On April 6, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in its Phase 1 clinical trial of COM902, an immuno-oncology therapeutic antibody targeting TIGIT, in patients with advanced malignancies (Press release, Compugen, APR 6, 2020, View Source [SID1234556149]).

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This Phase 1 open-label clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of escalating doses of COM902 monotherapy in patients with advanced malignancies who have exhausted all available standard therapies. The study will be conducted in multiple leading oncology clinical centers in the United States.

Manish Sharma, M.D., Associate Director of Clinical Research at START Midwest (Grand Rapids, MI) and a Principal Investigator in the Phase 1 COM902 study, said, "Being part of Compugen’s ongoing COM701 Phase 1 study, we are excited to expand our relationship with the Company and enroll patients in this clinical trial evaluating the inhibition of TIGIT, a part of the DNAM axis, with COM902. There remains a high unmet medical need to evaluate novel investigational agents in patients unresponsive to PD-1 or PDL-1 inhibitors. The two studies enable us to evaluate COM701 and COM902 in these patient populations."

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added "Advancing COM902 through Phase 1 studies is an important step towards testing the clinical effect of the dual blockade of PVRIG and TIGIT, two parallel inhibitory pathways in the DNAM axis. Our preclinical work suggests that the simultaneous blockade of TIGIT and PVRIG may be essential for inducing robust antitumor immune responses in patient populations where these two pathways are operative. This is further reinforced by our initial clinical data demonstrating preliminary antitumor activity by COM701 targeting PVRIG and pharma’s increasing focus on the blockade of TIGIT, which we and others discovered in 2009. As the only company, to our knowledge, currently with clinical programs targeting both TIGIT and PVRIG, we are uniquely positioned to synergistically target both immune checkpoints."

Dr. Cohen-Dayag continued, "Our various clinical studies targeting PVRIG and TIGIT, including the Phase 1/2 trial designed to evaluate the triple blockade of PVRIG, TIGIT and PD-1 expected to initiate in the second half of 2020, build our science-driven clinical pipeline designed to address the significant unmet need of patients who are non-responsive and refractory to currently approved cancer immunotherapies. We look forward to the multiple anticipated data readouts from our clinical studies, including updated data from our ongoing COM701 monotherapy and combination therapy dose escalation studies later this year, and from our COM701 Phase 1 monotherapy expansion cohorts and COM902 Phase 1 studies in 2021."

Additional information on the COM902 Phase 1 study will be available shortly at www.clinicaltrials.gov.

About COM902
COM902 is a high affinity, fully human antibody that blocks the interaction of TIGIT with PVR, its ligand, and consequently enhances T cell function. It is currently being evaluated in a Phase 1 clinical trial in patients with advanced malignancies who have exhausted all available standard therapies. Compugen has demonstrated in preclinical studies that simultaneous inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM axis, can increase antitumor immune responses, which may be further enhanced with the addition of PD-1 blockade. These data suggest that treatment with COM701 and COM902, targeting PVRIG and TIGIT, respectively, alone or in combination with a PD-1 inhibitor, has the potential to expand immuno-oncology treatment to patient populations who are non-responsive or refractory to existing immunotherapies.

The discovery of TIGIT, using the Company’s computational discovery platform, was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).

On April 6, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported a general corporate update, as follows (Press release, Ligand, APR 6, 2020, View Source [SID1234556148]):

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"As the business environment has evolved in response to the pandemic, Ligand has remained sharp with our operations and our partners have been highly productive over the past few weeks," said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. "Last week we completed an acquisition, we just signed a deal for a novel FAAH inhibitor out of our Vernalis unit, two partners recently closed important financings and over the past month partners have begun additional COVID-19 initiatives. Our OmniAb business is advancing with a recent NDA filing in China and positive Phase 2a data just announced. Notably, we are working to ensure our Captisol production meets the needs of our global partners. Finally, despite the volatile capital markets, we have used cash during the first quarter to buy back nearly a third of our outstanding convertible bonds at what we believe were attractive valuations."

Follow Ligand on Twitter @Ligand_LGND.

OmniAb Business Update

Ligand’s partners are actively progressing two OmniAb antibody discovery programs for the potential treatment of COVID-19. One multinational big pharma partner has initiated a program using OmniChicken and another partner is focused on antibodies derived from OmniRat.

Gloria Biosciences submitted an application for marketing approval to the Chinese National Medicines Products Administration for OmniAb-derived zimberelimab for the treatment of classical Hodgkin lymphoma.

