On January 27, 2021 LegoChem Biosciences (141080KS, ‘LCB’) reported that it has entered into a worldwide license agreement with Pyxis Oncology (hereinafter ’Pyxis’) for the development and commercialization of LCB67, an innovative antibody-drug-conjugate (ADC) candidate (Press release, LegoChem Biosciences, JAN 27, 2021, View Source;sc_seq=413 [SID1234628152]).

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Under the terms of the agreement, Pyxis will make an upfront payment of $9.5 million plus the cost LCB has spent for clinical trial material production upon its completion next year. LCB is eligible to receive milestone payments of up to $284.5 million as well as royalties on commercial sales. In addition, LCB has a right to exercise an option for obtaining Pyxis’ equity and revenue sharing upon Pyxis’ sublicense agreement with third party companies. Payments from Pyxis though this agreement will be shared with Y-Biologics based on pre-agreed terms

The licensed ADC program (LCB67, a DLK1-targeting ADC) is an Investigational Drug Candidate that has been generated through combining LCB’s next-generation ADC platform with anti-DLK1 antibody, which was in-licensed from Y-Biologics. DLK-1 is a novel cancer target which is associated with various solid tumors including liver and small cell lung cancers. Pyxis plans to advance this program to clinical trials for progressive solid cancers with high medical unmet needs

Pyxis is a Boston-based biotechnology company developing first-in-class and best-in-class oncology therapeutics with a broad oncology biologics pipeline. Under the direction of its management team of experienced industry professionals and experts in the field, Pyxis is further strengthening its portfolio through this agreement with LCB

The members of Pyxis are industry-leading US experts who have successfully led the development of innovative new drugs, and we have a strong confidence that Pyxis will enter LCB67 into clinical trials in the most efficient manner." said Dr. Yong-Zu Kim, CEO and President of LCB

Dr. Lara Sullivan, CEO of Pyxis, added, "LCB67 has significant potential to be an effective treatment for a range of indications. LegoChem’s unique ADC platform drastically improves upon existing technology to provide a highly stable therapeutic with unparalleled manufacturing consistency. Our partnership with LegoChem is crucial to advance this next generation ADC to the clinic and ultimately bring a new potential treatment option to patients

This agreement is the second case of LCB’s ADCs generated through successful collaboration between Korean biotech companies, first being LCB71, an anti-ROR1 ADC which was co-developed by LCB and ABL BIO and licensed to CStone Pharmaceuticals last month. This is the 4th global licensing agreement of LCB’s ADCs this year only

On January 27, 2021 LegoChem Biosciences reported that it has entered into a worldwide license agreement with Pyxis Oncology for the development and commercialization of LCB67, an innovative antibody-drug-conjugate (ADC) candidate (Press release, LegoChem Biosciences, JAN 27, 2021, View Source;sc_seq=413 [SID1234628151]).

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Under the terms of the agreement, Pyxis will make an upfront payment of $9.5 million plus the cost LCB has spent for clinical trial material production upon its completion next year. LCB is eligible to receive milestone payments of up to $284.5 million as well as royalties on commercial sales. In addition, LCB has a right to exercise an option for obtaining Pyxis’ equity and revenue sharing upon Pyxis’ sublicense agreement with third party companies. Payments from Pyxis though this agreement will be shared with Y-Biologics based on pre-agreed terms.

The licensed ADC program (LCB67, a DLK1-targeting ADC) is an Investigational Drug Candidate that has been generated through combining LCB’s next-generation ADC platform with anti-DLK1 antibody, which was in-licensed from Y-Biologics. DLK-1 is a novel cancer target which is associated with various solid tumors including liver and small cell lung cancers. Pyxis plans to advance this program to clinical trials for progressive solid cancers with high medical unmet needs.

"The members of Pyxis are industry-leading US experts who have successfully led the development of innovative new drugs, and we have a strong confidence that Pyxis will enter LCB67 into clinical trials in the most efficient manner." said Dr. Yong-Zu Kim, CEO and President of LCB.

