On July 15, 2019 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that plans to report second quarter 2019 financial results on July 30, 2019. Ligand’s CEO John Higgins, President and COO Matt Foehr, and Executive Vice President and CFO Matt Korenberg will host the conference call (Press release, Ligand, JUL 15, 2019, View Source [SID1234537525]).

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Second Quarter 2019 Earnings Call

What:

Ligand conference call to discuss financial results and provide general business updates

When:

Tuesday, July 30, 2019

Time:

9:00 a.m. Eastern time (6:00 a.m. Pacific time)

Conference Call:

(833) 591-4752 within the U.S.

(720) 405-1612 outside the U.S.

Conference ID – 1997313

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

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 15, 2019 Advaxis, Inc. (NASDAQ: ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported new immune data from its ongoing ADXS-NEO Phase 1 clinical trial that further support the clinical potential for the company’s platform in neoantigen-directed immunotherapies (Press release, Advaxis, JUL 15, 2019, View Source [SID1234537523]).

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ADXS-NEO is a personalized immunotherapy that is designed to help a patient’s immune system recognize and respond to mutation-derived tumor antigens, or neoantigens, that are unique to his or her tumor. ADXS-NEO is designed to express tLLO fused to up to 40 patient-specific neoantigens arranged sequentially as beads-on-a-string. As a live attenuated bacterial vector, ADXS-NEO can be rapidly taken up by antigen presenting cells, which recognize it as foreign and present the tLLO-NEO fusion proteins to T cells by the major histocompatibility complex class I and II pathways.

ADXS-NEO is being evaluated in an open-label, dose-escalation, multicenter Phase 1 clinical trial in the United States. Part A of the study is open to patients with metastatic non-small cell lung cancer (NSCLC), metastatic microsatellite stable colorectal cancer (MSS-CRC) and metastatic squamous cell carcinoma of the head and neck (SCCHN) who will receive ADXS-NEO as monotherapy. Part B of the study, anticipated to begin later this year, will be open to NSCLC patients as well as patients with melanoma SCCHN and bladder cancer and, for this part, ADXS-NEO will be administered in combination with a checkpoint inhibitor.

The new data were derived from deconvolution of neoantigen pools using single peptides and in vitro stimulation ELISpot assays (minimal CD8+ peptides). This has now been completed for the first two patients enrolled in this study, one with NSCLC and one with MSS-CRC. Highlights of the new post-vaccination data with ADXS-NEO are as follows:

CD8+ T cells were generated against 90% of the 40 neoantigen targets contained in the drug construct for the MSS-CRC patient (the NSCLC patient did not have 40 neoantigen targets and there were certain other issues with this patient’s sample that, together, made it unsuitable for inclusion in this "hit rate" analysis). This is consistent with Advaxis’ previously reported data from its preclinical studies as well as from clinical studies using pooled neoantigen peptides which were presented at the American Association of Cancer Research Annual Meeting last year and earlier this year, respectively. This is the highest "hit rate" publicly reported to-date in the neoantigen field. This high "hit rate", along with the rapid immune responses seen and antigen spreading, lay the foundation for the ADSX-NEO platform to be best-in-class for personalized, neoantigen-directed immunotherapies.

CD8+ T cells were also generated against the hotspot mutations found within each of the two patients’ tumors (i.e., EGFRL858R in the NSCLC patient and KRAS G12A in the MSS-CRC patient). This is important for the ADXS-NEO program as Advaxis believes a number of patient tumors likely will present with hotspot mutations, and generating or maintaining CD8+ T cell activity against these targets may increase the potential for killing cancer cells. All of the first four patients in this Phase 1 trial had a hotspot mutation. This is also relevant for the company’s ADXS-HOT program in that this is the first time Advaxis has observed the ability to generate or maintain specific CD8+ T cell activity against hotspot mutations. Hotspot mutations are important targets contained within the numerous drug constructs within the ADXS-HOT program and the specific hotspot mutations in these two patients, EGFRL858R and KRAS G12A, are included in the company’s ADXS-503 (HOT Lung) and ADXS-508 (HOT Colorectal) drug constructs, respectively.

Antigen spreading was confirmed in the MSS-CRC patient showing specific CD8+ T cells against neoepitopes that were not contained in the drug construct prepared for this patient (the NSCLC patient’s sample was not re-tested for antigen spreading). Thus, Advaxis believes ADXS-NEO may be able to induce a specific immune response against neoantigen-bearing tumor cells with the resultant cell death releasing secondary (nontargeted) tumor antigens. These secondary antigens can then prime subsequent immune responses (antigen spread) that are thought to be responsible for the improved clinical outcomes documented with other immunotherapies. Of note, antigen spreading has also been induced with other Lm constructs such as ADXS-HPV and ADXS-PSA in cervical and prostate cancer patients, respectively.

