On December 13, 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 that it will host a corporate update webinar on Wednesday, January 3, 2024, at 8:30 a.m. Eastern Time (Press release, Sellas Life Sciences, DEC 13, 2023, View Source [SID1234638532]).

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Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, will discuss the Company’s achievements in 2023 and provide an outlook for 2024. Dr. Stergiou will be joined by two key opinion leaders and principal investigators who will discuss the Phase 3 registrational REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia and the clinical program for SLS009, the Company’s CDK9 inhibitor:

Dr. Panagiotis Tsirigotis, Professor of Hematology, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece
Dr. Tapan Kadia, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, Texas
To access the webinar, please use the following information:

Date: Wednesday, January 3, 2024
Time: 8:30 a.m. Eastern Time
Dial-in (U.S.): 1-877-423-9813
International Dial-in: 1-201-689-8573
Webcast: SELLAS Update Call

On December 13, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s joint researcher, Mrs. Belén Toledo Cutillas, has commenced an internship at the Cancer Center Amsterdam – vUMC (University Medical Centers). In addition to Propanc Biopharma providing the financial resources to develop PRP, funding from two international grants has enabled Mrs. Toledo to join the Molecular Oncology Laboratory at the Cancer Center Amsterdam. Research by this team of scientists, led by Professor Elisa Giovanetti, focuses on chemotherapy resistance in pancreatic cancer (Press release, Propanc, DEC 13, 2023, View Source [SID1234638531]).

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"Chemotherapy is still considered an irreplaceable front-line therapeutic strategy to treat cancer. But multidrug resistance represents a common hurdle that profoundly compromises clinical outcomes, especially in pancreatic cancer. It is key to identify new drugs that could reduce chemoresistance and thus combat tumors with existing treatments," said Mrs. Toledo. The preclinical research undertaken by Mrs. Toledo at the Cancer Center Amsterdam focuses on the effects of pancreatic proenzyme formulation (PRP) on a panel of chemoresistant cancer cell lines that had previously been established in Professor Giovanetti’s lab.

"We wanted to evaluate the effect of PRP in the widest range of pancreatic cancer cell lines to gain a better idea how this treatment may affect actual tumors," said Mrs. Toledo. "So far, we have obtained very promising results. PRP seems not only to reduce chemoresistance of pancreatic tumor cells, but also appears to alter the tumor microenvironment."

Dr Julian Kenyon, MD, MB, ChB, Propanc’s Chief Scientific Officer said, "We are pleased to continue to drive success through our joint research partners, and Belén’s investigation into the effects of PRP as a chemosensitizing agent has significant implications for the planned clinical development of PRP as a novel therapy for the treatment and prevention of metastatic cancer. Tumor resistance to frontline chemotherapy means a poor prognosis for survival, especially in pancreatic cancer. We look forward to investigating the clinical effects of PRP in patients as we progress with future planned clinical trials, where an opportunity for a combinatorial therapeutic strategy may be uncovered to treat resistant tumors."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

For a full transcript of the interview with Mrs. Belén Toledo Cutillas, please click the following link: View Source

On December 13, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported the peer-reviewed publication in Frontiers in Immunology of preclinical data highlighting the potential of KVA12123 as a new immunotherapy against poorly immunogenic tumors (Press release, Kineta, DEC 13, 2023, View Source;utm_medium=rss&utm_campaign=kineta-publishes-preclinical-data-demonstrating-the-potential-of-anti-vista-antibody-kva12123-as-an-immunomodulatory-therapy-for-cancer [SID1234638530]). The publication titled "A Highly Potent Anti-VISTA Antibody KVA12123 – A New Immune Checkpoint Inhibitor and a Promising Therapy Against Poorly Immunogenic Tumors", reports on the development of KVA12123.

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"This scientific article summarizes the extensive characterization and selection of our clinical candidate KVA12123 that targets VISTA, a strong driver of immune suppression in the tumor microenvironment," said Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. "These data demonstrate that our engineered IgG1 anti-VISTA antibody binds to a unique epitope at neutral and acidic pH and has significant potential to address immuno-resistance in cancer patients."

