On October 13, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and Cancer Research UK, the world’s leading cancer charity dedicated to saving lives through research, reported encouraging preliminary results from an ongoing Phase 1 clinical study of VAC2 in non-small cell lung cancer (NSCLC) (Press release, Lineage Cell Therapeutics, OCT 13, 2020, View Source [SID1234568397]). VAC2 demonstrated remarkably potent induction of immune responses in all patients dosed to date, with high levels of peripheral antigen-specific immunogenicity observed at multiple time points and confirmed by multimer staining. On the basis of these findings, and following completion of the ongoing VAC2 clinical study in NSCLC, Lineage will seek to evaluate VAC2 in combination with therapies considered biologically complementary to VAC2, such as chemotherapy and the immune cell protectant properties offered by anti-PD1 immunotherapy.

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Lineage recently conducted an early exercise of its option to acquire data from Cancer Research UK and assumed responsibility for further development of the VAC2 product candidate as well as future development opportunities derived from the VAC platform, while Cancer Research UK’s Centre for Drug Development concludes the ongoing clinical study.

"Based on review of all available data, the therapy was safe and well tolerated in all patients. While the safety profile was expected, the immunogenicity data are remarkable and highly provocative," stated Christian Ottensmeier, MD, PhD, FRCP, Professor of Experimental Medicine at the University of Southampton and Chief Investigator on the VAC2 clinical study. "Antigen-reactive pentamer staining data induced by VAC2 suggest that the vaccine is highly potent, inducing significantly higher levels of antigen-specific T cells, compared with that invoked by alternative vaccine approaches, such as DNA- and RNA-based vaccines. From my perspective as an immuno-oncologist these data support rapid phase II testing, focused on clinical benefit."

Brian Culley, Chief Executive Officer of Lineage, said: "Interestingly, one patient experienced a radiological response following chemotherapy subsequent to VAC2 treatment. Although anecdotal and occurring after the patient had completed the VAC2 trial, responses in this setting are rare and support further investigation. Dendritic cells are the most potent antigen-presenting cells in the body and harnessing their power to accurately deliver information about foreign material is re-emerging as an attractive therapeutic modality based on their consistent safety profile and increasing knowledge of how to deploy them in the clinical setting. As a leader in the field of cell therapy, Lineage aims to advance the current VAC2 product candidate and identify ways to expand the VAC platform through internally-owned and externally-partnered antigens."

Dr. Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said: "We are pleased to see, after several years of development, the clinical progress that VAC2 has made and the impact it could have for people with lung cancer, which is the third most common cancer in the UK. We are excited to continue our support of the next phase of development of VAC2 and assist with the expansion of those efforts into additional cancers, and other potential areas with significant unmet medical need."

About VAC2

VAC2 is an allogeneic, or non-patient specific, off-the-shelf cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry any antigen, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 clinical study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About T Cell Induction

Lopes A, Vandermeulen G, Préat V. Cancer DNA vaccines: current preclinical and clinical developments and future perspectives. J Exp Clin Cancer Res. 2019;38(1):146.; Sebastian M, Schröder A, Scheel B, et al. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunology, Immunotherapy 2019;68(5):799-812.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

On October 13, 2020 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2020 (Press release, Johnson & Johnson, OCT 13, 2020, View Source [SID1234568387]. "Our third-quarter results reflect solid performance and positive trends across Johnson & Johnson, powered by better-than-expected procedure recovery in Medical Devices, growth in Consumer Health, and continued strength in Pharmaceuticals," said Alex Gorsky, Chairman and Chief Executive Officer. "I am proud of the relentless passion and Credo-led commitment to patients and customers that our colleagues around the world continue to demonstrate as we boldly fight the COVID-19 pandemic. Our world-class R&D team is working tirelessly to advance the Phase 3 trials of our COVID-19 vaccine and to uphold the highest standards of transparency, safety and efficacy; while other dedicated teams provide ongoing support to hospitals and patients as they return to sites of care, and ensure patients and consumers have the medicines and products they need. This resilient mindset, combined with our strategic capabilities and execution excellence, increase our optimism for continued recovery in 2020 and strong momentum entering into 2021."
OVERALL FINANCIAL RESULTS:

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REGIONAL SALES RESULTS:

SEGMENT SALES RESULTS:

SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased by 3.1%*, inclusive of the net negative impact of COVID-19 primarily in international over-the-counter products. Sales growth was driven by U.S. growth in over-the-counter products including TYLENOL analgesics and digestive health products; LISTERINE mouthwash in oral care products; OGX in skin health/beauty products; and wound care products, primarily BAND-AID Brand Adhesive Bandages.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 4.7%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization, and ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer. This growth was partially offset by the negative impact of COVID-19 as well as biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 3.3%*. The decline was primarily driven by the negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, and Vision businesses. Results reflect market recovery versus the second quarter. The decline was partially offset by growth in the Interventional Solutions business led by electrophysiology products.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases available online in the Investors section of the Company’s website at news releases.

Regulatory
Approvals
THERMOCOOL SMARTTOUCH – Biosense Webster Receives FDA Approval for SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation¹ (press release) SIMPONI ARIA (golimumab) – Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older (press release) SPRAVATO (esketamine) – Janssen Announces U.S. FDA Approval of CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior (press release) DARZALEX (daratumumab) – U.S. FDA Approves New DARZALEX-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma (press release) STELARA (ustekinumab) – U.S. Food and Drug Administration Approves Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (press release) Regulatory
Submissions UPTRAVI (selexipag) – Janssen Submits New Drug Application (NDA) to U.S. FDA for Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH) (press release) DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) – Janssen Submits Application Seeking U.S. FDA Approval for the Treatment of Patients with Light Chain (AL) Amyloidosis (press release) Other Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate ¹ (press release) Johnson & Johnson Completes Acquisition of Momenta Pharmaceuticals, Inc.¹ (press release) Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate (press release) CERENOVUS Launches New Suite of Technologies to Advance Stroke Treatment (press release) Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies (press release) Janssen to Discontinue Pimodivir Influenza Development Program (press release) Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine (press release) U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology (press release)
1 Subsequent to the quarter

FULL-YEAR 2020 GUIDANCE:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the Company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
The estimated impact of the COVID-19 pandemic is included in the guidance below.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the Company’s website at events-and-presentations.

On October 13, 2020 NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, presented virtually with NantOmics and ImmunityBio on September 29-30 2020, a session entitled "Deep-learning image-based tumor, stroma and lymphocytes spatial relationships and clinical features that affect survival in pancreatic cancer patients," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual special conference on pancreatic cancer (Press release, NantHealth, OCT 13, 2020, View Source [SID1234568386]). This Nant technology is an example of how digital pathology solutions may support the treatment of cancer.

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Prepared in collaboration with NantOmics, ImmunityBio, and the University of Colorado School of Medicine, the presentation examined differential survival in pancreatic cancer patients via stromal and lymphocyte density. In this study, the contributing researchers developed an automated deep-learning system to provide risk assessment upon spatial relationships between tumor, stroma, and lymphocyte regions in pancreatic pathology images from 82 pancreatic adenocarcinoma patients who underwent chemotherapy. Using Gaussian mixture models, researchers identified optimal thresholds in the image-based features and organized patients into unsupervised clusters, then linked those to differences in survival. Risk models were generated on standard clinicopathological features and used to compare against the proposed image-based risk models.

The study’s key findings include:

Cox PH models trained on image features more significantly stratified risk on unseen test patients than an optimal set of clinicopathological features
Image-based models suggest low-risk patients have:
Higher tumor-infiltrating lymphocytes despite having fewer overall lymphocytes
Higher tumor-adjacent stroma
The combination of both risk-models proved to be superior in training and testing sets and achieved better separation in survival curves than either model by itself
Image-based risk-associated features are independently prognostic of clinicopathological features
Even with a limited sample-size, the results showed significance to warrant a larger study
"Our combined analysis with NantOmics, ImmunityBio and the University of Colorado School of Medicine, provided results with a level of significance that show great promise for future studies using deep-learning models as a prognostic tool for pancreatic cancer patients," said Christopher Szeto, Director of Machine Learning, NantHealth. "These results provide a strong clinical platform not only to better understand pancreatic cancer for evidence-based prognosis but also reinforce the essential nature of advanced technology in the continued evolution of medicine."

