Novo Nordisk A/S – Share repurchase programme

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.

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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.

Compugen Announces Milestone Payment from AstraZeneca Triggered by First Patient Dosed with TIGIT Bispecific Derived from COM902

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.

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"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.

Research Highlights Freenome’s Blood Test for Colorectal Cancer to Primary Care Physicians

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.

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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."

Boston Scientific Announces Conference Call Discussing Third Quarter 2021 Results

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.

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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.

Himalaya Therapeutics Announces Submission in Mainland China of IND Applications for its CAB-AXL-ADC to treat sarcomas and NSCLC, its CAB-ROR2-ADC to treat melanoma and NSCLC

On October 4, 2021 Himalaya Therapeutics ("Himalaya"), a clinical-stage biopharmaceutical company focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment of solid tumor cancer, which are based on the Conditionally Active Biologics ("CAB") technology platform, reported that it has submitted four investigational new drug (IND) applications to the Center for Drug Evaluation (CDE) of the China National Medical Products Association (NMPA) (Press release, Himalaya Therapeutics, OCT 4, 2021, View Source [SID1234590776]).

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Himalaya submitted one IND for HTBA3011, its CAB-antibody drug conjugate (ADC) targeting AXL, a protein expressed on many tumor cells, for soft tissue and bone sarcomas, one for HTBA3011 for non-small cell lung cancer (NSCLC), one for HTBA3021, its CAB-ADC targeting ROR2, another protein expressed on many tumor cells, for melanoma, and one for HTBA3021 for NSCLC. AXL and ROR2 are both well-validated targets, where high expression has been correlated with aggressive disease in multiple cancer types and have both also been shown to be a common escape mechanism following PD-1, PD-L1, ALK and EGFR treatment.

"Although our Taiwan and Hong Kong sites are already part of the ongoing registrational global trials for these product candidates, adding Mainland China to our global trials as well will be a key milestone in our goal of providing treatment to patients in China for these deadly cancers for which availability of effective, novel treatments has been limited" said Brian Zhang, Himalaya’s CEO.

"This IND submission reflects our ability to operate quickly and efficiently in China by working closely with the regulatory authorities to advance its clinical candidates here" said Howe Li, Himalaya’s CMO. "This is an affirmation of the hard work, support and close coordination among not only our team members, but also our local and global partners, and BioAtla, our collaboration partner."