On September 15, 2021 Celularity Inc. (Nasdaq: CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported the appointment of Andrew L. Pecora, M.D., F.A.C.P., C.P.E., as President effective today (Press release, Celularity, SEP 15, 2021, View Source [SID1234591817]). Reporting to Robert J. Hariri, M.D., Ph.D., Chairperson and Chief Executive Officer, Dr. Pecora will provide senior leadership to advance Celularity’s clinical pipeline toward U.S. Food and Drug Administration (FDA) approval, including responsibility for preclinical and clinical development and regulatory affairs.

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"It is with great pleasure that we announce Andrew’s appointment as Celularity’s President," said Dr. Hariri. "Building on our recent Nasdaq listing, Andrew’s proven track record as an executive leader in biotechnology and healthcare innovation, delivery and reimbursement will help take Celularity to the next level as we advance our clinical pipeline of next-generation placental-derived cellular therapeutic candidates. Andrew and I trained together at the Weill Cornell Medical Center and have worked in cellular medicines on parallel paths for over 30 years," Dr. Hariri continued.

Dr. Pecora commented, "I am excited to take on this new role at Celularity. I have been very impressed by the early clinical insights and underlying translational science of these novel, placental-derived, off-the-shelf cellular medicines. The potential of Celularity’s clinical pipeline, including its CYNK-101, CyCART-19 and APPL-001 programs, is tremendous. I look forward to providing leadership and strategic vision, working with Bob and his team to realize the potential of these novel allogeneic cell therapies for patients with cancer, infectious disease and degenerative disease."

Dr. Pecora is an award-winning clinician, scientist, and healthcare executive and innovator, with a track record of success leading biotechnology companies to pioneer novel cellular medicines. He is among the world’s foremost experts in blood and bone marrow stem cell transplantation, drug development, and the advancement of novel cell therapies. Dr. Pecora previously served as President of the Physician Enterprise, Chief Innovations Officer, and the Institutional Research Official of Hackensack Meridian Health. There, he oversaw more than 7,500 physicians as well as the business and clinical operations of the John Theurer Cancer Center and clinical and basic research of the Center for Discovery and Innovation. Dr. Pecora also is a Professor of Medicine and Oncology at Georgetown University.

Dr. Pecora is Founder and serves as Chairman of Cota, Inc., a real-world evidence-based data and analytics company focused on leveraging information technology and big data analytics to bridge the gap between precision medicine and population-based health outcomes and to accelerate the development of innovative medicines for patients with difficult to treat diseases.

Prior to Cota, Dr. Pecora served as Co-Founder, Chair and CEO of Progenitor Cell Therapy (PCT), an internationally recognized cellular medicine cGMP manufacturing company. He facilitated the purchase of the Dendreon, Inc., which ultimately led to the FDA approval of PROVENGE (sipuleucel-T), the first FDA approved cell therapy used to treat certain men with advanced prostate cancer. Dr. Pecora eventually led the sale of PCT to Caladrius Biosciences, and co-led multiple public and private capital raises that exceeded USD 500 million.

Earlier in his career, Dr. Pecora was Founder and Chairman of Amorcyte, Inc., a clinical-stage cell therapy company focused on developing novel treatments for cardiovascular disease. At Amorcyte, Dr. Pecora led the capital raise, preclinical and clinical development efforts for AMR-001, a cellular therapy product candidate for vascular injury, through Phase 1 development. This work led to Amorcyte’s sale to Caladrius Biosciences, where Dr. Pecora led the regulatory and clinical development efforts for Amorcyte through Phase 2 development and facilitated a Phase 3 registration trial in Japan.

Dr. Pecora has authored more than 200 peer-reviewed publications and holds over 50 patents, many involving cellular medicines. He has led numerous clinical trials in cancer and other diseases serving as principal investigator. He also has served on national and international steering committees, and contributed to international guidelines for development of cellular medicines, FDA regulatory approval and commercialization standards, including FACT-ISCT International Standards for Hematopoietic Cellular Therapy Production, Processing and Administration. An award-winning healthcare executive, he was recognized in 2019 by Modern Healthcare as one of the top 50 influential clinical healthcare executives.

On September 15, 2021 Illumina, Inc. (NASDAQ: ILMN) reported that it has selected seven new genomics companies to join the third global funding cycle of Illumina Accelerator (Press release, NewStem, SEP 15, 2021, View Source [SID1234590974]). The global company creation engine, focused on partnering with entrepreneurs to build breakthrough genomics startups, invested in four companies for the 3rd funding cycle of Illumina Accelerator Cambridge, UK and three companies for the 13th funding cycle of Illumina Accelerator San Francisco Bay Area.