Key results from the publication include:

High affinity binding to VISTA through a unique epitope that is distinct from other clinical-stage anti-VISTA mAbs
High specificity against VISTA with no cross-reactivity against other members of the B7 family
Blockade of VISTA binding to all four of its respective ligands
Ability to reverse T cell suppression by myeloid-derived suppressor cells, one of the main drivers of immune suppression in the tumor microenvironment
Ability to induce T cell and NK-mediated monocyte activation
Strong single-agent antitumor activity in several syngeneic tumor models and enhanced efficacy in combination with anti-PD-1
On-target induction of cytokines/chemokines associated with VISTA blockade
Well tolerated in preclinical toxicology studies without antibody-dependent cellular cytotoxicity or induction of CRS-related cytokines
"We are excited to share the discovery, characterization and preclinical development of KVA12123 in Frontiers in Immunology, a well-known journal in the field," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "The publication highlights the differentiating potency and safety characteristics of KVA12123 that guided its advancement into clinical development. Our Phase 1/2 trial with KVA12123 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors is on track, demonstrating early promising safety and biomarker results in the clinic."

KVA12123 is currently being evaluated in a Phase 1/2 VISTA-101 open-label clinical trial as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors (NCT05708950). Additional clinical efficacy data in the monotherapy arm and initial combination data with pembrolizumab are anticipated in Q2 2024.

On December 13, 2023 HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) ("HUTCHMED") reported that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma ("RCC") in China (Press release, Hutchison China MediTech, DEC 13, 2023, View Source [SID1234638529]).

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The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC. The primary endpoint is progression free survival ("PFS") per RECIST 1.1 as assessed by blinded independent central review (BICR). The secondary endpoints include objective response rate ("ORR"), disease control rate ("DCR"), duration of response ("DoR"), time to response (TTR), overall survival ("OS"), safety, and quality of life. A total of 234 patients have been enrolled in the study. The leading principal investigators are Dr Dingwei Ye of Fudan University Shanghai Cancer Center and Dr Zhisong He of Peking University First Hospital. Additional details may be found at clinicaltrials.gov, using identifier NCT05522231.

The first patient in China received the first dose on October 27, 2022 and HUTCHMED expects to announce topline results from the study around year end 2024. If favorable, the results would enable a New Drug Application submission to China’s National Medical Products Administration ("NMPA").

About Kidney Cancer and RCC

It is estimated that approximately 430,000 new patients were diagnosed with kidney cancer worldwide in 2020.1 In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2020.2 Approximately 90% of kidney tumors are RCC.

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

About Fruquintinib and Second-line treatment of RCC

Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combination with other anti-cancer therapies including the approved PD-1 inhibitor, sintilimab.

The U.S. Food and Drug Administration ("FDA") has approved five immune-oncology combination therapies for first-line treatment of advanced RCC, however, no immune-oncology combination therapies have been approved in China, indicating an unmet medical need in these settings.

As presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), a proof of concept study of fruquintinib plus sintilimab demonstrated promising efficacy and tolerable safety profile in this setting. At the data cutoff date of November 30, 2022, all 20 enrolled previously treated patients were efficacy evaluable, and median follow-up duration was 23.3 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and mPFS was 15.9 months. OS was not reached.

On December 13, 2023, Genprex, Inc. (the "Company") reported to have entered into an At The Market Offering Agreement (the "Agreement") with H.C. Wainwright & Co., LLC, serving as agent (the "Agent") with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share (the "Common Stock"), having an aggregate offering price of up to $25.0 million (the "Shares") through the Agent (the "Offering"). Any Shares offered and sold in the Offering will be issued pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-271386) filed with the Securities and Exchange Commission (the "SEC") on April 21, 2023, which was declared effective on June 9, 2023, the related prospectus contained therein, and the prospectus supplement relating to the Offering to be filed with the SEC on December 13, 2023 and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement (Filing, 8-K, Genprex, DEC 13, 2023, View Source [SID1234638528]).

The Agent may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market ("Nasdaq") or on any other existing trading market for the Common Stock. The Agent will use commercially reasonable efforts to sell the Shares from time to time consistent with its normal sales practices and applicable federal rules, regulations and Nasdaq rules, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Agreement, and also has provided the Agent with customary indemnification and contribution rights.

The Agent is not required to sell any specific number or dollar amount of securities, but will use commercially reasonable efforts to sell, on behalf of the Company, all of the shares of common stock requested to be sold by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between the Agent and the Company. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the opinion of Lowenstein Sandler LLP relating to the legality of the issuance and sale of the shares in the Offering is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

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