On February 23, 2021 "BioInvent reported it has started 2021 with significant positive momentum We reported promising interim efficacy data from the ongoing Phase I/IIa trial of our lead drug candidate BI-1206 (Press release, BioInvent, FEB 23, 2021, View Source;december-31–2020,c3293713 [SID1234575415]).The company also closed a successful SEK 962 million financing round, expanding our institutional shareholder base. Furthermore, we announced the expansion of our clinical pipeline to include two further drug candidates for the treatment of solid tumors." – Martin Welschof, CEO BioInvent

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BI-1206 was out-licensed to CASI Pharmaceuticals for the Greater China region. The collaboration accelerates and expands BioInvent’s global development plans for BI-1206. BioInvent received $12 million upfront in combination of cash and equity investment and is eligible to receive up to $83 million in milestone payments, plus tiered royalties. The equity investment was approved at an EGM held on November 27, 2020. (R)
BioInvent received a $3 million milestone payment related to selection of antibodies under its collaboration with Pfizer. (R)
Approval of a CTA was received in Denmark for the Phase I/IIa study of BI-1808, as monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL).
BioInvent and Transgene received CTA approval for Phase l/lla trial of oncolytic virus BT-001 in solid tumors.
New preclinical data was presented on BI-1808 and BT-001 at the SITC (Free SITC Whitepaper) 35th Anniversary Annual Meeting. New promising clinical and preclinical data on BI-1206 was also presented at the ASH (Free ASH Whitepaper) Annual Meeting.
BioInvent received a €2 million milestone payment under its collaboration with Daiichi Sankyo related to the initiation of a global Phase I clinical trial with a GARP directed antibody. (R)
BioInvent and Cantargia signed a manufacturing agreement, which may generate revenue for BioInvent of up to SEK 30 million.
BioInvent announced the appointment of Cecilia Hofvander as Senior Director Investor Relations, a new position at BioInvent starting mid-February 2021.
The EGM held on November 27, 2020 approved the proposal on a reverse share split 1:25, a reduction of the share capital to adjust the share capital to the Company’s operations, and an updated authorization for the Board to decide on a new issue of shares comprising 4,375,121 shares (after the reverse share split). (R)
Events after the reporting period

In January 2021, BioInvent announced that Phase I/IIa data suggest that BI-1206 restores activity of rituximab in relapsed non-Hodgkin’s lymphoma patients. Responses in 6 out of 9 patients evaluated provide exciting evidence that BI-1206 has the potential to restore activity of rituximab in non-Hodgkin’s lymphoma patients who have relapsed after treatment with rituximab. Long-lasting complete responses observed in two patients beyond 12 months. (R)
On February 23, 2021, BioInvent successfully completed a directed share issue of approximately SEK 962 million before transaction costs. Investors in the directed share issue are a range of international and Swedish investors, including Redmile Group, LLC., Invus, HBM Healthcare Investments, The Fourth National Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. 2,834,399 new shares were issued based on the authorization granted by the EGM on November 27, 2020, and 16,260,601 new shares were issued subject to the approval of an EGM to be held on 23 March 2021. (R)
In January 2021, BioInvent announced that it had restructured a clinical development agreement with Cancer Research UK (CRUK) for BI-1206. In exchange for a one-time payment of £2.5 million, the revised deal simplifies and reduces Bioinvent’s obligations to CRUK. (R)
BioInvent announced in January 2021, enrollment of the first patient in a Phase I/IIa study of BI-1808.
In January 2021, BioInvent announced that An van Es Johansson should resign as a director of the board effective as of 15 February 2021, due to personal reasons. (R)
(R)= Regulatory event

Comments from the CEO

BioInvent has started 2021 with significant positive momentum. Promising interim efficacy data from the ongoing Phase I/IIa trial of our lead drug candidate BI-1206 was followed by a successful financing round, adding another specialized institutional owner to the company. Furthermore, we announced the expansion of our clinical pipeline to include two further drug candidates.

