AbbVie acquires LifeArc portfolio company DJS Antibodies

On October 20, 2022 AbbVie (NYSE: ABBV) reported that it has acquired LifeArc’s portfolio company DJS Antibodies Limited ("DJS"), a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs) (Press release, LifeArc, OCT 20, 2022, View Source [SID1234624139]).

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DJS’s lead programme is DJS-002, a potential first-in-class lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently in investigational preclinical studies for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases. IPF is an aggressive, high mortality disease caused by fibrotic scarring in the lungs and remains an area of high unmet medical need.

"We are excited to bring the innovative science behind DJS-002 and the talented team at DJS to AbbVie," said Jonathon Sedgwick, vice president and global head of discovery research at AbbVie. "This acquisition will deliver new capabilities to enhance our current antibody research activities, an opportunity to strengthen our immunology portfolio, and provide a strong foothold for expanded research efforts in the dynamic bioscience hub in Oxford, UK."

LifeArc co-led the £6m Series A financing in DJS Antibodies in 2020, recognising the potential of its HEPTAD platform to discover next generation antibody therapeutics.

Under the terms of the agreement, AbbVie will pay DJS shareholders approximately $255 million in cash at closing for the acquisition of DJS. DJS shareholders remain eligible for potential additional payments upon the achievement of certain development milestones related to the success of the DJS-002 programme. AbbVie anticipates retaining all current DJS employees and its facility in Oxford.

"The acquisition of DJS by AbbVie recognises DJS’s strong leadership and the potential of its exceptional science. LifeArc is proud to have invested in DJS and supported its growth through scientific and strategic guidance," said Clare Terlouw, Head of LifeArc Ventures.

DJS’s proprietary HEPTAD platform is a potential novel approach to antibody discovery with specific capabilities targeting transmembrane protein targets. A key benefit of this acquisition is for AbbVie, through DJS, to access the HEPTAD platform as a complement to its current robust capabilities in biotherapeutics research. DJS will leverage AbbVie’s extensive drug discovery expertise to continue generating antibody therapeutics and novel biology insights against targets like GPCRs, which have previously been intractable to biologics approaches.

"DJS was built on the principles of scientific curiosity and an aspiration to discover clinically-meaningful innovative medicines. We’ve been privileged to grow the company within the world-class scientific and entrepreneurial community of Oxford, from an initial concept through to a successful biotech comprising an extremely talented team," said David Llewellyn and Joe Illingworth, co-founders of DJS.

"The whole team is incredibly excited to take the next step in this journey with AbbVie as we work together to accelerate the translation of our lead programme into the clinic and develop an exciting research centre here in the UK."

NovaRock Biotherapeutics Announces Exclusive License Agreement with CSPC to Develop and Commercialize NBL-012 in Select International Territories

On October 20, 2022 NovaRock Biotherapeutics Ltd., a clinical-stage biotechnology company focusing on the development of innovative antibody therapies for cancer and inflammatory diseases, reported that it has entered a strategic collaboration and license agreement with Shanghai JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited ("CSPC"), for the development and commercialization of NBL-012 worldwide excluding US, Europe and Japan (Press release, NovaRock Biotherapeutics, OCT 20, 2022, View Source [SID1234623196]). CSPC has committed to advancing NBL-012 into Phase II studies in psoriasis and Inflammatory bowel diseases (IBD).

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Under the agreement, JMT-Bio will be responsible for the development and commercialization of NBL-012 in all indications in the licensed territories and share its clinical results with NovaRock. NovaRock will receive upfront and milestone payments, as well as royalties on future net sales in the licensed territories.

NBL-012 is a novel Interleukin 23 p19 neutralizing antibody, discovered and developed using NovaRock’s innovative antibody discovery platform. In the Phase I human trial, NBL-012 has demonstrated excellent safety profiles and superior pharmacokinetic properties compared to commercial products to the same molecular target. NBL-012 showed a significantly longer half-life and higher drug exposure in healthy human volunteers, suggesting a potential best-in-class candidate for treating psoriasis, IBD, and other hard-to-treat inflammatory diseases.

This collaboration between the two companies will enable the acceleration of the clinical development of NBL-012 and represents significant progress towards the advancement of NovaRock’s innovative portfolio into the global market.

As an antibody drug discovery engine, NovaRock strategically seeks partnerships with pharmaceutical and biotechnology companies to leverage their clinical, manufacturing, and commercial capabilities to facilitate the development of NovaRock’s pipeline products.

