On November 9, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that key highlights from its Investor Event held on November 9 (Press release, Geron, NOV 9, 2021, View Source [SID1234595038]). An archive of the presentation webcast is available through the Investor Relations section of Geron’s website under Events. The Company also reported its financial results for the third quarter and year to date 2021 periods. As of September 30, 2021, the Company had $215.8 million in cash and marketable securities. These financial resources, combined with expected future non-dilutive funding under a current debt facility, are expected to be sufficient to fund current operations, including the new programs presented at the Investor Event, through the end of the first quarter of 2023.

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"By targeting telomerase, imetelstat inhibits the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis and potential disease-modifying activity," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "The compelling efficacy, molecular and cytogenetic data from our Phase 2 trials in lower risk MDS and myelofibrosis patients indicate the potential modification of those underlying diseases, which gives us further confidence in the transformational potential of imetelstat and that the Phase 2 results will be confirmed in our ongoing Phase 3 trials. Our vision aims to bring this same disease modification potential to patients across multiple hematologic malignancies."

Investor Event Highlights

At the Investor Event, key opinion leaders (KOLs) in the treatment of hematologic malignancies presented their views on the current unmet medical needs in these diseases. In addition, the KOLs described the meaningful clinical benefits observed in patients from Geron’s Phase 2 trials in lower risk myelodysplastic syndromes (LR MDS) and myelofibrosis (MF), as well as their involvement in the new programs exploring the use of imetelstat in other indications and in combination with current standard of care treatments. Following is a summary of their perspectives.

Continuing Unmet Needs in LR MDS and MF Potentially Addressed with Imetelstat Treatment

In LR MDS, treatment options for ringed sideroblast negative patients, as well as potential durable transfusion independence, remain areas of unmet need.
In MF, patients have limited treatment options post-JAK inhibitors resulting in shortened survival.
Data from Geron’s Phase 2 trials provide strong evidence that imetelstat can potentially meet the needs in LR MDS and MF patients, which differentiate it from treatments currently available and in development today.
Disease Modification Potential Uniquely Positions Imetelstat in the Treatment of LR MDS and MF

As a first in class telomerase inhibitor, imetelstat inhibits telomerase activity, resulting in apoptosis of malignant cells, limiting the uncontrolled proliferation and survival of malignant clones that drive disease progression.
Clinical benefits observed from Geron’s Phase 2 trials would not have been expected in the absence of imetelstat-associated disease modification.
Correlation of cytogenetic data and mutational changes to clinical benefits further strengthens the evidence of disease-modifying activity of imetelstat.
Imetelstat’s disease modification potential could transform current treatment approaches in LR MDS and MF patients.
Programs to Explore New Indications and Combinations for Imetelstat Expand Telomerase Inhibition Potential

The Company unveiled three new clinical programs and one preclinical program for imetelstat. The clinical programs explore the use of imetelstat as a single agent and in combination with current standard of care treatments to expand the potential application of imetelstat.
The first new clinical program will evaluate imetelstat in combination with ruxolitinib in frontline MF patients. Named IMproveMF, the Geron-sponsored Phase 1 trial will begin as a dose-finding study in approximately 20 patients with a primary endpoint of safety. Upon finding a recommended dose of the combination therapy, the next portion of the trial will confirm the safety of the recommended dose and evaluate the efficacy of the combination therapy. Approximately 20 patients will be enrolled into the second part of the trial and the endpoints include safety, symptom response, spleen response and change in fibrosis. The Company expects the first clinical site for IMproveMF to be open in the first half of 2022.
The second new clinical program will evaluate imetelstat as a single agent in higher risk MDS and acute myeloid leukemia (AML) patients after failing hypomethylating agent (HMA) treatment. Named IMpress, this investigator-sponsored trial has been designed to enroll approximately 45 patients with overall response rate as the primary endpoint. The Company expects IMpress to begin in the first half of 2022.
The third new clinical program will evaluate imetelstat in combination with venetoclax or azacitidine in relapsed/refractory AML patients. Named TELOMERE, this investigator-sponsored trial has been designed to be conducted in two parts. The first part will be a dose finding study in approximately 20 patients with a primary endpoint of safety. Upon finding a recommended dose of the combination therapy, the next portion of the trial will confirm the safety of the recommended dose and evaluate the efficacy of the combination therapy. Approximately 50 patients will be enrolled into the second part of the trial and the primary endpoint is overall response rate. The Company expects TELOMERE to begin in the first half of 2022.
The preclinical program is being conducted at MD Anderson Cancer Center to define the role of imetelstat in lymphoid malignancies. In vitro and in vivo experiments are planned, and the Company expects preliminary results to be available by the end of 2022.
The Company also reviewed the commercial potential for imetelstat in lower risk MDS and refractory MF patients. Based on internal analyses of these two indications, the Company estimates potential peak revenue of more than $3 billion for imetelstat from the United States and the five largest countries in the European Union.

