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Iovance Biotherapeutics Announces Clinical Programs Update

On April 3, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported an update to its clinical programs with TIL therapy in the treatment of cervical cancer and non-small cell lung cancer (NSCLC) (Press release, Iovance Biotherapeutics, APR 3, 2019, View Source;p=RssLanding&cat=news&id=2393311 [SID1234534993]). The protocol for innovaTIL-04 (C-145-04), the Phase 2 study in cervical cancer, was amended to increase the sample size to 59 and to modify the primary endpoint of Objective Response Rate (ORR) to be determined by a Blinded Independent Review Committee (BIRC). The company made the changes in anticipation of a meeting with the U.S. Food and Drug Administration (FDA) planned for later this year to discuss the registration pathway for LN-145 in cervical cancer. Earlier this year, LN-145 received a Fast Track designation for cervical cancer.

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"Based on the prior FDA interactions on lifileucel for melanoma, we amended the protocol for the ongoing Phase 2 study of LN-145 in cervical cancer to incorporate certain design elements that we believe are necessary for registration," commented Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We believe these amendments will help to facilitate the discussion of the registration requirements necessary for this unmet medical need. We look forward to providing an update on the registrational path for LN-145 in cervical cancer later this year."

In addition to the modifications to the cervical study, the company will close the IOV-LUN-201 study in NSCLC and instead plans to add an additional arm to the global IOV-COM-202 study. The new arm will allow for treatment of PD-1/PD-L1 naive NSCLC patients with combination of LN-145 and pembrolizumab. The company anticipates that some of the clinical sites from the IOV-LUN-201 study will be added to the IOV-COM-202 study.

"As the treatment landscape evolves in non-small cell lung cancer, Iovance is adapting its clinical development plan to address the current medical needs," added Dr. Fardis. "Iovance continues to be committed in offering TIL therapy for both early and late line NSCLC through the IOV-COM-202 protocol."

Details on the updates include:

IOV-LUN-201. The Phase 2 trial combining LN-145 and durvalumab for the treatment of patients with non-small cell lung cancer (NSCLC) has been open for approximately a year (NCT 03419559). There are currently eight active sites in the United States seeking patients. No patients have been dosed to date. The treatment landscape for NSCLC has evolved rapidly in the past year. Combination treatment with the PD-1 inhibitor pembrolizumab, with or without chemotherapy, is now approved for use in a first-line setting for metastatic NSCLC and is now standard of care for these patients. Given the advances in the standard of care for these patients, Iovance and AstraZeneca have decided to close the IOV-LUN-201 study.

IOV-COM-202. Iovance remains highly committed to development of LN-145 in NSCLC. The company plans to add some of the existing NSCLC clinical sites and investigators into the IOV-COM-202 trial. IOV-COM-202 is a global study with sites participating from the United States and Europe. As the patient population is expected to be more accessible outside of the United States, this is believed to be a more appropriate location for recruitment of PD-1/PD-L1 naive NSCLC patients.

CTI BioPharma to Present at the 18th Annual Needham Healthcare Conference on Wednesday, Apr. 10

On April 3, 2019 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will provide a corporate overview at the 18th Annual Needham Healthcare Conference at 9:20 a.m. EDT at the Westin New York Grand Central (Press release, CTI BioPharma, APR 3, 2019, View Source;p=RssLanding&cat=news&id=2393308 [SID1234534989]).

Presentation details:

Event:

18th Annual Needham Healthcare Conference

Date:

Wednesday, Apr. 10

Time:

9:20 a.m. EDT

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

Entry into a Material Definitive Agreement

On March 28, 2019, Applied DNA Sciences, Inc. and its wholly-owned subsidiary, APDN (B.V.I.), Inc., (collectively, the "Company"), reported that it has entered into a Patent and Know-How License and Cooperation Agreement (the "Agreement") with ETCH BioTrace S.A. ("ETCH"), a wholly-owned subsidiary of TheraCann International Benchmark Corporation ("TheraCann"), a legal cannabis and hemp consultancy (Press release, Applied DNA Sciences, APR 3, 2019, View Source [SID1234534988]). The Agreement grants ETCH the exclusive right and license, with rights to sublicense, to use, offer to sell, sell and import the Company’s proprietary or patented DNA tagging, DNA tag application and DNA tag authentication technologies marketed under SigNature and/or CertainT (the "Technology") within the global cannabis sativa L and cannabis sativa L derivative product markets, excluding use in textiles. The Agreement further grants ETCH the non-exclusive right and license, with rights to sublicense, to use, offer to sell, sell and import the Technology within the global cannabis sativa L market and cannabis sativa L derivative product markets for use in textiles. The Agreement also grants ETCH the limited use of trademarks owned by the Company solely for the purpose of promoting, marketing and disclosing the Technology, with all goodwill and benefit arising from such use inuring to the exclusive benefit of the Company.

