AffyImmune Therapeutics presents novel CAR T development programs at the annual meeting of the American Association of Cancer Research

On July 2, 2020 AffyImmune Therapeutics, Inc. reported novel advancements in their proprietary affinity-tuned CAR T-cell programs and technology in three presentations at the recent Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, AffyImmune Therapeutics, JUL 2, 2020, View Source [SID1234561660]). One presentation reported on a new CAR T design for localized and inducible cytokine release. The other two described their affinity-tuned CAR T cell design approach that maintains robust tumor cell killing while reducing toxicity. The company currently has an open IND for the treatment of relapsed or refractory thyroid cancer using an affinity-tuned CAR T-cell targeting the ICAM-1 protein, which is overexpressed in advanced thyroid cancer.

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Chimeric antigen receptor (CAR)-T cell therapy has shown robust anti-cancer responses in hematologic malignancies, but applying this therapeutic approach to solid tumors has been hindered by multiple challenges, including impaired T cell infiltration of the immune-suppressive tumor environment and on-target/off-tumor cytotoxicity to normal tissues. To improve infiltration and mitigate toxicity, AffyImmune developed CARs with selective targeting and fine-tuned affinity.

Highly localized, inducible interleukin-12 release augments ICAM-1 CAR T cell activity against solid tumors

One presentation (abstract #4359) demonstrated that IL-12 secretion induced the expression of pro-inflammatory cytokines IFN-γ and TNF-α both in vitro and in vivo, suggesting a mechanism by which local release of inducible IL-12 can help overcome hostile tumor microenvironments and augment anti-tumor immune responses. The inducible IL-12 CAR T cells exhibited much more robust elimination of subcutaneous and peritoneal tumors compared to CAR T cells lacking inducible IL-12 expression.

Mitigating on-target off-tumor cytotoxicity of EpCAM CAR-T by affinity tuning

Two additional presentations focused on the multi-cancer biomarker epithelial cell adhesion molecule (EpCAM). EpCam is frequently over-expressed in a wide variety of carcinomas, including colon, gastric, pancreas, and breast cancers. This makes EpCAM attractive for targeted therapeutics, but recent clinical trials of EpCAM-targeting therapeutics have shown significant dose-limiting toxicities resulting in limited clinical responses. To selectively target EpCAM high tumors, AffyImmune is developing affinity tuned EpCAM CAR T cells.

In one EpCAM presentation (abstract #4534), author Huan Yang of AffyImmune described the development of AffyImmune’s EpCAM targeting technology, which involved a rational design approach incorporating lower-affinity single-chain antibody (scFv) variants. While high-affinity EpCAM-targeting CAR T-cells kill both normal human epithelial cells as well as EpCAM-high tumor cells, AffyImmune’s lower affinity CAR T-cells were shown to spare normal human epithelial cells while still effectively killing tumor cells expressing high levels of EpCAM. Further, transcriptional profiling suggested that lower affinity CAR T variants were less prone to exhaustion.

Eradication of EpCAM expressing solid tumors by low-affinity CAR T cells

In the final, complimentary presentation (abstract #4534), it was shown that potent in vivo anti-tumor activity could be obtained using lower affinity CAR T cells in an intraperitoneal gastric cancer model, an orthotopic pancreatic tumor model, and in a PDX model using a gastric cancer patient-derived xenograft. The authors concluded that the technology enabled "eradication of various difficult-to-treat solid tumors, without triggering severe treatment-related toxicities," showing promise for the fine-tuning approach as a general strategy for identifying a therapeutic window for CAR-T cells in challenging, solid tumor types.

"Together, these presentations demonstrate the elegance and effectiveness of AffyImmune’s strategy," said AffyImmune co-founder Moonsoo Jin. "We’re focused on identifying the optimal affinity for targeting tumor-associated antigens using CAR T-cells. In this way, it is possible to both avoid non-tumor cells expressing basal levels of the target and to optimize CAR T-cell function, longevity, and tumor killing."

All presentations were presented at the AACR (Free AACR Whitepaper) Virtual Annual Meeting II between June 22-24, 2020, and are available for on-demand viewing.

Menarini Ricerche Announces C-PRECISE-01, a New Phase Ib / II Trial of MEN1611 in Colorectal Cancer

On July 2, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported that it plans to launch in the second half of 2020 a new phase Ib / II trial of MEN1611, a potent and selective phosphatidylinositol 3-kinase inhibitor currently under development for the treatment of breast cancer (Press release, Menarini, JUL 2, 2020, View Source [SID1234561659]). The new study, called C-PRECISE-01, will evaluate MEN1611 in combination with cetuximab in patients with mutated pIK3 metastatic colorectal cancer (CRCm) and native RAS / BRAF who have not responded to treatment with irinotecan, oxaliplatin, 5-FU. and regimens containing anti-EGFR.