Third Quarter and Year-to-Date 2021 Results

For the third quarter of 2021, the Company reported a net loss of $26.7 million, or $0.08 per share, compared to $19.7 million, or $0.06 per share, for the comparable 2020 period. Net loss for the first nine months of 2021 was $84.1 million, or $0.26 per share, compared to $51.8 million, or $0.20 per share, for the comparable 2020 period.

Revenues for the three and nine months ended September 30, 2021 were $109,000 and $353,000, respectively, compared to $108,000 and $203,000 for the comparable 2020 periods. Revenues in 2021 and 2020 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron is entitled to receive royalties on sales from certain research or commercial products utilizing Geron’s divested intellectual property.

Total operating expenses for the three and nine months ended September 30, 2021 were $25.8 million and $83.4 million, respectively, compared to $20.1 million and $53.9 million for the comparable 2020 periods.

Research and development expenses for the three and nine months ended September 30, 2021 were $18.5 million and $61.6 million, respectively, compared to $13.6 million and $35.3 million for the comparable 2020 periods. The increase in research and development expenses for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily reflects increased clinical development costs associated with conducting two Phase 3 clinical trials, higher imetelstat manufacturing costs for producing validation batches at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes and higher personnel-related costs for additional headcount. Under current planning assumptions, the Company expects top-line results from the IMerge Phase 3 trial in lower risk MDS to be available the beginning of January 2023, and for the IMpactMF Phase 3 trial in refractory MF, expects the interim analysis in 2024 and the final analysis in 2025.

General and administrative expenses for the three and nine months ended September 30, 2021 were $7.3 million and $21.8 million, respectively, compared to $6.5 million and $18.6 million for the comparable 2020 periods. The increase in general and administrative expenses for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily reflects new costs in connection with pre-commercial activities, including modernizing the internal infrastructure to support a commercial launch, and higher legal costs.

Interest income for the three and nine months ended September 30, 2021 was $112,000 and $421,000, respectively, compared to $322,000 and $1.6 million for the comparable 2020 periods. The decrease in interest income for the three and nine months ended September 30, 2021, compared to the same periods in 2020, primarily reflects lower yields on the Company’s marketable securities portfolio.

Interest expense for the three and nine months ended September 30, 2021 was $1.1 million and $2.6 million, respectively and reflects the Company’s debt facility secured in September 2020 for up to $75 million. As of September 30, 2021, a total of $35.0 million has been drawn down under the facility.

Financial Resources

As of September 30, 2021, the Company had $215.8 million in cash and marketable securities. These financial resources, combined with expected future non-dilutive funding under the current debt facility, are expected to fund current operations, including the new programs presented at the Investor Event, through the end of the first quarter of 2023.

