On September 16, 2024 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that it has entered into securities purchase agreements with certain healthcare-focused and institutional investors to purchase (i) 9,090,910 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 18,181,820 shares of its common stock (the "Common Warrants") at a purchase price of $0.33 per share and associated Common Warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptevo Therapeutics, SEP 16, 2024, View Source [SID1234646668]). Each share of common stock is being offered together with two Common Warrants, each to purchase one share of common stock. The Common Warrants will have an exercise price of $0.33 per share, are exercisable upon stockholder approval, and will expire five years following the date stockholder approval.

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The offering is expected to close on or about September 18, 2024, subject to customary closing conditions. Roth Capital Partners is acting as placement agent of the offering. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $3.0 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-281892), that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on September 16, 2024. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected]. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company also has agreed to amend certain existing warrants that were previously issued in July 2024, April 2024 and November 2023 to purchase up to 11,822,774 shares of the Company’s common stock and have exercise price of $0.515 per share, effective upon the closing of the offering, such existing warrants will have a reduced exercise price of $0.33 per share and shall become exercisable upon stockholder approval.

On September 16, 2024 Debiopharm, a privately-owned, Swiss-based, biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported the signing of a partnership with WhiteLab Genomics (WLG), a Paris and Boston-based biotech company specializing in Artificial Intelligence for Genomic Medicine R&D (Press release, Debiopharm, SEP 16, 2024, View Source [SID1234646684]). This collaboration aims to achieve two key objectives. The first is to identify cancer-specific receptors that are overexpressed on the surface of cancer cells. The second is to find lead candidates capable of binding to these receptors. Once identified, these agents will be attached to the surface of lipid nanoparticles (LNPs) to enhance active tissue targeting.

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Lipid nanoparticles (LNPs) have emerged as a gold standard vector for drug delivery with the potential to transform the oncology landscape, particularly the genomic medicine field, through their high delivery efficacy. One of the challenges with LNPs is their tendency to accumulate in non-target organs like the liver, which limits their distribution to the desired site. To maximize LNPs potential, WLG is set to deploy its AI-powered platform to explore innovative in silico approaches for enhancing the targeted delivery capabilities of LNPs, creating new opportunities for therapeutic applications.

As a key investor in WLG, Debiopharm has consistently supported the company’s innovative approaches and cutting-edge solutions through Debiopharm’s Innovation Fund. This collaboration provides a significant opportunity to validate the potential of WLG’s AI platform and strengthen their ongoing relationship.

"WhiteLab’s innovative AI platform represents a significant advancement in the field of targeted cancer therapy. By improving the specificity and delivery of lipid nanoparticles, we aim to provide more effective treatments for patients suffering from hormonal cancers," said David Del Bourgo, CEO co-founder of WLG. "Our collaboration with a leading player such as Debiopharm further demonstrates our focus on developing cutting-edge solutions that have the potential to transform cancer treatments."

"As a company specialized in drug development, we know the hardships of the field and therefore we recognize the added value of AI powered platforms like the WhiteLab Genomics’ platform applied to the early stages of drugs R&D. We look forward to fully exploiting the potential of AI based solutions to develop drugs, de-risk assets, de-risk any toxicity, and ensure that we bring the most efficacious and personalized drugs to patients." said Betrand Ducrey, CEO of Debiopharm

On September 16, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported a poster presentation highlighting encouraging top-line results from its ongoing Phase 1 clinical study (NCT04900818) of givastomig, a novel first-in-class/ Claudin18.2 (CLDN18.2) and 4-1BB bispecific antibody immunostimulant, in patients with advanced cancers, especially gastric cancers (including gastroesophageal carcinoma, or GEC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, taking place in Barcelona, Spain (Press release, I-Mab Biopharma, SEP 16, 2024, View Source [SID1234646652]).

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Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2-positive tumor cells that conditionally activates T cells via the 4-1BB pathway in the tumor microenvironment, where Claudin 18.2 is expressed. Givastomig stands out among other Claudin 18.2-targeted therapies based on its nonclinical findings of localized, conditional activation, even in tumors with low levels of CLDN18.2 expression, and has exhibited a favorable safety profile in clinical trial participants to date.

"We believe givastomig has the potential to be a front-line treatment option for patients with gastric cancers. Data presented at ESMO (Free ESMO Whitepaper) 2024 show that givastomig demonstrated continued monotherapy efficacy signals in heavily pre-treated patients, especially gastric cancers with a range of Claudin 18.2 expression levels and a strong overall safety profile. Together, this profile supports our view that givastomig has the potential to be a differentiated, class-leading therapy," said Dr. Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "The first evaluation of givastomig as a front-line therapy for gastric cancers is underway. The Phase 1b dose expansion study will evaluate givastomig in combination with standard-of-care, nivolumab plus chemotherapy. We continue to be enthusiastic about the program, and we look forward to sharing the results from this study in the second half of 2025."

