On October 28, 2019, Sierra Oncology, Inc. (the "Company"), reported that it has entered into an amendment (the "Amendment") to the Asset Purchase Agreement, dated as of August 20, 2018 (the "Agreement"), among the Company, YM Biosciences Australia Pty Ltd. and Gilead Sciences, Inc. ("Gilead") (Filing, 8-K, Sierra Oncology, OCT 28, 2019, View Source [SID1234551147]). Pursuant to the terms of the Amendment, in exchange for a reduction in the royalties and milestones payable by the Company to Gilead under the Agreement, including the elimination of a $5.0 million milestone payment that would have been due to Gilead upon initiation of MOMENTUM, the Company’s planned Phase 3 clinical trial of momelotinib for patients with myelofibrosis, the Company agreed to issue to Gilead, pursuant to a private placement, shares of its common stock, par value $0.001 per share ("Common Stock"), equal to 7.5% of the Company’s outstanding shares of Common Stock after the automatic conversion of the Series A Preferred Stock sold in the Offering (as such terms are defined below) and a warrant to purchase up to the same number of shares of Common Stock with an exercise price equal to the conversion price of the Series A Preferred Stock (the "Warrant"). The effectiveness of the Amendment and the issuance of the shares of Common Stock and Warrant to Gilead is conditional upon the completion of the Offering and the conversion of the Series A Preferred Stock.

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The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

On October 28, 2019 Nuvation Bio, Inc., a stealth biotechnology company developing proprietary therapies focused on oncology, reported the closing of $275 million in an oversubscribed Series A financing (Press release, Nuvation Bio, OCT 28, 2019, View Source [SID1234550204]). The round was led, structured and syndicated by Omega Funds and included participation from leading biotechnology investors including Aisling Capital, Altitude Life Science Ventures, The Baupost Group, Boxer Capital of the Tavistock Group, EDBI (global Asian-based Investor), ECOR1 Capital, Fidelity Management and Research Company, Pavilion Capital, Perceptive Advisors, Redmile Group, Surveyor Capital (a Citadel Company) and other institutional investors.

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The Series A financing will enable Nuvation Bio to expand its development activities and advance a number of its oncology programs.

Nuvation Bio was founded by industry veteran David Hung, M.D., who previously founded and served as President and Chief Executive Officer of Medivation, Inc., which was subsequently sold to Pfizer, Inc. for $14.3 billion in 2016.

"My vision for Nuvation Bio is to provide patients with dramatic medical advancements that address their unmet needs across a wide range of oncology applications," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "I am extremely proud of what we accomplished at Medivation, developing in just seven years what is now the world’s largest prostate cancer drug. However, I believe we could have done so much more had we had more time. With seven mechanistically distinct programs at Nuvation Bio, along with the strong support of Omega Funds and a formidable syndicate of investors, we are well-positioned to expand upon the mission we started at Medivation. My team and I are extremely excited to develop even more game-changing therapies for the foremost unmet needs in oncology."

The Nuvation executive team is comprised of former senior leaders at Medivation including Michele D. Bronson, Ph.D., Melanie Morrison, and Thomas Templeman, Ph.D., who will serve as Nuvation’s Chief Development Officer, Vice President of Clinical Operations and Data Management and Senior Vice President of Pharmaceutical Operations and Quality, respectively. They are joined by new senior leaders including Chief Scientific Officer, Gary Hattersley, Ph.D., Chief Medical Officer, Sergey Yurasov, M.D., Ph.D., and Senior Vice President of Human Resources, Stacy Markel.

"The whole Omega Funds’ team has been thrilled to partner with David on the launch and Series A syndication of Nuvation Bio and thanks to deal leads Richard Lim and Michelle Doig for their efforts executing this transaction," said Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds. "The breadth and depth of Nuvation Bio’s innovative pipeline demands a large initial investment. By syndicating one of the largest-ever Series A biotech financings, David and his exceptional team are well-positioned to advance Nuvation Bio’s deep portfolio of therapies focused on dramatically improving the standard of care for those living with cancer," Stampacchia continued.

Joining Founder David Hung, M.D., on Nuvation Bio’s Board of Directors are Michelle Doig, Richard Lim and Otello Stampacchia of Omega Funds, as well as former Medivation directors Tony Vernon and Kim Blickenstaff.

On October 28, 2019 Neuralstem, Inc. (NASDAQ:CUR), reported that the company has changed its name to Seneca Biopharma, Inc (Press release, Neuralstem, OCT 28, 2019, View Source [SID1234550049]). The company anticipates that its shares will begin trading on the NASDAQ Capital Market under the symbol SNCA on November 1, 2019 or shortly thereafter subject to the satisfaction of customary conditions of the exchange. Concurrently with the name change, Seneca has launched its new corporate website at www.senecabio.com.

