On October 6, 2020 NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, reported they have added a third cohort to their ongoing Phase 2 trial of a novel immunotherapy for locally advanced or metastatic pancreatic cancer (Press release, NantKwest, OCT 6, 2020, View Source [SID1234568167]). The third cohort enables pancreatic cancer patients who have failed all approved standards of care to participate in the trial.

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The randomized, open-label study is evaluating safety and efficacy of a combination immunotherapy comprising NantKwest’s PD-L1 t-haNK, ImmunityBio’s IL-15 superagonist Anktiva (N-803), and aldoxorubicin, plus standard of care. The results will be compared to standard-of-care chemotherapy for first- and second-line treatment; the third-line cohort is a single arm, with no comparator. Each cohort will be studied independently to provide more precise comparative data for each disease stage.

"Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of just five percent, so new and more effective therapies are desperately needed," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "By adding the third cohort to this important study, we’re able to enroll patients at all stages of the disease, even those who experience disease progression after the first- or second-line treatment."

Trial Sites and Enrollment

Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which will serve patients in the tri-state area (Iowa, Nebraska and South Dakota). Forty patients are currently enrolled in or being evaluated for the trial.

NantKwest and ImmunityBio’s combination immunotherapy is designed to harness the body’s immune system to target, kill, and "remember" cancer cells. The agents in this trial are designed to find pancreatic cancer cells and initiate a large immune response against them. This may allow the body to develop its own antibodies to fight the cancer.

"Our research in pancreatic cancer, as well as many other forms of cancer, is focused on how we can recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells," said Dr. Soon-Shiong. "Our goal is to attack the disease aggressively so that we can provide more time and a higher quality of life to patients who today have a very poor prognosis."

Study Details

This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88, NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of cohorts A and B is progression-free survival (PFS) and the objective of cohort C is overall survival (OS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS).

Pancreatic cancer is the fourth leading cause of cancer-related death in the US, with an estimated 47,050 deaths and 57,600 new cases expected in 2020.1. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses).

1.Siegel RL, Miller KD, and Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70:7-30

On October 6, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the completion of the manufacturing of the GP2 active ingredient for its planned Phase III clinical trial (Press release, Greenwich LifeSciences, OCT 6, 2020, View Source [SID1234568166]). After having met all drug specifications and release criteria in compliance with current Good Manufacturing Practice (cGMP), the GP2 active ingredient has been released for formulation and filling into vials, which is the last step before storage and distribution of GP2 to clinical sites.

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Snehal Patel, CEO of Greenwich LifeSciences commented, "We are pleased to have completed this major manufacturing milestone. Last week we completed our IPO, in which members of senior management and directors invested funds aggregating in approximately 15% of the IPO gross proceeds. Our success in scaling up GP2 to large scale cGMP manufacturing and our recent fundraising moves us closer to commencing the upcoming Phase III clinical trial."

The Company’s commercial manufacturing partner, Polypeptide Laboratories, located in San Diego, California and a specialist in the manufacture of clinical and commercial grade peptides, initiated this clinical lot in 2019, which is at a commercial scale that can produce 50,000 doses and treat up to 4,500 patients. In addition, analytical methods were validated and a stability program has been initiated per cGMP requirements.

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On October 6, 2020 Elorac Biotherapeutics, Inc., a biopharmaceutical company focused on developing innovative, best-in-class, proprietary drugs, reported it has amended its current clinical trial evaluating the safety and efficacy of topically applied naloxone hydrochloride lotion, 0.5%, for the treatment of moderate or severe pruritus in patients with the mycosis fungoides or Sézary Syndrome forms of Cutaneous T-cell Lymphoma (CTCL) (Press release, Elorac, OCT 6, 2020, View Source [SID1234568165]). The original double-blind, cross-over, multi-center Phase 3 study has been amended to provide access to naloxone lotion to all enrolled subjects for an additional six months after study completion.

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Scott B. Phillips, MD, Elorac’s Sr. V.P. Scientific Affairs, who earlier this year presented an update on this trial at the 4th World Congress of Cutaneous Lymphomas in Barcelona, hosted an industry breakout room on September 12, 2020 as part of the Cutaneous Lymphoma Foundation’s patient conference.

"The availability of naloxone lotion within the current Phase 3 study offers potential relief to people living with cutaneous T-cell lymphoma whose quality of life is significantly impaired by chronic, unrelenting itching," said Susan Thornton, CEO, Cutaneous Lymphoma Foundation.

"The availability of a topical medication to effectively treat the pruritus of mycosis fungoides and Sezary syndrome will be welcomed by our patients whose itch, in many cases, is inadequately treated by currently available medications, and not only impacts their quality of life but can increase their morbidity and mortality due to infection," adds Lucia Seminario-Vidal, MD, PhD, Associate Director, Clinical Research Unit, Dermatology and Cutaneous Surgery, University of South Florida and Co-director of the Multi-disciplinary Cutaneous Lymphoma Clinic, Moffitt Cancer Center.

Elorac received Orphan Drug Designation for naloxone hydrochloride lotion from both FDA and the European Medicines Agency. Elorac also has Fast Track designation from FDA for this novel investigational new drug. Fast Track designation provides for earlier and more frequent interaction with FDA during a drug’s development and eligibility for receiving priority review and accelerated approval from FDA. Elorac holds worldwide marketing rights to naloxone lotion.