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"The global reach of Illumina Accelerator is demonstrated by our investment in these seven diverse startups from six countries," said Amanda Cashin, PhD, co-founder and Global Head of Illumina For Startups. "This diversity is testament to the strength and breadth of the talented entrepreneurs around the world focused on unlocking the power of the genome to improve human health and beyond."

During two, six-month funding cycles per year, Illumina Accelerator provides the selected startups with access to seed investment, access to Illumina sequencing systems and reagents, as well as business guidance, genomics expertise, and fully operational lab space adjacent to Illumina’s campuses in Cambridge, UK or the San Francisco Bay Area. The newest companies to join Illumina Accelerator’s portfolio of genomics startups include:

Illumina Accelerator Cambridge

BIXBIO LIMITED , a genomics startup from South Africa, is focused on unlocking the potential of diverse genetic data in Africa to transform the field of precision medicine.
EpiCombi.AI Limited , a genomics signature-driven therapeutics spinout from Oxford University, is overcoming epigenetic barriers in cancer complexity through the creation of AI-derived, network-acting multi-targeted drugs.
Genegoggle Sp. z o.o. , a biotech company from Poland, leverages multi-dimensional genomic and epigenetic elements to discover novel therapeutics and intelligent systems to improve human health.
NewStem Ltd. , a cancer therapeutics and diagnostics company from Israel, is developing genetic-based products utilizing a proprietary haploid human embryonic stem cells library of mutations.
Illumina Accelerator SF Bay Area

ImYoo Inc. , a direct-to-consumer single-cell transcriptomics company from the California Institute of Technology, aims to deliver personalized, biology-driven health insights by connecting people with similar immune profiles to share their health journeys.
Solena Ag, Inc. , an agriculture biotech company from Mexico, is commercializing innovative methods and proprietary biological solutions tailored to each farm, soil or region to improve crop profitability and soil health.
Yali Biosciences Inc. , a food tech company from San Francisco Bay Area, uses synthetic biology and genomics tools to make climate-smart, sustainable foods.
"Our newest investments demonstrate the depth and breadth of genomics applications across the globe," said Alex Aravanis, MD, PhD, Chief Technology Officer, Head of Research and Product Development at Illumina. "These seven genomics startups are focused on discovering breakthrough therapeutics, diagnostics, and direct to consumer applications to transform human health and beyond."

Illumina Accelerator is accepting applications for the next global funding cycle, which are due by October 1, 2021. Through a single, global application process, Illumina Accelerator will select up to five companies in each location. To learn more and apply, please visit our website.

About Illumina For Startups

Illumina for Startups is focused solely on creating an innovation ecosystem for the genomics industry by partnering with leading venture capital investors and entrepreneurs to create, launch, and grow genomics startups. Illumina for Startups initiatives include Illumina Accelerator, founded in 2014, and Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina, launching Fall 2021. Illumina Accelerator is a company creation engine co-located with Illumina research and development sites in San Francisco Bay Area and Cambridge, UK. Illumina Accelerator has invested in 61 genomics startups from across the globe, which have collectively raised over $1 billion in venture capital funding. For more information, visit our website.

On September 15, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported new biomarker analyses from two ongoing clinical trials of its lead immuno-oncology single strain Live Biotherapeutic, MRx0518, in both neoadjuvant and refractory solid tumor settings, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, September 16-21, 2021 (Press release, 4d Pharma, SEP 15, 2021, View Source [SID1234590217]).

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"At the core of 4D pharma’s platform is the importance of understanding the impact of Live Biotherapeutics on human biology to rationally select and develop candidates, predict and measure response. These new biomarker data provide us with critical guidance on the biological and mechanistic impact of MRx0518 therapy in patients with various solid tumors," said Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. "These new findings indicate the potential to predict patients most likely to respond to MRx0518 therapy based on tumor biology."

"Furthermore, the monotherapy data demonstrates that a short course of MRx0518 treatment is able to positively modulate prognostic indicators of immunotherapy response," he added. "We look forward to utilizing and implementing these important new findings as we work to progress this novel oncology Live Biotherapeutic through development towards approval."