Poster Title: Updated Safety and Efficacy from the Phase I Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody Immunostimulant, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC), Poster 1017

Data are based on the ongoing Phase 1 study that includes results from the Phase 1a dose escalation segment presented at ESMO (Free ESMO Whitepaper) 2023 and additional data from the Phase 1b dose expansion segment. The Phase 1b segment will evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig.

The poster presents data on 43 patients with advanced gastroesophageal carcinoma (GEC) who were enrolled in the dose expansion study. Participants were required to have GEC tumors centrally confirmed to be CLDN18.2-positive (CLDN18.2+), defined as ≥1% of tumor cells with ≥1+ intensity by immunohistochemistry (IHC).

Key observations include:

Of the 43 patients with CLDN18.2+ GEC who received givastomig monotherapy at doses ranging from 5 to 18 mg/kg, partial responses were observed in seven patients (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg) with an objective response rate (ORR) of 16.3% (7/43 patients) for single agent givastomig. Five of the seven patients who had achieved a partial response (71%) had previously received a checkpoint inhibitor. Stable disease (SD) was reported in 14 patients, which resulted in a disease control rate ("DCR") of 48.8% (21/43 patients).

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No dose-limiting toxicity was reported up to 15 mg/kg Q2W and 18 mg/kg Q3W, and a maximum tolerated dose (MTD) was not identified.
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The most common treatment-related adverse events (TRAEs) were mainly grade 1 or 2.
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Givastomig exhibited a linear PK at doses ≥5 mg/kg and showed a dose-dependent increase in soluble 4-1BB levels, reaching a plateau at doses 8 mg/kg to 18 mg/kg.
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CLDN18.2 expression in responders ranged from 11% to 100%. Five responders had received prior treatment of PD-(L)1 inhibitors.

A full copy of the poster is available on the I-Mab website under the "Innovation – Publications & Presentations" tab.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2-positive tumor cells. It conditionally activates T cells in the tumor microenvironment where Claudin 18.2 is expressed using 4-1BB. Givastomig appears to maintain a strong tumor binding property and anti-tumor activity, attributable to a synergistic effect of proximal interaction with CLDN18.2 and 4-1BB, while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with other emerging 4-1BB product candidates. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction. A Phase 1b study is ongoing evaluating combination therapy with standard-of-care, nivolumab plus chemotherapy, in patients with front-line gastric cancers, including gastroesophageal cancer (NCT04900818).

The program is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding China and South Korea, equally with ABL Bio.

On September 16, 2024 WestGene Biopharma, a leading innovator in mRNA therapeutics, reported the latest clinical data for its EBV-positive tumour mRNA vaccine, WGc-043, during a mini-oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 (Press release, WestGene Biopharma, SEP 16, 2024, View Source [SID1234646669]).

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Pioneering Advances in mRNA Therapeutics

WGc-043, the world’s first mRNA therapeutic vaccine targeting EBV-positive tumors to achieve IND approval in both China and the US, demonstrated exceptional safety, immunogenicity, and anti-tumor activity in the latest clinical trials. The vaccine is being developed specifically for adult patients with advanced EBV-positive solid tumours and refractory or relapsed EBV-positive lymphomas, diseases for which there are currently no effective, low-toxicity treatment options.

Impressive Clinical Performance Recognized by ESMO (Free ESMO Whitepaper)

Interim clinical data presented at ESMO (Free ESMO Whitepaper) 2024 highlighted the vaccine’s ability to activate the patient’s immune system, leading to the production of cytotoxic T cells, antigen-specific antibodies and memory T cells that target and destroy cancer cells. This novel mechanism offers a promising alternative to conventional CAR-T and monoclonal antibody therapies and also aims to prevent tumor recurrence, providing a triple benefit, particularly for patients with late-stage nasopharyngeal carcinoma and NK/T cell lymphoma.

Innovative Technology and Global Impact

WGc-043 is a testament to WestGene’s proprietary mRNA platform, which includes cutting-edge innovations in mRNA sequence design, novel lipid nanoparticle (LNP) delivery systems, and scalable manufacturing processes. The vaccine was developed using WestGene’s patented LNP technology, which is recognized for its superior efficacy and safety. This technology has been instrumental in overcoming the challenges associated with mRNA vaccine delivery and has positioned WestGene as a leader in the global mRNA therapeutic

Expanding Horizons in Cancer Treatment

The global market for mRNA cancer vaccines is expected to grow significantly, with estimates ranging from $230 billion to $300 billion by 2035. The success of WGc-043 at ESMO (Free ESMO Whitepaper) underscores the potential of mRNA technology not only to lead the field, but also to accelerate clinical development and provide safe, effective treatments for late-stage cancer patients.

