On March 18, 2022 Lynk Pharmaceuticals Co., Ltd. (Lynk Pharmaceuticals) and Simcere (2096.HK) reported a strategic partnership to develop and commercialize a highly selective JAK1 inhibitor LNK01001 in China (Press release, Lynk Pharmaceuticals, MAR 18, 2022, View Source [SID1234610332]).

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Under the terms of the agreement, Lynk Pharmaceuticals is responsible for the development of the product. Simcere will obtain the exclusive rights to market LNK01001 for the indications of rheumatoid arthritis and ankylosing spondylitis in China, after completing the payment of all commercialization rights and interests.

JAK1 belongs to an important subgroup of the cytosolic tyrosine kinase Janus kinase (JAKs) family that is closely related to the pathogenesis of various autoimmune diseases. 6 head-to-head clinical studies have demonstrated the huge clinical potential of selective JAK1 inhibitor as an emerging new treatment of rheumatoid arthritis, with significant advantages over methotrexate and several biological agents. Published data of JAK1 inhibitor as treatment of ankylosing spondylitis have shown sufficient superiority of JAK1 inhibitor in a head-to-head study over Humira, the TNFα targeting blockbuster. Selective JAK1 inhibitors are thus considered to be the next superstar of therapies.

LNK01001 is a highly selective JAK1 inhibitor with therapeutic potential for various autoimmune diseases. Clinical trials in Chinese and western patient groups are being carried out, including phase II studies in China in three indications of rheumatoid arthritis, ankylosing spondylitis, and atopic dermatitis. Previously, LNK01001 has completed Phase I clinical studies in healthy subjects in China and Australia. The results of preclinical data show that LNK01001 has higher selectivity and potentially better safety than other marketed JAK inhibitors. It is expected to provide patients with newer, safer and more effective treatment options.

"We are very pleased to have reached the commercialization cooperation of LNK01001 with Simcere in China. It marks a big step forward towards commercialization for Lynk through Simcere’s marketing strength." Said Dr. Zhao-Kui (ZK) Wan, founder & CEO of Lynk Pharmaceuticals, "Simcere is an innovation and R&D-driven company that ranks among top Chinese pharmaceutical enterprises. Its proven commercialization excellence, combining with our R & D capability, will likely to create more benefit for the patients sooner."

Mr. Jinsheng Ren, Chairman and CEO of Simcere said: "Autoimmune disease therapeutic are one of Simcere’s three strategic focuses. We are very pleased to have reached this cooperation with Lynk Pharmaceuticals. We will work closely with our partner with all efforts, and accelerate the development and commercialization process of LNK01001, to bring safer and more effective treatments to patients."

On March 18, 2022 EpiVax reported the 1st Annual Tregitope Summit will be held on Monday, May 16th 2022 at the The Westin Boston Seaport District (Press release, EpiVax, MAR 18, 2022, View Source [SID1234610333]).

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Registration is now open!

Organizing Theme: Activation of Regulatory T Cells for Induction of Immune Tolerance

Interest in therapeutics specifically for inducing and activating Tregs by various approaches including administration of Tregitopes, is growing, and we see the need for an annual meeting for academic and industry researchers to share ideas, create new collaborations and continue to expand this growing therapeutic area.

Session 1: Treg cells as therapeutics
Chair: Dr. David Scott, Uniformed Services University Health System

Session 2: Protein Therapeutics (including Tregitopes) and antigen specific approaches to Address Tolerance: Therapeutics designed to Stimulate Tregs
Chair: Dr. Amy Rosenberg, EpiVax

We encourage you to attend this unique forum. Registration link here: https://bit.ly/EpiVaxTregitopeSummit

Attending Hanson Wade’s Treg Directed Therapies? We’ve planned the Tregitope Summit for the Monday before for ease of attendance!

On March 18, 2022 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies, reported unaudited financial results for the fourth quarter of 2021 (Press release, Legend Biotech, MAR 18, 2022, View Source [SID1234610387]).

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"Legend Biotech ended the fourth quarter with strong data on our lead product candidate and nearly $900 million in cash," said Ying Huang, PhD, Chief Executive Officer and Chief Financial Officer of Legend Biotech. "Both achievements put us in a strong position to commercialize CARVYKTI in 2022 and advance our pipeline."