Highlights of the two ESMO (Free ESMO Whitepaper) 2021 poster presentations:

Baseline biomarkers associated with clinical benefit in patients with solid tumors refractory to immune checkpoint inhibitors (ICIs) treated with live biotherapeutic MRx0518 in combination with pembrolizumab

Presentation Number: 1024P

●Tumor biomarkers were assessed in patients with evaluable baseline samples (N = 12) in the ongoing Phase I/II study of MRx0518 in combination with anti-PD-1 immune checkpoint inhibitor (ICI) Keytruda (pembrolizumab)

●At baseline, patients who achieved complete response, partial response or stable disease for at least six months (collectively ‘responders’, N=4) from the combination of MRx0518 with Keytruda (pembrolizumab) had significantly greater densities of CD3+FOXP3+CD8- regulatory T cells (Tregs) and CD3+KI67+ proliferating T cells in tumors at baseline, compared to patients with progressive disease (PD, N=8), p=0.0381 and p=0.0048, respectively.

●In addition, significantly lower densities of CD68+ macrophages at baseline were observed in the tumor microenvironment of responders compared to patients with progressive disease, p=0.0303.

These data indicate the potential for MRx0518 to overcome Treg-mediated acquired resistance to cancer treatment, and presents a biomarker potentially able to identify patients most likely to respond to immunotherapy based on MRx0518. Further tumor sample analysis is ongoing for additional patients recruited into the study.

Neoadjuvant MRx0518 treatment is associated with significant gene and metagene signature changes in solid tumours

Presentation Number: 543P

●Gene expression profiling of paired tumor samples pre- and post-MRx0518 monotherapy across multiple solid tumor types (N=15) showed that treatment with MRx0518 for two to four weeks was associated with anti-tumor immune activity including antigen presentation, innate immune processes, and interferon response.

●Analysis of paired tumor samples also identified significant increases in mast cells, Th1, CD8+ T cell, neutrophil, endothelial cell and inflammatory chemokine metagene signatures following MRx0518 monotherapy.

●Effects were particularly pronounced in the cohort of breast cancer patients (N=7), with significant increases observed in total and activated dendritic cells, CD8+ T cells and cytotoxic cells in the tumor micro-environment.

●Functional metagene analysis also identified positive changes in prognostic indicators and metagene signatures predictive of immunotherapy response in patients with breast cancer, including inflammatory chemokines, cytotoxicity, lymphoid scores, and the Tumor Inflammation Signature (TIS)1 – demonstrated to retrospectively predict clinical benefit of anti-PD-(L)1 ICI therapy efficacy in various cancer types.

The immune biomarker data from this study of MRx0518, as a monotherapy dosed over a short period of just two to four weeks, demonstrates the potent activity of this oral Live Biotherapeutic directly on the human immune system, and the positive implications for clinical outcomes. This study is being conducted in collaboration with Imperial College London.

Both ePosters will be available under the "Posters and Publications" section of the 4D pharma website at www.4dpharmaplc.com at 7:30 GMT on Thursday 16th September 2021.

1 Ayers M, et al. J Clin Invest. 2017;127:2930–40

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumours. It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumours and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients who have previously progressed on anti PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. A fourth clinical trial, in collaboration with Merck KGaA and Pfizer Inc., of BAVENCIO (avelumab) in combination with MRx0518 as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, is expected to commence in Q4 2021.

On September 15, 2021 T–Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor therapy (TCR–T) products for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I clinical study evaluating a TCR–based product candidate for the treatment of tumors expressing Kita–Kyushu
lung cancer antigen 1 (KK–LC–1), such as gastric, cervical, lung, breast cancers and other KK–LC–1 positive epithelial cancers (NCT05035407) (Press release, T-Cure Bioscience, SEP 15, 2021, View Source [SID1234590212]). T–Cure acquired the KK–LC–1 TCR therapy under an exclusive, worldwide license with the National Cancer Institute (NCI) in 2020. This Phase I Clinical Study will be conducted and sponsored by the NCI, part of the National Institutes of Health, where Dr. Scott Norberg and Dr. James Gulley will be the main PIs for this investigator–
initiated trial. The trial will be done under a Cooperative Research and Development Agreement (CRADA) that T–Cure has in place with the NCI.

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Last year, T–Cure entered into an exclusive, worldwide license with the NCI for intellectual property related to autologous TCR–T treatment of tumors expressing KK–LC–1, such as gastric, lung, triple negative breast and cervical cancers.