As of September 30, 2021, the Company had 70 employees. The Company plans to grow to a total of approximately 80 to 85 employees by year-end 2021, of which the majority will be development and manufacturing personnel.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete response, partial response, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

On November 9, 2021 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative medicines, reported that the company’s in-house-developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy (CT120) has completed enrollment of the first patient in the phase I/II registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r B-NHL) (Press release, IASO Biotherapeutics, NOV 9, 2021, View Source [SID1234595332]). CT120 is the first fully human dual-targeted CAR-T cell therapy approved to enter the clinical stage. The clinical trial of CT120 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) will also start soon.

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The study is a phase I/II, multi-center clinical trial (registration number: CTR20212328). The phase I trial aims to evaluate the safety and tolerability of CT120 in patients with r/r B-NHL and to determine the maximum tolerated dose (MTD) of CT120 treatment and/or the recommended phase 2 dose (RP2D). The phase II trial aims to evaluate the efficacy of CT120 in the treatment of patients with B-NHL.

"This clinical trial greatly reduces the economic burden on patients, and makes it possible for them to benefit early from this innovative drug," said Professor Jianfeng Zhou at Tongji Hospital of Tongji Medical School of Huazhong University of Science and Technology, the principal investigator of the trial. "CT120 is the first dual-targeted CAR-T cell therapy to enter the clinical stage. Compared with available single-targeted CAR-T cell therapy, CT120 is expected to further reduce the risk of tumor recurrence clinically and prolong patient survival. In the exploratory clinical trial, CT120 has shown well-tolerated safety and good efficacy. Our hospital will take an ethics- and science-based approach to work with all partners to advance the trial so as to benefit more patients."

Dr. Wen (Maxwell) Wang, CEO of IASO Bio said, "On October 13th we received approval from the Human Genetic Resources Administration of China, on the 14th we signed a research agreement with Tongji Hospital, and on the 15th we held the project kick-off meeting. After screening, the first patient was enrolled at the end of October. We’d like to sincerely thank Professor Zhou for working closely with our team throughout the process."

"CT120 is the first fully human dual-targeted CAR-T candidate, and a highly innovative product independently developed by IASO Bio. The IIT study showed that CT120 can benefit not only CAR-T-naïve patients with relapsed/refractory B-NHL or B-ALL, but also patients whose disease progressed during or after treatment with the murine single-targeted CD19 CAR-T cell therapy. The company still has a pipeline of competitive products that are expected to achieve IND milestones. We look forward to leveraging our world-leading platform IMARS to develop more innovative fully human products and deliver on our mission of ‘making innovative treatment the backbone therapy to cure patients’," Dr. Wang noted.

About CT120

CT120 is an autologous dual-target CAR-T therapy. Its extracellular domain contains two fully human single-chain fragment variable (scFv) sequences that can specifically bind to CD19 and CD22, identifying tumor cells with CD19 and CD22 expressions, thereby reducing the tumor escape caused by the loss of target antigen. Adopting a fully human design, CT120 has low immunogenicity, reduces the ADA effect, and improves CAR-T cells’ viability.

Compared to the intracellular costimulatory signal CD28, CT120’s intracellular costimulatory signal 4-1BB and CD3ζ have lower neurotoxicity and improved viability of CAR-T cells, thus more durable efficacy. Upon binding with CD19/CD22 antigens on the tumor cells, CT120 eliminates targeted tumor cells through the release of granzyme and perforin while simultaneously releases cytokine to promote the proliferation of CAR-T cells, thus achieves its durable antitumor activity.

About Non-Hodgkin Lymphoma (NHL)

Lymphoma arises from immune cells. It may cause various organ damage and is commonly associated with a complicated pathological process. Lymphoma has two subtypes: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). NHL accounts for around 90% of all lymphoma cases, and 85% of NHL cases are B-NHL, which has numerous subtypes, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and small lymphocytic lymphoma (CLL). According to a Frost & Sullivan report, there were approximately 92,800 new incidences of NHL in China in 2020 with a total patient population of 514,200 and is expected to reach 632,300 in 2025. NHL has a high mortality rate, with a five-year survival rate of just 37% in China. The National Cancer Institute reports that the rate of new cases of non-Hodgkin lymphoma was 19.6 per 100,000 men and women per year. The death rate was 5.4 per 100,000 men and women per year. Non-Hodgkin lymphoma represents 4.3% of all new cancer cases in the U.S.

