On May 31, 2021 PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, reported that the U.S. Patent and Trademark Office (USPTO) has informed the company that a new US patent will be granted early June 2021 (Press release, PCI Biotech, MAY 31, 2021, View Source [SID1234585159]). The US patent covers the use of fimaVacc in combination with immune checkpoint inhibitors (ICIs).

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The use of ICIs has revolutionised cancer immunotherapy, as this class of drugs may induce long-lasting effects in those patients responding to treatment. Unfortunately, most patients do not respond to ICI therapy and different treatment combination strategies are explored with the aim to increase the number of patients responding. Combining ICIs with therapeutic cancer vaccines that induce relevant immune responses against the tumour cells is regarded as one of the most promising strategies. The patent that soon will be granted in the US covers the use of PCI Biotech’s fimaVacc vaccination technology in combination with important classes of ICIs and an important type of immunological adjuvants (a class of so-called Toll like receptor agonists).

"Increasing the response rates to ICI’s is one of the pharma industry’s main priorities in cancer and therapeutic cancer vaccination is a rational approach to this aim. The fimaVacc technology has delivered encouraging immune responses in early phase clinical trials and this US patent provides relevant intellectual property for the further development of this technology." said Dr. Per Walday, CEO of PCI Biotech.

As part of PCI Biotech’s strategy for applying the PCI technology for therapeutic cancer vaccines, several global patent applications were filed in 2013-2016. Today’s announced US patent secure protection until 2036 and this patent application is still pending in Europe and key Asian markets.

On May 31, 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, MAY 31, 2021, View Source [SID1234583305]). 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 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 25 May 2021, the following transactions have been made:

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

With the transactions stated above, Novo Nordisk owns a total of 12,620,192 B shares of DKK 0.20 as treasury shares, corresponding to 0.5% 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 28 May 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 13,781,694 B shares at an average share price of DKK 455.01 per B share equal to a transaction value of DKK 6,270,798,856.

On May 31, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that its CEO, Michael Engsig, and Chief Innovation & Strategy Officer, Agnete Fredriksen, Ph.D., will give a presentation of Vaccibody at the Jefferies Virtual Healthcare Conference at 4.30 pm CET / 10.30 am EDT on June 2, 2021 (Press release, Vaccibody, MAY 31, 2021, View Source/wp-content/uploads/2021/06/210531_PR_Jefferies-Virtual-Healthcare-Conference-June-1-4-2021-FINAL.pdf" target="_blank" title="View Source/wp-content/uploads/2021/06/210531_PR_Jefferies-Virtual-Healthcare-Conference-June-1-4-2021-FINAL.pdf" rel="nofollow">View Source [SID1234583303]).

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The presentation will be available on Vaccibody’s website at View Source

On May 31, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported that it confirms its previous forecast to be able to conclude recruitment for its multi-centre BRaVac Phase IIb study in Quarter 3 2021 (Press release, RhoVac, MAY 31, 2021, View Source;bravac-phase-iib-study-recruitment-to-close-in-quarter-3-2021-301302312.html [SID1234583298]). Also, all new US clinics have been initiated to boost recruitment in the final months and further raise awareness in the USA.

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As was the case with many clinical trials, RhoVac phase IIb study in prostate cancer, BRaVac, suffered some delays during the course of Covid-19-pandemic in 2020 and 2021. The latest update was announced early March in connection with the Covid-19-vaccine roll-out and in connection with this RhoVac promised to get back with a more informed forecast for recruitment conclusion at a later stage. Now that this spring’s patient recruitment has been completed and all new US clinics are operational, RhoVac confirms its forecast to complete the recruitment of the study during the third quarter of 2021. There are less than 50 patients left to recruit and the current recruitment pace points to a close in August; allowing for the impact of summer vacations in hospitals, RhoVac therefore forecasts recruitment closing in September. After closing, finalising the treatment of patients in the study is estimated to take 9-12 months.

RhoVac also announces that all new American sites have now been initiated so that the total number of clinics currently operating on the study in the USA is seven. Apart from contributing to the recruitment this also raises awareness of RhoVac and its drug candidate in America, home to most of the company’s potential partner companies.

