Cardinal Health to Webcast Discussion of Fourth-Quarter and Year-End Results for Fiscal Year 2020 on August 6

On July 2, 2020 Cardinal Health (NYSE: CAH) reported to release fourth-quarter and year-end financial results for its fiscal year 2020 on August 6 prior to the opening of trading on the New York Stock Exchange (Press release, Cardinal Health, JUL 2, 2020, View Source [SID1234561662]). The company will webcast a discussion of these results beginning at 8:30 a.m. Eastern.

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To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required. Presentation slides and a webcast replay will be available until August 5, 2021.

BioLife Solutions Announces Pricing of $75 Million Public Offering of Common Stock

On July 2, 2020 BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, reported the pricing of its public offering of 5,175,000 shares of its common stock at a public offering price of $14.50 per share, before underwriting discounts and commissions (Press release, BioLife Solutions, JUL 2, 2020, View Source [SID1234561661]). The gross proceeds from the offering to BioLife, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $75 million. The offering is expected to close on July 7, 2020, subject to the satisfaction of customary closing conditions. In addition, the underwriters have a 30-day option to purchase up to an additional 776,250 shares of common stock from BioLife at the public offering price, less underwriting discounts and commissions.

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BioLife anticipates using net proceeds from the offering for general corporate purposes, which includes, without limitation, potentially investing in or acquiring companies that are synergistic with or complementary to our technologies, and working capital.

Cowen, Oppenheimer & Co. and Stephens Inc. are acting as the joint book-running managers for the proposed offering. B. Riley FBR, Maxim Group LLC and Northland Capital Markets are acting as co-managers for the offering.

The shares described above are being offered pursuant to a shelf registration statement on Form S-3, including a base prospectus, which was filed by BioLife with the Securities and Exchange Commission ("SEC") on September 24, 2019 and became effective October 4, 2019, and an additional registration statement on Form S-3 to be filed with the SEC pursuant to Rule 462(b) under the Securities Act of 1933, as amended, which will be effective immediately upon filing. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York, 10004, by telephone at (212) 667-8563, or by email at [email protected]; or Stephens Inc., Attn: Equity Syndicate Desk, 111 Center Street, Little Rock, Arkansas 72201, or by telephone at (800) 643-9691.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any 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 any such state or jurisdiction.

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.