On October 5, 2023 Bayer AG reported that it has entered into an antibody discovery, option, and license agreement with Twist Bioscience Corporation, a company offering high-quality synthetic DNA using its silicon platform (Press release, Bayer, OCT 5, 2023, View Source [SID1234635676]).

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The company’s "Library of Libraries", a collection of synthetic antibody libraries that harness innovative structural and developability features to cover a wide range of antibody drug targets, is tailored to address specific challenges in antibody discovery.

It has the potential to increase the probability of success of antibody discovery programs across indications and focus areas.

"Partnering with Twist Bioscience complements our strategy to advance breakthrough innovations based on new scientific approaches and platform technologies," said Juergen Eckhardt, M.D., Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Business Development, Licensing & Open Innovation. "Their ‘Library of Libraries’ offers an optimal design to accelerate drug discovery processes to make a meaningful impact in patients’ lives faster."

Under the terms of the agreement, Twist will receive payments connected with the initiation of research and will be eligible to receive fees associated with research activities. The antibody leads discovered under the collaboration that enter clinical development qualify for certain success-based clinical and commercial milestone payments as well as royalties from product sales. In total, Twist is eligible to receive up to USD 188 million in clinical and commercial milestone payments plus royalties. In return, Bayer receives exclusive rights to license the antibodies for commercialization in all global territories.

On October 5, 2023 Artios Pharma Limited (Artios), a clinical-stage biotech company led by pioneers of DNA damage response ("DDR") drug development, reported that the Company will unveil data from the initial Phase 1 study of its ataxia telangiectasia and Rad-3 related ("ATR") kinase inhibitor ART0380 as part of a poster presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) 2023 taking place October 20 to 24, 2023 in Madrid, Spain (Press release, Artios Pharma, OCT 5, 2023, View Source [SID1234635675]).

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ART0380 is a competitive, oral, highly potent, and selective ATR inhibitor undergoing clinical evaluation as monotherapy in patients with solid tumors as well as in combination with chemotherapies in patients with molecularly selected cancers. Monotherapy data presented will include safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy.

Poster presentation details:

First results from the phase I trial of the ATR inhibitor, ART0380, in advanced solid tumors

Presenter: Kathleen Moore, Stephenson Cancer Center at the University of Oklahoma, Oklahoma City, United States of America

Poster Number: 680P

Session and Location: Developmental Therapeutics, Hall 8

Presentation Date and Time: Monday, October 23 from 12 – 13 CEST

On October 5, 2023 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported the pricing of its previously announced underwritten public offering of common stock and pre-funded warrants (Press release, ALX Oncology, OCT 5, 2023, View Source [SID1234635674]). ALX Oncology is selling 7,370,690 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,250,000 shares of common stock in the offering. The shares of common stock are being sold at a public offering price of $6.38 per share, the closing price on October 4, 2023, and the pre-funded warrants are being sold at a public offering price of $6.379 per pre-funded warrant, which represents the per share public offering price for each common share less the $0.001 per share exercise price for each pre-funded warrant. The gross proceeds to ALX Oncology from this offering are expected to be approximately $55.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any pre-funded warrants. All shares of common stock and pre-funded warrants to be sold in the offering are being offered by the Company. In addition, ALX Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,293,103 shares of its common stock at the public offering price per share less underwriting discounts and commissions. The offering is expected to close on or about October 10, 2023, subject to the satisfaction of customary closing conditions.

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ALX Oncology anticipates using the net proceeds from the offering to fund the continued clinical development of evorpacept and the related clinical trials, including ASPEN-06 clinical trial, and for working capital and other general corporate purposes.

Piper Sandler and Cantor are acting as joint lead book-running managers for the offering. UBS Investment Bank is also acting as a book-running manager for the offering. LifeSci Capital and H.C. Wainwright & Co. are acting as lead managers for the offering.

The securities described above are being offered by ALX Oncology pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected] or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 October 5, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a scientific article highlighting the 4-1BB FcγR-conditional agonist antibody ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer (Press release, Alligator Bioscience, OCT 5, 2023, View Source [SID1234635673]).

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The publication in the journal Cancer Immunology, Immunotherapy demonstrates how the design, detailed binding epitope (binding site) on 4-1BB and molecular properties of ATOR-1017 translate into very potent activity both in vitro and in vivo, as monotherapy and in combination with anti-PD-1 treatment, while being well tolerated in preclinical models.

ATOR-1017 binds to a unique epitope on 4-1BB enabling the activation of T cells, including cells with an exhausted phenotype, and NK cells, in a cross-linking dependent, FcγR-conditional manner. This translates into a tumor-directed and potent anti-tumor therapeutic effect in vivo, which is further enhanced with anti-PD-1 treatment.

The full article, entitled "ATOR-1017, an Fc-gamma receptor conditional 4-1BB agonist designed for optimal safety and efficacy, activates exhausted T cells in combination with anti-PD-1", is available online via this link.

