of our KISIMA platform to fight solid cancers while preserving AMAL’s approach to biotechnology research and our scientific and academic networks. Moreover, sharing resources and capabilities in clinical development will greatly help us to move ATP128 and other assets forward."

Boehringer Ingelheim’s Cancer Immunology group is built to discover therapies that engage triggering of immune responses against non-inflamed, "cold" tumors, which represent a large group of cancer types refractory to many treatments, including checkpoint inhibitor drugs. Immune targeting of cold tumors is a particular challenge. AMAL’s KISIMA vaccine technology, designed to stimulate potent immune responses, is a promising therapeutic option for patients with these type of cancers.

The AMAL acquisition, along with that of the 2018 acquisition of Vira Therapeutics (Vira-T) and in-license of OSE Immunotherapeutics’ SIRP-alpha targeting antibody, significantly strengthens Boehringer Ingelheim’s strategic focus on immune cell-directed therapies. By combining its world-class in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative immuno-oncology therapies and accelerating the delivery of the next-generation of cancer treatments.

AMAL is headquartered on the medical campus of the University of Geneva, from which it was spun-out in 2012, with financial backing from a syndicate of both corporate and institutional investors, including the Boehringer Ingelheim Venture Fund and High-Tech Gründerfonds as the initial seed investors. Additional investments were provided by VI Partners, Helsinn Investment Fund, BioMed Partners and Schroder Adveq. AMAL’s technology platform and derived products are protected by a broad portfolio of patents and licenses.

KISIMA
Unlike prophylactic vaccines that immunize a patient to prevent an infection before it occurs, therapeutic vaccines combat existing diseases. Anti-cancer therapeutic vaccines carry antigens, pieces of protein that also are in tumors. By presenting antigens to the patient’s immune system, a vaccine can prompt tailor-made responses, including activation of killer T cells that target the tumor and can boost memory immunity to reduce the risk of relapse.

AMAL’s proprietary technology platform KISIMA enables the assembly of three functional components into one patented fusion protein used as a vaccine: First, a proprietary cell-penetrating peptide for antigen delivery; second, a proprietary toll-like receptor (TLR) peptide agonist as an adjuvant, and third, a multi-antigenic cargo that can be tailored for specific indications.

ATP128
AMAL’s lead candidate, ATP128, is a therapeutic chimeric recombinant protein vaccine designed using KISIMA and currently developed for stage IV colorectal cancer. AMAL will conduct KISIMA-01, an international Phase Ib clinical study to evaluate the combination of ATP128 with Boehringer Ingelheim’s anti-PD1 compound BI754091, via a May 2019 collaborative agreement, in Microsatellite Stable (MSS) patients with stage IV colorectal cancer.

This first-in-human study will investigate ATP128 as single agent and in combination with BI754091 using safety and tolerability as primary endpoints. The study will also measure anti-tumor activity and characteristics of the immune response as secondary and exploratory endpoints.

On July 14, 2019 Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, reported that the company recently dosed the first patient successfully in a Phase I clinical trial of APG-2575, a novel Bcl-2 selective inhibitor, for the treatment of hematologic malignancies in China (Press release, , JUL 14, 2019, View Source [SID1234537515]). The Company also has an ongoing multi-center Phase I dose-escalation study of APG-2575 as a single agent in the United States and Australia. APG-2575 could potentially be the first China-made Bcl-2 inhibitor.

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APG-2575 is a novel, orally administered Bcl-2 selective inhibitor. It is designed to treat hematologic malignancies by selective blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Bcl-2 is the founding member of the Bcl-2 family proteins which are most notable for their critical roles in the regulation of apoptosis through the formation of heterodimers with pro-apoptotic proteins (BIM, BAD and most others). Due to the very large and hydrophobic interfaces of Bcl-2 proteins, it is difficult to develop a drug that targets Bcl-2 family protein. The marketed Bcl-2 inhibitor venetoclax/ABT-199 approved by the U.S. FDA in April 2016 has validated the clinical basis for further targeted drug development. Ascentage Pharma’s APG-2575 is one of the few Bcl-2 selective inhibitors in active clinical trials other than Venetoclax.

