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New statement to replace the FDA 1572 form for non-IND trials supported by NCI

On February 23, 2021 EORTC reported Collaboration between research groups is essential for sharing expertise and conducting clinical trials (Press release, EORTC, FEB 23, 2021, View Source [SID1234575425]). These collaborations result in better delivery of therapeutic progress to cancer patients. The regulatory challenges of cross border cooperation can be a barrier to progress. Therefore, the regulatory procedures need to be addressed when clinical trials are conducted in different territories.

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The Statement of Investigator Form FDA 1572 is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic. This form was not applicable to Europe and it was long recognised as an impediment to participation in non-IND trials (i.e., trials that do not involve investigational new drugs) for European clinical research groups, when joining US initiated clinical trials.

In 2019, signing the Form FDA 1572 was even deemed illegal and in certain European countries like Germany, EU GCP inspectors prohibited the completion of this form.

EORTC and US NCI addressed collegially the challenges. In January 2021, following discussions with EORTC, NCI have launched a new International Investigator Statement (IIS) in the Registration and Credential Repository (RCR) for European countries. This statement replaces the Form FDA 1572 for participation in US NCTN and NCORP trials that are not under IND. In order to participate in US trials that are under an FDA IND, the NCTN Group or NCORP group supporting the participation of European investigators must also obtain an official waiver from FDA that will exempt the investigator to signing the Form FDA 1572.

"We are grateful for NCI to adapt its CTEP platform requirements, enabling the registration of European clinical investigators without any legal complications from their own home countries," said Dr Denis Lacombe, EORTC Director General. "We value our collaboration with NCI. In removing these types of barriers, both organisations focus on conducting research, much more efficiently, which will be beneficial to cancer patients."

BioInvent International Financial Statement January 1 – December 31, 2020

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

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.

BioInvent International AB brings forward publication of Year-end report 2020

On February 23, 2021 BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) reported that the company changes the date for publication of the year-end report 2020, and the interim report for the fourth quarter 2020, to Tuesday February 23, 2021 (Press release, BioInvent, FEB 23, 2021, View Source,c3293702 [SID1234575414]). Earlier communicated publication date was February 25, 2021.

BioInvent successfully carries out a directed share issue of approximately SEK 962 million (approximately USD 116 million)

On February 23, 2021 The Board of Directors of BioInvent International AB ("BioInvent" or the "Company") (OMXS: BINV) reported that it has resolved to issue 19,095,000 shares (the "New Shares") in a directed share issue to international and Swedish institutional investors, where 2,834,399 New Shares are issued based on the authorization granted by the Extraordinary General Meeting on 27 November 2020, and 16,260,601 New Shares are issued subject to the approval of an upcoming Extraordinary General Meeting to be held on 23 March 2021 (together the "Directed Share Issue") (Press release, BioInvent, FEB 23, 2021, View Source;approxim,c3293708 [SID1234575413]).

The price for the New Shares is SEK 50.36 per share and corresponds to the 5-day volume weighted share price of BioInvent’s share, as traded on Nasdaq Stockholm.
Investors in the Directed Share Issue are a range of international and Swedish institutional investors.
Through the Directed Share Issue, BioInvent will receive proceeds amounting to approximately SEK 962 million (approximately USD 116 million) before transaction costs.
BioInvent changes the date for publication of the year-end report 2020 and the interim report for the fourth quarter of 2020 to Tuesday, February 23, 2021. The previously announced date for publication was February 25, 2021.
Comments from the CEO

"We are very pleased to carry out this successful share issue, proceeds from which will fund the continued transformation of BioInvent and expansion of our clinical programs. BioInvent has a strong clinical oncology pipeline thanks to our F.I.R.S.T technology platform, with four ongoing clinical trials of first-in-class antibodies with unique mechanisms of action. This capital injection enables us to accelerate and broaden our clinical development." said Martin Welschof, CEO of BioInvent.

"Assuming continued generation of positive data, we plan to in particular use the funds to prepare a pivotal clinical trial of our first-in-class anti-FcγRIIB antibody BI-1206 for the treatment of Non-Hodgkin’s Lymphoma, 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 the anti-TNFR2 antibody BI-1808 as monotherapy and in combination with Keytruda.

Investors in the Directed Share Issue are a range of international and Swedish institutional investors, including Redmile Group, LLC., Invus, HBM Healthcare Investments, The Fourth National Swedish Pension Fund, Swedbank Robur Fonder and Van Herk Investments. Upon completion, Redmile will become the largest shareholder in BioInvent representing approximately 16.8 per cent of the shares and votes in the company.

I would like to thank our existing investors for their continued support and am delighted to welcome new investors in BioInvent. I look forward to continuing to work with all our investors as we continue to advance our innovative treatments to improve patients’ lives."

The Directed Share Issue

The price for the New Shares is SEK 50.36 per share and corresponds to the 5-day volume weighted share price of BioInvent share, as traded on Nasdaq Stockholm. The price per share in the Directed Share Issue has been resolved by the Board of Directors in consultation with the Joint Global Coordinators, based on negotiations with the largest new investor. Through the Directed Share Issue, BioInvent will receive proceeds amounting to approximately SEK 962 million before transaction costs.