Dr. Lara Sullivan, CEO of Pyxis, added, "LCB67 has significant potential to be an effective treatment for a range of indications. LegoChem’s unique ADC platform drastically improves upon existing technology to provide a highly stable therapeutic with unparalleled manufacturing consistency. Our partnership with LegoChem is crucial to advance this next generation ADC to the clinic and ultimately bring a new potential treatment option to patients."

This agreement is the second case of LCB’s ADCs generated through successful collaboration between Korean biotech companies, first being LCB71, an anti-ROR1 ADC which was co-developed by LCB and ABL BIO and licensed to CStone Pharmaceuticals last month. This is the 4th global licensing agreement of LCB’s ADCs this year only.

On January 27, 2021 FORUS Therapeutics reported that launches bringing a new pharmaceutical company onto the Canadian landscape (Press release, FORUS Therapeutics, JAN 27, 2021, View Source [SID1234578027]). With a highly-experienced and proven team, an FDA-approved product already in its pipeline, and significant financial investment secured, the Toronto-based company looks to bring innovative cancer therapies to Canadian patients, new treatment tools for caregivers and physicians, and in the future, be a preferred partner for emerging Canadian-based research companies.

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To support its launch, FORUS has raised approximately $20 million from investors that include adMare BioInnovations, Canada’s global life sciences venture, and sophisticated international and institutional investors.

FORUS has also secured an exclusive Canadian distribution agreement with Karyopharm Therapeutics Inc. (Nasdaq: KPTI) for the commercialization of XPOVIO (selinexor), an FDA-approved cancer medicine for adults with multiple myeloma and lymphoma. "We are thrilled to launch on the heels of our first licensing agreement to deliver a novel cancer treatment for Canadians," said Kevin Leshuk, Founder and President of FORUS.

Multiple myeloma is the second most common blood cancer. Every year, 3,400 Canadians are diagnosed with multiple myeloma, and sadly 1,600 die from the disease. FORUS will submit XPOVIO to Health Canada for approval in the coming months.

"We are investing in and supporting the launch of FORUS to address a major gap in the Canadian life sciences ecosystem," said Gordon C. McCauley, President and CEO of adMare BioInnovations. "We have an abundance of world-leading health research, a growing industry to translate that research into new therapeutics, but we have limited home-grown companies to bring these innovations directly to Canadian patients. FORUS begins to fill this gap by connecting medical innovations with the healthcare and patient communities across the country."

"We’re turning the traditional start-up model upside down," said Leshuk. Biopharmaceutical start-ups typically begin with early research, then undergo an arduous process of translating the research into a product, which can take at least a decade and have high associated failure rates. In this case, FORUS is starting on strong footing with an FDA-approved product already in place, considerable investment, and an experienced team. The company will move quickly to identify and secure development partnerships with Canadian research companies and globally-sourced innovations.

Leshuk brings over 25 years of experience in the pharmaceutical industry. He and the FORUS founding team have delivered significant financial returns; and since 2009, secured 12 Health Canada approvals, including five in multiple myeloma. The FORUS goal is to continue this track record of success and bring important new medicines to Canadians to actively contribute to the Canadian life sciences innovation ecosystem.

On January 27, 2021 Zealand Pharma A/S ("Zealand") (Nasdaq: ZEAL), (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, reported that the board of directors of Zealand (the "Board") has in accordance with article 7.1 of Zealand’s articles of association today exercised an authorization granted by Zealand’s annual general meeting held on 2 April 2020, to increase Zealand’s share capital by issue of 3,600,841 new ordinary shares (the "New Shares") at a subscription price of DKK 208 per New Share (Press release, Zealand Pharmaceuticals, JAN 27, 2021, View Source [SID1234576926]).

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The issuance of the New Shares follows an offering at market price in a private placement directed at institutional and professional investors in Denmark and certain other jurisdictions (the "Offering"). The subscription price for the New Shares has been determined through an accelerated book building procedure as part of the Offering.

The Offering is expected to be completed on 1 February (subject to the satisfaction of customary closing conditions), and the New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen on 2 February 2021.