Under the Agreement, a $5,000,000 non-refundable up-front licensing fee is payable to the Company over a four-month period, with $1,000,000 due on or before April 15, 2019, $2,000,000 due on or before June 30, 2019 and $2,000,000 due on or before August 15, 2019. The Company and ETCH will jointly market and sell the Technology, with profits to be shared between the parties after specified gross profit minimums are reached. The Agreement also provides for specified annual cash payment minimums to the Company, scaling from $2,000,000 in year two, $7,000,000 in year three, $10,000,000 in year four, $12,000,000 in years five through ten, $16,000,000 in years ten through fifteen, to $20,000,000 in year fifteen, which TheraCann must pay to the Company to maintain its license exclusivity. Such annual cash payment minimums may be comprised of any cash payments from ETCH or any sublicensee for DNA taggant, profit share, DNA authentication devices/reagents, DNA authentication services, project fees, other service or product fees, and/or other cash payments. In lieu of the annual cash payment minimums for years one and two, the parties agree to create a mutually agreeable development plan for TheraCann’s commercialization of the Technology which will contain commercialization milestones that can be met by TheraCann in lieu of annual cash payment minimums.

The term of the license granted with respect to any licensed patent will continue until any valid claim with respect to such patent has expired, and the term of the license granted with respect to any licensed know-how (such as trade secrets and methods) is twenty years. Either party may terminate the Agreement on written notice to the other party if the other party materially breaches the Agreement and such breach is incapable of cure or being capable of cure, remains uncured sixty business days after written notice. The Company may immediately terminate the Agreement if ETCH, its affiliates, or sublicensee institutes or participates in a challenge to the licensed patents. Either party may terminate the Agreement effective immediately in the event the other party dissolves, becomes insolvent, or is subject to bankruptcy proceedings. Should the Company dissolve, become insolvent, become subject to bankruptcy proceedings, cease its business operations generally, cease manufacture of the Technology, or fail to provide ETCH with the Technology for twenty business days, among other things, ETCH and its affiliates are granted licenses to enable ETCH to manufacture and/or practice the Technology to the extent required to comply with ETCH’s ongoing commercial obligations, and the Company has agreed to place into escrow the know-how pertaining to the Technology in connection with such backup license.

During the term, any improvements to any licensed patent shall remain the sole property of the Company if conceived, made or reduced to practice in whole or in part by the Company or be jointly owned by the Company and ETCH where conceived, made, or reduced to practice in whole or in part by ETCH. The Company and ETCH shall agree on a filing strategy for each country where patent protection is sought, and the Company shall be obligated to prepare, file, and prosecute any patent applications, maintain all patents, and notify ETCH of any changes in status or deadlines. ETCH’s consent is required to abandon any patents, and the Company shall assign such abandoned patent to ETCH upon request.

The Agreement also contains mutual confidentiality and indemnification obligations for the Company and ETCH. The Company may not assign the Agreement without ETCH’s prior written consent, not to be unreasonably withheld. Due to an acknowledged level of uncertainty relating to contracts for the provision of services to the legal cannabis industry, both ETCH and the Company expressly waived any defense based on illegality.

The foregoing description of the Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of such agreement.

Anixa Biosciences Presents Cchek™ Prostate Cancer Detection Data at AACR Annual Meeting

On April 3, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported the latest data from its ongoing study on prostate cancer detection, utilizing Cchek, its artificial intelligence (AI) driven cancer detection technology, at the 2019 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Anixa Biosciences, APR 3, 2019, View Source [SID1234534984]). The meeting was held March 29–April 3, 2019 and was attended by world leading experts across the field of cancer research. Anixa’s presentation is available on the Company’s website, at: www.anixa.com/cchek/recent-data.

Dr. Amit Kumar, CEO of Anixa, stated, "We are pleased with the response received on our presentation from the scientific community, and look forward to the impact our technology may have on cancer treatment."

Checkpoint Therapeutics to Present at the 2019 H.C. Wainwright Global Life Sciences Conference

On April 3, 2019 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported that James F. Oliviero, President and Chief Executive Officer, will present a company overview at the H.C. Wainwright Global Life Sciences Conference on Monday, April 8, 2019, at 2:40 p.m. GMT (Press release, Checkpoint Therapeutics, APR 3, 2019, View Source [SID1234534983]). The conference will be held at the Grosvenor House Hotel in London, UK.

A live webcast of the presentation will be available on the Events page of the Investors & Media section of Checkpoint’s website: www.checkpointtx.com.