On November 9, 2021 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the posters being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting now are available at the Company’s website (Press release, Targovax, NOV 9, 2021, View Source [SID1234594805]).

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Both posters are scheduled for presentation 13 November 2021 at the SITC (Free SITC Whitepaper) congress.

Poster title: A randomised open-label phase I/II study adding ONCOS-102 to pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma – 24-month survival data
E-poster number: 462
Presenter: Dr Luis Paz-Ares, Medical Oncology, Hospital Universitario 12 Octubre, Madrid, Spain
Poster title: Consistent pattern of immune activation induced by oncolytic adenovirus ONCOS-102 across diverse types of solid tumors
E-poster number: 368
Presenter: Dr Lone Ottesen, Chief Development Officer, Targovax

On November 9, 2021 The Bayer Group reported that registered a significant increase in sales and earnings in the third quarter of 2021 (Press release, Bayer, NOV 9, 2021, View Source [SID1234594840]). "We delivered strong operational performance, with all divisions showing strong growth momentum," said Werner Baumann, Chairman of the Board of Management, on Tuesday when presenting the company’s third-quarter results. Bayer posted substantial growth in the agricultural business, while the Pharmaceuticals Division benefited in particular from large gains for the Eylea ophthalmology drug. Business at the Consumer Health Division was up in all regions and product categories. Bayer has also updated the upgraded outlook for 2021 that it had issued in August.

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Group sales in the third quarter of 2021 rose by 14.3 percent on a currency- and portfolio-adjusted basis (Fx & portfolio adj.) to 9.781 billion euros. There was a positive currency effect of 67 million euros. EBITDA before special items increased by 16.4 percent to 2.089 billion euros, and included a negative currency effect of 44 million euros. EBIT came in at 530 million euros (Q3 2020: minus 9.399 billion euros) after net special charges of 694 million euros (Q3 2020: 10.181 billion euros) that primarily related to restructuring measures at all three divisions. Net income amounted to 85 million euros (Q3 2020: minus 2.744 billion euros), while core earnings per share advanced by 29.6 percent to 1.05 euros, mainly due to the development of business within the Crop Science Division.

Free cash flow increased by 58.0 percent to 1.954 billion euros. Net financial debt as of September 30, 2021, decreased to 33.981 billion euros, down 1.1 percent from June 30, 2021.

Crop Science reports strong sales gains and significant earnings growth

In the agricultural business (Crop Science), sales rose by 25.8 percent (Fx & portfolio adj.) to 3.850 billion euros thanks to a substantial increase in volumes and prices. Growth was particularly strong at Corn Seed & Traits (Fx & portfolio adj. 92.6 percent), driven by gains in North America due to lower product returns and the later receipt of license revenues. As expected, these license revenues were recorded in the third quarter this year as opposed to the second quarter as in 2020. Sales also advanced in Latin America due to the launch of the new VTPro4 trait for improved pest control as well as higher volumes and prices. Soybean Seed & Traits also registered strong growth (Fx & portfolio adj. 58.0 percent), driven by gains in North America – due to lower product returns and higher license revenues – and in Latin America as a result of higher prices and volumes. Herbicides also posted a substantial increase in sales (Fx & portfolio adj. 15.2 percent), with the business recording encouraging gains in North America and Europe/Middle East/Africa, mainly due to an increase in prices for glyphosate-based products and higher volumes.

EBITDA before special items at Crop Science rose to 471 million euros (Q3 2020: minus 34 million euros), resulting in a margin of 12.2 percent. The improvement in earnings was mainly attributable to higher prices and volumes, an increase in license revenues, and contributions from ongoing efficiency programs. By contrast, earnings were diminished in particular by an increase in the cost of goods sold.

