On April 9, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported new preclinical data from the Company’s potent, selective, CNS-penetrant ErbB2 inhibitor program (Press release, Cogent Biosciences, APR 9, 2024, View Source [SID1234641927]). The data are being presented in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 Annual Meeting taking place in San Diego, California.

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"We’re excited with the progress we’ve made on our ErbB2 program and look forward to sharing our differentiated profile at this year’s AACR (Free AACR Whitepaper) meeting," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "These data further demonstrate Cogent’s capability to discover and advance potential best-in-class novel therapies for rare disease populations with high unmet medical need. Based on these results, we expect to initiate IND-enabling studies for our potent, selective, CNS-penetrant ErbB2 program in mid-2024."

AACR Poster Details

Title: Characterization of a Novel Mutant Selective, EGFR Sparing, ErbB2 Inhibitor with Activity Across Activating Mutations in Systemic and CNS Tumors
Session Category: Chemistry
Session Title: Drug Design and in Silico Screening
Session Date and Time: Tuesday, Apr 9, 2024 9:00 AM – 12:30 PM PT (12:00 PM – 3:30 PM ET)
Location: Poster Section 20
Poster Board Number: 15
Published Abstract Number: 4486

The poster can be accessed on the ‘Posters and Publications’ page of Cogent’s website.

Cogent is developing a potential best-in-class EGFR-sparing, brain-penetrant ErbB2 inhibitor that includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification. The poster presented today describes CGT4255’s exceptional stability in human whole blood and liver cytosol fractions and high oral bioavailability and low clearance across preclinical species. In addition, CGT4255 demonstrated 80% brain penetrance in mice and was well-tolerated at 10x concentration, resulting in mouse tumor regression, suggesting potential best-in class properties.

On April 9, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported the presentation of a poster during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 5 through 10 in San Diego, which focused on a first-in-class multimodal immunotherapy candidate for induction of tertiary lymphoid structures (TLS), being developed as a novel therapeutic strategy for solid tumors from Candel’s enLIGHTEN Discovery Platform (Press release, Candel Therapeutics, APR 9, 2024, View Source [SID1234641925]).

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TLSs are ectopic lymphocyte aggregation structures found in the tumor microenvironment and their induction could potentially improve anti-tumor immunity. The presentation describes the development of an investigational TLS-inducing multimodal therapeutic using the enLIGHTEN Discovery Platform. The enLIGHTEN Advanced Analytics suite was applied to immune checkpoint inhibitor-treated patient datasets, and the predicted payload components included factors regulating the development of TLS. Delivery of two unique in silico predicted payload combinations, using an enLIGHTEN programmable vector, resulted in TLS induction, monotherapy anti-tumoral activity, and enhanced responses in combination with anti-PD-1 antibody therapy in mouse models of solid tumors.

"The recent observation that the presence of TLS in tumors is an important prognostic factor associated with an improved response to immunotherapy has fueled drug development efforts in this area. However, TLS assembly is complicated and requires a series of events, including antigen presentation, stromal cell activation, and immune cell activation and aggregation, which are difficult to obtain with a single therapeutic," said Francesca Barone, MD, PhD, Chief Scientific Officer at Candel. "The enLIGHTEN Discovery Platform enables the generation of multimodal agents through the integration of artificial intelligence-driven payload combinations into programmable vectors. This makes it possible to create a single asset that may induce TLS formation and enhance anti-tumor immunity."

"The delivery of the second immunotherapy candidate based on the enLIGHTEN Discovery Platform, on an accelerated timeline, further validates the ability of this innovative platform to create new therapeutic candidates at a fast pace," added Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "Our platform is flexible and scalable, which makes it suitable for strategic partnerships, for example to create synergy with CAR-T cell therapy or other immunotherapies, potentially resulting in improved survival rates."

Further detail from Candel’s AACR (Free AACR Whitepaper) full poster presentation is available on the Candel website at: www.candeltx.com/media.

About the enLIGHTEN Discovery Platform

The enLIGHTEN Discovery Platform is a systematic, iterative herpes simplex virus (HSV)-based discovery platform leveraging human biology and advanced analytics to create new multimodal biological immunotherapies for solid tumors. The enLIGHTEN Discovery Platform has been designed to deconvolute the characteristics of the tumor microenvironment related to clinical outcomes. These characteristics are rapidly translated into optimized multi-gene payloads of tumor modulators that can be delivered to the tumor microenvironment for specific indications, disease stages, and rationally designed therapeutic combinations. In 2022, the Company announced a discovery partnership with the University of Pennsylvania Center for Cellular Immunotherapies to create new viral immunotherapies that could enhance the efficacy of chimeric antigen receptor T cell (CAR-T) therapy in solid tumors. During the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting and the 2023 International Oncolytic Virus Conference, Candel presented encouraging data on the first candidate from this platform, Alpha 201-macro-1, which was designed to interfere with the CD47/SIRP1α pathway, in mouse models of breast cancer and lung cancer.

On April 9, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that C4T management will participate in a fireside chat at the Stifel 2024 Targeted Oncology Forum taking place virtually from April 16 – April 17, 2024 (Press release, C4 Therapeutics, APR 9, 2024, View Source [SID1234641924]).

