On January 29, 2024 Immunocore Holdings plc (Nasdaq: IMCR), reported its intention to offer, subject to market and other conditions, $300.0 million aggregate principal amount of convertible senior notes due 2030 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Immunocore, JAN 29, 2024, View Source [SID1234639680]). Immunocore also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $45.0 million aggregate principal amount of the notes.

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The notes will be senior, unsecured obligations of Immunocore, will accrue interest payable semi-annually in arrears and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. Upon conversion, Immunocore will deliver ordinary shares represented by American Depositary Shares (the "ADSs") (each currently representing one of Immunocore’s ordinary shares), together with, if applicable, a cash payment in lieu of delivering any fractional ADS, at the then-applicable conversion rate. The interest rate, initial conversion rate and other terms of the notes will be determined at the pricing of the offering.

Immunocore intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to accelerate its clinical pipeline and for ongoing commercial expansion. In addition, Immunocore intends to repay in full loans outstanding under its loan agreement with investment funds managed by Pharmakon Advisors, LP. Immunocore intends to use any remaining proceeds for other working capital and general corporate purposes.

The offer and sale of the notes, the ADSs deliverable upon conversion of the notes and the ordinary shares represented thereby have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes, such ADSs and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes, the ADSs deliverable upon conversion of the notes or the ordinary shares represented thereby, nor will there be any sale of the notes, such ADSs or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On January 29, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the Company will focus its resources in two strategic areas: (1) prioritize the clinical development of a randomized trial for its HB-200 program in human papillomavirus 16 positive (HPV16+) head and neck squamous cell carcinoma (HNSCC) and (2) its two Gilead-partnered infectious disease cure programs for hepatitis B and human immunodeficiency virus (Press release, Hookipa Pharma, JAN 29, 2024, View Source [SID1234639679]).

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In the first-line setting HB-200, in combination with pembrolizumab, has demonstrated best-in-class antigen specific T cell activation and has doubled the historic objective response rates of standard of care treatment alone. The totality of the HB-200 data presents a clear opportunity for HOOKIPA to advance this program in a randomized trial starting in mid-2024.

"HOOKIPA has a tremendous opportunity to transform treatment of multiple disease areas using an entirely new class of medicines," said Joern Aldag, Chief Executive Officer at HOOKIPA. "As we move forward with our randomized trial for HB-200 in combination with pembrolizumab, we have made an important decision to focus our resources and pursue this opportunity in earnest. We will focus on clinical delivery and execution so that we can help address a significant unmet need for patients with advanced HPV16+ head and neck cancer."

The Company also announced that it has received notification from Roche of their decision to terminate the collaboration and licensing agreement for HOOKIPA’s HB-700 program in KRAS mutated cancers. To date, HOOKIPA has met all go-forward criteria under the agreement and remains eligible for a final milestone payment associated with IND submission. Effective April 25, 2024, HOOKIPA will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for this program. As part of its strategic refocus, HOOKIPA will pause development activities related to HB-300 and most of its preclinical research activities.

HOOKIPA will reduce its workforce by approximately 30 percent and rebalance its cost structure in alignment with the new prioritization of the Company’s programs. HOOKIPA maintains a strong cash position of $117.5 million1 as of December 31, 2023, and believes that the planned reductions will help to conserve resources and better align its organization in direct support of late-stage clinical development efforts.

Pipeline Update and Upcoming Catalysts-

The strategic priorities for HOOKIPA are to advance its clinical programs including HB-200 and its two Gilead-partnered infectious disease programs. The Company is planning to submit an IND for HB-700 in the first quarter of 2024 and will begin searching for a collaboration partner. At this time, the company will not pursue further preclinical programs into development and pause further development of its HB-300 to conserve capital and ensure pipeline success and operational efficiency.

Program Indication Upcoming Catalysts
Oncology Programs
HB-200 HPV16+ HNSCC
Additional first-line data for HB-200 in combination with pembrolizumab (1H 2024)
Initiation of randomized trial (mid-2024)
HB-700 KRAS
IND submission (1Q 2024)
Publication of preclinical research (1H 2024)
Search for new collaboration partner

Infectious Disease Programs: Gilead-Partnered
HB-400 HBV
Gilead-led: Phase 1b actively enrolling
Next milestone: Phase 2 initiation (Timing TBD)
HB-500 HIV
Initiation of Phase 1 trial
First patient dosed, milestone payment (1H 2024)

Paused Programs
HB-300 Prostate Cancer
Paused and utilize capital to support HB-200 development
Preclinical Multiple targets

Cash position as of December 31, 2023, is unaudited

On January 29, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 7,756,233 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $1.805 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market (Press release, Checkpoint Therapeutics, JAN 29, 2024, View Source [SID1234639678]). In addition, in a concurrent private placement, Checkpoint will issue and sell unregistered warrants to purchase up to 7,756,233 shares of common stock. The warrants will have an exercise price of $1.68 per share, will be exercisable immediately upon issuance and will expire five years following the issuance date.

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H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

The closing of the offering is expected to occur on or about January 31, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $14 million. Checkpoint intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the planned resubmission of its Biologics License Application ("BLA") for cosibelimab.