Pharmaceuticals reports higher sales – new products provide boost

Sales of prescription medicines (Pharmaceuticals) rose by 7.1 percent (Fx & portfolio adj.) to 4.539 billion euros. The division’s ophthalmology business was able to grow market share and continued to recover following the COVID-19 restrictions, especially in Europe. As a result, sales of Eylea advanced by 19.0 percent (Fx & portfolio adj.). Sales of the oral anticoagulant Xarelto increased by 4.3 percent (Fx & portfolio adj.), with substantial volume growth in Russia and Germany in particular offsetting a price-related decline in China. Sales of Adalat, one of the company’s products for the treatment of heart disease, rose by 24.2 percent (Fx & portfolio adj.) thanks to higher volumes in China. An increase in volumes in the United States resulted in sales gains for the pulmonary hypertension product Adempas (Fx & portfolio adj. 21.0 percent). Sales of Nubeqa rose significantly, driven by the cancer drug’s successful launch in the United States, which is currently ongoing. In addition, Bayer initiated the market launch of Kerendia, its product for the treatment of patients with chronic kidney disease and type 2 diabetes, in the United States. By contrast, sales of the cancer drug Nexavar declined against the prior-year period (Fx & portfolio adj. 27.8 percent), particularly in China, where business was negatively impacted by strong competition and modified tender procedures for various classes of active ingredients.

EBITDA before special items at Pharmaceuticals decreased by 9.8 percent to 1.366 billion euros, resulting in a margin of 30.1 percent. Earnings were diminished by an increase in marketing costs, which was largely attributable to the launch of Kerendia and Nubeqa, and by a rise in research and development expenses, which was partly related to the division’s cell and gene therapy unit.

Consumer Health continues to grow and increases earnings

Sales of self-care products (Consumer Health) came in at 1.346 billion euros, up 10.9 percent (Fx & portfolio adj.) against a very strong prior-year quarter, with growth in all regions and categories. Business primarily benefited from continued high demand in Nutritionals, which saw sales rise 20.1 percent (Fx & portfolio adj.), and the launch of innovative products in all categories throughout the year. The Pain & Cardio category also registered particularly strong growth of 17.4 percent (Fx & portfolio adj.)

EBITDA before special items at Consumer Health increased by 2.3 percent to 308 million euros, resulting in a margin of 22.9 percent. The growth in earnings was driven by the division’s strong business performance and continuous cost management efforts. This was partially offset by investments associated with the launch of innovative products and by inflation-related increases in costs. 

Updated outlook

Following the very good business performance in the third quarter, Bayer has revised the upgraded outlook for 2021 that it issued in August. On a currency-adjusted basis (i.e. based on the average monthly exchange rates from 2020), the company continues to expect sales to come in at approximately 44 billion euros. This now corresponds to currency- and portfolio-adjusted growth of approximately 7 percent (previously: approximately 6 percent). The forecast for the currency-adjusted EBITDA margin before special items remains unchanged at around 26 percent. Core earnings per share are now expected to come in at approximately 6.50 euros to 6.70 euros after adjusting for currency effects (previously: approximately 6.40 euros to 6.60 euros). Free cash flow is now anticipated to amount to between approximately minus 0.5 billion euros and minus 1.5 billion euros (previously: between approximately minus 2 billion euros and minus 3 billion euros) as a portion of the settlement payments for the glyphosate litigations are now expected to be made in 2022 instead of 2021. In addition, Bayer is now anticipating net financial debt of around 35.5 billion euros (previously: around 36 billion euros) at the end of the year after adjusting for currency effects.

Based on the closing exchange rates on September 30, 2021, the company continues to expect full-year sales to come in at approximately 43 billion euros. This now corresponds to currency- and portfolio-adjusted sales growth of approximately 7 percent (previously: approximately 6 percent). The EBITDA margin before special items is now expected to amount to approximately 25.5 percent (previously: approximately 25 percent). The company is now anticipating core earnings per share of approximately 6.10 euros to 6.30 euros (previously: approximately 6.00 euros to 6.20 euros). Free cash flow is now expected to come in at between approximately minus 0.5 billion euros and minus 1.5 billion euros (previously: between approximately minus 2 billion euros and minus 3 billion euros). The company’s forecast for net financial debt remains unchanged at around 35 billion euros.

