On July 31, 2020, Rexahn Pharmaceuticals, Inc. (the "Company") reported that entered into a Warrant Exchange Agreement (the "Agreement") with Armistice Capital Master Fund Ltd. ("Armistice") (Filing, 8-K, Rexahn, JUL 31, 2020, View Source [SID1234564590]). The Company previously issued to Armistice (a) a warrant to purchase 160,257 shares (on a post-reverse stock split basis) of its common stock, par value $.0001 per share (the "Common Stock") pursuant to the offering described in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on October 19, 2018 (the "2018 Warrant"), and (b) a warrant to purchase 208,334 shares (on a post-reverse stock split basis) of Common Stock pursuant to the offering described in the Company’s Current Report on Form 8-K filed with the SEC on January 25, 2019 (the "2019 Warrant" and together with the 2018 Warrant, the "Warrants"). Pursuant to the Agreement, on August 3, 2020, the Company is issuing to Armistice an aggregate of 215,000 shares of Common Stock in exchange for the surrender and cancellation of the Warrants.
On July 31, 2020 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported on the ongoing development of its product candidates for the quarter ending 30 June 2020 (Press release, Kazia Therapeutics, JUL 31, 2020, View Source [SID1234564085]).
Positive data from phase II study of paxalisib in glioblastoma presented at ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper) conferences in June 2020
Paxalisib on track for potential commencement of GBM AGILE registration study in 2H CY2020
~$9 million in new capital raised through oversubscribed institutional placement in April 2020 and subsequent share purchase plan in May 2020
Kazia CEO, Dr James Garner, commented, "we are making excellent progress in the development of paxalisib. Following very positive data in recent months, the drug remains on track to commence a phase III study for registration, subject to ongoing funding discussions, and we anticipate that it could enter the market within the next few years. The commercial opportunity in glioblastoma is conservatively estimated at US$ 1 – 1.5 billion per annum. Beyond that, we have studies well underway in other forms of brain cancer, and these could substantially expand the opportunity for paxalisib."
Positive Clinical Trial Data for Paxalisib
Kazia presented an interim analysis of the ongoing phase II study of paxalisib in glioblastoma at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in June 2020. This analysis determined a median overall survival of 17.7 months for patients treated with paxalisib, which compares favourably to the historical control of 12.7 months for patients treated with temozolomide, the existing standard of care1. The analysis also showed a median progression-free survival of 8.5 months, which is similarly encouraging in comparison to the historical control of 5.3 months associated with temozolomide. The study remains ongoing, and final data is expected in late CY2020 or early CY2021.
ME Hegi, A-C Desirens, T Gorlia, et al. N Engl J Med (2005); 352:997-1003
Board of Directors
Mr Iain Ross Chairman, Non-Executive Director
Mr Bryce Carmine Non-Executive Director
Mr Steven Coffey Non-Executive Director
Dr James Garner Chief Executive Officer, Managing Director
Three International Towers, Level 24, 300 Barangaroo Avenue, Sydney NSW 2000
Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)
Note: temozolomide figures are historical controls, and so may not be directly comparable
Broad Clinical Trial Program on Track
In addition to the ongoing phase II study in glioblastoma, four trials of paxalisib in other forms of brain cancer are ongoing.
Alliance for Clinical Trials in Oncology
Dana-Farber Cancer Institute
Breast cancer brain metastases
St Jude Children’s Research Hospital
DIPG (childhood brain cancer)
Memorial Sloan Kettering Cancer Center
Impact of COVID-19
The company has been closely attentive to the potential impact of the ongoing COVID-19 pandemic on its activities. To date, there has been only modest operational impact at certain hospitals participating in Kazia clinical trials, with no material impact thus far. Nevertheless, the company continues to exercise a high degree of prudence, and is regularly evaluating emergent operational and financial challenges.
Preparation Well Advanced for GBM AGILE Registration Study
The company has continued to work closely with the Global Coalition for Adaptive Research (GCAR) and with clinicians to bring paxalisib into the ongoing GBM AGILE study. It is expected that GBM AGILE will provide the substantial evidence for FDA approval of paxalisib in glioblastoma. The study remains on track to commence recruitment in 2H CY2020, and the company expects to provide further detail in the near future.
High Impact Academic Publications
Two peer-reviewed papers concerning paxalisib have recently been published in the prestigious journal, Clinical Cancer Research (CCR). CCR is published by the American Association of Cancer Research (AACR) (Free AACR Whitepaper) and is ranked the #10 most impactful oncology journal (out of 348 publications) by SCImago.
The first paper, by Wen et al.2, provides a complete review of the data from the phase I study of paxalisib in recurrent glioma that was performed by Genentech (NCT01547546). The paper concludes that ‘these data support the further development of GDC-0084 [paxalisib].’ The key results of this study have been previously presented (for example at ASCO (Free ASCO Whitepaper) in 2016), but their detailed analysis in a high-profile scientific journal provides a canonical reference point for researchers, investors, and partners. Unlike conference posters, such journal publications undergo an exacting process of ‘peer review’, and only those which represent a significant and reliable contribution to the field are accepted.
The second paper, by Ellingson et al.3, reports a highly innovative analysis of imaging data from the same phase I study. Professor Ellingson correlates the amount of paxalisib in a patient’s body with measurable changes on MRI and PET scans, and connects those changes with clinical outcomes. These data provide a powerful confirmation that paxalisib crosses the blood-brain barrier and inhibits the PI3K pathway, and that this biological activity translates to meaningful changes in disease progression. The work was previously the subject of a prize-winning oral presentation at the Society for Neuro-Oncology (SNO) Annual Meeting in November 2019.