The Offering has not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), and was made pursuant to applicable exemptions from the obligation to publish a Danish prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions, as a directed issue and private placement to eligible institutional and professional investors.

Summary of the Offering:

·3,600,841 New Shares were subscribed for in the Offering;
·the subscription price for the New Shares is DKK 208 per New Share;
·total gross proceeds from the Offering will amount to approx. DKK 749 million;
·allocation of the New Shares subscribed for in the Offering has been determined by the Board in consultation with Goldman Sachs International, Jefferies GmbH and Danske Bank A/S;
·a limited number of the New Shares have been allocated to Zealand’s Chief Executive Officer Emmanuel Dulac and Chief Financial Officer Matthew Dallas;
·Zealand expects to enter into an equity swap agreement to acquire a limited number of New Shares to be used for covering certain ordinary obligations under Zealand’s equity based incentive programs;
·following the Offering, Zealand will be subject to a 90 calendar days lock-up undertaking (calculated from admission of the New Shares to trading and official listing on Nasdaq Copenhagen A/S), and the members of Zealand’s executive management and board of directors will be subject to a 90 calendar days lock-up undertaking (calculated from 27 January 2021), both subject to certain customary exceptions and an exemption related to shares related to warrants which can be subscribed for by certain members of the executive management and board of directors;
·the New Shares will be issued without pre-emption rights for Zealand’s current shareholders and the New Shares will upon issuance rank pari passu with Zealand’s existing shares and carry the same dividend and other rights. The New Shares must be registered in the name of the holder in the Company’s register of shareholders;
·each New Share carries one vote at Zealand’s general meetings. Zealand only has one class of shares;
·following completion of the Offering, the registered share capital of Zealand will amount to DKK 43,400,547 divided into 43,400,547 shares of DKK 1 each; and
·a timetable of expected future principal events can be seen below.

Reasoning for the Offering and use of proceeds

Zealand’s gross proceeds from the Offering will be approximately DKK 749 million. Zealand intends to use the net proceeds from the Offering to help fund commercialization and pre-launch activities for Zealand’s late stage programs, accelerate development of the clinical pipeline, continue support for Zealand’s peptide platform, and for general corporate purposes.

In connection with the Offering, Zealand will enter into an equity swap agreement to acquire a limited number of New Shares to be used for covering certain ordinary obligations under Zealand’s equity based incentive programs. Part of the net proceeds will be used to fund the acquisition of these New Shares.

Admission to trading and official listing

The New Shares will be listed on Nasdaq Copenhagen in reliance on the exemption in article 1(5)a of the Prospectus Regulation and not on the basis of a prospectus.

The New Shares will be issued in the systems of VP Securities A/S and delivered to the investors in the temporary ISIN code DK0061531514. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription for the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0060257814, as soon as possible following registration of the share capital increase with the Danish Business Authority, expected on 1 February 2021. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S on or around 2 February 2021 in the permanent ISIN code for Zealand’s existing shares, DK0060257814.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement thereof and the Company making an announcement to that effect.

Expected timetable for the Offering

The completion of the Offering, including admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement thereof.

The New Shares

The New Shares will rank pari passu in all respects with existing shares in Zealand. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. U.S. investors that have acquired New Shares in the Offering have, however, undertaken certain trading restrictions for their New Shares. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

Managers and legal counsels

Goldman Sachs International, Jefferies GmbH and Danske Bank A/S are acting as joint global coordinators and joint bookrunners in the Offering, and Bryan, Garnier & Co. and Nordea Danmark, Filial af Nordea Bank Abp, Finland are acting as co-managers in the Offering (the joint global coordinators and the co-managers are jointly referred to as the "Managers"). Danske Bank A/S is acting as settlement agent for the Offering.

Plesner and Cooley LLP act as Danish and U.S. legal advisors respectively to the Company. Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Managers.

