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Clovis Oncology Announces Debt Exchange Transaction

On April 14, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that on April 14, 2020 it entered into a privately negotiated exchange agreement with a holder of its 2.50% Convertible Senior Notes due 2021 (the "2021 Notes") (Press release, Clovis Oncology, APR 14, 2020, View Source [SID1234556301]). Pursuant to the exchange agreement, Clovis Oncology will issue to such holder of the 2021 Notes approximately $36.05 million in aggregate principal amount of its currently outstanding series of 4.50% Convertible Senior Notes due 2024 (the "2024 Notes") in exchange for approximately $32.77 million in aggregate principal of 2021 Notes held by such holder. Clovis Oncology will not receive any cash proceeds from the issuance of these 2024 Notes. J.P. Morgan and BofA Securities acted as the exclusive agents to Clovis Oncology in connection with the exchange transaction.

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Clovis Oncology anticipates that the settlement of the exchange transaction will occur on or about April 20, 2020, subject to satisfaction of customary closing conditions. Upon completion of the exchange transaction, the aggregate principal amount of the 2021 Notes outstanding will be approximately $64.42 million, and the aggregate principal amount of 2024 Notes outstanding will be approximately $174.91 million.

About the 2024 Notes

The 2024 Notes issued in the exchange transaction will have substantially identical terms to the Clovis Oncology’s currently outstanding 2024 Notes and will be treated as a single series of securities with the currently outstanding 2024 Notes.

The 2024 Notes bear interest at a rate of 4.50% per annum, payable semi-annually in arrears on February 1st and August 1st of each year. The 2024 Notes will mature on August 1, 2024 unless earlier converted or repurchased. The holders of the 2024 Notes may convert their notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date at an initial conversion rate of 137.2213 shares of Clovis Oncology’s common stock per $1,000 principal amount of notes.

Clovis Oncology does not have the right to redeem the 2024 Notes prior to their maturity. Holders of the 2024 Notes may require Clovis Oncology to repurchase for cash all or part of their notes upon certain fundamental changes at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Clovis Oncology will, in certain circumstances, increase the conversion rate for a holder who elects to convert its 2024 Notes in connection with such corporate event.

The above summary of the terms of the 2024 Notes is qualified in its entirety by and should be read with the Indenture governing the 2024 Notes, filed with the Securities and Exchange Commission as Exhibit 4.5 to Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2019.

The 2024 Notes issuable in the exchange transaction and any shares of common stock issuable upon conversion of such 2024 Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law. Clovis Oncology does not intend to file a registration statement for resale of such 2024 Notes or the shares of common stock, if any, issuable upon conversion thereof. Accordingly, Clovis Oncology is offering the 2024 Notes only to persons who are both accredited investors (within the meaning of Rule 501 promulgated under the Securities Act) and qualified institutional buyers (as defined in Rule 144A under the Securities Act) in reliance on a private placement exemption from registration under the Securities Act. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

$6M, five-year NIH grant extends funding for collaborative Cleveland Digestive Diseases Research Core Center

On April 14, 2020 Case Western Reserve University reported a new $6 million, five-year grant from the National Institutes of Health extends funding for the Silvio O. Conte Cleveland Digestive Diseases Research Core Center (DDRCC), a cross-institutional collaboration of digestive disease investigators (Press release, Case Western Reserve University, APR 14, 2020, View Source [SID1234556299]).

In 2015, an initial $6 million, five-year NIH grant established the DDRCC as one of only 17 in the country. (There are now 18.)

The Cleveland collaborative, which includes the Case Western Reserve University School of Medicine, Cleveland Clinic, University Hospitals Cleveland Medical Center (UH) and the Louis Stokes Cleveland VA Medical Center (LSCVAMC), works to develop and advance research on digestive inflammation, gastrointestinal cancer and liver and metabolic diseases.

"The overall objective of the Cleveland DDRCC," said Fabio Cominelli, professor of medicine and pathology and associate dean for program development at the School of Medicine and the center’s director, "is to increase the availability of resources for center members and foster research, collaborations and new directions in digestive disease research, leading to important scientific discoveries."

Cominelli, the Herman Menges, MD Professor in Internal Medicine at the School of Medicine and chief scientific officer of the Digestive Health Institute at UH, is an internationally recognized expert in such conditions as inflammatory bowel disease, Crohn’s disease, gastrointestinal cancer and ulcerative colitis.

The Cleveland DDRCC’s mission is to:

Enhance the research capabilities of its investigators;
Develop and implement programs to support young investigators;
Attract established investigators not currently involved in digestive disease research;
Facilitate the translation of basic research discoveries to the clinical arena.
The center currently includes 47 full members and 35 associate members from 25 academic departments across Case Western Reserve, Cleveland Clinic, UH and LSCVAMC, representing a steady expansion during the previous funding cycle.

Together, these investigators comprise the center’s research base, which consists of $17.3 million in peer-reviewed federal and foundation grants for two specific focus research areas—digestive inflammation and tumorigenesis, and liver disease and metabolism.

