On December 16, 2019 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to offer shares of its common stock in an underwritten public offering (Press release, MEI Pharma, DEC 16, 2019, View Source [SID1234552400]). In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, as well as for working capital and other general corporate purposes.

Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. When available, copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York NY 10152, by telephone at 800-326-5897 or by email at [email protected]. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On December 16, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead drug candidate, tipifarnib, for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) after progression on platinum therapy (Press release, Kura Oncology, DEC 16, 2019, View Source [SID1234552399]).

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"We are very encouraged by our growing body of clinical data for tipifarnib in HRAS mutant HNSCC and believe that the FDA’s Fast Track designation puts us one step closer to delivering a precision medicine treatment for patients with this devastating disease," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "We continue to work with regulatory authorities in the U.S. and abroad in our effort to bring tipifarnib to patients as quickly as possible."

Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.

AIM-HN Enrollment Guidance

The Company also provided enrollment guidance for AIM-HN, its ongoing registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC. The global, multi-center trial was initiated in November 2018 and was originally projected to take approximately two years to fully enroll. Based on a recent evaluation of current enrollment rates, the Company now expects the trial to complete enrollment in the first quarter of 2021. The slower pace of enrollment is primarily due to delays in site activation and a higher than anticipated screen failure rate. The trial is now open in more than 81 clinical sites in the U.S., Europe and Asia.

"Although we experienced some delays in site activation, we’re encouraged to have the vast majority of the participating sites now open, with a corresponding increase in the rate of screening," said Kathleen Ford, Chief Operating Officer of Kura Oncology. "We recently presented impressive data from our Phase 2 trial in the same patient population and we believe that awareness of these data will continue to increase HRAS mutation testing and enrollment. Enrollment in AIM-HN remains our top priority and we remain steadfast in our commitment to bring tipifarnib to patients with HRAS mutant HNSCC for whom no treatment options are specifically indicated."

In addition, Kura plans to expand its targeted field-based medical science liaison team to help educate oncology practices on the importance of HRAS testing. The Company believes that this will provide HNSCC-treating physicians and their patients with more information about their diagnoses and enable them to make more educated decisions about their care, including potential clinical trial enrollment.

About Tipifarnib

Kura Oncology’s lead drug candidate, tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in December 2014. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

On December 16, 2019 Immune Therapeutics, Inc. (OTCQB: IMUN) ("Immune", "IMUN" or the "Company") and Aletheia Therapeutics Corp. ("Aletheia"), a privately held development-stage oncology therapeutics company, reported that Immune will acquire Aletheia in an all-stock transaction (Press release, Immune Therapeutics, DEC 16, 2019, View Source [SID1234552398]). Pursuant to completion of a definitive agreement, Immune will acquire all of the outstanding shares of Aletheia in exchange for Immune common stock . In connection with the acquisition, the Aletheia management team will join the leadership of the combined Company as well as selected Board members of Aletheia.

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Over the past several years researchers have demonstrated that cancer is inherently heterogenous and a single tumor can have up to one hundred different cell phenotypes. This knowledge has led to a new approach in cancer therapy in that targeting several different biological targets in cancer provides for better efficacy and lower toxicity. Specifically, a combination of drugs that each target an independent critical pathway in cancer growth is becoming widely recognized as the future of cancer treatment. The combined company will be focused on developing and commercializing precision cancer therapies by simultaneously targeting two or more of the following biological targets depending on the make-up of a patients’ cancer: DNA repair, T-cell activation, metabolic dysfunction, angiogenesis, apoptosis or inflammation.

"With this acquisition we will be able to develop a diverse platform of therapies that target multiple critical biological pathways that will be designed for an individual’s cancer," said Michael Handley, chief executive officer and president, Immune Therapeutics. "The combination of Aletheia’s diverse oncology product pipeline with Immune’s Lodonal and MENK product candidates will create an industry leading oncology company."

"Following an extensive evaluation and diligence process, the Immune Board of Directors concluded that the acquisition of Aletheia, with a strong platform technology, seasoned leadership team, and compelling clinical development plan, offered an excellent opportunity to create shareholder value for Immune," stated Dr. Roscoe Moore, the chairman of Immunes Board of Directors. "We believe Aletheia represents an attractive acquisition target for Immune, offering a novel approach to creating precision therapies for cancer patients with unmet medical needs."

