On July 2, 2020, Atreca, Inc. (the "Company") reported that it has entered into a Collaboration and License Agreement (the "Agreement) with Xencor, Inc. ("Xencor") (Filing, 8-K, Atreca, JUL 2, 2020, View Source [SID1234561752]). Under the Agreement, the parties will collaborate to research, develop and commercialize T cell-engaging bispecific antibodies as potential therapeutics in oncology.

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During an initial three-year research term, the parties will generate and evaluate bispecific antibodies comprising Atreca antibodies engineered with Xencor’s CD3 platform that bind to both a tumor target and a CD3 target, and the parties will each bear their own personnel costs, and will share equally the external, out-of-pocket costs, incurred in conducting the research activities. If a bispecific antibody arising during the research term meets certain specified criteria, then (a) the parties may elect to jointly fund the development and commercialization of products using such antibody in a joint program, (b) each party may develop and commercialize such antibodies on its own behalf in a unilateral program, or (c) the parties may agree to grant the rights to such antibodies to a third party in an out-licensed program. Each party has the right to participate in up to two joint programs and up to two unilateral programs. Using commercially reasonable efforts, the Company will lead development and commercialization under the first joint program, and Xencor will lead such activities under the second joint program. Each party will grant licenses to the other party under its relevant patents and know how in connection with the development, manufacture and commercialization of the products arising from the applicable program. Each party is subject to specified exclusivity obligations in connection with the targets to which the products arising from each collaboration are directed, and the antibodies included in such products, with the scope of such exclusivity determined based on whether such program is a joint or unilateral program.

Under each joint program, the parties will share all development and commercialization costs and profits and losses equally (50%/50%), subject to certain rights for the non-lead party to opt-out of its co-funding obligations at certain specified development points or upon specified triggers. Upon a party’s exercise of its right to opt out of a joint program, the other party will bear all development and commercialization costs, and pay the other party (a) development and commercialization milestone payments up to an aggregate of $95.0 million, (b) running royalties on net sales of products at a percentage in the mid-single digit to high-teens, and (c) a portion of the amounts (excluding royalties and certain payments) it receives as a result of the grant of a sublicense under the program at a percentage ranging in the mid-double digits, in each case of (a)-(c) depending on the timing at which the opt-out rights are exercised. Under each unilateral program, the lead party under such program will bear all development and commercialization costs, and pay the other party (i) running royalties on net sales of products at a percentage in the mid- to high-single digits, and (ii) a portion of the amounts (excluding royalties and certain payments) it receives as a result of the grant of a sublicense under the program at a percentage ranging in the low-double digits. Under each out-licensed program, the parties will share all amounts (excluding royalties and certain payments) received as a result of the grant of a sublicense under the program. The royalties for the opted-out joint programs and the unilateral programs will be payable, on a product-by-product and country-by-country basis, until the later of the expiration of each party’s patents that cover such product in such country, expiration of regulatory exclusivity for such product in such country, or ten years from first commercial sale of such product in such country.

The Agreement will expire on the later of (a) the first anniversary of the end of the three-year research term, and (b) the date on which all joint programs and all unilateral programs, including out-licensed programs, are either terminated or the payment obligations under such programs have expired. Each party may terminate the Agreement in its entirety, or on a program-by-program basis, for the other party’s uncured material breach. Each party may terminate the Agreement in its entirety for the other party’s insolvency.

The foregoing description of the Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending June 30, 2020. The Company intends to seek confidential treatment for certain portions of the Agreement pursuant to a Confidential Treatment Request submitted to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

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.

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.

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.

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. "