On May 3, 2018 C4 Therapeutics (C4T) reported that Andrew Phillips, Ph.D. has been appointed as President and Chief Executive Officer (Press release, C4 Therapeutics, MAY 3, 2018, View Source [SID1234526071]). Dr. Phillips has been leading C4T’s scientific efforts as Chief Scientific Officer since January 2016 and assumed corporate leadership responsibilities with his added appointment as President in September 2016. In conjunction with Dr. Phillips appointment as CEO, Stewart Fisher, Ph.D., has been promoted to Chief Scientific Officer.

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"Andy has played a key role in C4T’s growth and has helped define who we are today as a Company," said Marc Cohen, co-founder and Executive Chairman of C4T. "In addition to being a world-class scientist, Andy has provided exemplary leadership in recruiting a phenomenal management team, developing a robust internal pipeline of projects, and nurturing our strategic alliances with Roche and Calico. I look forward to working with Andy as CEO as we continue to build C4T’s targeted protein degradation platform and advance degraders into the clinic to address areas of high unmet medical need."

Prior to joining C4T, Dr. Phillips served as Senior Director for the Center for Development of Therapeutics at the Broad Institute of MIT and Harvard, where he led overall therapeutic efforts and provided strategic leadership for a number of major partnerships. Previously, he was a Full Professor of Chemistry at Yale University, where he received the ACS Cope Scholar Award for his research accomplishments which included the development of small molecules aimed at modulating ‘undruggable’ targets. Prior to this, he was a Full Professor of Chemistry and Biochemistry at the University of Colorado at Boulder, where his efforts in complex molecule synthesis and targeting protein-protein interactions garnered a number of awards, including an Alfred P. Sloan Research Fellowship, an Eli Lilly Grantee Award, and a National Science Foundation CAREER Award.

Dr. Phillips received a B.Sc. (Hons) in biochemistry and a Ph.D. in biochemistry and chemistry from the University of Canterbury in New Zealand and completed a postdoctoral fellowship in organic chemistry at the University of Pittsburgh.

On May 3, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended March 31, 2018 (Press release, Spectrum Pharmaceuticals, MAY 3, 2018, View Source [SID1234526089]).

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"We had a productive first quarter as we continued to advance our lead pipeline drugs poziotinib and ROLONTIS," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We were honored to have poziotinib data appear in Nature Medicine, be presented at AACR (Free AACR Whitepaper), and announce our strengthened IP with MD Anderson in addition to releasing ROLONTIS topline data. In the next few months, we look forward to announcing important clinical data from both therapies at key scientific meetings."

Clinical Program Update:

Poziotinib, an irreversible tyrosine kinase inhibitor:

The company has initiated a multi-center study which is currently enrolling non-small cell lung cancer (NSCLC) patients. This trial will enroll up to 87 patients with EGFR exon 20 insertion mutations and up to 87 patients with HER2 exon 20 insertion mutations at leading cancer centers throughout U.S. The study will evaluate objective response rate (ORR) as the primary endpoint, disease control rate (DCR), duration of response (DOR), progression free survival (PFS), quality of life (QOL) and safety as additional endpoints.
An investigator sponsored trial is ongoing at the University of Texas MD Anderson Cancer Center in NSCLC patients with exon 20 mutations in EGFR or HER2. The 50 patient EGFR cohort is fully enrolled.
In an April 2018 Nature Medicine publication, updated data from the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial showed a confirmed objective response rate of 64 percent. As noted in the publication, the median progression-free survival had not been reached, with a median follow up of 6.6 months. The safety profile was consistent with those previously described for poziotinib and other TKIs. The company expects additional data from this study at the World Conference on Lung Cancer, in Toronto (September 23-26, 2018).
Data presented at AACR (Free AACR Whitepaper) in April 2018, demonstrated pre-clinical and early clinical activity of poziotinib in HER2 exon 20 mutant NSCLC, suggesting poziotinib could be a promising agent for the numerous cancer types driven by HER2 exon 20 mutations.
The company is planning a basket trial to study poziotinib in exon 20 mutations across several solid tumors.
The company has entered into an exclusive licensing agreement with MD Anderson which strengthens and extends intellectual property on poziotinib. The filed patents, if granted, will extend until 2037.
ROLONTIS(eflapegrastim), a novel long-acting GCSF:

A registrational Phase 3 study, ADVANCE, was initiated under a special protocol assessment with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia.
The company announced the ADVANCE study met the primary efficacy endpoint of non-inferiority in duration of severe neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms. Phase 3 data abstract to be released by American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) followed by an oral presentation at Multinational Association of Supportive Care in Cancer (MASCC) in June 2018.
The company has completely enrolled RECOVER, an international Phase 3 study that has a design similar to ADVANCE.
Spectrum is working toward a pre-BLA meeting with the FDA to ensure alignment in preparation for a planned Q4 BLA submission.
Financial Guidance

The company has also raised guidance for 2018. Expected 2018 revenue will be between $95 million to $115 million, up from previously projected revenue of $90 million to $110 million. Additionally, the company expects its current cash and marketable securities to be sufficient to fund operations into 2020.

Three-Month Period Ended March 31, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $28.1 million in the first quarter of 2018. Product sales in the first quarter included: FOLOTYN (pralatrexate injection) net sales of $12.7 million, EVOMELA (melphalan) for injection net sales of $8.1 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.0 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $0.9 million, and FUSILEV (levoleucovorin) net sales of $0.6 million.

Spectrum recorded net loss of $15.8 million, or $0.16 per basic and diluted share in the three-month period ended March 31, 2018, compared to net loss of $23.5 million, or $0.30 per basic and diluted share in the comparable period in 2017. Total research and development expenses were $17.9 million in the quarter, as compared to $14.8 million in the same period in 2017. Selling, general and administrative expenses were $24.1 million in the quarter, compared to $19.1 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $14.7 million, or $0.15 per basic and diluted share in the three-month period ended March 31, 2018, compared to non-GAAP net loss of $11.4 million, or $0.14 per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $17.1 million, as compared to $14.3 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $20.4 million, as compared to $15.7 million in the same period in 2017.

Conference Call

Thursday, May 3, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 8765418

International: (973) 796-5077, Conference ID# 8765418

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on May 3, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On May 3, 2018 The NEOMED Institute reported that it has entered into a development collaboration with McGill University (Press release, NEOMED, MAY 3, 2018, View Source [SID1234527387]). Kemal Payza, Senior Project Director at NEOMED Institute will collaborate with Professor Alain Nepveu, Professor at the Goodman Cancer Research Centre and Departments of Oncology, Biochemistry and Medicine at McGill University, to discover new therapeutic small molecules to inhibit the protein target, Cut-Like Homeobox 1 (CUX1).

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"I am delighted that we have added this new drug discovery project into NEOMED’s pipeline and I look forward to working with Dr. Nepveu on this very exciting target. Dr. Nepveu is a renowned expert on the DNA repair function of CUX1, a mechanism upon which RAS-driven cancer cells are acutely dependent for their survival. This is very important, because currently there is no treatment that targets RAS-driven tumours," explains Payza.

"This academic/industrial collaboration that we have entered into with the NEOMED Institute will permit us to rapidly leverage our biological understanding of this important target to develop small molecule drug candidates. A drug capable of interfering with the ability of CUX1 to participate in DNA repair would target many types of cancers in which reactive oxygen species are produced as a consequence of mutation in a RAS gene or any oncogene that activates the RAS pathway; such activation is seen in 59% of pancreatic cancers and some 30% of human cancers overall," adds Professor Nepveu.

"This collaboration exemplifies, once again, the ability of NEOMED to deliver on its mission to help advance academic innovation and excellence by leveraging our industrial drug development experience and expertise. We look forward to collaborating with world-leading experts, like Professor Nepveu and Zubaidah Ramdzan, to translate their science into therapeutic options for patients within the Canadian ecosystem," concludes Donald Olds, President & CEO of NEOMED Institute.

About CUX1
Activation of the RAS pathway in cancer cells leads to higher production of reactive oxygen species, which cause DNA damage by oxidation. In turn, sustained DNA damage triggers cellular senescence. Cancer cells can adapt to such oxidative DNA damage by increasing their expression of CUX1, which stimulates the activities of two enzymes that repair oxidized bases in DNA. Knocking down the CUX1 protein has been found to kill all cancer cells that have high levels of reactive oxygen species (ROS). Thus, small molecules that inhibit the ability of CUX1 to stimulate those critical DNA repair enzymes would be expected to provide therapeutic benefit to patients with RAS-driven cancers. While therapeutic approaches targeting various aspects of the DNA damage response are strategically important in cancer, direct inhibition of base excision repair enzymes can cause severe adverse effects on normal cells. In contrast, CUX1 is not essential to normal cells, but is absolutely required for survival in situations of severe genotoxic stress such as that caused by reactive oxygen species in RAS-driven cancer cells or by DNA-damaging cancer treatments. Thus, small molecules that inhibit the ability of CUX1 to stimulate base excision repair enzymes are expected to treat RAS-driven cancers with an improved therapeutic window.