About Naloxone

Naloxone is an opiate antagonist with no agonist activity. Intravenous, subcutaneous, and intranasal formulations of naloxone are used to treat opiate overdoses, and naloxone is used orally in combination with buprenorphine to treat opiate dependence. Naloxone lotion is an investigational new drug designed to relieve pruritus associated with CTCL and is not approved for marketing in the United States.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL affects approximately 30,000 patients in the United States, with an estimated 3,000 new cases diagnosed each year. During the course of this disease most patients will experience chronic intractable pruritus unresponsive to standard antipruritic agents (e.g., antihistamines and topical corticosteroids). In addition to a very detrimental impact on quality of life, chronic intractable pruritus has been associated with an increase in the mortality rate for individuals with CTCL. There are currently no approved therapeutic treatment options for pruritus associated with CTCL.

On October 6, 2020 A2 Biotherapeutics (www.a2bio.com), a biotechnology company developing innovative cell therapies for solid tumor cancer patients, reported the closing of its $71.5M Series B financing. Proceeds will fund the advancement of its Tmod (T-cell module) platform and the clinical development and in-house manufacturing of its three near-term product candidates (Press release, A2 Biotherapeutics, OCT 6, 2020, View Source [SID1234568164]). Tmod-engineered T cells uniquely combine a potent activating mechanism to kill tumor cells with a blocking mechanism that protects normal cells from harm by exploiting the loss of genetic material in tumors. "We are the first company to create robust engineered T cells that can integrate two signals in this way, harnessing the awesome power of immune cells to attack tumors that have lost specific genes, while sparing normal cells whose genomes are intact," said Scott Foraker, president and chief executive officer of A2.

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The Tmod design and proof-of-concept work was published last Friday in Molecular Immunology (Hamburger et al., 2020). This paper describes the Tmod dual-targeting system and demonstrates its abilities to recognize and selectively kill tumor cells that have lost expression of defined target molecules.

Tmod provides a practical solution to two major problems of cancer research: distinguishing tumor vs. normal cells and accessing new cancer targets. A2 plans to use Tmod to exploit the large, untapped source of targets that are lost in tumors by genetic deletion, thereby opening up new cancer targets that were previously unaddressable and making existing targets safer and more effective. The Tmod platform can produce many products using different activator/blocker combinations. By enabling these combinations, the Tmod platform has the potential to treat nearly all solid tumor cancers, the cause of approximately a half-million deaths/year in the U.S. alone.

A2 has an experienced team of former Amgen and Kite Pharma drug and cell therapy developers to fulfill the vast potential of these therapies. Alexander Kamb, co-founder and chief scientific officer of A2, said: "We have first-rate discovery scientists who can deliver on pioneering cancer programs and technology, as well as experienced development and manufacturing staff who enable us to innovate on both sides of the cell-therapy product—the Tmod target/receptor system and the T cells."

A2 Biotherapeutics, established in 2018, is a fully integrated discovery, development and manufacturing organization with more than 40 staff located in Agoura Hills, California. The company has raised $136M since inception. The company plans to use the Series B funds to support operations, including:

Development of three near-term product candidates, the first of which is slated to begin clinical testing in 2022
Extension of the Tmod platform to produce additional product candidates
Operation of A2’s completed, in-house cell-therapy manufacturing facility
Investors in the Series B include The Column Group, Vida Ventures, Samsara BioCapital, Nextech Invest, Casdin Capital, Euclidean Capital, UC Investments (Office of the Chief Investment Officer of the Regents) and Hartford HealthCare Endowment.

On October 6, 2020 Maze Therapeutics, a company focused on translating genetic insights into new medicines, reported that Sarah Noonberg, M.D., Ph.D., has been appointed as the company’s chief medical officer (Press release, Maze Therapeutics, OCT 6, 2020, View Source [SID1234568163]). Dr. Noonberg brings significant industry and clinical experience to Maze as the company works to advance its pipeline.

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"Sarah is an exceptional leader who has helped guide multiple companies through various stages of clinical development and commercialization, and we are thrilled to welcome her to the Maze team," said Jason Coloma, Ph.D., chief executive officer of Maze. "We have been working hard to build an exciting pipeline of potential therapeutics based on targets generated through our platform, and Sarah’s broad experience leading programs from translational research through commercialization for both rare and common diseases will be instrumental. As we take important steps toward entering the clinic and defining our development strategies, we could not be more excited to have her on board and for the future of Maze."

Dr. Noonberg is a board-certified physician-scientist with broad expertise and a proven track record in global clinical development and corporate strategy. Dr. Noonberg joins Maze from prior roles as chief medical officer of Nohla Therapeutics and Prothena Biosciences, and earlier, head of global clinical development at BioMarin Pharmaceutical, Inc., where she advanced a broad portfolio including cerliponase alfa (Brineura) for CLN2 disease, pegvaliase (Palynziq) for phenylketonuria, and gene therapy for hemophilia A. Prior to BioMarin, she was senior vice president at Medivation leading translational and early development activities as well as late-stage development of enzalutamide (XTANDI) for advanced prostate cancer. Dr. Noonberg currently serves on the board of directors of Protagonist Therapeutics and Neoleukin Therapeutics. She holds an M.D. from the University of California, San Francisco, a Ph.D. in bioengineering from the University of California, Berkley, and a B.S. in engineering science from Dartmouth College.

"Maze has assembled all of the key ingredients to produce a diverse pipeline of meaningful therapeutics that could significantly impact the treatment of patients with a broad range of diseases," said Dr. Noonberg. "I have been impressed by the company’s approach of leveraging human genetics insights and functional genomics to build an exceptional platform. I look forward to helping lead Maze’s programs through development, and ultimately, bringing them to patients in need."