Taken together, these papers substantially reinforce the body of published scientific data for paxalisib and provide new insights into its mechanism of action and potential clinical efficacy.
During 4Q FY2020, the company received confirmation from the United States Adopted Name (USAN) Council that ‘paxalisib’ had been confirmed as the non-proprietary name for the drug formerly designated GDC-0084. This follows confirmation of paxalisib as the International Non-Proprietary Name (INN) for ex-US territories in December 2019.
As noted in the accompanying Appendix 4C, the company’s cash position at 30 June 2020 was AU$ 8.8 million. The company invested AU$ 2.1 million in research and development activities during 4Q FY2020, and incurred G&A expenses of AU$ 0.7 million.
These figures imply that approximately 75% of the company’s expenditure is devoted directly to research and development, representing a very high level of operating efficiency.
PY Wen et al. Clin Cancer Res 2020;26:1820–28
BM Ellingson et al. Clin Cancer Res 2020;26:3135-44
The company would also highlight that, while G&A expenses are incurred fairly evenly throughout the year, cash invested in research and development activities tends to vary considerably by quarter. In particular, the cashflows reported in this Appendix 4C include milestone payments associated with the completion of the Cantrixil phase I study, as well as one-off costs for the set-up of GBM AGILE. Accordingly, it is difficult to draw inferences as to the anticipated expenditure in FY2021.
In April and May 2020, the company raised approximately AU$ 9.0 million (before costs) in an oversubscribed institutional placement and subsequent Share Purchase Plan. The proceeds of these transactions will be used to advance the clinical development of paxalisib towards registration.
Should it be required, the company has contingency plans in place to adjust operational execution of its studies and, as necessary, to conserve cash.
The key milestones for the next two quarters are as follows:-
Commencement of recruitment to GBM AGILE registration study for paxalisib in glioblastoma
Additional interim data from the ongoing phase II study of paxalisib in glioblastoma
Interim data from the ongoing phase II study of paxalisib in breast cancer brain metastases at Dana-Farber Breast Cancer Institute
Interim data from the ongoing phase I study of paxalisib in DIPG at St Jude Children’s Research Hospital
The milestones are indicative and may be subject to change.
On July 31, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it will host a conference call on August 5, 2020 at 4:30 PM Eastern Time to discuss results for its second quarter ended June 30, 2020 (Press release, INmune Bio, JUL 31, 2020, View Source [SID1234562699]).
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Second Quarter Conference Call when reaching an operator.
Date: August 5, 2020
Time: 4:30 PM Eastern Time
Participant Dial-in: 212-231-2931
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available for approximately one week by calling 412-317-6671 and entering PIN no. 2196725.
On July 31, 2020 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported it will be presenting at the SNN Network Virtual Conference on Monday, August 3rd at 2:30 PM EDT (Press release, Helix BioPharma, JUL 31, 2020, View Source [SID1234562661]). Dr. Heman Chao, Helix’s Chief Executive Officer will be hosting the presentation and answering questions from attendees.
On July 31, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) approved MorphoSys’ Monjuvi (tafasitamab-cxix), a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT) (Press release, Xencor, JUL 31, 2020, View Source [SID1234562655]). The most common adverse reactions (≥ 20%) are neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. Xencor has earned a $25 million milestone payment from MorphoSys under the license agreement between the companies for Monjuvi in connection with the regulatory approval.
Xencor licensed exclusive worldwide rights to develop and commercialize Monjuvi, product code MOR208 and previously XmAb5574, to MorphoSys in 2010. Monjuvi incorporates Xencor’s XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity and antibody-dependent cellular phagocytosis.
"We are incredibly proud of Xencor’s discovery and early development of Monjuvi, an anti-CD19 antibody we engineered with our Cytotoxic XmAb Fc domain. Data from the L-MIND study highlight Monjuvi’s potential as treatment for people living with relapsed or refractory DLBCL, an aggressive form of lymphoma with poor clinical outcomes," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Monjuvi follows Alexion’s Ultomiris (ravulizumab-cwvz) as the second product incorporating XmAb technology to receive a marketing approval. These partnerships expand the use of our XmAb technology and provide us with an important source of non-dilutive capital, used to advance and expand our broad internal portfolio of novel XmAb bispecific antibodies and cytokine drug candidates."
Xencor is eligible to receive royalties on worldwide net sales in the high-single to low-double digit percent range and additional development, regulatory and sales milestone payments. Monjuvi will be co-commercialized in the U.S. by MorphoSys and Incyte Corporation. The European Marketing Authorization Application (MAA) for tafasitamab, based on data from the L-MIND study and supported by the Re-MIND observational retrospective study, is currently under review by the European Medicines Agency (EMA).
About Cytotoxic XmAb Fc Technology
Xencor’s Cytotoxic XmAb Fc domain is designed to improve the immune system’s elimination of tumors and other pathologic cells by antibody-dependent cellular cytotoxicity. The Cytotoxic Fc domain is engineered to increase binding affinity to activating Fcγ receptors to enhance activation of natural killer (NK) cells, as well as other immune cells such as macrophages, which play a role in immunity by engulfing and digesting foreign material.