ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that the MTD has been declared in a Phase I investigator sponsored clinical trial (IST), named rESPECT, of its lead product candidate eryaspase for the first-line treatment of pancreatic cancer, defining the recommended dose for future clinical trials in this indication at 100 U/kg (Press release, ERYtech Pharma, OCT 4, 2021, View Source [SID1234590814]).

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

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

                  Schedule Your 30 min Free Demo!

After review of the safety data, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no DLT. Consequently, the MTD has been declared at a dose of 100 U/kg eryaspase. Interestingly, all six patients evaluated for response achieved disease control, four patients with objective response and two with stable disease.
The trial will continue to enroll additional patients at the 100 U/kg dose level to further assesss the safety and clinical activity. The declared MTD of 100 U/kg eryaspase corresponds with the dose currently being used in clinical trial in second-line patients and it can now be taken forward into future late-stage clinical studies in first-line pancreatic patients.
Full disclosure of both safety and efficacy information will be made at a future medical congress. Dr Marcus Noel, Associate Professor of Medicine at Georgetown University, Washington DC, USA, commented: "As an oncologist, one of my biggest challenges is the ability to add treatments to existing backbone chemotherapies, such as mFOLFIRINOX, which are already difficult for patients to tolerate. It is highly encouraging that this study has demonstrated the possibility to add a novel treatment, eryaspase, to mFOLFIRINOX without observing DLT. Furthermore, whilst the trial is not designed to answer if eryaspase is efficacious, partial responses in four out of the six patients with imaging are clearly encouraging."
Dr Iman El-Hariry, ERYTECH’s Chief Medical Officer, added: "We are delighted to be working alongside Dr Noel at the University of Georgetown and reaching the important milestone of declaring the MTD of eryaspase in first-line pancreatic patients. We look forward to discussing future study designs with Dr Noel and other Key Opinion Leaders so that we can bring this potentially valuable therapy to first-line pancreatic patients at the earliest opportunity. In the fourth quarter of this year , we also expect top-line results from the TRYbeCA-1 Phase 3 clinical trial in second-line pancreatic cancer. If that trial confirms the survival benefit we observed in the earlier Phase 2 trial, we will plan to launch a pivotal trial in first-line pancreatic cancer and potentially other settings such as locally advanced pancreatic cancer."
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030. Every year, there are approximately 185,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Approximately half of patients are diagnosed with metastatic disease and approximately 30% of patients are diagnosed with locally advanced disease. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate below 10%. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug
combinations with the aim of improving overall patient outcomes and quality of life.

On October 4, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, OCT 4, 2021, View Source [SID1234590804]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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

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

                  Schedule Your 30 min Free Demo!

Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement 27 September 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer to Novo Nordisk of 700 B shares in the period from 27 September 2021 to 1 October 2021. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 20,941,138 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 1 October 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 22,133,972 B shares at an average share price of DKK 500.45 per B share equal to a transaction value of DKK 11,076,914,348.

On October 4, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that Compugen is entitled to receive a $6 million milestone payment from AstraZeneca (LSE: AZN) (STO: AZN) (Nasdaq: AZN) triggered by the dosing of the first patient in a Phase 1/2 study evaluating AZD2936, a TIGIT/PD-1 bispecific antibody, in patients with advanced or metastatic non-small cell lung cancer (Press release, Compugen, OCT 4, 2021, View Source [SID1234590785]). AZD2936 is derived from COM902, Compugen’s high-affinity clinical-stage anti-TIGIT antibody.

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

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

                  Schedule Your 30 min Free Demo!

"We are proud that AstraZeneca’s TIGIT bispecific program, derived from COM902, has advanced to the clinic and become our fourth clinical stage program originating from our innovative pipeline" said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen. "We hope COM902’s differentiated properties will contribute to the clinical success of AZD2936 and we look forward to the advancement of this important clinical program."

About the Compugen-AstraZeneca License Agreement

In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen’s monospecific antibodies that bind to TIGIT, including COM902, for the development of bi-specific and multi-specific antibody products, excluding such bi-specific and multi-specific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. To date, Compugen has received a $10 million upfront payment, an additional $2 million milestone payment and is entitled to an additional $6 million payment triggered by this first patient being dosed, out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional products are developed based on Compugen’s monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.

On October 4, 2021 Freenome, a privately held biotech company, reported that presented at the American Association of Family Practitioners (AAFP) Family Medicine Experience virtual meeting last week (Press release, Freenome, OCT 4, 2021, View Source [SID1234590780]). The poster1 describes the development of Freenome’s multiomics blood test for the detection of early-stage colorectal cancer (CRC) and its validation study. The study, called PREEMPT CRC, is the largest registrational study to date for a noninvasive test for CRC screening in an average-risk population.

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

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

                  Schedule Your 30 min Free Demo!

PREEMPT CRC, builds on the results from a study at last year’s American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) Gastroenterology annual meeting, that demonstrated Freenome’s blood test detected early-stage (I/II) CRC with a sensitivity of 94% and specificity of 94%.

Freenome’s multiomics approach combines tumor and non-tumor signals from DNA and protein and uses machine learning to detect CRC and advanced adenomas. The registrational study, PREEMPT CRC, is a large, multi-center study of average-risk participants that uses both traditional and virtual recruitment to ensure a diverse and representative clinical trial population.

"Regular screenings can help detect colorectal cancer early, providing a better chance of survival," said Theodore R. Levin, M.D., clinical lead for colorectal cancer screening for the Permanente Medical Group, research scientist at the Kaiser Permanente Division of Research, principal investigator of PREEMPT CRC and co-author of the study. "Continued research will help us develop a test that makes it easier for patients to be screened, ultimately saving more lives."

Currently, only 67% of average-risk individuals over the age of 50 are up to date on CRC screening,2 which is likely to decrease even more with new guideline changes recommending lowering the age to initiate CRC screening from 50 to 45.3

"This presentation demonstrates how our multiomics platform works in detecting early-stage colorectal cancer," said Mike Nolan, chief executive officer of Freenome. "We want to make CRC screening easy and accessible, so as we near the completion of PREEMPT CRC, we’re driven to accomplish that goal."

On October 4, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the third quarter ended September 30, 2021 on Wednesday, October 27, 2021 at 8:00 a.m. EDT (Press release, Boston Scientific, OCT 4, 2021, View Source [SID1234590778]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the third quarter on October 27 prior to the conference call.

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

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

                  Schedule Your 30 min Free Demo!

A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available beginning approximately one hour following the completion of each event.