To date, dosing of ADXS-NEO at 1×108 colony forming units (CFU) has been well-tolerated in two patients. ADXS-NEO dosed at 1×109 CFU was beyond the maximum tolerated dose with reversible Grade 3 hypoxia (n=2) and Grade 3 hypotension (n=1) dose-limiting toxicities.

"This preliminary dataset of the deconvolution assays shows the generation of specific CD8+ T cell response in one MSS-CRC patient against 90% of the neoantigens in that patient’s personalized Lm construct together with antigen spreading, both of which we believe are critical for potential clinical benefit. These encouraging results are consistent with data from our previous preclinical and ELISpot-pooled clinical studies, and we look forward to presenting data from all patients in the monotherapy arm later in the year," said Andres Gutierrez, M.D., Ph.D., Chief Medical Officer of Advaxis. "In addition, we are gaining valuable insight from our ADXS-NEO platform to help advance our ADSX-HOT drug constructs, as for the first time we observed the ability to generate specific CD8+ T cell activity against hotspot mutations in the clinic. We continue to enroll patients in this Phase 1 study for ADXS-NEO and look forward to starting Part B with ADXS-NEO in combination with a checkpoint inhibitor later this year."

On July 15, 2019 AbbVie (NYSE: ABBV) reported that it has acquired Seattle-based Mavupharma, a privately held biopharmaceutical company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer (Press release, AbbVie, JUL 15, 2019, View Source [SID1234537522]).

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STING pathway signaling plays an important role in the generation of an immune response directed at tumors, and enhancing STING signaling has shown promise in a variety of tumor models. STING pathway stimulation has the potential to increase the susceptibility of tumors and broaden treatment options for patients.

"AbbVie’s vision in oncology is to advance breakthrough areas of science leading to a strong pipeline of innovative cancer therapies," said Steve Davidsen, Ph.D., vice president of oncology discovery, AbbVie. "Mavupharma’s platform has the potential to further our immuno-oncology portfolio and assist in the development of transformative medicines for patients."

Mavupharma’s lead clinical candidate is MAVU-104, a first-in-class, orally active, small molecule inhibitor of ENPP1, an enzyme involved in the regulation of the STING pathway. Inhibiting ENPP1 activity with MAVU-104 allows for highly controlled enhancement of STING signaling in tumors without the need for injections.

"AbbVie has built a leadership position in oncology and their world-class capabilities will enable the accelerated development of our pipeline of STING modulators," said Michael Gallatin, Ph.D., former president and a co-founder of Mavupharma.

"We made tremendous strides in developing our novel STING modulators and advancing MAVU-104 towards the clinic. We are confident in AbbVie’s ability to continue to advance this exciting science for patients," added former chief scientific officer and co-founder Gregory Dietsch, Ph.D.

Financial terms of the transaction were not disclosed.

On July 15, 2019 Vaccitech, a clinical-stage T cell immunotherapy company developing viral vectors as vaccines to treat and prevent Cancer and Infectious Diseases, reported that it has appointed Mariem Charafeddine as Chief Medical Officer (Press release, Vaccitech, JUL 15, 2019, View Source [SID1234537519]).

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Mariem brings over 15 years’ experience in the Biopharmaceutical Industry, spent both advancing the clinical development and commercialisation of Infectious Disease products, and in delivering post-marketing monitoring of licensed medical products. Mariem has previously worked in international medical leadership roles and drug development in Infectious Diseases.

She joins Vaccitech after 6 years at Abbvie, where she most recently served as Medical Director for Pharmacovigilance and Patient Safety Sciences, Infectious Diseases and Neurosciences. Mariem’s prior roles include Global Clinical Development at AbbVie and Hoffmann-La Roche/Genentech, as well as Medical Manager at Hoffmann-La-Roche in France. She is a qualified physician, with clinical practice and research experience focused in Infectious Diseases and Hepatology. Mariem also holds a Master’s degree in Marketing Management, gained from ESCP Europe.

Mariem will oversee the development of Vaccitech’s growing clinical-stage pipeline and will help implement the global clinical development strategy and medical plans across Vaccitech’s therapeutic and prophylactic vaccine products.

"We are delighted to have Mariem join our team as we advance towards the Phase 2b read-outs of our lead clinical program in influenza," said Tom Evans, Vaccitech CEO. "Her wide-ranging clinical development and post-marketing expertise in infectious diseases also puts us in great stead ahead of first in human studies for our HPV and HBV therapeutics. We look forward to her input on how best to develop our vaccines for the patients that need them."