Dr. Huang added: "As we close another quarter, I continue to be impressed by our incredible teams around the world. Thanks to their dedication, our pipeline candidates have shown tremendous promise across multiple therapeutic areas, including gastric cancer. As I look to the year ahead, I am confident that Legend will continue its work of realizing the promise of CAR-T."

Recent Highlights

The U.S. Food and Drug Administration (U.S. FDA) approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have received four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Legend Biotech and its collaboration partner Janssen Biotech, Inc. (Janssen) is progressing the CARTITUDE clinical development program in earlier lines across Phase 3 studies, including a collaborative study.
CARTITUDE-4 completed enrollment. The Phase 3, open-label study evaluates cilta-cel in patients with multiple myeloma who have received 1-3 prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent and are refractory to lenalidomide. The purpose of this study is to compare the efficacy of cilta-cel with standard therapy – either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
CARTITUDE-5 initiated enrollment. The Phase 3, randomized, open-label study compares bortezomib, lenalidomide and dexamethasone (VRd) induction followed by cilta-cel vs. VRd induction followed by lenalidomide and dexamethasone (Rd) maintenance in patients with newly diagnosed MM for whom autologous stem cell transplant (ASCT) is not planned as initial therapy (NCT04923893)
CARTITUDE-6 (not yet recruiting; sponsored by the European Myeloma Network). The Phase 3, randomized, open-label study compares daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by cilta-cel vs. DVRd followed by autologous stem cell transplant (ASCT) in newly diagnosed patients with MM who are transplant eligible (NCT05257083)
New and updated results from the CARTITUDE clinical development program studying cilta-cel in various clinical settings were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in 2021. Two-year follow-up data for CARTITUDE-1 were presented showing continued deep and durable responses of cilta-cel in patients with heavily pretreated MM.
A New Drug Application for cilta-cel was submitted to the Ministry of Health, Labour and Welfare (MHLW) in Japan by Janssen in December 2021.
New, preclinical in vivo data on Legend Biotech’s novel tri-specific, single-domain antibody (VHH) CAR-T (LCAR-AIO) were presented at ASH (Free ASH Whitepaper) 2021 as a poster (Abstract #1700). LCAR-AIO targets three antigens—CD19, CD20 and CD22.
Legend Biotech raised approximately $345 million in gross proceeds in a follow-on public offering of its American depositary shares (ADSs).
Marc L. Harrison was appointed Vice President and General Counsel of Legend Biotech in January 2022. Mr. Harrison brings more than 20 years of experience in healthcare and life sciences to the role. He previously served as Vice President, General Counsel and Head of Compliance at Breckenridge Pharmaceutical, Inc. and has held senior legal and leadership positions at Ipsen Biopharmaceuticals, Medco Health Solutions and WebMD.
A clinical hold was placed by the U.S. FDA in February 2022 on the Phase 1, open-label, multicenter clinical trial to evaluate LB1901, an investigational autologous CD4-targeted CAR-T therapy for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) (NCT04712864). Legend Biotech subsequently received an official clinical hold letter from the FDA dated March 1, 2022. In the letter, FDA stated that the reason for the hold is because the related IND does not contain sufficient information required by 21 CFR 312.23 to assess the risks to subjects.
Legend Biotech achieved two milestone payments amounting to $50 million, under the terms of its collaboration and license agreement with Janssen for the joint development and commercialization of cilta-cel.
Financial Results for the Quarter and Year Ended December 31, 2021

Cash Position

As of December 31, 2021, Legend Biotech had approximately $887.1 million of cash and cash equivalents, deposits and short-term investments.

Revenue

Revenue for the three months ended December 31, 2021 was $39.0 million compared to $40.8 million for the three months ended December 31, 2020. The decrease of $1.8 million was mainly due to the timing of when different milestones were achieved during those quarters.

Revenue for the year ended December 31, 2021 was $89.8 million, compared to $75.7 million for the year ended December 31, 2020. This increase of $14.1 million was primarily driven by revenue recognized from three additional milestones achieved in fiscal year 2021 and an exclusive licensing of certain patents to Nanjing Probio Biotech Co., Ltd and its affiliates during the year ended December 31, 2021. We have not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended December 31, 2021 were $86.5 million compared to $66.9 million for the three months ended December 31, 2020. This increase of $19.6 million was primarily due to continuous research and development activities in cilta-cel and for other pipelines in 2021. Research and development expenses in 2021 were $313.3 million, compared to $232.2 million for the year ended December 31, 2020, an increase of $81.1 million.

