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Immatics announces Clinical Trial Collaboration in Immunotherapy for Solid Cancers

On February 26, 2019 Immatics reported a collaboration with Roche to evaluate the safety and efficacy of IMA101, Immatics’ investigational autologous cell therapy, in combination with atezolizumab (TECENTRIQ), in patients with solid cancers (Press release, immatics biotechnologies, FEB 26, 2019, View Source [SID1234554002]).

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IMA101 is a personalized, multi-targeted investigational immunotherapy for the treatment of multiple advanced/ metastatic solid tumors. IMA101 is based on Immatics’ ACTolog approach, which follows the principle of expanding target-specific endogenous T-cells, a technique pioneered by Cassian Yee, M.D., Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center.

The combination trial will evaluate potential synergistic effects generated by using the investigational immunotherapies together, as atezolizumab may enhance IMA101’s ability to kill cancer cells by blocking inhibitory immune checkpoints.

The combination clinical trial which is expected to begin later this year under an amendment to the ACTolog IMA101-101 study protocol (Clinicaltrials.gov: NCT02876510) will be conducted at MD Anderson, led by Apostolia Tsimberidou, M.D., Ph.D., Professor of Department of Investigational Cancer Therapeutics at MD Anderson.

Stephen Eck, M.D., Ph.D., Chief Medical Officer (CMO) at Immatics US, Inc., said: "Our innovative ACTolog process allows us to utilize a patient’s own T cells to generate a targeted approach for treating solid tumors with increased safety and efficacy potential. We are extremely pleased that, in collaboration with our long-term partner, we are now combining this promising personalized cell therapy with atezolizumab."

About ACTolog T-cell therapy

The ACTolog IMA101 phase 1 clinical trial is led by Prof. Apostolia Tsimberidou, Professor at the Department of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT). The ACTolog concept is based on the principle of endogenous T-cell therapy pioneered by Professor Cassian Yee, M.D. Unlike tumor-infiltrating lymphocytes, ACTolog T-cell products are generated from peripheral blood cells with defined target selectivity. Utilizing its proprietary antigen discovery platform XPRESIDENT, Immatics has created a warehouse of eight cancer targets. From this warehouse, the most suitable targets for each patient’s tumor are identified by analyzing the tumor biomarkers. Up to four personalized T-cell products are then activated and manufactured for each patient by isolation and enrichment of the patient’s endogenous T cells in vitro. Billions of such activated and specific T cells are then re-infused into the cancer patient to attack the tumor. The ACTolog T-cell products are manufactured at The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with The University of Texas Health Science Center in Houston (UTHealth).

Gracell Biotechnologies Completes $85 Million Series B for Immune Cell Gene Therapies

On February 26, 2019 Gracell Biotechnologies, Co., Ltd. ("Gracell") reported the completion of its $85 million series B funding today (Press release, Gracell Biotechnologies, FEB 26, 2019, View Source [SID1234539454]). The financing was led by Temasek with Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji also participated in the round. This new funding will enable Gracell to enter clinical trials with several of its next generation immune cell gene therapy candidates.

Founded by Dr. Wei (William) Cao in 2017, Gracell is an innovative biomedical company focusing on the development of next generation immune cell gene therapies. Dr. Cao was previously co-founder and CEO of a Nasdaq-listed cell therapy company. Gracell was initially supported by series A financing from 6 Dimensions shortly after its establishment.

Gracell says it is committed to developing high-quality, low-cost cellular gene therapies and solving many of the technical difficulties in the cellular gene therapy field, including complex manufacture, lack of off-the-shelf products, and short duration efficacy. To implement its vision, Gracell believes it has gathered one of the top teams in the industry from China and the U.S.

To date, Gracell has completed pre-clinical development of a series of low-cost CAR-T products and entered clinical research through Institutional Review Board (IRB) studies. Other products under development include CAR-T cell products developed on the company’s FasT(TM) CAR technology, Dual-CAR technology, Off-the-shelf CAR-T products, and CAR-T products for the treatment of refractory solid tumors.

