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.

Selecta Biosciences Announces Strategic Licensing Agreement with Takeda to Develop Next-Generation Gene Therapies for Patients with Lysosomal Storage Disorders

On October 4, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that it has entered into a strategic licensing agreement with Takeda Pharmaceutical Company Limited ("Takeda") to develop targeted, next-generation gene therapies for two indications within the field of lysosomal storage disorders (Press release, Selecta Biosciences, OCT 4, 2021, View Source [SID1234590734]). The collaboration leverages Selecta’s ImmTOR platform to enable redosing of transformative therapies.

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Carsten Brunn, Ph.D., president and chief executive officer of Selecta, added, "Takeda is an ideal partner to maximize the potential of our ImmTOR platform in gene therapy. Their extensive capabilities as a global biopharmaceutical leader and expertise in rare diseases gives us a high degree of confidence that Selecta’s vision will be realized. Together, we look forward to overcoming barriers to current efforts in AAV-driven gene therapy, as well as striving to address immunogenicity constraints and unmet patient needs. This collaboration provides additional validation and further demonstrates the robust value of our ImmTOR platform, which may enable redosing of potentially life-saving gene therapies. We are excited to expand our growing pipeline with Takeda and build on the momentum of our rapidly advancing proprietary gene therapy programs."

Under the terms of the agreement, Selecta is entitled to receive an undisclosed upfront payment and up to $1.124 billion in future additional payments over the course of the partnership that are contingent on the achievement of development or commercial milestones or Takeda’s election to continue its activities at specified development stages. Selecta is also eligible for tiered royalties on future commercial sales.

"Partnerships are critical as we look to build differentiated gene therapy programs where we have the opportunity to combine novel platform technologies that each aim to solve the challenges associated with first-generation gene therapies," said Madhu Natarajan, head of Takeda’s rare diseases drug discovery unit. "Selecta’s ImmTOR platform is designed to mitigate unwanted immune responses allowing for redosing, which could have broad applicability across our gene therapy programs for a range of diseases."

Corporate Slide Presentation of Checkmate Pharmaceuticals, Inc.

On October 4, 2021 Checkmate Pharmaceuticals Presented the Corporate Presentation (Presentation, Checkmate Pharmaceuticals, OCT 4, 2021, View Source [SID1234590743])

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PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

On October 4, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer (Press release, PDS Biotechnology, OCT 4, 2021, View Source [SID1234590865]). 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

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VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

"Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [email protected] or visit the website at View Source to learn more.

Curaleaf Completes Acquisition of Los Sueños

On October 4, 2021 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that it has successfully completed the acquisition of Los Sueños Farms and its related entities ("Los Sueños"), the largest outdoor grow in Colorado (Press release, Curaleaf Holdings, OCT 4, 2021, View Source [SID1234591159]).

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Boris Jordan, Executive Chairman of Curaleaf, stated, "We’re very excited about the closing of the Los Sueños acquisition. The vertical integration of our business in Colorado significantly strengthens Curaleaf’s market presence in the second largest state cannabis market in the U.S. This deal provides Curaleaf with a high-quality, efficient, and low-cost supply of biomass to support our wholesale and retail customers in Colorado and, once interstate commerce is allowed, on a regional scale. Overall, our newly expanded cultivation capacity will allow us to better serve Colorado’s $2.2 billion annual cannabis market opportunity."

Following the successful completion of the Los Sueños acquisition, Curaleaf gains three Pueblo, Colorado outdoor cannabis grow facilities covering 66 acres of cultivation capacity including land, equipment and licensed operating entities; an 1,800 plant indoor grow; and two retail cannabis dispensary locations serving adult use customers. As the largest cannabis biomass producer in the state, the Los Sueños facilities will help fuel the Company’s Select brand’s already market-leading presence in Colorado with a variety of best-in-class cannabis products distributed to nearly 2,000 locations across 18 states.

Bob DeGabrielle, Los Sueños founder and Colorado cannabis industry expert, will continue to oversee the Los Sueños operation and will take responsibility for Curaleaf’s Colorado wholesale and retail businesses.

Joseph Bayern, CEO of Curaleaf, commented, "The Los Sueños acquisition provides important new cultivation capacity to accelerate our growth and share in the fast-growing Colorado market. By leveraging the outdoor grow expertise of the talented Los Sueños team, we will optimize our new outdoor scale and cultivation technologies to lower our total cost of delivery, with the genetics that we perfect there serving as a center of excellence for all our future U.S. outdoor cultivation capabilities."