The Directed Share Issue consists of two separate tranches: the first tranche amounting to 2,834,399 New Shares based on the authorization granted by the Extraordinary General Meeting held on 27 November 2020 ("Tranche 1") and the second tranche of 16,260,601 New Shares which will be subject to the approval of the Extraordinary General Meeting to be held on 23 March 2021 ("Tranche 2"). Completion of Tranche 1 is not conditional upon completion of Tranche 2.

The first day of trading for the New Shares in Tranche 1 will be on or about 26 February 2021 Subject to the approval of the Extraordinary General Meeting, the first day of trading for the New Shares in Tranche 2 is expected to be on or about 30 March 2021.

Tranche 2 of the Directed Share Issue will be subject to a listing prospectus prior to shares being admitted to trading on Nasdaq Stockholm. The listing prospectus is expected to be approved by the Swedish Financial Supervisory Authority on or about 24 March 2021, i.e. before the shares in Tranche 2 are subject to trading.

The reasons for deviating from the shareholders’ preferential rights are to diversify the shareholder base in the Company amongst international and Swedish institutional investors and at the same time take advantage of the opportunity to raise capital in a time and cost-efficient manner. The Board of Directors’ assessment is that the price per share in the Directed Share Issue is in accordance with market conditions.

The Directed Share Issue will entail a dilution of approximately 32.7 per cent of the number of outstanding shares and votes in the Company after the Directed Share Issue. Through the Directed Share Issue, the number of outstanding shares and votes in the Company will increase from 39,376,096 to 42,210,495 through Tranche 1 and from 42,210,495 to 58,471,096 through Tranche 2. The share capital will increase from SEK 7,875,219.20 to SEK 8,442,099 through Tranche 1 and from SEK 8,442,099 to SEK 11,694,219.20 through Tranche 2.

The Directed Share Issue is subject to certain customary conditions of the placing agreement entered into by the Company with the Joint Global Coordinators in connection with the Directed Share Issue, mainly entailing that the placing agreement is not terminated prior to the delivery of the respective Tranches.

Background and reasons

The net proceeds from the Directed Issue are mainly intended for: (i) preparations towards a pivotal clinical trial with the aim of receiving an accelerated regulatory pathway for BI-1206 for the treatment of Non-Hodgkin’s Lymphoma assuming continued generation of positive data; (ii) progressing the clinical development of BI-1206 in its Phase I/II trial for the treatment of advanced solid tumors in combination with Keytruda (pembrolizumab). Assuming positive clinical data, the net proceeds may be used to broaden the clinical studies; (iii) progressing the clinical development of BI-1808, as monotherapy and in combination with Keytruda (pembrolizumab), for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). Assuming positive clinical data, the net proceeds may be used to broaden the clinical studies; (iv) developing BT-001, in partnership with Transgene, for the treatment of solid cancers. Assuming positive clinical data, the net proceeds may be used to broaden clinical studies; (v) advancing BI-1607 into clinical development for the treatment of solid cancers; and (vi) continued development of the Company’s prioritized preclinical projects with the aim to generate additional clinical programs.

Moreover, a strengthened financial position enables increased strategic flexibility and improved ability to negotiate with potential partners.

Lock-up undertakings and voting commitments

In connection with the Directed Share Issue, the Company has undertaken, subject to customary exceptions and the completion of the Directed Share Issue, to not issue additional shares for a period of 180 days as from launch of the Directed Share Issue. In addition, shareholding members of the Board of Directors and management of BioInvent have undertaken to not sell shares in the Company for a period of 90 days as from launch of the Directed Share Issue, subject to customary exceptions.

Shareholders together currently representing approximately 43 per cent of the shares and votes in the Company, have undertaken, or indicated an intention, to vote in favor of the EGM approval of Tranche 2.

Advisors

Van Lanschot Kempen Wealth Management N.V. (Kempen & Co) and Pareto Securities AB have been appointed as Joint Global Coordinators in connection with the Directed Share Issue. Mannheimer Swartling Advokatbyrå acts as legal counsel to the Company and Baker McKenzie acts as legal counsel to the Joint Global Coordinators.

Cue Biopharma to Present at the 7th Annual Immuno-Oncology 360° Conference

On February 22, 2021 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, will deliver an oral presentation and participate in a panel discussion at the 7th Annual Immuno-Oncology 360° Conference on February 25, 2021 (Press release, Cue Biopharma, FEB 22, 2021, View Source [SID1234608292]).

Presentation Details
Title: Next Generation Synthetic Vaccines
Immuno-STATs: Drugging the Tumor-specific T-cell Repertoire
Date and Time: Thursday, February 25, 2021 at 10:45 a.m. EST

Dr. Suri will present an overview of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform and its next generation derivative, Neo-STAT. He will also highlight the IL-2 based CUE-100 series Immuno-STATs exemplified by CUE-101, the Company’s lead clinical candidate for HPV+ R/M HNSCC and CUE-102, our second drug program designed to target Wilms’ tumor 1 (WT1) specific T cells for the treatment of patients with solid and hematological cancers. The overview will include data supporting mechanistic advantages of the Immuno-STAT and Neo-STAT approach to targeting and activating disease-relevant T cells directly in the patient’s body.

Panel Details
Title: Vaccine Expert Discussion
Date and Time: Thursday, February 25, 2021 at 11:30 a.m. EST

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.