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Fireside Chat Details:
Event: Stifel 2024 Targeted Oncology Forum
Date/Time: Tuesday, April 16, 2024 from 10:30 am ET – 10:55 am ET

A live webcast will be available on the Investors section of the company’s website at www.c4therapeutics.com. An archived replay of the webcast will be available for approximately 30 days following the live event.

On April 9, 2024 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported that it will attend the 2024 Bloom Burton & Co. Healthcare Investor Conference taking place at the Metro Toronto Convention Centre in Toronto from April 16-17, 2024 (Press release, Aurinia Pharmaceuticals, APR 9, 2024, View Source [SID1234641923]).

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Aurinia management will host one-on-one meetings with investors and will participate in a fireside chat and Q&A session on Tuesday, April 16, from 10:30 to 11:00 AM Eastern Time. A live webcast of the session will be available on the Investor section of Aurinia’s website, which can be found here.

On April 9, 2024 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 encouraging clinical data from the ongoing Phase 1/2 investigator-sponsored trial ("IST") of evorpacept in combination with R2 in patients with indolent and aggressive R/R B-NHL (Press release, ALX Oncology, APR 9, 2024, View Source [SID1234641922]). The new data were presented in an oral presentation at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting.

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The clinical trial enrolled a total of 20 patients with indolent (n=18) and aggressive (n=2) R/R B-NHL where all patients had received prior rituximab and 72% had received prior chemoimmunotherapy. Patients received evorpacept 30 mg/kg Q2W (n=3) or 60 mg/kg Q4W (n=17) in combination with standard R2 treatment. The regimen was well tolerated, and there were no dose-limiting toxicities. The maximum administered dose for evorpacept was 60 mg/kg Q4W. The most common adverse events due to any cause were fatigue, ALT increase, anemia, and AST increase, all of which were mostly low grade. There were no reported treatment-related deaths on study. Patients with indolent R/R B-NHL (n=18) had a best ORR of 94% and a CRR of 83%. The median duration of response was not reached. The AUGMENT Phase 3 clinical trial1, a benchmark study in a similar patient population, reported an ORR of 78% and a CRR of 34% with R2 alone.

"While standard frontline treatments have shown benefit in the indolent B-NHL setting, many patients are likely to see their disease progress after initial treatment," said Paolo Strati, M.D., the trial’s lead investigator and Assistant Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center. "We are pleased evorpacept in combination with R2 demonstrated a favorable safety profile and encouraging response in this patient population. These data further illustrate the importance of exploring novel combinations with evorpacept to elicit anti-tumor activity by way of the innate immune response. We are excited to build upon these preliminary results as we evaluate the evorpacept-R2 combination in the ongoing Phase 2 portion of this clinical trial in patients with previously untreated indolent B-NHL."

"These initial results reinforce evorpacept’s differentiated drug design that has resulted in anti-cancer activity while minimizing hematologic toxicities inherent to other CD47 blocking agents," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "Furthermore, the findings presented today build upon the promising data reported from the ASPEN-01 Phase 1 clinical trial of evorpacept in combination with rituximab in R/R NHL2. We look forward to applying these and other clinical trial data to inform new evorpacept combinations in our expanding pipeline. We would like to thank the patients and research team for conducting this important clinical trial."

Details of the Oral Presentation at the 2024 AACR (Free AACR Whitepaper) Annual Meeting are as follows:

A Phase 1 investigator-initiated trial of evorpacept (ALX148), lenalidomide and rituximab for patients with relapsed or refractory B-cell non-Hodgkin lymphoma
Session Title: Clinical Trials Minisymposium / Novel Agents and Emerging Therapeutic Strategies
Presentation Date and Time: Tuesday, April 9, 2024, 2:50 PM – 3:00 PM PT
Abstract: CT037 (full abstract is available online here)

The presentation is available on the publications page of the ALX Oncology website here.

About the Phase 1/2 IST Investigating Evorpacept Combination to R2 in NHL

The Phase 1/2 IST is an ongoing, open-label, single arm clinical trial designed to evaluate the safety, tolerability, and efficacy of evorpacept, otherwise known as ALX148, in combination with R2 in patients with R/R B-cell NHL (both indolent and aggressive) histology. Patient enrollment is currently open to the Phase 2 portion of the study evaluating patients with previously untreated indolent B-NHL (NCT05025800). The study is sponsored and conducted by MD Anderson Cancer Center.

About Non-Hodgkin Lymphoma

Approximately 500,000 people worldwide are diagnosed with NHL each year. In the U.S., NHL is the seventh most common type of cancer, and over 80,000 newly cases of NHL were estimated in 20233. NHL can be divided into two groups according to how the disease progresses: indolent and aggressive lymphomas. The most prevalent form of NHL, accounting for about 32% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma. Follicular lymphoma is the most common subtype of indolent NHL and accounts for about 17% of newly diagnosed NHL cases. Indolent B-cell lymphomas tend to grow more slowly and may have fewer signs and symptoms than aggressive lymphomas when first diagnosed. For patients with indolent B-cell lymphoma, current first-line treatments include radiotherapy, anti-CD20 monoclonal antibodies, and chemoimmunotherapy. Despite advances in treatment, follicular lymphoma remains a significant cause of death.