This Phase I trial is designed to assess the safety and tolerance of APG-2575 in patients with hematologic malignancies and confirm the maximal tolerated dose (MTD) or recommended Phase II dose (RP2D) of APG-2575. Included in this trial are patients with acute myelogenous leukemia (AML), non-Hodgkin’s lymphoma (NHL). Currently, the first patient enrolled in China has been dosed at Institute of Hematology, Blood Disease Hospital of Chinese Academy of Medical Sciences during the first stage of dose-escalation.

The Phase I dose-escalation clinical trial of APG-2575 in the United States and Australia is being conducted at several academic institutions including MD Anderson Cancer Center and Mayo Clinic. Included in this trial are patients with various types of blood cancer, such as CLL, NHL, MM, AML. At present, 4 dose cohorts have been completed in the United States and Australia. Preliminary data suggested that APG-2575 was well tolerated and safe, it had promising anti-tumor activity in the treatment of relapsed/refractory CLL.

During the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, Ascentage Pharma released several preclinical research results of APG-2575, which demonstrated the potential in combination therapy.

"APG-2575 is a key product in our development pipeline of apoptosis. Initiating the clinical trial in China represents a new step in our global clinical development. We believe that APG-2575 may provide more therapy options to patients with blood diseases," said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma.

About APG-2575
APG-2575 is a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma. It is designed to treat hematologic malignancies by selective blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

The Company recently initiated a phase I clinical trial of APG-2575 in China, which is the first domestic Bcl-2 selective inhibitor entered the clinical stage. Ascentage previously has initiated a multi-center Phase I dose-escalation study of APG-2575 as a single agent in multiple hematologic malignancies in the United States and Australia in August 2018.

On July 12, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC PINK: IPATF), an industry leader in the discovery of novel, therapeutic monoclonal antibodies, reported that it has entered into a new antibody discovery collaboration with Entos Pharmaceuticals Inc., to develop a therapeutic candidate against an undisclosed, immuno-oncology target, by leveraging ImmunoPrecise’s proprietary B cell Select platform (Press release, ModiQuest Therapeutics, JUL 12, 2019, View Source [SID1234537526]).

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ImmunoPrecise’s well-established B cell Select platform is capable of screening tens of millions of cells, to identify a greater diversity of antibodies, with very little manipulation. This proprietary platform is species and tissue independent, allowing for the generation of antibodies from samples not possible using other methods. The B cell Select platform takes advantage of the diversity of the animal’s immune repertoire, and allows for screening of any protein class, complex therapeutic targets, post-translational modifications, and small molecules.

"Our B cell Select platform has a proven track record of discovering large panels of high-affinity antibodies against a broad range of antibody targets, including difficult membrane proteins. Our North American B cell laboratory boasts over one decade of experience with a 94% success rate. This is, in part, why we are very confident in these collaborations, and continue to field requests from such reputable groups," said Dr. Jennifer Bath, IPA President and CEO. "We are pleased that Entos Pharmaceuticals Inc., a global leader in next generation nucleic acid-based therapies, considers us to be a trusted partner in antibody discovery."

"The team at Entos is committed to developing breakthrough medicines to address pressing clinical unmet needs," said Dr. John Lewis, CEO of Entos. "We have been extremely impressed with IPA’s B cell Select platform, which provides an ideal approach to develop therapeutic candidates."

Andy Nixon stepping down from ImmunoPrecise’s Board.

The Company also announces that board director Andy Nixon has stepped down from his duties due to an arisen conflict of interest.

ImmunoPrecise’s Chair, James Kuo, stated they "regretfully" accepted Andy’s resignation "We will miss Andy’s contribution on the ImmunoPrecise board. He is a highly qualified Director and we wish him every success in the future", Kuo said.

