On June 23, 2020 BioInvent International AB ("BioInvent") (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported the enrollment of the first patient in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA(pembrolizumab) for patients with solid tumors (Press release, BioInvent, JUN 23, 2020, View Source [SID1234561407]).

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The objective of this trial is to explore the safety and tolerability profile of the combination of BI-1206 with KEYTRUDA, to characterize the pharmacokinetic/pharmacodynamic (PK/PD) profile and to determine the recommended dose of BI-1206 when combined with KEYTRUDA. It will be conducted in several sites across the US and Europe and will assess potential signs of antitumoral activity, as well as exploring the expression of potential immunological markers that might be associated, and eventually predict clinical responses.

The Phase I/IIa trial is divided into part A, a dose escalation of BI-1206 in combination with the standard dose of KEYTRUDA, and part B, which will explore the activity of the combination treatment in patients with advanced lung cancer, melanoma and other types of malignancies. Patients will be refractory to or have progressed on previous treatments with anti-PD1/PDL1 targeting agents.

BI-1206 is a first-in-class monoclonal antibody that exquisitely targets FcgRIIb, the only inhibitory Fcg receptor, "the brakes" of the innate immune system. It is currently also being investigated in patients with non-Hodgkin lymphoma (NHL).

Martin Welschof, CEO of BioInvent, said, "We are very excited to be starting this trial in collaboration with MSD. Based on a strong scientific rationale the trial will explore a potentially important mechanism of resistance to anti-PD1/PDL1 targeting agents. We believe BI-1206’s potential ability to increase and enhance the response rates to anti-PD1 targeting agents such as KEYTRUDA may be a powerful approach for the future treatment of a broad range of solid and liquid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (NYSE: MRK), with whom BioInvent has a clinical trial collaboration and supply agreement for this study.

On June 23, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported its participation in the Noble Capital Markets c-suite webinar series (Press release, Onconova, JUN 23, 2020, View Source [SID1234561405]).

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The webinar was led by Noble Capital Markets Biotechnology Analyst Ahu Demir, Ph.D., with participation by Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, and Richard C. Woodman, M.D., Chief Medical Officer. The session included a comprehensive discussion of recent Company developments, upcoming milestones, and addressable markets.

The webinar, recorded June 16, is now available on-demand at channelchek and will be accessible for one year.

On June 23, 2020 Medtronic, a global leader in medical technology, reported that it has committed $1 million over five years to fund an endowed professorship at the Case Western Reserve University School of Medicine (Press release, Case Western Reserve University, JUN 23, 2020, View Source [SID1234561404]).

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The new "Medtronic Professor of Biomedical Discovery and Innovation" will be used to recruit new faculty or retain faculty who have achieved significant success by at least their mid-career.

Medtronic’s pledge was matched by an anonymous commitment by a third party to meet the university’s $2 million requirement to establish a named professorship.

The Medtronic gift reflects the ongoing impact of a $20 million challenge grant announced in fall 2018 from two anonymous donors to establish 20 endowed professorships in engineering and medicine.

"We are delighted to receive this level of support from one of our corporate friends, Medtronic," said Pam Davis, dean and senior vice president for medical affairs at the School of Medicine. "We have long had a positive relationship, with our students and trainees taking internships and permanent positions at the corporation, and our faculty collaborating with Medtronic on research projects. This gift is a wonderful flowering of an excellent partnership."

The inaugural Medtronic Professor will lead the development of the World Medicine Pathway, a newly created program focusing on preparing medical students for excellence in global health care. The program will focus on research, clinical, cultural and collaborative study with diverse populations and health systems.

"Through this endowed professorship, we are thrilled to support innovation in biomedical discovery and the World Medicine Pathway program being developed at Case Western Reserve," said Richard Kuntz, Medtronic’s senior vice president, chief medical and scientific officer and a 1983 CWRU School of Medicine alumnus. "The program will provide a strong foundation for global public health research as well as mentorship for medical students and post-graduate physicians seeking advanced training and careers that address global-health challenges."

Named professorships are recommended to the university board of trustees by the university president, in consultation with a selection committee of School of Medicine leaders and faculty.

Subject to board approval, the School of Medicine has recommended Chris Longenecker, associate professor of medicine at the School of Medicine and director of the Research & Innovation Center at the University Hospitals Harrington Heart & Vascular Institute, as the inaugural holder of the Medtronic Professorship.

Longenecker is a clinical researcher whose work, conducted in Cleveland and Uganda, focuses on mechanisms and prevention of cardiovascular disease in adults living with HIV. He has an additional interest in endemic cardiovascular diseases in sub-Saharan Africa, especially rheumatic heart disease. His clinical area of expertise is non-invasive cardiovascular imaging and cardiovascular disease prevention.

Medtronic plc, based in Dublin, Ireland, with operational headquarters in Minneapolis, is a global leader in medical technology, services and solutions, operating in more than 150 countries.

On June 23, 2020 Poseida Therapeutics reported that it filed a new preliminary prospectus for a $115 million initial public offering (IPO) (Press release, BioSpace, JUN 23, 2020, View Source [SID1234561403]). The company is focused on developing cell and gene therapies based on a proprietary DNA modification, gene editing and delivery technology.

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Initially, Poseida had been aiming for an IPO in January of last year. However, the company changed its plans after it raised $142 million in a Series C funding round. It received a $75 million equity investment from Novartis Pharma AG, and also had support from new investors including Aisling Capital Management, Pentwater Capital Management and Perceptive Advisors.

"We welcome the support and investment from Novartis, a leader in the cell and gene therapy field," said Eric Ostertag M.D., Ph.D., chief executive officer of Poseida, following the closure of the Series C financing round. "They are joined by an impressive group of new investors whose commitment enables us to accelerate the pursuit of our bold vision to create gene therapy product candidates that could result in single-treatment cures for numerous oncologic indications and orphan genetic diseases, with an initial focus on chimeric antigen receptor T cell (CAR-T) therapies."