Entry into a Material Definitive Agreement

On October 20, 2022, Ionis Gazelle, LLC ("Ionis Gazelle"), a wholly owned subsidiary of Ionis Pharmaceuticals, Inc. ("Ionis"), reported that it entered into a purchase and sale agreement (the "Campus Purchase Agreement") with 2850 2855 & 2859 Gazelle Owner (DE) LLC (the "Campus Purchaser"), a subsidiary of Oxford Properties Group, pursuant to which Ionis Gazelle agreed to sell certain real estate located at 2850, 2855 and 2859 Gazelle Court, Carlsbad, California (the "Existing Campus") to the Campus Purchaser for a purchase price of $258.4 million (the "Campus Sale-Leaseback Transaction"), plus $5.0 million held in escrow (the "Additional Purchase Price"), subject to terms and conditions contained in the Campus Purchase Agreement (Filing, 8-K, Ionis Pharmaceuticals, OCT 20, 2022, View Source [SID1234622300]). The closing of the Campus Sale-Leaseback Transaction occurred concurrently with the parties’ execution of the Campus Purchase Agreement. On October 20, 2022, Ionis concurrently entered into a purchase and sale agreement (the "BTS Purchase Agreement") with Oxford I Asset Management USA Inc. (the "BTS Purchaser"), also a subsidiary of Oxford Properties Group, pursuant to which Ionis agreed to sell certain real estate consisting of vacant land located near the Existing Campus, comprising Lots 21 and 22, Carlsbad Oaks North Business Park, Carlsbad, California (the "BTS Property") to the BTS Purchaser for a purchase price of $33.0 million (the "BTS Sale-Leaseback Transaction"), subject to terms and conditions contained in the BTS Purchase Agreement. The closing of the BTS Sale-Leaseback Transaction will occur after, and is contingent upon, Ionis obtaining entitlements necessary to construct certain office and laboratory improvements on the BTS Property (the "Improvements"). If closing of the BTS Sale-Leaseback Transaction occurs, the purchase price for the Existing Campus will be deemed to have increased by $5.0 million, to $263.4 million in the aggregate, and the Additional Purchase Price will be released from escrow to Ionis.

Upon the closing of the Campus Sale-Leaseback Transaction, Ionis and the Campus Purchaser concurrently entered into a lease agreement (the "Campus Lease"), pursuant to which Ionis leases the Existing Campus from the Campus Purchaser for an initial term of 180 months (which term will automatically be extended to be co-terminus with the term of the BTS Lease (defined below), if closing of the BTS Sale-Leaseback Transaction occurs), with two renewal options of five years each. The total annual base rent under the Campus Lease is currently $15,542,037 per year, and will increase annually by the Consumer Price Index, subject to a floor of 2.5% and ceiling of 5.5%. Ionis will also be responsible for payment of all operating expenses, property taxes and insurance for the Existing Campus. Pursuant to the terms of the Campus Lease, Ionis has a right of first offer to purchase the Existing Campus should the Campus Purchaser intend to sell the Existing Campus to a third party.

If closing of the BTS Sale-Leaseback Transaction occurs, Ionis and the BTS Purchaser will enter into a lease agreement (the "BTS Lease"), pursuant to which Ionis will lease the to-be-constructed Improvements on the BTS Property from the BTS Purchaser for an initial term of 180 months, with two renewal options of five years each. Upon entering into the BTS Lease, the BTS Purchaser will, at its cost, construct the shell and core of the Improvements, and Ionis will, at its cost (but subject to reimbursement from a tenant improvement allowance from the BTS Purchaser), complete the tenant improvements for the Improvements. The term of the BTS Lease will commence on the date that is the earlier of (i) ten months following delivery of the Improvements to Ionis for commencement of construction of the tenant improvements, and (ii) the date Ionis begins operating in the premises for business purposes. The total annual base rent under the BTS Lease for the first year of the term will equal 6.35% multiplied by the costs incurred by the BTS Purchaser to acquire, design, construct, finance, and otherwise develop the shell and core of the Improvements, including, among other things, the tenant improvement allowance. Such base rent will increase annually by the Consumer Price Index, subject to a floor of 2.5% and ceiling of 5.5%. Ionis will also be responsible for payment of all operating expenses, property taxes and insurance for the BTS Property and Improvements. Pursuant to the terms of the BTS Lease, Ionis has a right of first offer to purchase the BTS Property and Improvements should the BTS Purchaser intend to sell the BTS Property and Improvements to a third party.

The foregoing description of the material terms of (i) the Campus Purchase Agreement is qualified in its entirety by reference to the full text of the Campus Purchase Agreement, (ii) the BTS Purchase Agreement is qualified in its entirety by reference to the full text of the BTS Purchase Agreement, and (iii) the Campus Lease is qualified in its entirety by reference to the full text of the Campus Lease, a copy of each of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the quarter and year ended December 31, 2022.