Entry into a Material Definitive Agreement

On February 26, 2019, Alder BioPharmaceuticals, Inc. ("Alder") reported that it has entered into a common stock purchase agreement (the "Purchase Agreement") with Redmile Group, LLC and certain institutional and other accredited investors affiliated with or managed by Redmile Group, LLC (collectively, "Redmile") (Press release, Alder Biopharmaceuticals, FEB 26, 2019, View Source [SID1234533902]). The Purchase Agreement provides that, subject to the closing of the Offering (as defined in Item 8.01 below) and the satisfaction of other customary closing conditions, Redmile will purchase 1,739,130 shares of Alder’s common stock, par value $0.0001 per share ("Common Stock"), at a price per share of $11.50, which is equal to the price to the public in the Offering (the "Redmile Shares"). The issuance of the Redmile Shares will be made in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"). The Underwriters (as defined in Item 8.01 below) will serve as placement agents for the placement of the Redmile Shares and receive a placement agent fee equal to a percentage of the total purchase price of the Redmile Shares, which percentage will be equal to the percentage discount the underwriters will receive on shares sold in the Offering. In the event that the Offering has not closed within 20 business days of the date of the Purchase Agreement, either Alder or Redmile may terminate the Purchase Agreement. The net proceeds to Alder from the sale of the Redmile Shares are expected to be approximately $18.8 million, after deducting placement agent fees. The Purchase Agreement requires Alder to enter into a registration rights agreement with Redmile upon the closing of the issuance of the Redmile Shares. Under the registration rights agreement, Alder will be required to register the Redmile Shares for resale under the Securities Act no later than the day after the expiration of Alder’s 60-day lock-up period following the date of the Underwriting Agreement (as defined in Item 8.01 below). The Purchase Agreement contains customary representations, warranties and agreements by Alder and Redmile.

The Purchase Agreement is filed as Exhibit 10.1 to this report, and the description of the terms of the Purchase Agreement is qualified in its entirety by reference to such exhibit.

Redmile is affiliated with one of Alder’s directors, Jeremy Green, and is Alder’s largest stockholder. In connection with Alder’s January 2018 issuance of convertible preferred stock to Redmile, Alder entered into a registration rights agreement with Redmile. Under the registration rights agreement, Alder filed a prospectus supplement under its effective registration statement on Form S-3 (SEC File No. 333-216199), and is required to file, if needed, one or more additional registration statements, as permissible and necessary, for the resale of the shares of Common Stock issued or issuable upon conversion of the convertible preferred stock and a warrant to purchase an aggregate of 75,000 shares of convertible preferred stock that Alder may be required to issue to Redmile.

Entry into a Material Definitive Agreement

On February 26, 2019 On February 26, 2019, Ultragenyx Pharmaceutical Inc. ("we," "Ultragenyx" or the "Company")reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Merrill Lynch, Pierce, Fenner & Smith Incorporated, and Cowen and Company, LLC (the "Underwriters"), providing for the offer and sale in an underwritten public offering (the "Offering") of 5,072,464 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a public offering price of $60.00 per share, to be purchased by the Underwriters from us at a price of $56.70 per share. Pursuant to the Underwriting Agreement, the Company granted the Underwriters a 30-day option (the "Option") to purchase up to an additional 760,869 shares of Common Stock on the same terms (Filing, 8-K, Ultragenyx Pharmaceutical, FEB 26, 2019, View Source [SID1234533869]). On February 27, 2019, the Underwriters exercised the Option in full.

The Offering closed on March 1, 2019. In the Underwriting Agreement, the Company agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or to contribute to payments that the Underwriters may be required to make because of such liabilities.

We estimate that the net proceeds we will receive from the Offering will be approximately $330.4 million, after deducting the Underwriters’ discounts and commissions and estimated offering expenses payable by us.

The Offering was made under a prospectus supplement and related prospectus filed with the Securities and Exchange Commission pursuant to the Company’s automatically effective shelf registration statement on Form S-3 (Registration No. 333-223123). The Offering was not registered under any state blue sky laws.

Iovance Biotherapeutics was Granted Fast Track Designation for LN-145 for Cervical Cancer

On February 26, 2019 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical cancer who have progressed while on or after chemotherapy (Press release, Iovance Biotherapeutics, FEB 26, 2019, View Source;p=RssLanding&cat=news&id=2389051 [SID1234533762]). LN-145 is the Company’s adoptive cell therapy produced using its proprietary TIL manufacturing technology.

"We are pleased to have received Fast Track designation for LN-145 for the treatment of cervical cancer in patients who have failed chemotherapy treatment," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "The designation is an important positive step for the development of LN-145 in a serious and unmet medical need patient population. We are excited about the clinical data for LN-145 in cervical cancer patients and look forward to a closer collaboration with the FDA as we advance the clinical development of LN-145 for the treatment of cervical cancer."

The Fast Track designation from the FDA is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, which includes providing a therapy that may be potentially better than the available ones. With the Fast Track designation for LN-145, Iovance is expected to have more frequent meetings and communication with the FDA and is eligible, if relevant criteria are met upon submission, for a Rolling Review of the Biologic License Application (BLA) and potentially Accelerated Approval.1

The Company had previously reported preliminary data from the Phase 2 study of LN-145 for cervical cancer (C-145-04) in October 2018 for 15 patients yielding an overall response rate (ORR) of 27%. Patients in the study had a median of five prior therapies. The most common treatment-emergent adverse events included chills, pyrexia and anaemia. The protocol for the cervical cancer study has since been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. The study is actively recruiting patients at 32 clinical sites in the United States and Europe. The company anticipates providing an update on this study at an upcoming medical meeting in 2019.