On February 28, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases – including COVID-19, the disease caused by the SARS-CoV-2 virus – reported that the AMP-270 Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer ("LAPC") has opened its first clinical site and has begun recruiting patients (Press release, AIM ImmunoTech, FEB 28, 2023, View Source [SID1234627800]).

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The AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability.

Thomas K. Equels, M.S., J.D., Chief Executive Officer of AIM ImmunoTech, commented, "We continue to believe that Ampligen and the AMP-270 study have the potential to establish a much-needed new standard of care for LAPC where there remains a significant unmet need. Our team continues to execute on advancing this important study forward and we are pleased that the first of our sites is open for recruitment. We are working closely with preeminent cancer institutions across the United States and Europe to build momentum toward the commencement of patient enrollment and dosing and look forward to achieving those milestones as soon as possible."

AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The site at Gabrail Cancer & Research Center in Canton, Ohio, has opened, with additional clinical sites at other premier cancer centers across the U.S. and Europe expected to open and enroll patients in the near future.

For more information about the AMP-270 please visit ClinicalTrials.gov and reference identifier NCT05494697.

About Ampligen

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

On February 28, 2023 ADC Therapeutics SA (NYSE: ADCT) reported financial results for the fourth quarter and full year ended December 31, 2022, and provided business updates (Press release, ADC Therapeutics, FEB 28, 2023, View Source [SID1234627799]).

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Recent Highlights and Developments

ZYNLONTA (loncastuximab tesirine-lpyl)

• Revenue from the net sales of ZYNLONTA in the fourth quarter of 2022 increased to $19.8 million, a 16.5% increase over the same quarter in 2021, and $74.9 million for the full year 2022, partially offset by higher gross-to-net sales deductions. The sequential third quarter to fourth quarter slight decline of 7.0% in net sales was due to higher gross-to-net and individual ordering account fluctuations.

• The European Commission (EC) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for the use of ZYNLONTA (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

• The Company entered into a collaboration and clinical supply agreement with Roche to evaluate ZYNLONTA in combination with glofitamab and mosunetuzumab in addition to polatuzumab in the Phase 1 LOTIS-7 trial.

Cami (camidanlumab tesirine)

• Based on the positive pivotal Phase 2 data, the Company is actively seeking a partner to progress this program.

Pipeline

• ADCT-901 (targeting KAAG1): Dose escalation in the Phase 1 single-agent trial is progressing. The Company is amending the protocol to explore different dosing schedules to optimize the potential clinical outcomes for patients and in preparation for regulatory interactions.

• ADCT-601 (targeting AXL): Dose escalation in the Phase 1b trial is progressing and the IHC assay is under final validation. The study is comprised of a monotherapy arm including patients with sarcoma, non-small cell lung cancer and those with AXL gene amplification and a combination arm with gemcitabine in patients with sarcoma.

• ADCT-602 (targeting CD22): Initial data showing encouraging clinical activity from the Phase 1 study of ADCT-602 for patients with relapsed or refractory acute lymphoblastic leukemia were released in an oral presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting by The University of Texas MD Anderson Cancer Center.

Corporate Update

• Mohamed Zaki, MD, PhD, was appointed the Company’s new Chief Medical Officer (CMO), effective January 3, 2023. Dr. Zaki is a pharmaceutical industry veteran with over 20 years of experience in oncology and hematology drug development. Most recently, he served as Vice President & Global Head of Oncology Development at AbbVie. Dr. Zaki worked on ibrutinib, venetoclax, lenalidomide and pomalidomide, among many other notable therapies.

• Jose "Pepe" Carmona was appointed the Company’s new Chief Financial Officer (CFO), effective December 19, 2022. Mr. Carmona is a seasoned CFO with over 20 years of financial leadership optimizing capital formation, developing and implementing capital allocation strategies, managing multibillion-dollar international commercial businesses and executing partnerships in the pharmaceutical and biotech industry, both in the U.S. and internationally.

