On April 14, 2020 Immunophotonics reported that it has received Swissmedic approval to commence a new clinical trial entitled "Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors (Press release, Immunophotonics, APR 14, 2020, View Source [SID1234556306])." This is a multicenter phase 1B/2A trial with expansion cohorts in melanoma and soft tissue sarcoma patients. The therapeutic approach taken by this trial (SAKK 66/17) is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.

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Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn "cold" tumors into "hot" tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as long-term response mediated by the patient’s immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect).

This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection in patients with laser ablation-accessible solid tumors (6 patients, "all comers," Part 1, safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity is a primary objective (Part 2, Cohort 2).

On April 14, 2020 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2020 and withdrew its 2020 guidance (Press release, Illumina, APR 14, 2020, View Source [SID1234556305]).

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Subject to quarter-end closing adjustments, the Company expects to report first quarter revenue of approximately $858 million, compared to $846 million in the first quarter of 2019. Strong sequencing consumable revenue more than offset the impact of COVID-19 including disrupted system sales in the closing weeks of the quarter.

"Our priority in the midst of this global pandemic is the safety of our employees, partners and customers," said Francis deSouza, President and CEO. "We are also committed to ensuring continuity of supply for our customers, many of whom are performing critical clinical testing for patients. We share the commitment of the scientific community to do everything we can to fight COVID-19, and are supporting researchers using sequencing to track transmission, study the evolution of the virus’ genome and how it could impact the effectiveness of diagnostics and therapies, or explore how surveillance could be adopted to reduce the impact of future outbreaks of new infectious diseases."

"While our preliminary first quarter results were strong overall, we expect the second quarter to be significantly impacted by COVID-19 related disruption," said Sam Samad, Illumina’s Chief Financial Officer. "We are confident that this is a temporary disruption that in no way alters the long-term trajectory of sequencing adoption and demand. That said, it is not possible at this time to forecast the severity and duration of this outbreak. As a result, we believe it is prudent at this time to withdraw our 2020 revenue and earnings per share guidance."

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, April 30, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597, or 1 (647) 689-6853 outside North America, both with conference ID 9492366.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 14, 2020 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 937 million in the first quarter of 2020 (Press release, Genmab, APR 14, 2020, View Source [SID1234556304]). Net trade sales were USD 463 million in the U.S. and USD 474 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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About DARZALEX (daratumumab)

DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

On April 14, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported the appointment of Thomas Civik as President and Chief Executive Officer and a member of the Board of Directors of the company (Press release, Five Prime Therapeutics, APR 14, 2020, View Source [SID1234556303]). Mr. Civik joins Five Prime from Foundation Medicine, where he served as Chief Commercial Officer. William Ringo, who has served as interim CEO since September 2019 and as Chairman of the Board, will step down as CEO and will continue as Chairman of the Board of Directors.

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"We are delighted to attract an oncology leader of Tom’s stature to propel Five Prime to its next level of achievement," said William Ringo, interim Chief Executive Officer and Chairman of the Board. "Having led teams through the launch, commercialization and lifecycle development of several blockbuster oncology products, including some of the most revolutionary cancer treatments and diagnostics, Tom brings leadership experience to a strong executive team that will enable Five Prime to realize its full potential. I also look forward to my continued work at Five Prime providing important continuity as I work with Tom and the Executive Team in my capacity as Chairman."

Mr. Civik is an industry leader with more than 25 years of commercial and lifecycle management experience in the biotech, biopharma, and diagnostics sectors. At Foundation Medicine, Mr. Civik built a commercial and lifecycle management team that launched FoundationOne CDX, the first FDA approved pan-cancer comprehensive genomic test, and FoundationOne Liquid, a second-generation liquid biopsy test, in addition to expanding the company’s global footprint. Prior to that, Mr. Civik built a distinguished career as an oncology executive at Genentech where he commercialized new and established global brands such as Avastin, Tarceva, Tecentriq, and Alecensa.

"I’m thrilled to join this science-driven organization that has several novel products in the clinic, an impressive portfolio of compounds in preclinical development, and the financial discipline to allocate resources to the most promising opportunities," said Tom Civik. "I consider it an honor to work in the life sciences and I’m excited to contribute to fulfilling the Five Prime mission, which is to fundamentally improve the lives of oncology patients in ways never before possible. I look forward to working with the Five Prime team, our board of directors, our advisors, and our partners to have a meaningful impact on the lives of people with cancer."

Five Prime is focused on advancing its pipeline of proprietary programs in clinical development, novel late-stage research programs and partnered programs. The company remains on track to achieve program milestones and clinical data disclosures in 2020 that will allow the company to prioritize future pipeline investments. The company has also implemented measures in response to the COVID-19 pandemic to protect the health and safety of its employees and their families while still allowing the continued execution of the company’s operations and progress of its programs.

On April 14, 2020 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that effective at 5:00 p.m., Eastern Time, on April 14, 2020 (the "Effective Time"), the Company will effect a one-for-twenty reverse stock split of its outstanding common stock (Press release, Cyclacel, APR 14, 2020, View Source [SID1234556302]). The reverse stock split, which was unanimously approved by the Company’s Board of Directors, was approved by its stockholders at a Special Meeting of Stockholders held on October 28, 2019. The Company’s common stock will open for trading on The NASDAQ Capital Market on April 15, 2020 on a post-split basis.

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As a result of the reverse stock split, every twenty shares of the Company’s common stock issued and outstanding at the Effective Time will be consolidated into one issued and outstanding share. No fractional shares of common stock will be issued as a result of the reverse stock split; stockholders will be paid cash in lieu of any such fractional shares. Proportional adjustments will be made to Cyclacel’s outstanding warrants and stock options. The Company’s authorized shares and the nominal par value per share of $0.001 will remain unchanged.

In addition, upon the effectiveness of the reverse stock split, the conversion of Cyclacel’s outstanding 6% convertible exchangeable preferred stock and series A convertible preferred stock will be adjusted proportionally and automatically in accordance with the terms of the Company’s Certificate of the Powers, Designations, Preferences and Rights of the 6% Convertible Exchangeable Preferred Stock and Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Preferred Stock, respectively.

The reverse stock split is intended to increase the per share trading price of the Company’s common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market. Trading of the Company’s common stock on The NASDAQ Capital Market will continue, on a split-adjusted basis, with the opening of the markets on Wednesday, April 15, 2020, under the existing trading symbol "CYCC" and under a new CUSIP number 23254L603. The reverse stock split reduces the number of shares of the Company’s common stock outstanding from approximately 17.2 million pre-reverse split shares to approximately 860,000 post-reverse split shares.

Information for Stockholders

The Company has retained its transfer agent, American Stock Transfer & Trust Company, LLC ("AST"), to act as its exchange agent for the reverse stock split. AST will provide stockholders of record as of the Effective Time a letter of transmittal providing instructions for the exchange of their stock certificates. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to such brokers’ particular processes, and will not be required to take any action in connection with the reverse stock split. For more information regarding the reverse stock split, please refer to the Company’s definitive proxy statement for its most recently held annual meeting of stockholders which can be accessed through Cyclacel’s website at View Source