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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

On June 23, 2020 Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary of Hong Kong-listed CK Life Sciences Int’l., (Holdings) Inc., reported that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L, its melanoma cancer vaccine for the adjuvant treatment of stage IIB/IIC melanoma patients post-resection to improve recurrence-free survival (Press release, Polynoma, JUN 23, 2020, View Source [SID1234561419]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The Fast Track designation by the FDA provides further validation of seviprotimut-L as a potential new and important cancer vaccine for patients with localized melanoma," said Alan Yu, Chairman of Polynoma and Vice President & Chief Operating Officer at CK Life Sciences. "We look forward to advancing seviprotimut-L in a pivotal trial as an adjuvant treatment of melanoma."

Fast Track is designed to facilitate the development and expedite the review of drugs which treat serious or life-threatening conditions and fill an unmet medical need. The FDA defines filling an unmet medical need as "providing a therapy where none exists or providing a therapy which may be potentially better than available therapy,"1 based on criteria such as:

Showing superior effectiveness, or improved effect on serious outcomes;
Avoiding serious side effects of an available therapy;
Decreasing a clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment;
Ability to address anticipated public health need.
Benefits of Fast Track designation include more frequent communication with the FDA, a rolling submission of the marketing application, and eligibility for Priority Review and Accelerated Approval, if relevant criteria are met.

The interval between progression from Stage II to Stage III/IV melanoma marks a critical therapeutic intervention point to improve survival. Treatment of Stage IIB/IIC melanoma is primarily limited to surgery, coupled with a "wait and see" approach. However, recurrence of the disease can occur following definitive resection of the melanoma. Many patients progress to more advanced stages following resection and five-year survival rates fall sharply after a patient passes from localized Stage II melanoma into regional Stage III disease (98.4% to 63.6%). Five-year survival rates are distinctly lower (22.5%) for metastatic Stage IV.2

Final analysis of clinical data from Part B1 of MAVIS (Melanoma Antigen Vaccine Immunotherapy Study), a Phase III study of seviprotimut-L was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, held online May 29-31, 2020.

Highlights of the presentation are as follows:

Improved outcomes in Stage IIB/C patients: Final analysis of subgroups confirmed the findings from the interim analysis, suggesting enhanced RFS for seviprotimut-L in patients with AJCC Stage IIB/IIC melanoma, particularly those under age 60, and those with ulceration, whose lesions are considered more serious because they have a greater risk of metastasis.3
Early evidence of survival benefit in Stage IIB/C patients: For Stage IIB/IIC melanoma patients under 60, there was a trend toward improved overall survival for those treated with seviprotimut-L.
Favorable adverse event profile: Seviprotimut-L was well-tolerated with treatment-emergent adverse events (AEs) similar to patients given placebo. There were no treatment-related serious adverse events.
About MAVIS
MAVIS (Melanoma Antigen Vaccine Immunotherapy Study) is a multicenter, double-blind, placebo-controlled adaptive Phase III trial to assess the safety and efficacy of seviprotimut-L, with primary endpoints of recurrence-free survival (RFS) and overall survival (OS) in patients with melanoma at high risk of recurrence after definitive surgical resection. MAVIS is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. For additional information about the trial, please visit View Source

About Seviprotimut-L
Seviprotimut-L is an allogeneic, polyvalent, partially purified shed melanoma antigen vaccine derived from three proprietary human melanoma cell lines. Seviprotimut-L stimulates humoral and cellular immune responses. Melanoma-associated antigens (MAAs) found in seviprotimut-L are taken up by antigen-presenting cells (e.g., dendritic cells) which then activate the production of antigen-specific cytotoxic T-lymphocytes (CTLs) as well as develop antibody responses against MAAs. These CTLs and antibodies then recognize and act on tumor cells expressing the MAAs on their surfaces, causing cell death. Seviprotimut-L is currently in development for the adjuvant treatment of patients with Stages IIB to IIIC melanoma, following definitive resection.

On June 23, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that Nicholas Green has been appointed president and chief executive officer, as well as a member of the company’s board of directors, effective July 30, 2020 (Press release, Avid Bioservices, JUN 23, 2020, View Source [SID1234561387]). He will succeed Rick Hancock who has served as interim president and CEO since May 2019. Mr. Hancock will continue to serve on Avid’s board of directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mr. Green has more than 30 years of experience in the global pharmaceutical and healthcare services industry with significant expertise in the contract manufacturing of novel pharmaceutical products. His global pharmaceutical experience spans four continents, having run 31 facilities in nine countries spanning North America, South America, Europe, and Asia. Throughout his career, Mr. Green has held a number of senior management roles for several contract manufacturing organizations and life science companies, where he is credited with successfully building and expanding those businesses and delivering significant value for customers, patients, employees, and other stakeholders.