Administrative Expenses

Administrative expenses for the three months ended December 31, 2021 were $17.1 million compared to $9.2 million for the three months ended December 31, 2020. The increase of $7.9 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to facilitate continuous research and development activities as well as activities to establish elements of a commercialization infrastructure. Due to the consistent business expansion, administrative expenses for the year ended December 31, 2021 increased by $23.8 million, to $46.9 million, compared to $23.1 million for the year ended December 31, 2020.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended December 31, 2021 were $52.8 million compared to $24.2 million for the three months ended December 31, 2020. This increase of $28.6 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel launch. Due to the consistent business expansion, selling and distribution expenses for the year ended December 31, 2021 increased by $52.9 million, to $102.5 million, compared to $49.6 million for the year ended December 31, 2020.

Other Income and Gains

Other income and gains for the three months ended December 31, 2021 was $0.7 million compared to $2.1 million for the three months ended December 31, 2020. The decrease of $1.4 million was primarily driven by a decrease in foreign exchange gain. Other income and gains for the year ended December 31, 2021 was $3.1 million compared to $6.1 million for the year ended December 31, 2020. The decrease of $3.0 million primarily resulted from less interest income from time deposits of lower average interest rate and less government grants.

Other Expenses

Other expenses for the three months ended December 31, 2021 was $2.2 million compared to $0.3 million for the three months ended December 31, 2020. The increase of $1.9 million was primarily due to higher foreign exchange loss. Other expenses for the year ended December 31, 2021 was $9.1 million compared to $0.3 million for the year ended December 31, 2020. The increase was primarily due to foreign exchange loss and loss from disposal of assets.

Finance Costs

Finance costs for the year ended December 31, 2021 was $0.9 million, mainly composed of interest for advance funding, which is interest-bearing borrowings funded by the collaborator and constituted by a principal and applicable interests upon such principal. Finance costs for the year ended December 31, 2020 was $4.2 million, resulted from the finance costs for the issuance of convertible redeemable preferred shares (Series A Preferred Shares) that were fully converted into ordinary shares upon the completion of Legend Biotech’s initial public offering in June 2020.

Fair Value Loss of Warrant Liability

Fair value loss of warrant liability for the year ended December 31, 2021 was $6.2 million caused by changes in the fair value of a warrant that we issued to an institutional investor through a private placement transaction in May 2021 with initial fair value of $81.7 million at the issuance date. The warrant was assessed as a financial liability with a fair value of $87.9 million as of December 31, 2021.

Fair Value Loss of Convertible Redeemable Preferred Shares

For the year ended December 31, 2020, Legend Biotech reported a one-time non-cash charge of $80.0 million caused by changes of the fair value of its Series A Preferred Shares. Upon Legend Biotech’s listing of its ADSs on the Nasdaq Global Market, all outstanding Series A Preferred Shares were automatically converted into ordinary shares of Legend Biotech and all accrued but unpaid dividends were settled in the form of ordinary shares of Legend Biotech. No such fair value loss in 2021 as the Company has no outstanding preferred shares after the listing.

Loss for the Period

Net loss for the three months ended December 31, 2021 was $88.3 million, or $0.30 per share, compared to $57.8 million, or $0.22 per share, for the three months ended December 31, 2020. Net loss for the year ended December 31, 2021 was $386.2 million, or $1.37 per share, compared to $303.5 million, or $1.28 per share, for the year ended December 31, 2020.

On March 18, 2022 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, and Brookline Capital Acquisition Corp. (Nasdaq: BCAC, BCACU, BCACW), a special purpose acquisition company ("SPAC"), reported they have entered into a definitive business combination agreement (Press release, Apexigen, MAR 18, 2022, View Source [SID1234610334]). Upon closing of the transaction, Brookline Capital Acquisition Corp. will be renamed Apexigen, Inc. (the "Combined Company") and will be led by Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer of Apexigen. The Combined Company expects to list its stock on Nasdaq under the ticker symbol "APGN".