The data from the study of BI-1206, in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL), are very encouraging. The responses in these severely ill patients suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. Furthermore, the duration of complete response in two patients are particularly impressive and indicate that BI-1206 has the potential to significantly improve the lives of NHL patients who have progressed after previous lines of treatment.

We were proud to host a key opinion leader (KOL) event on these results with renowned lymphoma expert Professor Mats Jerkeman, MD, of Lund University. Based on these results, we will now move to identify the recommended dose for the Phase IIa part of the study. We also presented new data on BI-1206 at the ASH (Free ASH Whitepaper) Annual Meeting in December and are excited to further evaluate its potential to bring much needed innovation to lymphoma patients.

This progress is reinforced by our partnership with CASI Pharmaceuticals for the development and commercialization of BI-1206 in mainland China, Taiwan, Hong Kong and Macau. Under this agreement for both liquid and solid cancers, BioInvent received $12 million upfront in combination of cash and equity investment and is eligible to receive up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales. CASI is a proven leader in China and their clinical development and regulatory expertise will be important in generating additional data on BI-1206.

We have simplified and reduced our obligations to CRUK related to BI-1206 by restructuring our clinical development agreement with CRUK (Cancer Research UK) for BI-1206, in exchange for a one-time payment. This provides us with further flexibility to carry out development and partnering activities with BI-1206.

Our innovative pipeline is expanding beyond BI-1206. We now have three products in clinical development, underlining the ability of our n-CoDeR/F.I.R.S.T platforms to produce novel, differentiating drug candidates.

In January, we enrolled the first patient in a Phase I/IIa, first-in-human study of BI-1808, a first-in-class anti-TNFR2 antibody, as monotherapy and in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of solid tumors and CTCL. This is based on a solid preclinical data set for BI-1808, including the new data presented at the 35th Annual Meeting of SITC (Free SITC Whitepaper) in November.

We have now received CTA approval to start a Phase I/IIa clinical trial of the novel oncolytic vaccinia virus BT-001 in solid tumors, through our collaboration with Transgene. BT-001 combines multiple mechanisms of action and has outstanding potential in a wide range of indications due to its combination of multiple anti-cancer properties. We also presented new data on BT-001 at SITC (Free SITC Whitepaper).

On February 23, we further reinforced our financial position with a directed share issue that raised approximately SEK 962 million before transaction costs. These proceeds intend to fund the continued transformation of BioInvent and expansion of our clinical programs. Assuming continued generation of positive data, we plan to in particular use the funds to prepare a pivotal clinical trial of BI-1206 for the treatment of NHL, with the aim of receiving an accelerated regulatory pathway. We also expect to expand the clinical programs of BI-1206 in combination with Keytruda and BI-1808 as monotherapy and in combination with Keytruda.

Our partner Pfizer has selected antibodies, directed at a previously selected target, under our agreement covering developing antibodies from the F.I.R.S.TTM drug discovery platform targeting tumor-associated myeloid cells. This is an impressive example of the productivity of our platform and further strengthens our financial position by $3 million. We may now move forward to develop other antibodies internally or with other partners.

We also generated important revenue from a €2 million milestone payment under a collaboration with Daiichi Sankyo and we signed a new manufacturing agreement with Cantargia, under which BioInvent may generate revenue of up to SEK 30 million.

As previously communicated, BioInvent has taken all the necessary precautions with regards to managing the impact of Covid-19. Although we still observe viral spread throughout the community, which is of course terrible for all those affected and their families, we remain on track with our clinical trials and results. As the situation is still evolving, timelines may be impacted in geographic areas most severely affected. We will provide updates as necessary.

The company has made significant progress in delivering on our strategy in 2020 and this has set us up for a number of important milestones as we progress our portfolio through clinical development. 2021 promises to be a very exciting year for BioInvent.