Upcoming Expected Milestones

ZYNLONTA

• European phased launch by partner Sobi in 2Q 2023

• Complete enrollment of the LOTIS-5 study in 2024

• Preliminary safety and efficacy data from the LOTIS-9 study in 2024

• Preliminary safety and efficacy data from the LOTIS-7 study in 2024

Pipeline

ADCT-901 (targeting KAAG1)

• Preliminary data from Phase 1 dose escalation study in 1H 2024

ADCT-601 (targeting AXL)

• Preliminary data from Phase 1 dose escalation/expansion study in 1H 2024

ADCT-212 (targeting PSMA)

• Initiate Phase 1 study in 1H 2024

ADCT-602 (targeting CD22)

• Complete Phase 1 dose expansion study in 1H 2024

ADCT-701 (targeting DLK-1)

• Initiate Phase 1 study in 2H 2023

Fourth Quarter and Full Year Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $326.4 million as of December 31, 2022, compared to $380.9 million as of September 30, 2022. This does not include the $50.0 million milestone received in February 2023 from Sobi, triggered by European regulatory approval of ZYNLONTA in third-line DLBCL. Based on the Company’s business plan and expected $75.0 million milestone from HealthCare Royalty Partners, triggered by the first EU commercial sale, the Company expects its cash runway now extends into the middle of 2025.

Product Revenue

Net product revenue was $19.8 million for the fourth quarter and $74.9 million for the full year ended 2022, compared to $17.0 million for the same quarter and $33.9 million for the full year ended 2021. Net product revenues are for U.S. sales of ZYNLONTA which commenced in May 2021. The 120.9% year-over-year increase was principally due to a full year of sales activity in 2022 as compared to a partial year in 2021. The increase in sales volume was partially offset with higher gross-to-net deductions.

License Revenue

License revenue was $50.0 million for the fourth quarter of 2022. The Company recognized $50.0 million from Sobi for the European regulatory approval of ZYNLONTA in third-line DLBCL. License revenue was $135.0 million for the full year 2022 and included the $50.0 million European regulatory approval milestone from Sobi, as well as $85.0 million in upfront payments from our partners, Sobi and Mitsubishi Tanabe Pharma Corporation.

Cost of Product Sales

Cost of product sales was $0.5 million for the fourth quarter and $4.6 million for the full year 2022, compared to $0.8 million for the same quarter and $1.4 million for the year full 2021. The increase of $3.2 million for the year was primarily associated with $2.5 million of impairment charges for product intermediates and antibodies that did not meet the Company’s specifications. The specification issues did not, and are not expected to, impact the Company’s ability to supply commercial product. In addition, cost of product sales increased due to a full year of sales activity in 2022 as compared to 2021 due to the commencement of ZYNLONTA sales in May 2021.

Research and Development (R&D) Expenses

R&D expenses were $48.7 million for the fourth quarter and $187.9 million for the full year 2022, compared to $42.5 million for the same quarter and $158.0 million for the full year 2021. R&D expenses increased as a result of continued investments in the pipeline.

Selling and Marketing (S&M) Expenses

S&M expenses were $16.2 million for the fourth quarter and $69.1 million for the full year 2022, as compared to $18.6 million for the same quarter and $64.8 million for the full year 2021. The decrease in S&M expenses for the quarter was primarily due to lower share-based compensation expense. The increase in S&M expenses during the year is primarily due to increased professional expenses relating to the commercial launch of ZYNLONTA during the year partially offset by lower share-based compensation expense.

General and Administrative (G&A) Expenses

G&A expenses were $15.1 million for the fourth quarter and $72.0 million for the full year 2022, compared to $17.9 million for the same quarter and $71.5 million for the full year. G&A expenses decreased during the fourth quarter primarily due to lower share-based compensation expense. G&A expenses for the full year increased primarily due to higher professional fees and costs associated with the CEO transition, partially offset by lower share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $24.2 million, or a net loss of $0.30 per basic and diluted share for the fourth quarter and $155.8 million, or a net loss of $1.99 per basic and diluted share for the year ended December 31, 2022. This compares to a net loss of $34.4 million, or a net loss of $0.45 per basic and diluted share, for the same quarter and $230.0 million, or a net loss of $3.00 per basic and diluted share, for the year ended December 31, 2021.

Adjusted net loss, which is a non-IFRS financial measure, was $7.9 million, or an adjusted net loss of $0.10 per basic and diluted share for the fourth quarter and $81.7 million, or an adjusted net loss of $1.05 per basic and diluted share for the full year ended December 31, 2022. This compares to an adjusted net loss of $30.0 million, or an adjusted net loss of $0.39 per basic and diluted share, for the same quarter and $186.1 million, or an adjusted net loss of $2.42 per basic and diluted share, for the year ended December 31, 2021.

The decrease in net loss and adjusted net loss for the quarter and year ended December 31, 2022, as compared to the same period in 2021, was primarily due to higher product and license revenue, partially offset by the increase in operating expenses. The decrease in net loss for the quarter and year-ended December 31, 2022 was also attributable to lower share-based compensation expense and

income arising from changes in the fair value of our convertible loan derivatives and warrant obligations, offset by the extinguishment of our convertible loans and derivatives.

