On April 4, 2022 Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported a publication in Nature Communications on the preclinical development of davoceticept, Alpine’s lead immuno-oncology therapeutic candidate uniquely designed to combine PD-L1-dependent CD28 costimulation with dual PD-L1 and CTLA-4 checkpoint inhibition (Press release, Alpine Immune Sciences, APR 4, 2022, View Source [SID1234611404]). CD28 is a critical T cell receptor recognized as a principal target of immune checkpoints like PD-1 and CTLA-4.

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"Lack of sufficient CD28 costimulation in the tumor microenvironment may underlie checkpoint inhibitor resistance and, therefore, CD28-directed treatments hold much promise. Davoceticept is an exciting first-in-class CD28-targeting drug that is distinct among others in this space for its triplicate mechanism and structural elegance," said Rafi Ahmed, PhD, Professor of Microbiology and Immunology and Vaccine Center Director at Emory University, and member of Alpine’s scientific advisory board.

"This achievement is the culmination of years of our scientists’ efforts to target CD28 in a highly differentiated fashion," remarked Stanford Peng, MD PhD, President and Head of R&D at Alpine. "It distinctively illustrates the unique yet powerful approach of our discovery platform, and further encourages us to continue to pursue clinical development of davoceticept with vigor."

Davoceticept is being studied in two clinical trials, NEON-1 as monotherapy, and NEON-2 in combination with pembrolizumab, in adults with advanced malignancies. Data from NEON-1 will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans on April 12.

About Davoceticept (ALPN-202)

Davoceticept (ALPN-202) is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor intended for the treatment of cancer. Preclinical studies of davoceticept have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. Completion of dose escalation and initiation of expansion cohorts of NEON-1 (NCT04186637), a Phase 1 monotherapy dose escalation and expansion trial in patients with advanced malignancies, is anticipated in the first half of 2022. NEON-2 (NCT04920383), a combination study of davoceticept (ALPN-202) and pembrolizumab was initiated in June 2021 and is currently on partial clinical hold.

On April 4, 2022 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that three posters featuring two pipeline programs (HFB200603 and HFB101110) and our Drug Intelligent Science (DIS) driven predictive biomarker approach will be presented at AACR (Free AACR Whitepaper) 2022, which will be held April 8-13, 2022, in New Orleans, LA (Press release, HiFiBiO Therapeutics, APR 4, 2022, View Source [SID1234611402]).

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"We are excited to share with the oncology research community at AACR (Free AACR Whitepaper) updates for two of our preclinical development programs – HFB200603, a novel anti-BTLA blocking antibody on track for IND submission, and HFB101110, an anti-CCR8 depleting antibody that was recently licensed to FibroGen. We will also present work using our DISTM approach to discover predictive biomarkers of response for our clinical programs HFB200301, a first in class TNFR2 agonist and HFB301001, a differentiated second generation OX40 agonist for the treatment of advanced DISTM selected solid tumors," said Francisco Adrian, Chief Scientific Officer of HiFiBiO Therapeutics. "HiFiBiO’s innovative DIS approach leveraging single cell capabilities is positioned to transform the drug discovery and development paradigm by integrating deep understanding of immune-modulation with a world-leading single cell platform and machine learning-enabled data analysis."

Details on the posters are as follows:

Title: HFB200603, a novel anti-BTLA monoclonal antibody that provides therapeutic potential for immune escape and synergizes with anti-PD-1 treatment
Permanent Abstract Number: 4248
Session: Therapeutic Antibodies 3
Session Date and Time: Wednesday, April 13, 2022; 9:00 am – 12:30 pm
Venue: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 39

Title: Targeting regulatory T cells with HFB101110, a novel anti-human CCR8 antibody for the treatment of solid tumors
Permanent Abstract Number: 2899
Session: Therapeutic Antibodies 2
Session Date and Time: Tuesday, April 12, 2022; 9:00 am – 12:30 pm
Venue: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 38

Title: Discovery of predictive biomarkers of response to T cell-targeting biologics using ex vivo single-cell profiling coupled with TCR clonotype characterization
Permanent Abstract Number: 618
Session: Immune Response to Therapies 2 / Immune Monitoring and Clinical Correlates
Session Date and Time: Sunday, April 10, 2022, 1:30 – 5pm
Venue: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 39

On April 4, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that a permanent J-code, J9359, has been issued for ZYNLONTA by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2022 (Press release, ADC Therapeutics, APR 4, 2022, View Source [SID1234611401]).