Erratum

In May 30th news Release Extension of Warrant Expiry Dates, the actual placement date should’ve read June 18, 2018.

"The Company also announces that it will apply to the TSX Venture Exchange to extend the expiry date of 875,000 share purchase warrants issued in a private placement financing on June 18, 2018 (see news release dated June 19, 2018). The share purchase warrants are exercisable at a price of $1.00 per share and the expiry date is being extended from June 18, 2019 to June 18, 2020. The extension of the expiry date is subject to the acceptance of the TSX Venture Exchange."

On July 12, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that it has entered into an agreement with BliNK Biomedical for an exclusive commercial license to certain antibodies targeting CD47, for potential development and commercialization into novel bispecific therapeutics created via Genmab’s proprietary DuoBody Platform technology (Press release, Genmab, JUL 12, 2019, View Source [SID1234537501]). This agreement supports Genmab’s established product pipeline strategy. Under the terms of the agreement, Genmab will pay BliNK Biomedical an upfront fee of USD 2.25 million. BliNK Biomedical is also eligible to receive up to approximately USD 200 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.

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"With this agreement the scope of product concepts under development at Genmab has been expanded. CD47 has shown potential as a target for cancer and we believe that a bispecific approach may open up potential for differentiated therapies. We are always looking to use our in-house expertise in novel ways; we look forward to seeing the results from the combination of Genmab’s DuoBody technology with a CD47 antibody from BliNK Biomedical," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

BliNK Biomedical is a privately-owned biopharmaceutical company based in Marseille, France, focused on discovery and development of therapeutic antibodies in oncology and immuno-oncology.

On July 12, 2019 AstraZeneca reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Imfinzi (durvalumab) for the treatment of small cell lung cancer (SCLC) (Press release, AstraZeneca, JUL 12, 2019, View Source [SID1234537503]).

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SCLC constitutes about 15% of all lung cancer diagnoses. It is the most aggressive type of lung cancer with only 6% of patients alive after five years. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

In June 2019, the Phase III CASPIAN trial met its primary endpoint with Imfinzi by showing a statistically-significant and clinically-meaningful improvement in overall survival for patients with extensive-stage SCLC. These patients were treated with Imfinzi in combination with standard-of-care etoposide and platinum-based chemotherapy vs. chemotherapy alone. Results will be shared at a forthcoming medical meeting. Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.

José Baselga, Executive Vice President, R&D Oncology said: "This Orphan Drug Designation comes on the heels of positive results from the Phase III CASPIAN trial, which is the first trial to offer the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer. We are eager to expand treatment options for patients facing such a devastating diagnosis and look forward to working with regulatory authorities to bring forward new options as soon as possible."

Imfinzi is currently approved for unresectable, Stage III non-small cell lung cancer (NSCLC) after chemotherapy and radiation therapy in more than 45 countries including the US, EU, and Japan based on the Phase III PACIFIC trial.

About small cell lung cancer

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.1 Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.2 About two-thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.3 SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.4 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.3

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is also approved for previously-treated patients with advanced bladder cancer in the US, Canada, Brazil, Australia, Israel, India, United Arab Emirates, Qatar, Macau and Hong Kong.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small-cell lung cancer (SCLC), bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumours.

About AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease and lines of therapy. We aim to address the unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa (gefitinib) and Tagrisso (osimertinib) and ongoing Phase III trials FLAURA, ADAURA and LAURA as well as the Phase II exploratory combination trials SAVANNAH and ORCHARD.5-7

Our extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer. Imfinzi (durvalumab), an anti-PDL1 antibody is in development as monotherapy (Phase III trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in combination with tremelimumab and/or chemotherapy (AEGEAN, PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III trials).

About AstraZeneca’s approach to Immuno-Oncology (IO)

IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. Our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PDL1) as monotherapy and in combination with tremelimumab (anti-CTLA4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and from our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.