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, 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, Celsion Corporation (the "Company"), reported that it entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital") which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $10.0 million of shares of the Company’s common stock over the 24-month term of the Purchase Agreement (Filing, 8-K, Celsion, OCT 28, 2019, View Source [SID1234549921]). Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the "Registration Rights Agreement"), in which the Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, as amended (the "Securities Act"), registering the sale of the shares of the Company’s common stock that have been and may be issued to Aspire Capital under the Purchase Agreement.

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Under the Purchase Agreement, after the Securities and Exchange Commission (the "SEC") has declared effective the registration statement referred to above, on any trading day selected by the Company, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice"), directing Aspire Capital (as principal) to purchase up to 100,000 shares of the Company’s common stock per business day, up to $10.0 million of the Company’s common stock in the aggregate at a per share price (the "Purchase Price") equal to the lesser of:

the lowest sale price of the Company’s common stock on the purchase date; or
the arithmetic average of the three (3) lowest closing sale prices for the Company’s common stock during the ten (10) consecutive trading days ending on the trading day immediately preceding the purchase date.

In addition, on any date on which the Company submits a Purchase Notice to Aspire Capital in an amount of 100,000 shares, the Company also has the right, in its sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase an amount of stock equal to up to 30% of the aggregate shares of the Company’s common stock traded on its principal market on the next trading day (the "VWAP Purchase Date"), subject to a maximum number of shares the Company may determine. The purchase price per share pursuant to such VWAP Purchase Notice is generally 97% of the volume-weighted average price for the Company’s common stock traded on its principal market on the VWAP Purchase Date.

The Purchase Price will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split, or other similar transaction occurring during the period(s) used to compute the Purchase Price. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed.

The Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of the Company’s common stock is less than $0.25. There are no trading volume requirements or restrictions under the Purchase Agreement, and the Company will control the timing and amount of sales of the Company’s common stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases from the Company as directed by the Company in accordance with the Purchase Agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. In consideration for entering into the Purchase Agreement, concurrently with the execution of the Purchase Agreement, the Company issued to Aspire Capital 100,000 shares of the Company’s common stock (the "Commitment Shares"). The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost to the Company. Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging of the Company’s common stock during any time prior to the termination of the Purchase Agreement. Any proceeds from the Company receives under the Purchase Agreement are expected to be used for working capital and general corporate purposes.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement and, by its nature, is incomplete. Copies of the Purchase Agreement and Registration Rights Agreement are filed herewith as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. All readers are encouraged to read the entire text of the Purchase Agreement and the Registration Rights Agreement.

The issuance of the Commitment Shares and all other shares of common stock that may be issued from time to time to Aspire Capital under the Purchase Agreement is exempt from registration under the Securities Act, pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act.

On October 28, 2019 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported new preclinical data on its lead program ORIC-101 – a selective and potent glucocorticoid receptor (GR) antagonist in Phase 1b – and its CD73 inhibitor program – an orally bioavailable small molecule inhibitor of a key node in the adenosine pathway – at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference on Molecular Targets & Cancer Therapeutics in Boston, Massachusetts (Press release, ORIC Pharmaceuticals, OCT 28, 2019, https://www.prnewswire.com/news-releases/oric-pharmaceuticals-presents-preclinical-data-on-glucocorticoid-receptor-antagonist-and-cd73-inhibitor-programs-at-aacr-nci-eortc-annual-conference-300945867.html [SID1234549937]).

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Glucocorticoid Receptor Antagonist Program

The ORIC-101 preclinical data were presented in abstract LB-A10, "ORIC-101 Overcomes Glucocorticoid-Driven Resistance to Enzalutamide in Castration-Resistant Prostate Cancer."

The glucocorticoid receptor has been identified as a potential antiandrogen bypass mechanism in patients with castration-resistant prostate cancer; thus GR-targeted therapies may overcome this therapeutic resistance to restore or prolong antiandrogen sensitivity. The poster presentation showed that GR is widely expressed in prostate cancer cell lines, organoids, and tumor tissue, and that GR levels are upregulated upon enzalutamide treatment. The data demonstrated that glucocorticoids promote tumor cell growth, stimulate expression of androgen regulated genes, and drive resistance to enzalutamide. Importantly, these effects were completely reversed by ORIC-101, suggesting ORIC-101 overcomes GR-driven resistance to enzalutamide.

ORIC-101 is currently in a Phase 1b study in combination with nab-paclitaxel in patients with advanced solid tumors. ORIC also plans to initiate a second Phase 1b study of ORIC-101 in combination with enzalutamide in patients with metastatic prostate cancer in the fourth quarter of 2019.

CD73 Inhibitor Program

Preclinical data from ORIC’s second program were presented in abstract LB-A19, "Intratumoral Immunosuppression is Reversed by Blocking Adenosine Production with an Oral Inhibitor of CD73."

The poster presentation showed that CD73 can drive adenosine generation from adenosine monophosphate (AMP) in vitro, resulting in suppression of anti-CD3/CD28-induced T cell activation and proliferation. The findings indicated that a novel, orally bioavailable CD73 inhibitor was able to effectively inhibit AMP to adenosine conversion both in vitro and in vivo, while an anti-CD73 antibody had incomplete effects. Small molecule-based inhibition of CD73 also fully restored proliferation and cytokine production of AMP/adenosine-suppressed T cells. Based on these results, an orally bioavailable small molecule inhibitor of CD73 represents a potential therapeutic approach to reverse immunosuppression within the tumor microenvironment.

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.