KK–LC–1 is a cancer germline (CG) antigen that has restricted expression in healthy tissues and frequent expression in epithelial cancers including lung cancer, gastric cancer, triple negative breast cancer, cervical cancer and others. Adoptive T–cell therapy is one potentially powerful treatment for cancer that genetically modifies natural T cells to make them tumor–specific and to improve their ability to destroy tumor cells. TCR–T cell therapy targeting CG antigens has been shown to induce objective responses without autoimmunity or off–target toxicity in patients with melanoma, synovial cell sarcoma and cervical carcinoma.

"TCR–T cell therapy is a promising new treatment modality that has demonstrated clinical activity in a subset of solid tumors." stated Scott Norberg, D.O., Assistant Research Physician, Genitourinary Malignancies Branch, of NCI and Principal Investigator of the study. "Our hope is that KK–LC–1 TCR–T cell therapy can be effective against common epithelial cancers, which account for 80–90% of all human malignancies."

"We are excited that NCI has obtained the regulatory approval from FDA to initiate a first–in–human trial against a very important target in multiple solid tumors." stated Gang Zeng, Ph.D., Chief Executive Officer of T–Cure Bioscience. "Dr. Norberg and Dr. Gulley have extensive experiences in developing novel adoptive T–cell therapies for cancer and they will be invaluable as we advance this program."

Of note, the TCR was isolated from the tumor–infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, it may hold great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue.

On September 15, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that the investigational new drug (IND) application of multi-specific antibody CS2006/NM21-1480 has been approved by the National Medical Products Administration (NMPA) of China (Press release, CStone Pharmaceauticals, SEP 15, 2021, View Source [SID1234587864]). CS2006/NM21-1480 represents a leading class of next-generation anti-PD-1/PD-L1 cancer immunotherapies and a new backbone molecule for combinations.

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CS2006/NM21-1480 is a monovalent, tri-specific antibody-based molecule targeting PD-L1, 4-1BB, and human serum albumin (HSA).CS2006/NM21-1480 is designed to bind to the immune co-stimulation receptor 4-1BB and conditionally activate T cells only when engaging the checkpoint receptor ligand PD-L1 on the surface of tumor cells, potentially preventing the liver toxicities observed with previous anti-4-1BB agonistic antibodies. As a potential best-in-class drug, CS2006/NM21-1480 could be used as monotherapy or in combination with multiple treatments. The upcoming clinical study is designed to evaluate the safety, pharmacokinetics, and anti-tumor efficacy of CS2006/NM21-1480 in Chinese patients with various advanced solid tumors.

Compared to other PD-L1/4-1BB bispecific antibody candidates, CS2006/NM21-1480’s unique monovalent structure and ultra-high-affinity PD-L1-binding is designed to fully exploit the synergistic potential of tumor-localized modulation of PD-L1 and 4-1BB, to provide broader and more sustained treatment response and at the meantime, to avoid systemic toxicities. Furthermore, half-life extension via the HSA-binding motif enables convenient dosing schedules for patients. CS2006/NM21-1480 is anticipated to be effective against tumors with a wide range of PD-L1 expression levels and may overcome primary and/or acquired resistance to anti-PD-1/PD-L1 therapies.

Dr. Archie Tse, Chief Scientific Officer of CStone, said, "We are very glad that the IND application of CS2006/NM21-1480 in China has been approved by the NMPA, with the clinical trial starting soon, it marks a significant milestone in CStone’s Pipeline 2.0 strategy which focused on assets with first-in-class or best-in-class potential. Since April 2020, the first-in-human study of CS2006/NM21-1480 has been well underway in the US. Moving forward, we will step up our efforts to drive the research and development of CS2006/NM21-1480, and other pipeline assets to provide potentially more effective treatments for Chinese and global patients."

CS2006/NM21-1480 was discovered and engineered by Numab Therapeutics ("Numab"), CStone’s partner, using its proprietary λcap technology and MATCH platform. CStone and Numab signed an exclusive regional licensing agreement for the development and commercialization of the drug candidate. Pursuant to the terms of the licensing agreement, CStone will fund the research and development of CS2006/NM21-1480 up to completion of an initial Phase Ib clinical trial. In exchange, CStone obtains exclusive rights from Numab to develop and commercialize CS2006/NM21-1480 in Greater China (including Mainland China, Hong Kong, Macau and Taiwan), South Korea and Singapore. Numab retains all CS2006/NM21-1480 rights for the rest of the world. Upon completion of CStone’s funding period, no further financial obligations will be owed by either party.