Immunovant announced positive results from its ongoing Phase 2a proof-of-concept study of OmniAb-derived IMVT-1401 in thyroid eye disease. IMVT-1401 is a novel investigational anti-FcRn antibody delivered by subcutaneous injection. The results showed a 65% mean reduction in total IgG observed from baseline to end of treatment, with a pharmacodynamic response nearly identical to modeled predictions for the dosing regimen tested in the trial. IMVT-1401 was generally well-tolerated.

Ligand’s partner Pandion Therapeutics closed an $80 million financing on March 31, 2020 and announced that proceeds will support the advancement of their pipeline of modular proteins and bi-functional antibodies for the treatment of autoimmune diseases. Ligand entered into an OmniAb Platform agreement with Pandion in January 2020.

Captisol Business Update

During the first quarter Ligand announced it is supplying Captisol to partners evaluating remdesivir in clinical trials as a potential treatment for COVID-19. Ligand continues to meet Captisol requirements to support remdesivir clinical trials and manufacturing scale-up. Our partner Gilead Sciences announced that it has accelerated manufacturing timelines to increase the supply of the drug before knowing whether remdesivir is safe and effective in patients with COVID-19. Multiple clinical trials for remdesivir are underway, involving thousands of patients with COVID-19 across the world. Public information indicates initial clinical trial data will be available over the next several weeks.

Ligand’s Captisol technology has applicability in a broad array of therapeutic indications. Captisol is used in approved treatments such as Amgen’s Kyprolis and Acrotech/CASI’s Evomela to treat patients with multiple myeloma, a life-threatening cancer, and is utilized in Sage Therapeutics’ Zulresso, which was recently approved by the FDA for mothers suffering from post-partum depression.

Ligand’s Captisol network is served by manufacturing plants in two European countries and five distribution facilities around the globe, all of which remain fully operational. Ligand has substantial capacity to supply Captisol manufactured according to cGMP and our focus is to ensure sufficient supply to meet all existing and future partner needs, and to supply Gilead should remdesivir be demonstrated to be safe and effective to treat COVID-19. Ligand is also evaluating plans with its supply partner to further increase capacity by bringing additional sites online if needed.

Vernalis Business Update

Ligand recently entered into an exclusive worldwide license agreement with Neuritek Therapeutics to develop and commercialize V158866, a novel, oral, selective fatty acid amide hydrolase (FAAH) inhibitor that was discovered using the Vernalis Design Platform (VDP). Neuritek plans to develop V158866 for post-traumatic stress disorder and other CNS diseases. Under the terms of the agreement, Ligand will receive an upfront license fee and is eligible to receive a financing-related milestone, development and commercialization milestones and tiered royalties on net sales in the mid-to-high single digits. On March 31, 2020, Neuritek announced it had secured approximately $27 million in a capital commitment from the GEM group, GEM Global Yield LLC SCS.

Recent third-party academic drug analyses suggest a potential role for heat shock protein 90 (Hsp90) inhibitors in treating COVID-19 infection. Based on these studies, we are evaluating potential collaborations or partnerships relating to intravenous luminespib (AUY-922) as a potential treatment for patients with COVID-19. Luminespib is a Phase 2-ready Hsp90 inhibitor, previously investigated in clinical trials for cancer.

Acquisition Update

On April 1, 2020 Ligand closed its acquisition of the core assets of Icagen’s North Carolina operations, including two significant partnered programs, proprietary ion channel screening and assay platforms, x-ray fluorescence capabilities, custom screening technologies and six preclinical-stage internal programs applicable to a range of indications including diabetes, Parkinson’s disease, pain and others. The two partnered programs are a collaboration with Roche to develop and commercialize therapies for neurological diseases, which includes research funding, up to $274 million in potential milestone payments and tiered royalties on net sales, and a collaboration with the Cystic Fibrosis Foundation (CFF) Collaboration to discover therapeutics to treat patients with cystic fibrosis caused by specific genetic mutations. The CFF collaboration allows for up to $11 million in research funding, up to $59 million in milestone payments and tiered royalties on net sales.

Capital Deployment and Strategy Update

Ligand estimates that, as of March 31, 2020, its cash and cash equivalents were approximately $735 million and outstanding convertible debt was approximately $516 million. First quarter estimated cash and cash equivalents is lower compared to the end of 2019, primarily because over the past several weeks Ligand repurchased $234 million in principal amount of its convertibles notes at a price of $203 million, and repurchased 473,000 common shares for $37 million. These estimated amounts are preliminary and are subject to completion of financial and quarterly closing procedures.