On September 16, 2024 CEL-SCI Corporation (NYSE American: CVM) reported new data from its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* that were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress on Saturday, September 14, 2024 in a poster titled "Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy" (Press release, Cel-Sci, SEP 16, 2024, View Source [SID1234646685]). This data is highly relevant to CEL-SCI’s 212 patient confirmatory Registration Study which has received the U.S. Food and Drug Administration’s (FDA) go-ahead and is currently under preparation.

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Summary of Phase 3 Study: Multikine-treated patients who were recommended treatment of surgery and radiotherapy had a nearly 4-year survival benefit over control group

As previously reported, CEL-SCI’s completed Phase 3 study of 923 patients showed that newly diagnosed head and neck cancer patients who were deemed at low risk for recurrence after surgery (and therefore recommended to receive only radiotherapy after surgery) had a median overall survival (OS) benefit of 46.5-months, almost 4-years, over control patients. However, patients who were deemed to be high risk for recurrence after surgery (and therefore recommended to have chemotherapy added to the radiotherapy after surgery) showed no survival benefit.

Upcoming FDA Confirmatory Registration Study

Since the completed Phase 3 study showed clear survival benefit for some, but not all of the patients, the FDA requested that CEL-SCI conduct a confirmatory Registration Study focusing on the patients who showed the best survival benefit. Based on the data, CEL-SCI determined this target population to be patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and with low PD-L1 tumor expression. Applying these selection criteria to the completed Phase 3 study of 923 patients resulted in the target population (n=114) having a 73% survival at 5 years vs a 45% survival at 5 years for the control patients, log rank p=0.0015. The hazard ratio was an exceptional 0.34, with a 95% confidence interval upper limit of 0.65; Wald p=0.0012 and achieving a 66% reduction in the overall risk of death.

Summary of New Data Presented at ESMO (Free ESMO Whitepaper)

The new data presented at ESMO (Free ESMO Whitepaper) includes a further analysis of the 114 patients in the completed Phase 3 study who met these target population selection criteria and form the basis for the confirmatory study. Specifically, the new analysis focused on those patients who were deemed low risk for recurrence (recommended to be given only radiotherapy – but no chemotherapy, per National Comprehensive Cancer Network "NCCN" guidelines) following surgery (n=79) as opposed to the selected patients who were deemed high risk for recurrence and who were recommended to have chemotherapy added to their treatment following surgery per the same guidelines (n=35).

While the overall survival benefit was clear and statistically significant (log rank p=0.0015) for the entire target population (n=114), the 79 patients who were recommended to receive only radiotherapy benefited to an even greater degree from pre-surgery treatment with Multikine than the group of 114 as a whole. This target low risk population (n=38) had a 5-year overall survival of 82.6% when treated with Multikine vs. 47.3% when treated with standard of care alone (n=41), without overlap in their respective 95% confidence intervals. More recent analysis for the target low risk population (n=79) showed a hazard ratio of 0.27 (95% CI [0.12, 0.64], Wald p=0.0027) achieving a 73% reduction in overall risk of death.

Management Commentary

"The additional data presented this weekend at ESMO (Free ESMO Whitepaper) 2024 provides further evidence that we have identified the target population that has the greatest survival benefit from Multikine, and that our study criteria can select for these patients upon diagnosis, before surgery," stated CEL-SCI CEO Geert Kersten. "It makes sense that Multikine, an immunotherapy, provides even greater benefit to patients who are not scheduled to receive chemotherapy following surgery, given the known detriments of chemotherapy on the immune system. Seeing more clearly than ever that patients who were not recommended chemotherapy benefited the most begs the question: What if, through better diagnostic technology such as the PET scan, which we will be using in the confirmatory study, resulting in better patient selection, we could treat only those patients who are supposed to be treated with radiotherapy alone, and not chemotherapy? The data presented at ESMO (Free ESMO Whitepaper) is clear. This would lead to even better 5-year survival, 82% instead of 73%."

CEL-SCI’s CSO Eyal Talor, Ph.D. commented, "The criteria we developed for selecting these locally advanced head and neck cancer patients clearly showed that when patients were treated with Multikine before surgery, they demonstrated an overall survival advantage over control irrespective of whether these patients were characterized as being at low- or high-risk for recurrence following surgery. With this new analysis we also saw that patients selected by these criteria who are deemed low risk for recurrence post-surgery have a further improved survival outcome with a hazard ratio of 0.27, which even is better than the already exceptional hazard ratio of 0.34 seen for the overall selected population."

The data were presented at ESMO (Free ESMO Whitepaper) 2024 by the study’s co-author József Tímár MD, PhD, DSc, Professor Department of Pathology, Forensic and Insurance Medicine at Semmelweis University in Budapest, Hungary. Dr. Timar served as the Director of the Central Pathology Laboratory for CEL-SCI’s IT-MATTERS Phase 3 study. With 174 peer reviewed studies published, Dr. Timar is a founding editor, editor in chief, or a member of the editorial board of four oncology journals. He is the recipient of a dozen honors and awards for excellence in cancer research and teaching.