The shares of common stock (or common stock equivalents) described above (but not the unregistered warrants issued in the concurrent private placement or the shares of common stock underlying such unregistered warrants) are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333-270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, and subsequently declared effective on May 5, 2023. The shares of common stock (or common stock equivalents) offered in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

The unregistered warrants described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement with the SEC or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which 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 January 29, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported positive top-line results from the OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer (Press release, Alligator Bioscience, JAN 29, 2024, View Source [SID1234639677]). The open-label, multi-center study assessed the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients.

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The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone.[1]

The cut-off time for analysis was November 14, 2023 with a median follow-up duration of 12.7 months. At the time of the analysis, a total of 29 (51%) patients were still alive, of these 18 (32%) were still on treatment. The longest ongoing treatment duration was 23 months. Three patients demonstrated complete remission of their target lesions. The study further demonstrated:

Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the NAPOLI 3 Phase 3 trial[2]
An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX[2]
The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX[1] and 45.6% for NALIRIFOX[2]
Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX[2]
Mitazalimab’s manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed
As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up.

"We are very pleased to announce that the OPTIMIZE-1 study has successfully met its primary endpoint, with the data demonstrating that when combined with mFOLFIRINOX, mitazalimab provides significant survival benefit to pancreatic cancer patients compared to the standard of care," said Søren Bregenholt, CEO of Alligator Bioscience. "The unprecedented duration of response is to us a clear confirmation of the strong immune activation that mitazalimab triggers, which translates into a much improved overall survival. As of today, more than half of the patients are still in the study and we expect these promising data to improve even further."
"It is very rewarding for us to see the OPTIMIZE-1 top-line results demonstrate the clear clinical signal and survival benefit of mitazalimab in combination with mFOLFIRINOX," said Prof. Jean-Luc van Laethem, Head of the Digestive Oncology Clinic in the Gastroenterology Department of Erasmus Hospital (ULB) Brussels and Principal Investigator of the OPTIMIZE-1 trial. "Metastatic pancreatic cancer is particularly hard to treat due to its highly complex and aggressive nature, so for mitazalimab to have delivered such data in previously untreated patients is a remarkable and promising outcome."
"Successfully meeting its primary endpoint, together with a very long durability of response and median overall survival, is a highly encouraging result for the OPTIMIZE-1 study, which demonstrates mitazalimab’s potential in pancreatic cancer," said Dr. Zev Wainberg, Professor of Medicine at University of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal (GI) Oncology Program. "With current therapeutic options so limited, I remain highly optimistic that mitazalimab can have a significant impact on the way pancreatic cancer is treated and I look forward to the next stage of its clinical development. These data also warrant a broader evaluation of mitazalimab in other tumor types."
Phase 3 expected to start in early 2025
Alligator Bioscience has undertaken discussions with the US Food and Drug Administration (FDA) and has been able to establish a clear development and approval pathway for mitazalimab in pancreatic cancer. Based on the emerging data from the OPTIMIZE-1 study, FDA has provided additional guidance and has endorsed OPTIMIZE-1 as a Phase 3 enabling study. Consequently, mitazalimab can proceed directly to a global Phase 3 registration study, which Alligator is preparing to initiate in early 2025.

Mitazalimab has been granted orphan drug designation in pancreatic cancer by both FDA and the European Medicines Agency (EMA).

Webcast – Monday 29th January 2024 – 4 pm CET / 10am ET
A webcast will be held today, January 29th 2024, at 4pm CET / 10am ET, to discuss the top-line data of the mitazalimab OPTIMIZE-1 Phase 2 study with Dr. Zev Wainberg, Professor of Medicine at University of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal (GI) Oncology Program. A formal presentation will be followed by a Question and Answer Session.

Please use the following link to connect to the webcast via Alligator’s Youtube channel.

On January 29, 2024 (the "Effective Date"), Abbott Laboratories, an Illinois corporation ("Abbott"), reported to have entered into a Five Year Credit Agreement (the "Revolving Credit Agreement") with the lenders from time to time party thereto and JPMorgan Chase Bank, N.A., as administrative agent (Filing, 8-K, Abbott, JAN 29, 2024, View Source [SID1234639676]).

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The Revolving Credit Agreement provides Abbott with the ability to borrow up to $5 billion on an unsecured basis. Any borrowings under the Revolving Credit Agreement will mature and be payable on the fifth anniversary of the Effective Date. As of the date of this Current Report on Form 8-K, there are no outstanding borrowings under the Revolving Credit Agreement.

Abbott’s borrowings under the Revolving Credit Agreement will bear interest, at Abbott’s option, based on either a base rate or a SOFR rate, plus an applicable margin based on Abbott’s credit ratings in effect from time to time. Abbott will also pay to the lenders under the Revolving Credit Agreement certain customary fees.

The Revolving Credit Agreement contains representations and warranties and affirmative and negative covenants customary for unsecured financings of this type as well as customary events of default.

The foregoing description of the Revolving Credit Agreement is qualified in its entirety by reference to the full text of the Revolving Credit Agreement, a copy of which will be filed with Abbott’s annual report on Form 10-K for the period ending December 31, 2023.

Some of the lenders under the Revolving Credit Agreement and/or their respective affiliates have in the past performed, and may in the future from time to time perform, investment banking, financial advisory, lending and/or commercial banking services, or other services for Abbott and its subsidiaries, for which they have received, and may in the future receive, customary compensation and expense reimbursement.