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The study design will be presented at the ESMO (Free ESMO Whitepaper) 2020 Virtual World Congress on Gastrointestinal Cancer [1-4 July 2020], with the e-poster entitled "C-PRECISE-01 Study: a phase Ib / II trial of MEN1611, a PI3K inhibitor, and cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens. "

MEN1611 is an oral PI3K inhibitor active on p110α, β and γ isoforms, while preserving δ. Preclinical and clinical evidence supports the development of MEN1611 in combination with other agents in the context of solid tumors. the presence of PIK3CA mutations in CRCm has been correlated with a prediction of a negative response to anti-EGFR treatment, making PI3K an attractive therapeutic target. The primary objective of Study C-PRECISE-01 is to determine the recommended phase 2 dose (RP2D) of MEN1611 in combination with cetuximab, and to assess the antitumor activity of MEN1611. Secondary objectives will include evaluation of the safety, tolerability and pharmacokinetic profile of MEN1611 in combination with cetuximab.

Speaking by Andrea Pellacani , CEO of Menarini Ricerche: "Colorectal cancer is among the most prevalent malignancies in the world and there is an urgent need to discover new therapeutic options to help CRC patients, especially those with metastatic lesions. The start of the C-PRECISE-01 trial will give us the possibility to investigate the potential of MEN1611 in a disease with a high medical need, where PIK3CA represents an adequate therapeutic target. This confirms our commitment to advance in precision oncology and develop effective therapeutic alternatives that mean before and after for cancer patients. "

Castle Biosciences Announces Full Exercise of Underwriters’ Option to Purchase Additional Shares of Common Stock

On July 2, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), reported that the underwriters of its recently closed underwritten public offering of 2,000,000 shares of its common stock have exercised in full their option to purchase an additional 300,000 shares of common stock at the public offering price of $37.00 per share, less underwriting discounts and commissions (Press release, Castle Biosciences, JUL 2, 2020, View Source [SID1234561657]). The gross proceeds to Castle Biosciences from the offering, including the shares sold pursuant to the underwriters’ option, before deducting the underwriting discounts and commissions and offering expenses, were $85.1 million.

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SVB Leerink and Baird were joint book-running managers for the offering and representatives of the underwriters. Canaccord Genuity was passive book-runner and BTIG was co-manager for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission ("SEC") and became effective on June 24, 2020. The offering was made only by means of a prospectus. A copy of the final prospectus related to the offering may be obtained for free by visiting the SEC’s website located at View Source; from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone: (800) 808‐7525, ext. 6218, or by email: [email protected]; or from Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone: (800) 792-2473, or by email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

Moleculin Provides Update on Annamycin Clinical Development

On July 2, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported an update on its clinical development plan for Annamycin (Press release, Moleculin, JUL 2, 2020, View Source [SID1234561656]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

After consultation with both US and European regulatory agencies, Moleculin has mapped out a course for development of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML"). In its End of Phase 1 meeting with the US Food and Drug Administration ("FDA") the Company agreed to expand its protocol-mandated testing for cardiotoxicity throughout the remainder of its European Phase 1 trial. The expansion of testing will provide additional safety data, investigating the continued evidence of little to no cardiotoxicity, and efficacy data that both US and European regulators may consider as the Company prepares to transition to a Phase 2 clinical trial, which management believes will focus on Europe.

Moleculin has now received approval from European authorities to increase the increment for dose-escalation from 30 mg/m2 per cohort to 60 mg/m2 per cohort, as treatment to date in its clinical trials has been at what the Company considers to be subtherapeutic levels. The first patient in the European trial has now been treated at 240 mg/m2 with no evidence of cardiotoxicity or other dose limiting toxicities. Once 2 more patients are successfully treated at this level, the next cohort will be treated with 300 mg/m2. With these timing and dosing expectations, the Company believes that European dosing will increase in 2020, allowing a recommended Phase 2 Dose to be established in 2021.

"Based on what we know from prior clinical trials, we think it may require a dose level of 300 to 360 mg/m2, or possibly higher, before we begin to see a solid therapeutic window for Annamycin in AML," commented Walter Klemp, Chairman and CEO of Moleculin. "Now, with 5 clinical sites open in Poland, the European trial is in the best position to complete the safety portion of our development. That also allows us to close out the US trial, which has already reached its primary safety endpoint."

The Company intends to use what it learns from the Phase 1 clinical trials in AML to inform the starting dosage in clinical testing of Annamycin for the treatment of lung metastases, for which it hopes to file an Investigational New Drug application or its European equivalent by the end of this year.

Mr. Klemp concluded: "With the confirmation of animal model activity in lung metastases we just announced last week, we are pushing hard to prepare to seek regulatory approval to begin a Phase 1 clinical trial in sarcomas that have metastasized to the lungs, a condition for which there is a significant unmet need."

BeiGene to Host Investor Conference Call and Webcast to Discuss the Company’s Early Development Pipeline and Research

On July 2, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that it will host an investor conference call and webcast on Thursday, July 9, 2020 at 9:00 a.m. ET to discuss the Company’s early development pipeline and research (Press release, BeiGene, JUL 2, 2020, View Source/news-releases/news-release-details/beigene-host-investor-conference-call-and-webcast-discuss-0" target="_blank" title="View Source/news-releases/news-release-details/beigene-host-investor-conference-call-and-webcast-discuss-0" rel="nofollow">View Source [SID1234561655]).

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A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available for 90 days following the event.