Under the initial terms announced today, Immune, through a subsidiary, will initiate an offer to acquire all outstanding shares of Aletheia. The closing of the offer will be subject to certain conditions, including completing due diligence, the employment of the Aletheia management team to Immune management team and the assignment of all intellectual property to Immune. Furthermore, Aletheia has signed definitive stock purchase agreement with an investor group for $25 million that should fund before the end of the year. Once the acquisition is complete Aletheia and Immune will be funded with sufficient capital to execute on the product development strategy in 2020. The acquisition is expected to close early in the first quarter of 2020.

On December 16, 2019 GlaxoSmithKline reported treatment with the investigational single-agent belantamab mafodotin resulted in a clinically meaningful 31% overall response rate (ORR) with the 2.5 mg/kg regimen in patients with heavily pre-treated multiple myeloma (Press release, GlaxoSmithKline, DEC 16, 2019, View Source [SID1234552397]). Patients in the trial received a median of seven prior lines of treatment, were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38 antibody. The median duration of response has not been reached at six months of follow-up.

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Full results from the DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study of belantamab mafodotin were published today in The Lancet Oncology. GSK also confirmed submission of a Biologics License Application to the US Food and Drug Administration (FDA) seeking approval of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab mafodotin is not currently approved for use anywhere in the world.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Patients with multiple myeloma whose disease has progressed despite currently available therapy have limited options and poor outcomes. Data from the DREAMM-2 study show that, if approved, belantamab mafodotin could offer an important new treatment option for these patients."

DREAMM-2 is an open label study of belantamab mafodotin, a humanised, immunoconjugate against B-cell maturation antigen (BCMA).[i] Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.

Dr Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory University, Chair of Emory Department of Hematology and Medical Oncology and Principal Investigator for DREAMM-2, said: "Each day in my practice, I see patients who would benefit from additional therapeutic options because their disease has advanced and is no longer responding to available treatments. In recent years, BCMA has become one of the most promising targets in multiple myeloma research. The data published today from DREAMM-2 not only reinforce the significance of BCMA as a potentially viable target, but also underscore the potential of belantamab mafodotin, if approved, as a practical treatment option in this patient population."

The results demonstrated in DREAMM-2 were consistent with those observed in a similar subset of patients in the DREAMM-1 study. Based on these data, GSK is moving forward with a US FDA submission seeking approval of the 2.5 mg/kg dose. If approved, belantamab mafodotin will be the first anti-BCMA agent available in the US.

Thirty of the 97 patients (31%) in the 2.5 mg/kg cohort achieved an overall response. Of these responders, 18 patients achieved a very good partial response or better, including three patients with stringent complete or complete responses. In addition, overall survival in patients achieving a response was not reached in the six month follow-up period.

The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin. The three most commonly reported Grade 3 or 4 adverse events in the 2.5 mg/kg arm were keratopathy (27%), thrombocytopenia (20%) and anaemia (20%). Keratopathy is characterized as changes in the corneal epithelium as seen on eye examination which can manifest with or without symptoms. Corneal events leading to treatment discontinuation affected 1% of patients in the 2.5 mg/kg cohort.

Additional studies are testing the effect of belantamab mafodotin as third-line monotherapy in relapsed/refractory multiple myeloma and in combination with standard and novel treatments in the first and second line setting as part of the broader DREAMM clinical development programme.

In 2017, GSK2857916 was granted Breakthrough Therapy designation from the US FDA and PRIME designation from the European Medicines Agency.

In the US, an expanded access program for belantamab mafodotin is available to eligible patients with multiple myeloma. For patients to be considered for enrollment in the programme, they must be assessed according to specific inclusion and exclusion criteria by their treating physician. Additional information about the expanded access protocol can be found on ClinicalTrials.gov (NCT03763370).

About multiple myeloma
Multiple myeloma is the second most common blood cancer and is generally considered treatable, but not curable.[ii] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[iii]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[iv]

About the DREAMM clinical trial programme for belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational immunoconjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Completed

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Phase II Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495

Planned

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887/

NCT04126200

Recruiting

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664/ NCT04091126

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS / GSK Co-Sponsored Study

209418/ NCT03715478

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On December 16, 2019 The board of directors of Eli Lilly and Company (NYSE: LLY) reported a 15 percent increase in its quarterly dividend (Press release, Eli Lilly, DEC 16, 2019, View Source [SID1234552396]). The dividend for the first quarter of 2020 will be $0.74 per share on outstanding common stock. This raises the annual indicated rate to $2.96 per share.

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The dividend is payable March 10, 2020, to shareholders of record as of the close of business on February 14, 2020.