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J-codes are permanent reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B injectable drugs like ZYNLONTA that are administered by a physician. Claims submission and documentation are simplified with a permanent J-code, facilitating and streamlining the billing and reimbursement process.

The permanent J-code for ZYNLONTA, J9359 (Injection, loncastuximab tesirine-lpyl, 0.075 mg), took effect April 1, 2022. The permanent J-code is also published online on the CMS website here.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On April 4, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Quality, Affordable Self-Care Products, reported that it has launched a private offering (the "Offering") of $500 million aggregate principal amount of senior notes due 2030 (the "Notes"), subject to market and other conditions, through its indirect wholly-owned subsidiaries, Perrigo Investments, LLC and Perrigo Investments Capital, Inc. (together, the "Issuers") (Press release, Perrigo Company, APR 4, 2022, View Source [SID1234611400]).

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The Company intends to use the net proceeds from the Offering, together with cash on hand and borrowings under the term loan facilities of its previously-announced syndication of new senior secured credit facilities, to finance the proposed acquisition (the "Acquisition") of Héra SAS ("Héra") and to refinance certain existing indebtedness of the Company and its subsidiaries, including its outstanding term loan facility, its 4.00% Senior Notes due 2023 and its 5.1045% Guaranteed Senior Notes due 2023.

The Notes are expected to be fully and unconditionally guaranteed on a senior unsecured basis by Perrigo and each of Perrigo’s subsidiaries that provide guarantees under the new senior secured credit facilities.

The closing of the Offering is not conditioned on, and it is expected that the Offering will be consummated prior to, the closing of the Acquisition. Concurrently with the closing of the Offering, the Issuers expect to deposit into a segregated escrow account an amount of cash equal to the gross proceeds of the Offering, plus the amount of interest that will accrue on the Notes to and including December 31, 2022. If (i) the Acquisition has not been consummated on or prior to December 31, 2022, (ii) the acquisition agreement is terminated in accordance with its terms, or (iii) the Acquisition is otherwise abandoned, the Issuers will be required to redeem all of the Notes at a redemption price equal to 100% of their principal amount, plus accrued and unpaid interest to, but excluding, the redemption date.

The terms of the proposed refinancing, including but not limited to the principal amount and interest rate of the Notes, and the consummation of the acquisition of Héra, are subject to a number of significant conditions, and there can be no assurance that the Company will consummate any of these transactions on the anticipated terms or timing, or at all.

The Offering will be made in a private transaction in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), only to investors who are reasonably believed to be "qualified institutional buyers," as that term is defined in Rule 144A under the Securities Act, and to non-U.S. persons outside of the United States pursuant to Regulation S under the Securities Act. The Notes have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from, or in a transaction not subject to, such registration requirements.

This press release is not an offer to sell or the solicitation of an offer to buy the Notes, nor shall there be any sale of the Notes in any state or other jurisdiction where such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On April 4, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported abstract acceptance with a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in New Orleans from April 8-13, 2022 (Press release, Spectrum Pharmaceuticals, APR 4, 2022, View Source [SID1234611399]).

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Session title and information for the poster is listed below and is now available on the AACR (Free AACR Whitepaper) online itinerary planner.

Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations
Session Title: PO.CL11.03 – Cell-Free DNA 2
Session Date and Time: Tuesday, April 12, 2022; 1:30 PM – 5:00 PM CT
Location: New Orleans Convention Center, Section 31
Abstract / Poster: 3400 / 6

Copies of the presentation will be available on Spectrum’s website at View Source following presentation at the meeting.