On May 3, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended March 31, 2018. Net loss for the first quarter of 2018 was $6.3 million, or $0.29 per share, compared with a net loss of $2.8 million, or $0.25 per share, for the first quarter of 2017 (Press release, Vical, MAY 3, 2018, View Source [SID1234526014]). Revenues for the first quarter of 2018 were $0.7 million, compared with revenues of $3.2 million for the first quarter of 2017, reflecting revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

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Vical had cash and investments of $58.3 million at March 31, 2018. The Company’s cash burn for the first quarter of 2018 was $4.6 million, which was consistent with the Company’s full year 2018 guidance of between $20 million and $24 million.

Program updates include:

VCL-HB01 HSV-2 Therapeutic Vaccine

Vical expects to announce top-line results from a Phase 2 study of its HSV-2 therapeutic vaccine during the second quarter of 2018. The last subject in the study has now completed nine months of surveillance; the primary endpoint of annualized recurrence rate will be calculated based on recurrences that are both clinically- and virologically-confirmed. This endpoint provides important information on the number of genital lesion recurrences over time in this chronic disease setting and is clinically meaningful for both patients and treating physicians. The Phase 2 study is being conducted in HSV-2 seropositive healthy adult subjects, 18 to 50 years of age who are randomized 2:1 to receive either vaccine or placebo.
VL-2397 Antifungal Drug

During the first quarter of 2018, Vical initiated a Phase 2 trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (ClinicalTrials.gov Identifier: NCT03327727). The Company intends to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. Only one new class of antifungal therapy has been approved in the last 30 years. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals. VL-2397 was isolated from a leaf litter fungus in a Malaysian national park, and was in‑licensed from Astellas in 2015.
Hepatitis B Virus (HBV) Therapeutic Drug

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. This preclinical development effort is being conducted in collaboration with Vical’s partner, AnGes, Inc. of Osaka, Japan.
Vical will conduct a conference call and webcast today, May 3, at noon Eastern Time, to discuss the Company’s financial results and program updates. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (323)794-2567 (preferred), or (888)278-8469 (toll-free), and reference confirmation code 1443635. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719)457-0820 (preferred) or (888)203-1112 (toll-free) and enter replay passcode 1443635. The webcast will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858)646-1127 or by e-mail at [email protected].

On May 3, 2018 apceth Biopharma GmbH, a company with the mission of improving patients’ lives with next generation cell therapies, reported that it has been selected for 2 oral presentations on apceth-201 and apceth-301 at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2018 Annual Meeting that will take place in Chicago on May 16-19, 2018 (Press release, apceth, MAY 3, 2018, View Source [SID1234526045]).

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apceth’s first presentation is titled "Intracerebral Immunomodulation Using Genetically Engineered Mesenchymal Stem Cells Induces Long-Term Survival and Immunity in Glioblastoma" and will be given by Prof. Dr. Nils Ole Schmidt from the University Clinic Hamburg-Eppendorf. Prof. Schmidt will present the latest results regarding apceth-301 which is being developed for the treatment of solid tumors. The presentation will take place on Wednesday May 16 between 11:15 AM – 11:30 AM in Salon A-1/2 (abstract number 22).

The second presentation is titled "Human Mesenchymal Stem Cells Genetically Engineered to Express Alpha-1 Anti-Trypsin (apceth-201) Confer a Long-Term Survival Benefit in a Lethal, Haplo-Identical Mouse Model of Graft-Vs-Host-Disease" and will be given by Dr. Ulf Geumann of apceth. The presentation will take place on Thursday May 17 between 5:00PM – 5:15PM in the International Ballroom North (abstract number 351).
"We are honored to have been invited by ASGCT (Free ASGCT Whitepaper) to present the most recent data on apceth-201 and apceth-301", said Dr. Christine Guenther, CEO of apceth Biopharma. "We are very excited about the data and are currently preparing to move into clinical development."