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"The name change represents a new philosophy in our organization as we move away from our prior emphasis on research related to neurological disorders to a new focus which is geared towards finding promising new science, developing a pipeline of biopharmaceuticals and commercializing those products while at the same time creating value for our stakeholders," commented Dr. Ken Carter, executive chairman of Seneca.

On October 28, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an update on the ongoing development of its product candidates (Press release, Immutep, OCT 28, 2019, View Source [SID1234549973]).

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Eftilagimod alpha ("efti" or "IMP321") Clinical Update

AIPAC – Phase IIb clinical trial

The Company is fully on track to report progression-free survival data and overall response rate data in Q1 of calendar year 2020. AIPAC is potentially a pivotal clinical trial, meaning it could serve as the basis to pursue appropriate regulatory approval pathways for efti, subject to sufficient and clinically meaningful data from the trial and regulatory interactions. Importantly AIPAC would be the first successful randomised trial in solid tumors for an antigen presenting cell activator and would be a very significant step in validating this new class of products.

TACTI-002 – Phase II clinical trial

Immutep presented initial encouraging data of the first cohort of 17 patients for Part A (patients with first line non-small cell lung cancer) of its TACTI-002 Phase II study, which is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada), in June. Part A has been expanded by the data monitoring committee in September to include 19 additional patients.

Recruitment is ongoing for Part B (second line non-small cell lung cancer) and Part C (second line head and neck squamous cell carcinoma), where 6 and 12 patients have been recruited, respectively. There is also potential to expand Parts B and C, subject to the required number of predefined patient responses being observed in these groups. Hence, in total 35 patients have been recruited across all three groups in TACTI-002.

Immutep will report data updates from the open label TACTI-002 study at SITC (Free SITC Whitepaper) on 8 November, at 7.00am EST, as well as in Q1 2020.

TACTI-mel – Phase I clinical trial

Immutep’s CSO and CMO presented final efficacy data at the World Immunotherapy Congress in Basel on 15 October 2019. The key findings were efti has a favourable safety profile in combination with pembrolizumab with no dose-limiting toxicities and the recommended dosage level for a Phase II trial is 30 mg of efti (this is the dosage level currently being evaluated in the ongoing TACTI-002 Phase II trial).

In addition, final efficacy data has been reported, confirming deep durable responses have been observed, with 12 patients (50%) having a decrease of ³ 75% in the target lesions and 9 patients (38%) being treated for ³ 12 months with pembrolizumab plus efti.

Final safety data is expected to be presented in H1 2020.

INSIGHT-004 – Phase I clinical trial

In June 2019, the first patient was enrolled in Germany and has received the first dose of treatment in INSIGHT-004, the fourth arm of the INSIGHT trial (INSIGHT-004 is also known as Stratum D of INSIGHT) which is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. The first cohort (6 mg of efti) is now fully recruited with six patients in total. The second cohort (30 mg of efti) will recruit six patients, bringing the total participants in the study to 12 patients.

Initial safety data from the study is expected to be reported in Q4 2019.

Efti Manufacturing

The company is also working on upscaling the manufacturing process from 200L to 2,000L single-use bioreactors at the WuXi Biologics manufacturing plant (Wuxi, China) in order to be better prepared for potential commercial manufacturing and additional registration trials in multiple indications.

IMP761 Update

IMP761

Immutep is continuing cell line development and the associated manufacturing steps of its IMP761 product candidate following encouraging preclinical results that demonstrated the immunosuppressive activity of IMP761.

Update on Programs Fully Funded by Immutep’s Licensing Partners

GlaxoSmithKline (GSK) – Phase I and II clinical trials

In September, Immutep announced that it will receive a milestone payment from GSK of £4 million (~A$7.39 million) related to the first patient being dosed in GSK’s Phase II clinical trial evaluating GSK2831781 in ulcerative colitis. This milestone payment was received by Immutep from GSK in October.

Novartis – Phase I and II clinical trials

Immutep’s partner Novartis, is conducting five trials of LAG525, derived from IMP701, which is licensed from Immutep. Earlier this year, it commenced the recruitment of 220 patients for its combinatory Phase Ib clinical trial in triple negative breast cancer.

Recruitment is also ongoing for its Phase II study in advanced triple negative breast cancer and its Phase II study in melanoma. A further two trials are active, namely a Phase I/II trial in advanced solid tumors and a Phase II trial in a range of advanced malignancies.

Eddingpharm (EOC Pharma) – Phase I clinical trial

The Phase I clinical study is ongoing with efti for the treatment of metastatic breast cancer.