The AACR (Free AACR Whitepaper) Virtual Special Conference: Pancreatic Cancer is a conference focused on bringing together experts across industries to better understand and further advance pancreatic cancer research and treatment. The conference attracts a range of attendees, including those in government, clinical roles, patient advocacy, and companies who make groundbreaking technology and discoveries in oncology.

On October 13, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting significant unmet needs in the treatment of tumors and viruses, reported additional preliminary data from the Phase 1 clinical trial of its immuno-stimulating STAT3 inhibitor, WP1066, in patients with glioblastoma (GBM) (Press release, Moleculin, OCT 13, 2020, View Source [SID1234568385]). This supports the progression of the trial to the fourth and final dose escalation cohort. Three patients have completed treatment in the third cohort at a dose level of 8 mg/kg with no adverse events related to WP1066 and the study will now proceed to the next higher dose of 16 mg/kg.

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Walter Klemp, Chairman and CEO of Moleculin, stated, "On the heels of our recent positive announcement regarding the progress of the pediatric brain tumor trial of WP1066, we are pleased to also report on the progress of the adult GBM clinical trial for the same drug candidate. The trial in adults has been important in leading the way to establishing a safe and tolerable human dose level for what we believe is a first-in-class compound that crosses the blood-brain barrier and is being developed for the treatment of central nervous system malignancies. In animal models, WP1066 has been shown to stimulate immune responses that successfully modulate oncogenic transcriptional activity in tumor cells and repress their ability to drive tumor growth.

Mr. Klemp continued: "In addition to providing valuable pharmacokinetic data, this trial also creates the foundation for future studies in WP1066, including another investigator-initiated study, which is currently being proposed to examine the combination of WP1066 with radiation for the treatment of GBM. This next clinical trial is being proposed as a result of recent discoveries presented in a peer-reviewed article published in Clinical Cancer Research (Clin Cancer Res June 30 2020 DOI:10.1158/1078-0432.CCR-19-4092), which reported findings that Moleculin’s STAT3 inhibitor, WP1066, used in combination with traditional whole brain radiation therapy, resulted in long-term survivors and enhanced median survival time relative to monotherapy in mice with implanted human brain tumors."

Mr. Klemp concluded, "In keeping with our established clinical trial reporting policies, we look forward to updating investors on the continued progress of this trial once this final cohort is completed."

On October 13, 2020 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported the advancement to large-scale production of BMC128, its Live Bacterial Product (LBP) candidate consortium (Press release, Evogene, OCT 13, 2020, View Source [SID1234568384]). The microbes, which will be produced in large-scale are expected to support Biomica’s first-in-man proof-of-concept clinical trials for its immuno-oncology program, anticipated to begin in 2021. BMC128 is advancing to the GMP production stage following the successful completion of the initial R&D stage of drug product development and manufacturing, conducted by Biose Industrie (Aurillac, France).

Biomica’s immuno-oncology program is focused on its leading 4-strain candidate consortium BMC128. Biomica recently announced positive results in the program, demonstrating the efficacy of BMC128 in potentiating the response to immune-checkpoint inhibitors (ICI) in preclinical studies. In these studies, BMC128 was administered to mice bearing cancer tumors prior to and during ICI therapy, and the results showed that treatment with BMC128 significantly improved anti-tumor activity.

Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. As previously announced earlier this year, Biomica engaged Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

Elran Haber, CEO of Biomica stated: "We are pleased with the continual advancements achieved with the production of our leading drug candidate, BMC128. The success seen in the R&D phase indicates that the production of these microbes is not only feasible but can be done efficiently in large scale. We will now be able to produce these microbes, which have demonstrated efficacy in pre-clinical trials, in large quantities in preparation for our proof-of-concept clinical trials in 2021."

Ofer Haviv, Chairman of Biomica and President & CEO of Evogene stated: "This is an additional important developmental milestone for Biomica. I am very proud of the progress that Biomica has achieved in 2020, and particularly that of its advancing immune-oncology program. We see significant opportunity in this program which has the potential to bring new solutions for patients currently uncurable under available therapies."

About BMC128

Developed as a Live Bacterial Product (LBPs), BMC128 is a rationally-designed LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

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