On January 27, 2021 Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, reported a $50M Series A financing from Deerfield Management (Press release, Nuvalent, JAN 27, 2021, View Source [SID1234574363]). The company also announced its launch of a portfolio of innovative small molecule kinase inhibitors with parallel lead programs in non-small cell lung cancer (NSCLC), including NUV-520 – a potential best-in-class ROS1-selective inhibitor – and NUV-655 – an ALK-selective inhibitor. These novel molecules have been designed through Nuvalent’s proprietary discovery efforts to specifically solve for the dual challenges of kinase resistance and selectivity, with the goals of minimizing adverse events and driving more durable responses for patients with cancer. Chief Executive Officer James Porter, Ph.D., leads an experienced team with deep expertise in structure-based drug design, oncology drug development and company building.

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"Kinase inhibitors remain at the leading edge of targeted therapies for patients with cancer, but the clinical utility of currently available treatments is limited by resistance mutations and off-target effects," said Dr. Porter. "At Nuvalent, we are leveraging our expertise in structure-based design to solve for the dual challenges of resistance and selectivity, with the goal of driving deeper and more durable responses for patients living with cancer. We have partnered with leading physician-scientists to understand the limitations of existing cancer therapies that target proven oncogenic kinases and assembled an accomplished team to translate those insights into a novel pipeline of precisely targeted therapies."

The founding technology was developed at Nuvalent under the guidance of Matthew Shair, Ph.D., Professor of Chemistry and Chemical Biology at Harvard University. Professor Shair serves as Founder, Head Scientific Advisor and member of the Board of Directors for Nuvalent.

"Our goal at Nuvalent is to develop medicines with the potential to achieve deep and durable responses with minimal side effects. Off-target kinases sometimes differ from mutant oncogenic kinases by minor differences at the drug binding site, which has made it challenging for drug developers to achieve the desired level of selectivity," said Professor Shair. "The Nuvalent approach leverages deep expertise in structure-based drug design and innovative molecular structures, allowing us to thread the needle and achieve high affinity and unparalleled selectivity against drug-resistant targets in cancer."

Nuvalent’s first lead program, NUV-520, is a novel ROS1-selective inhibitor and potential best-in-class therapy for patients with advanced NSCLC driven by a ROS1 fusion. NUV-520 inhibits wild-type ROS1 and is designed to remain active in tumors that have developed treatment resistance, including tumors with the prevalent G2032R solvent front mutation, in addition to other key mutations D2033N, L2026M and S1986F. NUV-520 has been optimized for central nervous system (CNS) penetrance to improve treatment options for patients with CNS metastases. In addition, NUV-520 has been shown to selectively inhibit ROS1 compared to the structurally related tropomyosin receptor kinase (TRK) family. NUV-520 offers the potential to minimize TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients with ROS1-mutant variants. Nuvalent anticipates initiating a Phase 1/2 trial investigating NUV-520 in ROS1-positive NSCLC in the second half of 2021.

Nuvalent’s second lead program is NUV-655, a novel ALK-selective inhibitor created for patients with advanced NSCLC tumors driven by an ALK fusion. NUV-655 is designed to inhibit wild-type ALK and remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M or G1202R / G1269A. NUV-655 has been optimized for CNS penetrance and ALK selectivity to improve treatment options for patients with CNS metastases and minimize CNS adverse events related to off-target inhibition of the structurally-related TRK family. A Phase 1/2 trial investigating NUV-655 in ALK-positive NSCLC is planned to begin in the first half of 2022.

In addition to selective ROS1 and ALK inhibition, Nuvalent is exploring a robust pipeline of programs with a focus on addressing the limitations of existing therapies for other clinically proven kinase targets in oncology.

"Cancer remains one of the most challenging diseases to treat, with many patients inevitably running out of therapeutic options," said Cameron Wheeler, Ph.D., Chairman of the Board of Nuvalent and a Partner at Deerfield Management. "Nuvalent has assembled a team with leading expertise in structure-based drug design and the deep clinical and development insights needed to address prioritized areas of patient need. Backed by the confidence and experience of an accomplished team of collaborators and advisors, Nuvalent is well positioned to deliver on its mission of delivering precisely targeted therapy options that bring renewed hope to patients in need."