Hansoh Expands AI Partnership with Atomwise after Early Success for Key Target in Therapy-Evading Cancers

On April 14, 2020 Hansoh Pharma (3692:HK), a leading biopharmaceutical company in China, and Atomwise, the leader in artificial intelligence (AI) for drug discovery, reported the expansion of their strategic partnership for AI-accelerated drug discovery (Press release, Atomwise, APR 14, 2020, View Source [SID1234556296]). Expansion of the partnership immediately follows completion of their first hit-discovery collaboration, which successfully identified and experimentally confirmed several novel hit compounds for a previously challenging oncology target in only 4 months.

The collaboration began in November 2019, focusing on identifying hit compounds that are specific towards an intractable drug target. Atomwise performed AI-based molecular screening using their proprietary AI technology, AtomNet, to generate compound hits with predicted activity against multiple mutant forms of the oncology targets for Hansoh. With AtomNet, the collaboration was able to screen an ultra-large and diverse virtual library of over 12 billion compounds, finding 200 predicted candidates displaying specificity for the targets in only 2 weeks from a single virtual screen.

"We are really impressed by Atomwise’s capability to deliver potential candidates," said Rudi Bao, M.D. Ph.D., SVP of Hansoh R&D. "Our expanded partnership will accelerate major initiatives to discover innovative medicines for patients."

"It is a privilege to partner with Hansoh Pharma to develop their first-in-class or best-in-class portfolio of novel small molecule therapies," said Dr. Abraham Heifets, CEO of Atomwise. "Therapies with high specificity and potency are urgently needed for oncology, infectious diseases, and personalized medicine. We look forward to expanding our work with Hansoh on additional challenging targets."

Intensity Therapeutics Signs Clinical Collaboration Agreement with Bristol Myers Squibb for Advanced Solid Tumors

On April 14, 2020 Intensity Therapeutics reported it has entered into a clinical trial collaboration agreement with Bristol Myers Squibb Company (NYSE: BMY) (Press release, Intensity Therapeutics, APR 14, 2020, View Source [SID1234556294]). The program will evaluate the safety and efficacy of Intensity’s lead product INT230-6, an investigational, novel and potent anti-cancer drug designed to directly kill cancer cells through intratumoral injection and improve immune cell recognition of cancer, when dosed in combination with Bristol Myers Squibb’s Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) immune checkpoint inhibitor Yervoy (ipilimumab). The combination will be evaluated in patients with breast cancer, liver cancer and advanced sarcoma in a series of new cohorts within IT-01, Intensity’s ongoing Phase 1/2 clinical trial. Intensity will sponsor and conduct the clinical trial and Bristol Myers Squibb will supply Yervoy for use in the study.

"We are excited to have entered into this clinical collaboration with Bristol Myers Squibb, a global leader and pioneer in immuno-oncology," said Lewis H. Bender, President and CEO of Intensity Therapeutics. "This new collaboration builds upon our other partnerships to evaluate the potential of INT230-6 in combination with immunotherapy. A joint publication with the National Cancer Institute last year, showed remarkable synergy with the combination of INT230-6 and CTLA-4 antibodies in nonclinical in vivo models. The ability to combine our drug in the clinic with Yervoy, may benefit patients with cancers that have high unmet medical need. Results from this collaboration could accelerate the timeline for clinical development and approval of our drug."

Ian. B. Walters, M.D., Intensity’s Chief Medical Officer, added, "We will be able to evaluate the combination of INT230-6 and Yervoy in a variety of difficult-to-treat tumor types. To date, our Phase 1/2 study has produced solid evidence of activity with INT230-6 as a single agent, as well as a favorable safety profile, in patients with a variety of highly refractory, advanced cancers. In our studies we have also shown systemic immune activation and local recruitment of immune cells in treated tumors. The combination cohorts should enable further expansion of the immune response."

About INT230-6

INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term, protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunogy, showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy.

ImmunoPrecise Announces Agreement with Janssen

On April 14, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTC QB: IPATF), a global leader in therapeutic antibody discovery and development, reported that it, through its subsidiary Talem Therapeutics, has entered into a research license agreement (the "Agreement") with Janssen Research & Development, LLC ("Janssen"), providing Janssen exclusive access to a panel of novel, monoclonal antibodies against an undisclosed target (Press release, ImmunoPrecise Antibodies, APR 14, 2020, View Source [SID1234556293]). Pursuant to the Agreement, Janssen holds an option to acquire all commercial rights to the antibodies. The financial details of the transaction have not been disclosed.

"This Agreement validates Talem’s business concept in early antibody discovery and development," said Ilse Roodink, Chairwoman of Talem’s Scientific Advisory Committee and Scientific Director at IPA Europe. "It is a significant milestone to see this exclusive agreement through Talem finalized with Janssen, a company so well positioned to further develop and maximize the potential of these lead candidates for clinical applications."

"Talem continues to build a therapeutic program pipeline for commercial partnering, thus optimizing shareholder value creation based on IPA’s infrastructure across Europe and North America," added Jennifer Bath, President and CEO of IPA.