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Defeasance Agreement

On October 20, 2022, Ionis Gazelle, as "Original Borrower," entered into a Defeasance Pledge and Security Agreement (the "Defeasance Agreement") with Wells Fargo Bank, National Association, as Trustee for the Benefit of the Registered Holders of UBS Commercial Mortgage Trust 2017-C3, Commercial Mortgage Pass-Through Certificates, Series 2017-C3, as secured party (Trustee or its successors and assigns, "Lender"), and, for the sole purpose of agreeing to the provisions of Sections 6(a)(viii), 7, 8, 9(b), 12, 14, 15, 16, 22, 25 and 26 of the Defeasance Agreement, U.S. Bank Trust Company, National Association, a national banking association, as Securities Intermediary and Custodian (together with its successors and assigns, "Intermediary").

UBS AG, by and through its branch office at 1285 Avenue of the Americas, New York, New York ("Original Lender"), made a loan (the "Mortgage Loan") to Original Borrower in the original principal amount of $51.35 million, pursuant to a Loan Agreement dated July 18, 2017 between Ionis Gazelle and UBS AG (the "Loan Agreement"), and evidenced by (1) a Promissory Note A-1 dated July 18, 2017 in the original principal amount of $36.35 million (the "Note A-1"), (2) a Promissory Note A-2 dated July 18, 2017 in the original principal amount of $5.0 million (the "Note A-2"), and (3) a Promissory Note A-3 dated July 18, 2017 in the original principal amount of $10.0 million (Note A-1, Note A-2 and Note A‑3 are, individually and collectively, the "Note" or the "Notes"). The Mortgage Loan and the Notes were secured by, among other things, a Deed of Trust and Security Agreement dated July 18, 2017 from Original Borrower to and for the benefit of Original Lender (the "Security Instrument"), which granted to Original Lender, among other things, a lien on the real and personal property described in the Security Instrument (the "Mortgaged Property"). The Mortgage Loan was further evidenced or secured by various other documents, including guaranties, executed by Original Borrower and others in favor of Original Lender (together with the Notes, the Loan Agreement and the Security Instrument, the "Mortgage Loan Documents"). Original Lender assigned all of its right, title and interest in the Mortgage Loan and the Mortgage Loan Documents, by one or more assignments, to Lender in connection with the issuance of UBS Commercial Mortgage Trust 2017-C3, Commercial Mortgage Pass-Through Certificates, Series 2017-C3. Midland Loan Services, a division of PNC Bank, National Association ("Servicer"), is the Master Servicer under the Pooling and Servicing Agreement dated as of August 1, 2017.

Pursuant to the Mortgage Loan Documents, Original Borrower directed Lender to release the Mortgaged Property and all escrows and reserves from the liens and security interests of the Security Instrument and to release any other collateral or security previously given by Original Borrower as security for the Mortgage Loan upon Original Borrower’s defeasance of the Mortgage Loan (the "Defeasance"). Original Borrower is the legal and beneficial owner of the securities listed in Exhibit A to the Defeasance Agreement. Pursuant to the Mortgage Loan Documents, one of the conditions precedent to Lender’s obligation to release the lien of the Security Instrument on the Mortgaged Property is that Original Borrower grant a security interest in the Pledged Collateral, as defined in the Defeasance Agreement, to Lender to secure the payment and performance in full when due of all amounts payable under the Mortgage Loan Documents.

Following the execution of the Defeasance Agreement, Lender, Servicer, Original Borrower, DHC UBSCM 17 C3 Successor Borrower-R, LLC, a Delaware limited liability company ("Successor Borrower"), and Intermediary entered into the Defeasance Assignment, Assumption and Release Agreement, dated October 20, 2022 (the "Defeasance Assignment Agreement"), pursuant to which, among other things, Original Borrower transferred the Pledged Collateral, as defined in the Defeasance Agreement, to Successor Borrower and, to the extent set forth in the Defeasance Agreement and related documents, Successor Borrower assumed the rights and obligations of Original Borrower under (i) the Notes, (ii) the Defeasance Agreement, and (iii) the Defeasance Account Agreement dated as of October 20, 2022 among Original Borrower, Lender, Servicer, Intermediary and U.S. Bank National Association as account bank (the "Defeasance Account Agreement").

The foregoing description of the material terms of (i) the Defeasance Agreement is qualified in its entirety by reference to the full text of the Defeasance Agreement, (ii) the Defeasance Assignment Agreement is qualified in its entirety by reference to the full text of the Defeasance Assignment Agreement, and (iii) the Defeasance Account Agreement is qualified in its entirety by reference to the full text of the Defeasance Account Agreement, a copy of each of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the quarter and year ended December 31, 2022.

