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SELLAS Life Sciences Provides Update on Phase 3 REGAL Clinical Trial for Galinpepimut-S in Acute Myeloid Leukemia

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."

Bexion Pharmaceuticals, Inc. to Participate in the 3rd Annual Needham Private Biotech Company Virtual 1×1 Forum

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]).

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

Entry into a Material Definitive Agreement

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]).

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.

Mission Bio’s Tapestri Platform Leveraged by Top Academic and Pharma Institutions to Pinpoint Disease-Driving Clones in Multiple Myeloma

On October 12, 2023 Mission Bio, the pioneer in high-throughput, targeted single-cell DNA and multi-omics analysis, reported data underscoring the ability of the Tapestri Platform to potentially impact cancer therapy by correlating cell surface protein expression of potential therapeutic targets with multiple myeloma (MM) clonal populations (Press release, Mission Bio, OCT 12, 2023, View Source [SID1234635922]). This breakthrough data demonstrates the potential for single-cell multi-omics to improve myeloma patient stratification and disease surveillance.

Annually, MM, a blood cancer originating from bone marrow, results in approximately 200,000 new diagnoses globally. Despite advancements in blood cancer research, MM showcases a daunting 100% relapse rate and a mere 54% five-year survival rate, prompting a wave of precision therapy development. Mission Bio’s Tapestri Platform is a unique tool that provides detailed information on clonal evolution and potential therapeutic targets at a single-cell level of resolution. Such insights into MM, acute myeloid leukemia (AML), and other blood cancers could augment, or even replace, multiple other assays that each provide only a fraction of the patient’s disease characteristics.

At two recent industry-leading events, Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio, and Adam Sciambi, PhD, co-founder and Chief Technology Officer at Mission Bio, took center stage to present this late-breaking MM data generated by Hervé Avet-Loiseau, MD, PhD, from The Cancer Research Center of Toulouse, and Genentech’s Director of Translational Medicine, Cedric Dos Santos, PhD. In the novel, proof-of-concept project, the Tapestri Platform was used to characterize the clonal architecture of multiple MM patient samples by single nucleotide variants (SNVs), copy number variants (CNVs), and surface immunophenotypes — marrying flow cytometry and bulk next-generation sequencing (NGS), but offering single-cell resolution.

The approach demonstrates the potential of Tapestri to move beyond a binary "yes/no" answer to the presence or absence of disease, but also provide researchers and clinicians with critical information about MM disease progression and offer actionable personalized therapeutic target information that could enhance patient outcomes. The data were presented at the 13th World Clinical Biomarkers & CDx Summit and the 20th International Myeloma Society Annual Meeting and Exposition.

"Following our successful launch of the scMRD AML Multiomics Assay, where clinician researchers from Memorial Sloan Kettering Cancer Center and Erasmus MC utilized the Tapestri to characterize relapse and recurrence in AML, we are excited now to see institutions like The Cancer Research Center of Toulouse and Genentech demonstrate additional Tapestri capabilities in MM clonal profiling and surveillance," said Dr. Druley. "At Mission Bio, we are dedicated to supporting our academic and pharma customers by providing novel solutions to advance research and the deployment of personalized therapy for these debilitating blood cancers."

Mission Bio will host a webinar titled "Myeloma Matters: Advancing Research and Therapy Development with Single-cell DNA + Protein Multi-Omics" on October 18, 2023, with Dr. Druley and Dr. Sciambi. Registration is open to the public and additional information can be found here.

EpimAb Biotherapeutics and Almirall Announce Bispecific Antibody License Agreement

On October 12, 2023 EpimAb Biotherapeutics, a clinical stage biopharmaceutical company specializing in the development of multispecific antibodies, and Almirall, a global biopharmaceutical company focused on medical dermatology, reported a license agreement on the development of bispecific antibodies for up to three undisclosed target pairs (Press release, EpimAb Biotherapeutics, OCT 12, 2023, View Source [SID1234635919]).

Under the terms of this agreement, Almirall will gain a license to utilize EpimAb’s proprietary Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform technology to generate, develop and commercialize bispecific antibodies, for which Almirall will have exclusive global rights. In exchange, EpimAb is eligible to receive milestone payments totaling up to $210 million contingent upon launch and commercial success of multiple products, plus royalties on net sales for any commercialized product. Further financial details were not disclosed.

"We are pleased to partner with Almirall to expand the application of our FIT-Ig technology beyond the oncology space," said Dr. Chengbin Wu, CEO and founder of EpimAb. "While we have made significant progress in utilizing our platform technology to develop a differentiated portfolio of bispecific antibodies in oncology, the potential of our platform in other areas such as immunology remains untapped. We believe Almirall is the partner of choice for this endeavor and look forward to exploring the use of our novel bispecific platform to offer additional treatment options for patients with immune-related disorders."

Karl Ziegelbauer, Executive Vice President R&D and Chief Scientific Officer of Almirall, commented that "This agreement with EpimAb is an important step forward and a great example of our ambition to develop new biologics in the dermatology field to ultimately bring innovation to patients."

FIT-Ig, EpimAb’s proprietary technology platform, generates bispecific antibodies solely utilizing the basic structural parts of monoclonal antibodies without adding any complex changes, and is patented in all major markets of the world. With four bispecific molecules advanced into the clinic using this technology, EpimAb has also demonstrated the potential of this novel platform to rapidly advance drug candidates from idea to development.