Poseida has several CAR-T product candidates, which are manufactured utilizing its non-viral DNA modification system, which results in a high percentage of stem cell memory cells (Tscm). Tscm cells are the only T cell that is self-renewing and long-lived, which can translate into more efficacious, less toxic and durable product candidates.

Some of Poseida’s product candidates include P-BCMA-101, an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma; P-PSMA-101, an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer; and P-MUC1C-101, an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications.

Poseida announced in May 2019 that P-BCMA-101 had received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed and/or refractory multiple myeloma.

"FDA orphan designation is an important regulatory milestone in the continued development and commercialization of P-BCMA-101," said Ostertag, at the time of the announcement. "P-BCMA-101 has demonstrated outstanding potency, with strikingly low rates of toxicity in our phase 1 clinical trial. In fact, the FDA has approved fully outpatient dosing in our Phase 2 trial starting in the second quarter of 2019."

In May of this year, Poseida also announced that it had made progress with P-PSMA-101 by dosing its first patient with the candidate in a Phase 1 clinical trial, evaluating the autologous CAR-T therapeutic product for the treatment of metastatic castration-resistant prostate cancer. The goal of the Phase 1 study is to determine which dose is best for patients with the fewest side effects. P-PSMA-101 is designed to target prostate-specific membrane antigen, which is expressed on metastatic castration-resistant prostate cancer cells.

"Extending our gene engineering technology to solid tumors represents the next opportunity in oncology where we believe our proprietary platforms and approach have advantages over others in the space," said Ostertag. "Our platform technologies, which include the piggyBac DNA Modification System and Cas-CLOVER site-specific gene editing system, are driving our diverse pipeline of next-generation CAR-T treatments for hematologic and solid tumors, as well as gene therapies addressing rare diseases."

Poseida remains dedicated to engineering a wide array of next-generation cell and gene therapeutics using its various platform technologies.

On June 23, 2020 Gilead Sciences, Inc. (Nasdaq: GILD) reported that for $275 million the company will acquire a 49.9 percent equity interest in Pionyr Immunotherapeutics Inc., a privately held company developing first-in-class cancer immunotherapies, and an exclusive option to purchase the remainder of Pionyr (Press release, Gilead Sciences, JUN 23, 2020, View Source [SID1234561402]). Under the agreement, Pionyr’s shareholders may receive up to an additional $1.47 billion in option exercise fees and future milestone payments.

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Pionyr’s Myeloid Tuning therapies have the potential to treat patients who currently do not benefit from checkpoint inhibitor therapies. PY314 and PY159 have demonstrated preclinical efficacy, suggesting potential in solid tumors in combination with established anti-PD(L)-1 agents. Pionyr plans to file investigational new drug (IND) applications with the U.S. Food and Drug Administration for both PY314 and PY159 in the third quarter of this year. Pending Phase 1b results from either candidate – or sooner if Gilead chooses – Gilead can exercise its exclusive option to acquire the remainder of Pionyr.

"Pionyr is pursuing promising, novel biology in the field of immuno-oncology," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "The agreement represents important progress as we continue to build out Gilead’s presence in immuno-oncology with innovative and complementary approaches. We look forward to seeing the programs advance with the goal of developing new therapies that will improve the treatment of cancer."

"This agreement underscores the value of our myeloid tuning platform and the potential of our pipeline of antibody therapeutics designed to turbocharge the immune system within the tumor microenvironment," said Steven P. James, President and Chief Executive Officer, Pionyr. "PY314 and PY159 are first-in-class antibodies designed to remove or reprogram, respectively, the immune suppressive cells in the tumor microenvironment and thereby enhance anti-tumor immunity. We are grateful that Gilead has acknowledged the promise of this transformational approach to potentially benefit patients across a range of solid tumors."

Terms of the Agreement

Under the terms of the agreement, Pionyr’s shareholders will receive $275 million upon closing. Gilead will receive 49.9 percent of the common stock of Pionyr and an exclusive option to purchase the remaining equity. Gilead may exercise its exclusive option upon completion of Phase 1b studies for PY314 and PY159, or at an earlier time if Gilead chooses to do so, for a $315 million option exercise fee and up to $1.15 billion in potential future milestone payments. In addition, Gilead will provide Pionyr with additional funding for the PY314 and PY159 clinical programs, as well as ongoing research and development programs.

The transaction is subject to customary closing conditions and is expected to close shortly.

Gilead will have the right to nominate one individual to Pionyr’s Board of Directors upon closing of the transaction. In addition, Gilead and the other stockholders of Pionyr will jointly select and nominate one independent individual to Pionyr’s Board of Directors.

BofA Securities is acting as financial advisor to Gilead. Centerview Partners LLC is acting as financial advisor to Pionyr.

About Myeloid Tuning

Pionyr has developed a research approach called Myeloid Tuning, which is designed to rebalance the tumor microenvironment (TME) to promote anti-tumor immunity. Myeloid cells are a family of cell types that play an important role in both the activation and in the suppression of immune response to cancer. PY314 targets TREM2, a protein commonly found on the surface of a certain type of immunosuppressive, pro-tumor myeloid cells. PY314 is designed to selectively deplete these cells, resulting in a rebalancing of the tumor microenvironment that favors anti-tumor immunity. PY159 targets TREM1, a protein that is expressed on multiple immunosuppressive myeloid cells such as macrophages, neutrophils and myeloid derived suppressor cells. PY159 is designed to reprogram these immunosuppressive cells to instead stimulate a pro-inflammatory, anti-tumor immune response