On October 13, 2023 Aprea Therapeutics presented its corporate presentation (Presentation, Aprea, OCT 13, 2023, View Source [SID1234635942]).

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On October 12, 2023 Synaffix B.V., a Lonza company (SIX:LONN), focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported that its Founder and head of R&D, prof. Floris van Delft, will present data on the launch of two new technologies during a plenary session at the World ADC conference in San Diego, at 8.15 am PDT on Wednesday 18 October 2023 (Press release, Synaffix, OCT 12, 2023, View Source [SID1234636414]).

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GlycoConnectHigh DAR Technology

GlycoConnectenables any antibody to be converted into a stable conjugated ADC in a non-genetic fashion, by modifying the native antibody glycan using Synaffix’s efficient enzymes and metal-free click chemistry approach. The extension of GlycoConnectwith High DAR Technology enables ADCs with high drug loading (6, 8 and above), while retaining high drug substance homogeneity and therapeutic index.

SYN-PNU Linker-Payload

Synaffix’s proprietary toxSYN linker-payloads provide multiple options to maximize efficacy by matching the best mechanism of action with the tumor biology specific to the ADC target. The newest proprietary linker-payload, "SYN-PNU" is part of the established and expanding toxSYN linker-payload portfolio. SYN-PNU represents (based on pre-clinical models) a significantly potency-attenuated and better tolerated version of PNU-159,682, to enable enhanced administered dose levels and competitive therapeutic properties versus ADCs prepared using the original molecule. The reference compound (PNU-159,682) is metabolite of the anthracycline Nemorubicin and represents a highly potent DNA topoisomerase II inhibitor.

Prof. Floris van Delft, Founder and Chief Scientific Officer, Synaffix, said: "I look forward to presenting the underlying data supporting our new High DAR and SYN-PNU technologies at the World ADC conference, announcing the addition of a new and powerful Mode-of-Action (MoA) to our tox-SYN linker-payload toolbox and demonstrating how we can achieve higher drug loading on any antibody without departing from our ‘engineering free’ approach that all our clients love. We are excited by the potential of these new technologies to further enhance the ability of our licensees to discover, develop and commercialize ADCs with best-in-class therapeutic properties."

On October 12, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported an update on its Phase 3 open-label registrational clinical trial (the REGAL study) for galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy (CR2 patients) (Press release, Sellas Life Sciences, OCT 12, 2023, View Source [SID1234635946]).

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The Company expects to complete enrollment in the REGAL study, other than the 20-25 patients anticipated to be enrolled in China, in November 2023. The number of patients needed for the pre-specified interim and final analyses have already been enrolled. The interim analysis (after 60 events) is on track to occur in late 2023 or early 2024 and the final analysis (after 80 events) is on track to occur by the end of 2024. Because these analyses are event driven, they may occur at a different time than currently expected.

The Company anticipates that 3D Medicines Inc. (3D Medicines), its commercialization partner for GPS in Greater China, will begin enrolling patients in China in the REGAL study in the fourth quarter of 2023 which will trigger two development milestone payments totaling $13.0 million. The Company and 3D Medicines had previously projected that enrollment in China would commence in the third quarter of 2023, however, unforeseen supply-chain delays in China impacted the projected timeline. 3D Medicines has successfully obtained all regulatory permits, recruited investigators, and set up an expansive network of 11 treatment centers across China for participation in the REGAL study.

The next meeting of the Independent Data Monitoring Committee for the REGAL study is scheduled for the end of November 2023.

"We are pleased to be so close to achieving this most important milestone – the completion of enrollment in the REGAL study – and, at the same time, it is important to note that we already have a sufficient number of patients enrolled for the pre-specified analyses," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Furthermore, 3D Medicines’ enthusiasm for the REGAL study remains high. We expect the first patient dosing in China to take place this quarter which will trigger the milestone payment, and we are exploring options to potentially expedite the payment. Importantly, adding approximately 25 patients from China could potentially facilitate drug approval in this significant market, assuming positive data, further yielding additional milestone payments and royalties for SELLAS."

On October 12, 2023 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported that the Company will participate in the 3rd Annual Needham Private Biotech Company Virtual 1×1 Forum. The conference will be held virtually, from October 17-18, 2023 (Press release, Bexion, OCT 12, 2023, View Source;1-forum/ [SID1234635944]).

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Scott Shively, CEO and President of Bexion Pharmaceuticals, and Joyce LaViscount, Chief Financial Officer of Bexion Pharmaceuticals, will attend the conference.

On October 12, 2023, Applied Therapeutics, Inc. (the "Company") reported to have entered into an exchange agreement (the "Exchange Agreement") with entities affiliated with Venrock Healthcare Capital Partners (the "Exchanging Stockholders"), pursuant to which the Company exchanged an aggregate of 5,658,034 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), owned by the Exchanging Stockholders for pre-funded warrants (the "Exchange Warrants") to purchase an aggregate of 5,658,034 shares of common stock (subject to adjustment in the event of stock splits, recapitalizations and other similar events affecting common stock), with an exercise price of $0.001 per share (Filing, 8-K, Applied Therapeutics, OCT 12, 2023, View Source [SID1234635941]).

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The Exchange Warrants are immediately exercisable from the date of issuance and do not have an expiration date. They have an exercise price of $0.001. The Exchanging Stockholders may not exercise any Exchange Warrants that would cause the aggregate number of shares of common stock beneficially owned by the Exchanging Stockholder to exceed 9.99% of the Company’s outstanding common stock immediately after exercise. The Exchange Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the Exchanging Stockholders will be entitled to receive, upon exercise of the Exchange Warrants, the kind and amount of securities, cash or other property that the Exchanging Stockholders would have received had they exercised the Exchange Warrants immediately prior to such transaction. The Exchange Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of common stock are entitled.

The descriptions of the Exchange Agreement and the Exchange Warrants are not complete and are qualified in their entirety by reference to the Exchange Agreement and the form of Exchange Warrant, which are filed as Exhibit 10.1 and Exhibit 4.1, respectively, to this Current Report on Form 8-K and incorporated herein by reference.