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A group of healthcare investors and existing Apexigen stockholders has committed to participate in the transaction through a $15 million common stock and warrant PIPE at a purchase price of $10 for a unit consisting of one share and a half warrant for one share. Gross proceeds of the transaction available to the Combined Company at closing will be approximately $73 million (assuming no redemptions from Brookline Capital Acquisition Corp.’s trust account and before transaction expenses). In addition, Brookline Capital Acquisition Corp. and Lincoln Park have entered into a committed investment agreement under which the Combined Company would have the right to direct Lincoln Park to purchase up to an aggregate of $50 million of common stock of the Combined Company over a 24-month period (subject to certain requirements under the investment agreement), providing financing flexibility to the Combined Company.

"We’re tremendously pleased with the strong support from our investors and Lincoln Park, as well as from the experienced team at Brookline Capital Acquisition Corp. and their public life science investment banking affiliate, Brookline Capital Markets," said Dr. Yang. "This transaction brings Apexigen public and strengthens our balance sheet to advance the Phase 2 development of our lead program, sotigalimab, as well as to maximize the therapeutic potential of Apexigen’s APXiMAB antibody discovery platform and innovative pipeline of other antibody therapeutics. We remain encouraged by emerging data from ongoing Phase 2 clinical trials of sotigalimab, a potentially first-in-class and best-in-class CD40 agonist that may provide superior clinical benefit across multiple important cancer indications. Together with Brookline Capital Acquisition Corp., we look forward to driving sotigalimab through Phase 2 development and delivering on our shared vision to overcome outstanding challenges in oncology."

Dr. Samuel P. Wertheimer, Chairman and Chief Executive Officer of Brookline Capital Acquisition Corp., commented, "We are thrilled to partner with Apexigen to power the next generation of immuno-oncology therapeutics. Apexigen’s validated APXiMAB antibody discovery platform and expanding pipeline hold significant promise across multiple cancer indications with high unmet needs, as well as potential applications beyond oncology. We have great confidence in management’s ability to lead Apexigen through this next phase of growth as a publicly listed company, to reach new inflection points across its pipeline and to drive long-term value for stockholders."

Apexigen Overview

Apexigen Wholly Owned Pipeline: Apexigen’s wholly owned pipeline is focused on innovative antibody-based therapeutics for oncology, with an emphasis on new immuno-oncology agents that may harness the patient’s immune system to combat and eradicate cancer. The company’s pipeline of immuno-oncology therapeutic candidates is led by sotigalimab, which is currently in Phase 2 clinical development, and also includes multiple preclinical programs.

Sotigalimab: a potentially first-in-class and best-in-class CD40 agonist antibody, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and safety. Activation of CD40 initiates and amplifies a multi-cellular immune response, engaging components of both the innate and adaptive arms of the immune system to work in concert against cancer. As such, CD40 activation could play a fundamental role in tumor-specific immune activation. To maximize the therapeutic potential of sotigalimab, several Phase 2 trials are currently underway across multiple important cancer indications, lines of therapy and combination settings.
Phase 2 preliminary data from sotigalimab in combination with chemoradiation as a neoadjuvant therapy in esophageal/gastro-esophageal junction cancer is expected 1H22.
Phase 2 preliminary data from sotigalimab in combination with standard of care chemotherapy in sarcoma is expected by year-end 2022.
The company intends to consult with the FDA about a potential registrational path in post-anti-PD-(L)1 melanoma in mid-2022.
APX601: an anti-TNFR2 antagonist antibody designed to reverse immune suppression in the tumor microenvironment and unleash immune-mediated tumor killing activity through a unique mechanism of action. APX601 can deplete and inactivate TNFR2-expressing Tregs, reverse myeloid-mediated T cell suppression and directly kill TNFR2-expressing tumor cells. APX601 shows potent anti-tumor activity and is well-tolerated in preclinical models. Apexigen plans to develop APX601 for the treatment of multiple tumor indications of unmet medical need and continues to progress toward a mid-2022 IND application filing.
APX801: an NK cell engager designed to specifically activate natural killer cells leading to effective killing of tumor cells.
Partnered Programs: Apexigen’s pipeline includes five out-licensed product candidates that were discovered using the APXiMAB platform. One of these out-licensed products is commercially available and generating royalties for Apexigen. The other out-licensed product candidates are advancing in clinical development.