RhoVac CEO, Anders Månsson, comments: "Keeping the phase IIb study going in the midst of the pandemic was quite a challenge, but we can now conclude that we seem to have emerged successful, where others have unfortunately failed. I now see no obstacles to concluding the study according to forecast, and I look forward to entering the final stage of the trial. I am very happy about our increased US presence and the enthusiasm and commitment of the new centres, and I am full of gratitude to the centres that have prevailed during the pandemic and delivered in spite of the difficult circumstances. I believe we are now entering an exciting phase for RhoVac!"

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 31-05-2021 13:00 CET.

On May 31, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and AnHeart Therapeutics Co., Ltd. ("AnHeart"), a clinical stage oncology company focused on underserved patients in global markets, reported an exclusive license agreement for the co-development and commercialization of AnHeart’s lead drug candidate, taletrectinib – a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK – in Greater China, including mainland China, Hong Kong, Macau and Taiwan (Press release, Innovent Biologics, MAY 31, 2021, View Source [SID1234583297]).

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Under the terms of the agreement, Innovent will obtain exclusive rights to co-develop and commercialize taletrectinib in Greater China. AnHeart will continue to be responsible for the development of taletrectinib up to regulatory approval in mainland China and for supplying taletrectinib for both developmental and commercial purposes in Greater China. Innovent has the right to co-develop taletrectinib in Hong Kong, Macau and Taiwan up to regulatory approval.

According to the agreement, AnHeart will receive an upfront payment, R&D fees, and potential milestone payments totaling USD189 million in addition to tiered royalties based on annual net sales of taletrectinib in Greater China.

Taletrectinib is currently undergoing three phase 2 studies, including (i) the phase 2 study for first line treatment of TKI-naive and second line treatment of TKI-pretreated ROS1-positive non-small cell lung cancer (NSCLC) in China, (ii) the phase 2 study for NTRK-positive solid tumors in China, and (iii) the phase 2 study for first line and second line treatment of ROS1-positive NSCLC globally.

"We are excited to collaborate with Innovent, a leading biopharmaceutical company which has demonstrated outstanding development and commercialization capabilities, to commercialize taletrectinib in greater China," said Jerry Junyuan Wang, PhD, CEO and co-founder of AnHeart. "Following the first commercial partnership in Korea we entered into with NewG Lab in July 2020, our collaboration with Innovent further advances our mission to accelerate global patient access to taletrectinib upon approval."

Dr. Yong Jun Liu, president of Innovent, stated, "We are very pleased to enter a collaboration with AnHeart. We have been impressed with our partner’s capability to advance the global development of taletrectinib and we are excited to help bring taletrectinib to patients in Greater China. This collaboration further strengthens our position in oncology by adding a late stage and potential best-in-class targeted therapy into our portfolio. At the same time, it further proves that Innovent is an ideal partner for biopharmaceutical companies in terms of accelerating development and commercialization progress."

About Taletrectinib

Taletrectinib is an investigational next-generation TKI designed to effectively target ROS1 and NTRK with potential to treat TKI-naïve or pretreated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK fusion is estimated to be an oncogenic driver in approximately 0.5 percent of patients across multiple advanced solid tumors. There’s very limited approved therapy available for advanced ROS1-positive lung cancer patients and NTRK-positive cancer patients in Greater China. After treatment with existing therapies, most patients eventually acquire resistance for which there are significant unmet medical needs globally.

AnHeart has observed a 100% overall response rate (ORR) by investigator review from 11 ROS1-positive NSCLC patients who were not previously treated with a tyrosine kinase inhibitor (TKI) utilizing a January 15, 2021 data cut-off from the Phase 2 portion of the ongoing taletrectinib TRUST trial. Taletrectinib was also generally well-tolerated. These data demonstrate the potential for taletrectinib to be a best-in-class treatment. Data with more patient from first line (ROS1 TKI naive) and second line (ROS1 TKI pretreated) will be published during the 2021 ASCO (Free ASCO Whitepaper).

More information about the ongoing TRUST study of taletrectinib may be found by searching clinical trial identifier NCT04395677 at View Source