"New technologies vitally important for health and nutrition"

"Our third-quarter performance shows that we are very much on the right track – both in terms of operational development and the market launch of new products," said Baumann, underlining Bayer’s strength in delivering innovations. "We have aligned our corporate strategy and our innovation potential toward health and nutrition, which are areas of systemic importance. In doing so, we are looking to help solve a question of fundamental importance: How do we feed and satisfy the health needs of a growing population in the face of climate change?"

New technologies are vitally important in this respect, he explained. Together with its partners, the company is working on numerous projects involving technologies that can really make a difference for society. For example, Bayer is working on two novel therapeutic approaches for Parkinson’s, a nervous system disorder for which there is currently no cure. Via its Leaps unit, the company has also invested in three biotech start-ups that are harnessing various technologies in their research on microbial engineering, potentially paving the way for more crops to fertilize themselves in the future. This would be great news for the climate, as it would enable farmers to bypass nitrogen fertilizers, which are used to grow around 40 percent of the world’s food but also account for roughly 4 percent of all greenhouse gas emissions worldwide.

Sustainability: Three-fold increase in volume of renewable energy sourced via supply agreements

Bayer is also working intensively on its ambitious sustainability targets, with the company committed to becoming carbon neutral in its own production operations by 2030. In addition to investing in more energy-efficient facilities and building technologies, it is also extensively harnessing renewable energy sources. As of the end of the third quarter, Bayer has this year concluded agreements covering around 400,000 megawatt-hours of green energy, representing a three-fold increase in volume.

Reinforcing its commitment to improve access to family planning, especially in low- and middle-income countries, the company recently initiated the construction of a new production site in Costa Rica and the expansion of an existing facility in Finland. Both sites are set to produce long-acting reversible contraceptives in the future. These investments are a milestone as the company works toward meeting its sustainability target of providing 100 million women with access to modern family planning by 2030.

On November 9, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported that the abstract titled, "Allogeneic CAR T cells with Deoxycytidine Kinase Knockdown Demonstrate Resistance to Fludarabine" has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting taking place November 10 – 14, 2021 in Washington, D.C (Press release, Precision Biosciences, NOV 9, 2021, View Source [SID1234594872]).

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Abstract/Poster Details:

Abstract Number & Title: Abstract #140. Allogeneic CAR T cells with Deoxycytidine Kinase Knockdown Demonstrate Resistance to Fludarabine
Category: Cellular Therapies
Authors: Michelle B. Pires, M.S., and Aaron J. Martin, Ph.D., both of Precision BioSciences

Abstracts for the SITC (Free SITC Whitepaper) 36th Annual Meeting are now available on the SITC (Free SITC Whitepaper) Annual Meeting website and in the Journal for ImmunoTherapy of Cancer (JITC). This abstract will be presented as an electronic poster that will be displayed on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7 AM EST on Friday, November 12, 2021 until the virtual meeting platform is closed on January 9, 2022.

In this preclinical study, ARCUS gene editing was used to disrupt the endogenous T cell receptor by inserting a transgene carrying a CD19-specific CAR and an RNAi sequence designed to specifically knockdown deoxycytidine kinase (dCK), a protein that converts fludarabine from its prodrug form to an active compound. This single-step approach generated allogeneic, fludarabine-resistant (FluR) CAR T cells. In these cells, the dCK RNAi sequence produced a 70% reduction in dCK mRNA abundance, and resistance to fludarabine was confirmed in vitro. Additionally, treatment of tumor-bearing mice with fludarabine and FluR CAR T cells resulted in enhanced tumor clearance and survival compared to mice receiving control CAR T cells alone or control CAR T cells and fludarabine.