APXiMAB discovery platform: This platform has enabled Apexigen and its licensing partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies.

Summary of Transaction
The transaction values Apexigen at $205 million on a net-equity basis, net of exercise proceeds for Apexigen’s pre-closing options and warrants. As a result of the transaction, gross proceeds available to the Combined Company at closing will be approximately $73 million funded by approximately $58 million in cash held in Brookline Capital Acquisition Corp.’s trust account (assuming no stockholders exercise their redemption rights at closing and before transaction expenses) and $15 million from a fully committed PIPE that involves the sale of units consisting of one share and half a warrant for one share at a purchase price of $10.00 per unit. The PIPE includes participation from healthcare institutional and individual investors. This does not include proceeds from Lincoln Park’s $50 million committed equity line.

In addition, Brookline Capital Acquisition Corp. and Lincoln Park have entered into a committed investment agreement and related registration rights agreement under which the Combined Company will have the right to direct Lincoln Park to purchase up to an aggregate of $50 million of common stock of the Combined Company over a 24-month period under certain conditions and restrictions as outlined in Brookline’s Form 8-K. Sales of shares of common stock to Lincoln Park would be subject to the filing and effectiveness of a registration statement with the Securities and Exchange Commission (the "SEC"), which would not occur until after closing the business combination between Apexigen and Brookline. Lincoln Park has agreed not to cause or engage in any manner in any direct or indirect short selling or hedging of shares of common stock of the Combined Company.

The Boards of Directors of Brookline Capital Acquisition Corp. and Apexigen have unanimously approved the merger and related agreements and transactions. Following the Merger, the Combined Company’s board of directors shall consist of seven members, of which Apexigen will select six and Brookline Capital Acquisition Corp. will select one. Completion of the merger is subject to approval of Brookline Capital Acquisition Corp. and Apexigen stockholders and other customary closing conditions, including the filing of a definitive proxy statement with the SEC. The parties currently expect to complete the transactions in July 2022.

Brookline Capital Markets is acting as capital markets advisor to Brookline Capital Acquisition Corp. Wedbush PacGrow is acting as exclusive strategic financial advisor to Apexigen.

DLA Piper LLP (US) is serving as legal advisor to Brookline Capital Acquisition Corp. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal advisor to Apexigen.

For more information, please visit www.brooklinecapitalacquisitioncorp.com.

Conference Call Information
Apexigen and Brookline Capital Acquisition Corp. will host a conference call today, Friday, March 18, 2022, at 8:30 a.m. Eastern Time, to discuss the proposed transaction. To access the conference call, please dial 1-877-407-9716 (domestic) or 1-201-493-6779 (international) at least 10 minutes prior to the start time and reference conference ID: 13727957. A live or archived webcast of the conference call can be accessed here or in the News & Events section of the Apexigen website at View Source

On March 18, 2022 Dr. Fred Aswad, SVP of Biology at Apeiron reported that it will present preclinical data on GTAEXS617, a novel, orally bioavailable, selective small-molecule inhibitor of CDK7 discovered using AI-driven drug discovery (Press release, GT Apeiron Therapeutics, MAR 18, 2022, View Source [SID1234610335]). GTAEXS617 is currently in IND-enabling studies. Preclinical data demonstrates that GTAEXS617 has favorable drug like properties and exhibits potent anti-tumour activity in HGSOC and TNBC xenograft tumour-bearing mice, resulting in complete tumour regression. Furthermore, by leveraging Exscientia’s precision oncology platform, Apeiron and Exscientia are examining the impact of GTAEXS617 on primary patient cancer samples to identify predictive biomarkers that may enable patient and indication enrichment in early clinical development.

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The AACR (Free AACR Whitepaper) Conference (American Association for Cancer Research) being held in New Orleans from April 8-13, 2022, is the focal point of the cancer research community.

Stay tuned for Apeiron session:
Title: AI-driven discovery and profiling of GTAEXS-617, a selective and highly potent inhibitor of CDK7
Session Title: Emerging New Anticancer Agents
Abstract Number: #3930
Date/Time: Wednesday, April 13 / 9:00 AM – 12:30 PM CT