Joseph Carleone, Ph.D., chairman of the Avid board of directors, said, "On behalf of the Avid board, I’d like to welcome Nick as our new president and CEO. His appointment is the result of a deliberate and comprehensive search for an industry executive capable of leading Avid to achieve its full potential. Nick’s lengthy and impressive career in the pharmaceutical contract development and manufacturing sector, which has included senior leadership roles at several successful companies, positions him perfectly to oversee Avid’s ongoing efforts aimed at customer base expansion and revenue growth. The board and I look forward to the positive impact that Nick will make on the company’s business over both the near and long-term."

"I am excited to join the Avid team and contribute my industry experience to helping the company continue its impressive growth trajectory," said Mr. Green. "Today, there is significant and growing demand for companies at the leading edge of contract development and manufacturing services for biologics. With its high-quality offerings in the areas of process development, analytical services, and CGMP manufacturing, combined with its more than 25 years of experience in manufacturing complex biologics, Avid is among the best positioned companies to seize this opportunity."

"I thoroughly enjoyed my role as the interim president and CEO of Avid and am proud of what the company has achieved during that time in diversifying our client base and increasing revenues," said Rick Hancock. "I believe that Avid is well positioned to execute successfully on its growth strategy moving forward and the addition of a leader such as Nick will only serve to strengthen the company’s prospects. The appointment of someone of Nick’s caliber, combined with the strength and talents of the entire Avid team, make it easy for me to step aside and transition back into the sole role of board member at this time. I would like to express deep gratitude to all Avid team members for their commitment and hard work during my tenure."

Mr. Green most recently served as president and CEO of Therapure Biopharma, a Canada-based biopharmaceutical company which includes Therapure Biomanufacturing. In this role, he oversaw the growth of the company’s CDMO business, while also leading the creation of Therapure’s proprietary plasma protein business, named Evolve. Prior to Therapure, he held a number of senior management roles, most notably managing director of Nipa Laboratories Ltd., head of the life science division of Clariant International Ltd. in the USA, president and CEO of Rhodia Pharma Solutions Ltd. and president of Codexis, Inc.’s pharma division. Mr. Green holds a bachelor’s degree in chemistry from Queen Mary College in London and an MBA from the University of Huddersfield.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 SkylineDx reported that it signed the 10th collaboration agreement with an academic partner for research under the extensive Falcon R&D Program to further validate both melanoma (skin cancer) tests (Press release, SkylineDx, JUN 23, 2020, View Source [SID1234561420]). The 10 clinical centers represent 6 countries on 3 continents with data on over 3,500 cutaneous melanoma patients. The data generated will be used in the validation of the Merlin and Peregrine assay. The Merlin assay has been developed to predict a patient’s risk of having metastasis in the sentinel lymph node. If a patient is identified as low-risk, the surgery that removes the sentinel lymph node can be safely avoided. The Merlin assay is developed on a US patient dataset[2] and validated in a European dataset[3]. The group of patients without metastasis in their sentinel lymph nodes, are currently considered low risk, although a significant number of patients will see their melanoma returning within 5 years. The Peregrine assay has been developed to identify patients at high risk of disease recurrence within this group of patients now considered low-risk, so treatment options can be discussed[4-5].

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am very pleased that we are continuing our research with global partners for retrospective validation studies. Even more clinical groups have expressed interest to collaborate and are likely to be added in the near future to this research initiative. Processing of the biobanked samples is in full swing and we expect to have all the results for analyses by the end of 2020. The peer reviewed publication will follow shortly in 2021," explains Dharminder Chahal, CEO SkylineDx.

About Merlin & Peregrine

Both assays are using the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes (predictive use) and the risk of the melanoma returning (prognostic use). The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age. The model has been previously published in JCO Precision Oncology[2]. The predictive use of the CP-GEP model is the main focus of the Merlin Study Initiative. The prognostic use of the CP-GEP model is the main focus of the Peregrine Study Initiative. Both are developed under the wings of the Falcon R&D Program. More information on www.falconprogram.com.