We have a successful track record of acquiring innovative companies and subsequently growing revenue, increasing our partnered portfolio, and leveraging technology and customer synergies. Given our significant financial resources and talented operating team, we believe we are well positioned to pursue acquisitions and new opportunities to expand our business.

First Quarter 2020 Earnings Conference Call

Ligand announced plans to report first quarter 2020 financial results and hold an earnings conference call on May 6, 2020 after market close. Details about the conference call will be announced approximately two weeks in advance.

On April 6, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported that management will participate in a panel discussion on bispecifics at the Canaccord Genuity Horizons in Oncology Conference on Wednesday, April 8, 2020 at 10:15 a.m. ET. The conference will be held in a virtual meeting format (Press release, Bicycle Therapeutics, APR 6, 2020, View Source [SID1234556147]).

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A live webcast of the panel will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 60 days following the presentation date.

On April 6, 2020 LabCorp (NYSE: LH) reported that it will release its first quarter of 2020 financial results before the market opens on Wednesday, April 29, 2020, and then will host a conference call and webcast beginning at 9:00 a.m. EDT to discuss the results (Press release, LabCorp, APR 6, 2020, View Source [SID1234556146]). The earnings release and accompanying financial information will be posted on the LabCorp Investor Relations website.

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Interested parties can access the conference call by dialing 1-844-634-1444 within the U.S. and Canada, or 1-615-247-0253 internationally, using the passcode 3137489. In addition, a real-time webcast of the conference call will be available on the LabCorp Investor Relations website.

An audio replay of the conference call will be available from 1:00 p.m. EDT on April 29, 2020, until 11:30 a.m. EDT on May 13, 2020, by dialing 1-855-859-2056 within the U.S. and Canada, or 1-404-537-3406 internationally, using the passcode 3137489. The webcast of the conference call will be archived and accessible through April 16, 2021, on the LabCorp Investor Relations website.

On March 31, 2020, Pieris Pharmaceuticals, Inc. (the "Company") and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, "BVF") reported that it has entered into an Exchange Agreement (the "Exchange Agreement") pursuant to which BVF agreed to exchange (the "Exchange") an aggregate of 3,000,000 shares of the Company’s common stock, par value $0.001 ("Common Stock"), owned by BVF for an aggregate of 3,000 shares of the Company’s newly-designated Series D Convertible Preferred Stock, a "toothless" preferred stock, par value $0.001 per share ("Series D Preferred Stock") (Filing, 8-K, Pieris Pharmaceuticals, APR 6, 2020, View Source [SID1234556145]). The Exchange closed on April 1, 2020.

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As described below, the Series D Preferred Stock has substantially the same terms as the Company’s Series C Convertible Preferred Stock, par value $0.001 per share ("Series C Preferred Stock"), issued in November 2019, Series B Convertible Preferred Stock, par value $0.001 per share ("Series B Preferred Stock"), issued in January 2019, and Series A Convertible Preferred Stock, par value $0.001 per share ("Series A Preferred Stock"), issued in June 2016, all currently held by entities affiliated with BVF. The shares of Series D Preferred Stock issued in the Exchange are convertible into an aggregate of 3,000,000 shares of Common Stock (subject to adjustment as provided in the Series D Certificate of Designation, as defined below), subject to a 9.99% beneficial ownership blocker provision described below.

As of the date of the Exchange Agreement, BVF represented to the Company that it beneficially owned 5,872,762 shares of Common Stock, representing approximately 10.64% of the shares of Common Stock outstanding as of such date. In addition, BVF holds (i) 2,907 shares of Series A Preferred Stock, which are convertible into 2,907,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series A Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series A Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series A Certificate of Designation; (ii) 5,000 shares of Series B Preferred Stock, which are convertible into 5,000,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series B Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series B Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series B Certificate of Designation; and (iii) 3,522 shares of Series C Preferred Stock, which are convertible into 3,522,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series C Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series C Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series C Certificate of Designation.

A copy of the Exchange Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The foregoing is only a brief description of the material terms of the Exchange Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of the Exchange Agreement. The representations, warranties and covenants made by the Company in the Exchange Agreement were made solely for the benefit of the parties to the Exchange Agreement, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of March 31, 2020. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of the Company’s affairs.