On October 28, 2019 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of a development update and validation data for its cutaneous squamous cell carcinoma (SCC) prognostic test, DecisionDx-SCC (Press release, Castle Biosciences, OCT 28, 2019, View Source [SID1234549951]).

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The study titled, "Development and validation of a prognostic gene expression profile (GEP) for stratification of cutaneous squamous cell carcinoma (SCC) patients by 3-year risk of regional or distant metastases," was presented during an Oral Abstract session at the American Society for Dermatologic Surgery (ASDS) Annual Meeting, October 24-27 in Chicago.

Study Background

Approximately 1 million patients are diagnosed with SCC in the U.S. each year, and the incidence continues to grow.
Many patients with SCC will have a favorable prognosis, but an estimated 15,000 people in the U.S. die from SCC each year, surpassing the number of U.S. deaths from cutaneous melanoma estimated to be as high as 9,000.
National guidelines define different treatment pathways and follow-up schedules for low-risk and high-risk SCC patients, but the low positive predictive value (PPV) of available staging systems means that the majority of high-risk patients do not develop metastases. Thus, many high-risk patients may be over-treated with radiation, chemotherapy or other interventions even when they may not be needed.
There is a clear need for more accurate methods to identify high-risk SCC patients to appropriately direct work-up and treatment plans.
To address this need, Castle Biosciences has developed DecisionDx-SCC, a proprietary 40-gene prognostic test. The test was designed to improve upon existing clinicopathologic staging systems and identify SCC patients who are classified as high risk based upon clinicopathologic staging, but who are actually at a low biological risk for metastasis, and thus, can be considered for de-escalation in their treatment plan. Conversely, the test is also designed to identify a biologically high-risk group that has a significantly higher risk of metastasis than would be determined by clinicopathologic staging alone.

Study Findings

Successful development of a 40-gene signature that identifies three groups of patients with significantly different risk for regional/distant metastasis using a training set of 122 patients.
The multicenter validation study included 321 patients, of which 93% had one or more high-risk features and 52 patients experienced metastasis.
Patients with a Class 1 result (n=203; lowest risk group) had a 91.6% 3-year metastasis-free survival (MFS) rate, significantly better than the MFS rate for patients with a high-risk Class 2A (80.6%; n=93) or highest risk Class 2B (44%; n=25) test result (p<0.0001).
The negative predictive value (NPV) for the DecisionDx-SCC Class 1 was 91.1%. Among all patients in the study, 63% had a Class 1 (lowest risk) result. This group could be considered for de-escalation in their treatment plan.
The PPV for DecisionDx-SCC Class 2B was 60% compared to the PPV for Brigham and Women’s Hospital (BWH) staging of 35.3% and American Joint Committee on Cancer (AJCC version 8) staging of 20.9%.
DecisionDx-SCC demonstrated strong independent prognostic value in multivariate analyses compared to the BWH and AJCC v8 staging systems. Specifically, when compared to the BWH staging system, DecisionDx-SCC Class 2B had a hazard ratio (HR) of 8.9 (p<0.001) compared to an HR of 1.9 for BWH high risk (p<0.05). Similarly, when compared to the AJCC v8 staging system, DecisionDx-SCC Class 2B had an HR of 9.8 (p<0.001) compared to an HR of 2.6 for AJCC high risk (p<0.001).
"Clinical validation of this prognostic test for SCC demonstrates significant progress towards improved identification of high-risk patients beyond currently available staging systems," commented Ashley Wysong, M.D., University of Nebraska Medical Center, Omaha NE, study investigator and presenter. "Clinical application of this test may allow us to de-escalate care in patients identified as low risk by tumor biology, as well as provide us objective data to guide implementation of adjuvant radiation, chemotherapy and clinical trial recommendations for those at actual high risk."

Additional DecisionDx-SCC performance studies are currently underway, including a prospective study. The DecisionDx-SCC test is the second skin cancer test discovered, developed and validated by Castle Biosciences.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (SCC), a nonmelanoma skin cancer, is one of the most common cancers. Approximately 1,000,000 patients are diagnosed with SCC each year in the U.S. Most patients have a favorable prognosis, but a subset of patients will develop metastasis and up to 15,000 patients each year die from their disease, exceeding the number of deaths from cutaneous melanoma. As current staging parameters have a low positive predictive value, many more patients are considered high risk than actually develop metastatic disease. Conversely, many patients who develop metastatic disease are misidentified as low risk. This may lead to over and undertreatment of a substantial number of SCC patients. To address this clinical need, Castle Biosciences has developed a gene expression profile test designed to improve upon current staging systems and identify patients with SCC at high risk for metastasis or recurrence, in order to enable more informed clinical decisions regarding adjuvant therapy and other management options.