Plus Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights

On October 20, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the third quarter ended September 30, 2022, and provided an overview of recent business highlights (Press release, PLUS THERAPEUTICS, OCT 20, 2022, View Source [SID1234622267]).

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"The third quarter of 2022 was another period of significant progress for Plus Therapeutics, highlighted by the achievement of three key milestones," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "First, our CPRIT award of $17.6 million substantially funds the LM program through Phase 2 for our lead investigational drug, Rhenium-186 Nanoliposome (186RNL). Second, we moved 186RNL toward a Phase 2 trial for recurrent GBM, which we expect to initiate in the fourth quarter of 2022. Third, we met our timeline for cGMP 186RNL drug availability for all future trials. In addition, the combination of current cash, committed grant funding in conjunction with existing discretionary capital sources, secures our cash runway through 2025."

RECENT HIGHLIGHTS

On September 9, 2022, Dr. Andrew Brenner, ReSPECT-GBM trial principal investigator, presented Phase 1 results from the ReSPECT-GBM Phase 1/2a dose escalation trial evaluating 186RNL in patients with recurrent GBM at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. The Phase 1 results demonstrated safety and a potential efficacy signal in heavily pretreated patients with recurrent GBM.
On August 17, 2022, Plus Therapeutics announced the award of a three-year, $17.6 million Product Development Research grant by the Cancer Prevention & Research Institute of Texas (CPRIT) to fund 186RNL for the treatment of patients with LM.
On August 29, 2022, Plus announced a summary of its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the CMC program for 186RNL. The Company determined that it may proceed in utilizing its 186RNL in its planned Phase 2 programs.
On September 6, 2022, Plus announced a summary of its Type C meeting with the FDA regarding its clinical development program for 186RNL for recurrent GBM. Based on that meeting, the Company plans to begin a Phase 2 trial of 186RNL in patients with recurrent GBM, with a focus on small and medium-sized tumors. The Company will also continue exploration of both higher and multiple doses of 186RNL.
The Company initiated enrollment of Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with LM.
On October 18, 2022, at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM), the Company presented data from two ongoing clinical trials evaluating 186RNL in recurrent GBM and LM. The findings presented at EANM indicate the potential for 186RNL as a safe, well-tolerated and promising radiotherapeutic for both GBM and LM.
THIRD QUARTER 2022 FINANCIAL RESULTS

The Company’s cash balance was $20.3 million at September 30, 2022, compared to $18.4 million at December 31, 2021. The Company believes that the current cash on hand, anticipated funding from the National Institutes of Health (NIH) and CPRIT and existing discretionary capital sources are sufficient to fund both its currently planned overhead and development expenses through 2025.
Grant revenue of $73,000 was recognized in the third quarter of 2022, which represents CPRIT’s initial share of the costs incurred for development of 186RNL for the treatment of patients with LM. The Company expects the first CPRIT grant funds of approximately $1.9 million to be disbursed to the Company by October 31, 2022.
Total operating expenses for the third quarter of 2022 were $5.2 million, compared to total operating expenses of $3.5 million for the third quarter of 2021. The increase is due primarily to incremental CMC spend, now winding down, related to the development of GMP 186RNL drug and key regulatory consulting activities. In addition, to a lesser extent, the Company had a forecasted increase in litigation, legal, professional fees and other general corporate expenses.
Net loss for the third quarter of 2022 was $5.2 million, or $(0.19) per share, compared to a net loss of $3.7 million, or $(0.28) per share, for the third quarter of 2021.
UPCOMING EVENTS AND MILESTONES

During the remainder of 2022, the Company expects to accomplish the following key business objectives:

ReSPECT-GBM Phase 2 clinical trial initiation
Present updated data from the ReSPECT-GBM and ReSPECT-LM trials at the Society for Neuro-Oncology (SNO) Annual Meeting and Education Day, November 17-20, 2022
Complete Cohort 2 of ReSPECT-LM Phase 1/2a dose escalation trial
Submit an Investigational New Drug (IND) application to the FDA for the study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC), ependymoma and high-grade glioma
Complete certain key CMC and IND-enabling studies for 188RNL-BAM
Third Quarter 2022 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.

Beyond Air® Schedules Second Fiscal Quarter 2023 Financial Results Conference Call and Webcast

On October 20, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it will report financial results for its second fiscal quarter ended September 30, 2022 on Tuesday, November 8, 2022 (Press release, Beyond Air, OCT 20, 2022, View Source [SID1234622265]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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