On September 27, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) reported that Eddie Gray, Dynavax’s Chief Executive Officer, will present at the 2018 Cantor Global Healthcare Conference on Monday, October 1, 2018 at 10:40 AM ET at the InterContinental New York Barclay Hotel (Press release, Dynavax Technologies, SEP 27, 2018, View Source [SID1234530121]).

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The live and replayed versions of the webcast will be available on the "Events and Presentations" section of the Dynavax website at View Source

On September 27, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported its update on the Phase 2 clinical trial of ProscaVax for early-stage prostate cancer (Press release, Oncbiomune, SEP 27, 2018, View Source [SID1234529910]). The Company is pleased to report that initial installments for the study have been made and the final preparations culminating in enrollment are being completed between Theradex Oncology, the Contract Research Organization overseeing the study, and the host hospital, Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). Per study protocol, approximately 120 patients are expected to be enrolled. The patients will be in what is termed "active surveillance," a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy. To the Company’s knowledge, the trial of ProscaVax is the first ever worldwide for a prostate cancer vaccine technology addressing the active surveillance patient population.

"Our excitement is growing as we draw closer to enrollment. We (our Company and the host hospital) have already fielded inquiries from prostate cancer patients interested in participating in the study, which is an encouraging sign about recruitment once the trial is opened," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We think the interest is owed to the strong safety profile and meaningful immunological effect demonstrated in the Phase 1 study of ProscaVax in advanced-stage prostate cancer patients and the simple fact that there are no FDA-approved therapeutic options for the tens of thousands of active surveillance patients that want to be proactive in addressing their cancer. We believe that ProscaVax has a lot to offer these patients and potential future partners as the only vaccine of this type."

In preparation for the trial and other pipeline developments, the Company has taken measures to clean its balance sheet, including recently retiring $900,000 in convertible, floorless debt. Management is currently in negotiations with its lenders and accredited investors to secure additional funding structured under attractive terms, including preferred stock and fixed-rate convertible debentures.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On September 27, 2018 Akari Therapeutics, Plc ("Akari" or the "Company") (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, reported that it has entered into a Securities Purchase Agreement (the "Agreement") of up to $20 million with Aspire Capital Fund, LLC ("Aspire Capital") (Press release, Akari Therapeutics, SEP 27, 2018, View Source [SID1234529899]). Under the terms of the Agreement, Aspire Capital has committed to purchase up to $20 million of Akari’s American Depositary Shares ("ADSs") at Akari’s request from time to time during a 30-month period beginning on the effective date of a registration statement related to the transaction, and at prices based on the market price at the time of each sale. There are no warrants, derivatives, or other share classes associated with the Agreement. Akari will control the timing and amount of all sales of its ADSs to Aspire Capital.

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"This transaction provides Akari with efficient and opportunistic access to up to $20 million of equity funding to advance the company through key clinical milestones," said Clive Richardson, [interim] CEO of Akari Therapeutics. "These funds are expected to allow Akari to complete three Phase II trials studies and on the basis of this data initiate potential pivotal trials in Bullous pemphigoid (BP), Atopic keratoconjunctivitis (AKC) and thrombotic microangiopathies (TMA). In addition, Akari will continue to develop Coversin for treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH)."

Proceeds are intended to be used by Akari for general corporate purposes, including research and development, clinical trial activity and working capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. Akari has the right to terminate the Agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligation under the Agreement, Akari issued 30,000,000 ordinary shares at $0.02 per ordinary share (equivalent to $2.00 per ADS) to Aspire Capital as a commitment fee and sold to Aspire Capital 25,000,000 ordinary shares at $0.02 per share (equivalent to $2.00 per ADS). Akari also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement. Additional detail regarding the Agreement and the related Registration Rights Agreement is set forth in Akari’s Report on Form 6-K filed today with the SEC.

This press release does not constitute an offer to sell or the solicitation of any offer to purchase any securities. The securities referenced in this press release have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933.

On September 27, 2018 Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, reported its financial results for the second quarter ended June 30, 2018 (Press release, Akari Therapeutics, SEP 27, 2018, View Source [SID1234529898]).

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"We made several important advancements since the beginning of 2018 and now have a diversified clinical portfolio with four ongoing disease programs and up to a $20 million funding facility provided by Aspire Capital Fund, LLC," commented Clive Richardson, Interim Chief Executive Officer of Akari Therapeutics.