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 diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), 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 February 28, 2023 AbbVie (NYSE: ABBV) reported that it will participate in the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023 (Press release, AbbVie, FEB 28, 2023, https://news.abbvie.com/news/press-releases/abbvie-to-present-at-cowen-43rd-annual-health-care-conference.htm [SID1234627798]). Robert A. Michael, vice chairman and president, Scott Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, will present at 8:10 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 28, 2023 2seventy bio, Inc. ("2seventy bio") (Nasdaq: TSVT), a cell and gene therapy company focused on the research, development, and commercialization of transformative treatments for cancer, reported that it has commenced an underwritten public offering of $100 million of shares of its common stock (Press release, 2seventy bio, FEB 28, 2023, View Source [SID1234627797]). All of the shares in the proposed offering are being offered by 2seventy bio. In addition, 2seventy bio intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Cowen and Company, LLC and SVB Securities LLC are acting as joint book-running managers for the offering.

The securities are being offered by 2seventy bio pursuant to 2seventy bio’s registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2022 and became effective on November 18, 2022. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, NY 10282, telephone: (866) 471-2526, facsimile: (212) 902-9316, email: [email protected]; Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected] or by telephone at (833) 297-2926; or SVB Securities LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

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

On February 28, 2023 Clinical-stage oncology entity Prescient Therapeutics (ASX: PTX) focused on the development of novel and personalised cancer-related therapies reported its half-year report for the period ended 31 December 2022 (Press release, Prescient Therapeutics, FEB 28, 2023, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-reports-progress-in-cancer-studies-during-h1-fy23-kalkine-media [SID1234627785]).

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The company has highlighted an increase in net assets for the period, besides the "strong financial position" of PTX following a capital raise of AU$11.3 million through a Share Purchase Plan (SPP) and a top-up placement. In November last year, the company also received a tax refund of AU$1.6 million by the Australian government for its research & development activities.

Below are the other major operational highlights of Prescient Therapeutics during the reported report.

Targeted Therapies
PTX-100

Prescient reports that its PTX-100 received the Orphan Drug Designation from the US Food and Drug Administration (FDA) during the half year ended December 2022. This pertained to PTX-100’s use in treatment for peripheral T cell lymphomas (PTCL). The FDA designation is a special status for drugs that are designed to treat rare diseases, Prescient says.

PTX-100 also continued to demonstrate encouraging efficacy and safety profile during the half year with respect to patients with relapsed and refractory TCL. The drug trial has advanced to an expansion cohort of 12 patients, with Professor H. Miles Prince, AM leading this endeavour.

PTX-200

PTX 200 — Prescient’s novel PH domain inhibitor — is undergoing trial at the Moffitt Cancer Centre. PTX says that the study so far on four patients exhibited complete responses and on one patient reflected a partial response. The drug is being studied to treat relapse and refractory acute leukaemia.

Cell Therapies
OmniCAR

A major development was Prescient’s collaboration during the reported period with the US-based The University Texas MD Anderson Cancer Centre. This effort is targeted to provide adaptable CAR-T cell therapies for the treatment of haematological malignancies.

PTX also entered into a manufacturing services agreement for OmniCAR with Q-Gen Cell

Therapeutics. The latter is a specialised cell therapy manufacturer. Q-Gen is related to the QIMR

Berghofer Medical Research Institute, which is one of Australia’s biggest manufacturers of cell-based drugs. It is stated by PTX that Q-Gen would incorporate the former’s CellPryme-M enhancement in the production process of OmniCAR T cells.

A material transfer agreement was also signed with a large international entity, targeted at manufacturing of OmniCAR T cells using non-viral methods..

CellPryme

Unveiled at the annual CAR-TCR Summit, Boston, the CellPryme-A cell therapy enhancement platform is administered in combination with cellular immunotherapy, PTX says. CellPryme-A has the capability to enhance CAR-T therapies’ tumor killing ability. PTX further says that the benefits of CellPryme-A increase when combined with CAR-T cells that used CellPryme-M in the production process.

PTX has said that its CellPryme technologies, cited above, are all set for clinical trials.

The half-year report for period ended 31 December 2022 also includes a mention of business outlook, with PTX seeking to "maintain the positive momentum" and build further on previous achievements.

PTX shares were trading at AU$0.089 in the early hours of 28 February 2023.