"The publication of this article in the renowned scientific journal Cancer Immunology, Immunotherapy is an important recognition of our research into 4-1BB as a target for cancer immunotherapy," said Søren Bregenholt, CEO of Alligator Bioscience. "The first generation of 4-1BB agonists were limited by poor efficacy and unacceptable safety profiles but the preclinical data presented in this article, and the results of our recent Phase 1 dose-escalation study, demonstrate how ATOR-1017 is both a potent 4-1BB agonist and a safe and well tolerated drug candidate with a significant therapeutic potential."
In September 2022, Alligator announced that its Phase 1 open-label dose-escalation study of ATOR-1017 in patients with histologically confirmed, advanced, and/or refractory solid cancer (NCT04144842) had successfully met its primary objective to investigate the safety and tolerability of ATOR-1017 at therapeutic doses. ATOR-1017 demonstrated excellent safety and tolerability at doses up to 900 mg and stable disease as the best tumor response confirmed its previously reported indications on clinical benefit.

On October 5, 2023 Novartis reported that it will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, highlighting latest developments from across its oncology portfolio and addressing unmet needs of patients diagnosed with some of the most prevalent cancers, including prostate and breast (Press release, Novartis, OCT 5, 2023, View Source,some%20of%20the%20most%20prevalent [SID1234635654]).

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Key data from the Phase III PSMAfore trial investigating PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan) as an earlier line of treatment for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have not been exposed to a taxane-containing regimen will be presented. PSMAfore met its primary endpoint of radiographic progression-free survival (rPFS) in December 2022, and data collection for the key secondary endpoint of overall survival (OS) is ongoing. Data from the primary rPFS analysis and the second interim OS analysis will be presented at ESMO (Free ESMO Whitepaper).

"Metastatic prostate cancer has a five-year survival rate of about 30 percent, and patients who progress despite taking androgen-receptor pathway inhibitor therapy need additional treatment options with reduced toxicity," said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development at Novartis. "Pluvicto is the first and only approved, targeted radioligand therapy to significantly extend life in patients with mCRPC who have been treated with ARPI therapy and taxane-based chemotherapy. We look forward to sharing new data from the Phase III PSMAfore trial, which adds to the growing body of evidence demonstrating the potential of our radioligand therapy platform in earlier lines of therapy."

Key highlights of data accepted by ESMO (Free ESMO Whitepaper) include:

Medicine Abstract title Presentation Number / Presentation Details
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Phase 3 trial of [177Lu]Lu-PSMA-617 in taxane-naïve patients with metastatic castration-resistant prostate cancer (PSMAfore) Presentation Number #LBA13
Presidential 3 (Proffered Paper session):
Monday, October 23,
17:10 – 17:22 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) First real life data on [177Lu]Lu-PSMA-617: Descriptive analysis on the largest metastatic castration-resistant prostate cancer (mCRPC) cohort treated in early access in France Presentation Number #1814P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Enzalutamide and 177Lu-PSMA-617 in poor-risk metastatic, castration-resistant prostate cancer (mCRPC): a randomized phase 2 trial: ENZA-p (ANZUP 1901) Presentation Number #LBA84
Proffered Paper session:
Friday, October 20,
16:40 – 16:50 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Prognostic value of neutrophil-to-lymphocyte ratio and lymphopenia in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with [177Lu]Lu-PSMA-617: VISION post-hoc analysis Presentation Number #1838P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Association of health-related quality of life with efficacy outcomes in the VISION study of patients with metastatic castration-resistant prostate cancer Presentation Number #1810P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Molecular features of circulating tumour cells (CTCs) associate with response to 177Lu PSMA 617 plus pembrolizumab for metastatic castration resistant prostate cancer (mCRPC). Presentation Number #1825P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Kisqali (ribociclib)* Invasive disease-free survival (iDFS) across key subgroups from the Phase III NATALEE study of ribociclib (RIB) + a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2- early breast cancer (EBC) Presentation Number #LBA23
Mini oral session:
Monday, October 23,
17:05 – 17:10 CEST
Kisqali (ribociclib)* First-line ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in aggressive HR+/HER2- advanced breast cancer (ABC): a subgroup analysis of patients (pts) with or without visceral crisis from the Phase II RIGHT Choice study Presentation Number #402P
Poster available:
Saturday, October 21,
9:00 – 17:00 CEST
Kisqali (ribociclib)* Quality of life (QOL) analysis from the Phase II RIGHT Choice study of first-line ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in aggressive HR+/HER2- advanced breast cancer (ABC) Presentation Number #456P
Poster available:
Saturday, October 21,
9:00 – 17:00 CEST
Lutathera (lutetium Lu 177 dotatate) A Prospective Phase II Single-Arm Trial on Neoadjuvant Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE Followed by Surgery for Pancreatic Neuroendocrine Tumors (NeoLuPaNET) Presentation Number #1186MO
Mini oral session:
Sunday, October 22,
17:25 – 17:30 CEST

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