Clinical development highlights and upcoming milestones

Coversin clinical trials focused on orphan diseases mediated by both the complement and leukotriene pathways:
Phase II trial in patients with bullous pemphigoid, a severe blistering skin disease, with initial data expected in the first quarter of 2019
Phase I/II trial in patients with atopic keratoconjunctivitis, a sight threatening surface of the eye condition, with initial data anticipated in the first quarter of 2019
Coversin clinical trials in orphan diseases in which complement dysregulation is the primary disease driver:
Phase III trial in naïve patients with paroxysmal nocturnal haemoglobinuria (PNH) and a Phase II trial in patients with PNH who are resistant to eculizumab
Phase II trial in atypical haemolytic syndrome, a severe thrombotic microangiopathy
All patients who completed phase 2 have opted to enroll into the Coversin long term Phase III safety study. Currently there is over 15 years of safety data on Coversin with no drug related severe adverse events to date.
Second Quarter 2018 Financial Results and Business Highlights

Operating expenses, which include research and development (R&D) expenses and general and administrative (G&A) expenses, were $8.0 million in the second quarter of 2018, as compared to $7.3 million in the same quarter the prior year. Operating expenses for the six months ended June 30, 2018 were $12.3 million, as compared to $15.6 million for the same period the prior year.
R&D expenses in the second quarter of 2018 were $5.1 million, as compared to $3.8 million in the same quarter the prior year. The increase was due primarily to higher manufacturing costs for Coversin as the Company manufactured clinical trial material for supply through 2019.
G&A expenses in the second quarter of 2018 were $2.9 million, as compared to $3.6 million in the same quarter last year. This decrease was due primarily to lower legal fees, partially offset by higher rent expense.
Total other expense for the second quarter of 2018 was $43,000, as compared to total other income of $7.0 million in the second quarter of 2018. This change was primarily attributed to a $7.0 million gain in fair value of the stock option and warrant liabilities in the second quarter of 2017, compared to a $153,000 loss in the second quarter of 2018.

Net loss for the second quarter of 2018 was $8.0 million, compared to a net loss of $0.3 million for the same period in 2017. This year over year increase in net loss was due primarily to the aforementioned $7.0 million gain in fair value of the stock option and warrant liabilities in the second quarter of 2017.
The Company has entered into a Securities Purchase Agreement of up to $20 million with Aspire Capital Fund, LLC ("Aspire Capital"). Under the terms of this agreement, Aspire Capital has committed to purchase up to $20 million of Akari’s American Depositary Shares (ADSs) at Akari’s request from time to time during a 30-month period beginning on the effective date of a registration statement related to the transaction and at prices based on the market price at the time of each sale. As consideration for Aspire Capital’s obligation under the Agreement, Akari issued 30,000,000 ordinary shares at $0.02 per ordinary share (equivalent to $2.00 per ADS) to Aspire Capital as a commitment fee and sold to Aspire Capital 25,000,000 ordinary shares at $0.02 per share (equivalent to $2.00 per ADS).
As of June 30, 2018, the Company had cash of $15.1 million, as compared to cash of $28.1 million as of December 31, 2017

On September 27, 2018 Janssen Biotech, Inc. (Janssen) reported its decision not to continue the collaboration and license agreement with Geron Corporation for imetelstat (Press release, Johnson & Johnson, SEP 27, 2018, View Source [SID1234529885]). The decision not to continue the collaboration is the result of a strategic portfolio evaluation and prioritization of assets within the robust Janssen portfolio. Janssen will work with Geron to transition the imetelstat program back to the company. Patients currently enrolled in the ongoing imetelstat clinical trials will continue to be supported through the respective trial protocols, including treatment and follow-up. The imetelstat collaboration began on November 13, 2014 when Janssen entered into an exclusive worldwide collaboration and license agreement with Geron to develop and commercialize imetelstat in oncology, including hematologic myeloid malignancies. About the Janssen Pharmaceutical Companies of Johnson & Johnson At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Biotech, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Media Inquiries: Brian Kenney Phone: 1-215-620-0111 Satu Kaarina Glawe Phone: +49 172 294 6264 Investor Relations: Christopher DelOrefice Phone: 1-732-524-2955 Lesley Fishman Phone: 1-732-524-3922 U.S. Medical Inquiries: 1-800-526-7736 View original content:View Source SOURCE Janssen Biotech, Inc. News Provided by Acquire Media

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