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]).

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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.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On July 31, 2020 Hologic, Inc. (Nasdaq: HOLX) reported that disappointed that the American Cancer Society (ACS) has released guidelines for cervical cancer screening that significantly diverge from those of other leading medical and governmental institutions, including the American College of Obstetricians and Gynecologists (ACOG), the United States Preventive Services Task Force (USPSTF) and the Women’s Preventive Services Initiative (WPSI) (Press release, Hologic, JUL 31, 2020, View Source [SID1234562654]). By moving toward limiting options for women and overlooking critical data that supports time-tested screening strategies, the ACS now stands alone as an outlier among these organizations and institutions.

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The rate of cervical cancer, which was a leading cause of death among women, has fallen by more than 70 percent since the Pap test was introduced over 50 years ago.1,2 Previously, cervical cancer was the leading cause of cancer death in women, but now it is the fourteenth most frequent.3,4 However, with the lengthening of screening intervals, cervical cancer rates have stagnated across the screening population and are increasing in some populations.5 So it is unclear why the ACS would want to put women’s health at risk by moving toward a future screening paradigm in which the preferred approach does not include the Pap test, and younger women – those under 25 years of age – would be excluded from screening altogether.

Importantly, the ACS guidelines are based on a proprietary model, the details of which have not been available to the scientific community for analysis, and conclusions based on this model are inherently contradictory. Specifically, the model predicts the identification of more treatable pre-cancer (CIN2 and CIN3) using the current standard of care over the newly recommended approach, yet counter-intuitively it also predicts increased rates of cancer incidence and death using the current standard of care.

In addition, real-world data demonstrate the superior performance of co-testing (the Pap test and HPV test together) as compared to either Pap or HPV testing alone. In particular, new clinical findings published earlier this month, based on the largest and most diverse longitudinal cervical cancer screening data to date, reaffirmed the use of co-testing as the most effective strategy for identifying women at risk of, or with, prevalent precancer and cancer. The analysis showed that co-testing identified 99.7 percent of pre-cancer cases and 94.1 percent of cervical cancer cases in women (<12 months of diagnosis).6* This study also demonstrated that the use of HPV alone testing misses twice as much cervical cancer as co-testing, which is an astonishing increase and a significant step back in our efforts to reduce cervical cancer.

Current guidelines by other organizations7,8,9 agree and maintain that the Pap test is a highly effective screening option for women ages 21 to 29 years old and recommend a combination of both the Pap test and HPV test (i.e., co-testing) for women ages 30 to 65 years old. The proposed ACS guidelines would diminish opportunities for women and their providers to make choices together as well as significantly reduce the options available to younger women, with potential unintended consequences to the care they receive. The evidence6 continues to show that standardized Pap and HPV testing together has been proven to detect the most cancers and save the most lives, which is why it is trusted and used by the majority of healthcare providers10 and laboratory professionals within the U.S.11 Less than 1 percent of healthcare providers use HPV testing alone.10

For more than 30 years, Hologic has developed and brought to market new advances in cervical cancer screening, as well as supported critical cervical cancer research, education and collaboration efforts. As such, it is difficult to understand why decisions are being made that continue to erode women’s access to crucial preventive healthcare. We want all women to have access to early and accurate diagnostic testing that has been proven to save lives. Instead of simplifying, we fear the contradictory guidelines from the ACS will sow confusion among women and their healthcare providers and dangerously impact the incredible progress society has made in preventing cervical cancer.

We urge the ACS to live up to its mission of freeing the world from cancer by reconsidering its cervical cancer guidelines so women can continue to have access to the proven-effective tests they not only need but deserve.

*In the study, co-testing identified 99.7 percent of pre-cancer cases compared to 97.6 percent by the HPV test and 89.3 percent by the Pap test. Co-testing also identified 94.1 percent of cervical cancer cases compared to 77.5% by the HPV test and 85.1% by the Pap test.

About Pap+HPV Together

Pap+HPV Together (co-testing) provides the best protection currently available against cervical cancer for women ages 30-65.12-13 Studies show up to 95% of cervical cancers can be detected by testing with Pap+HPV Together.6,14 The Pap test helps healthcare providers detect the presence of abnormal cervical cells, and the HPV test identifies HPV infections that can lead to cervical disease.15,16,17 Pap+HPV Together utilizes the same sample to screen for both cervical pre-cancer and cancer in women.

On July 31, 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the second quarter ending June 30, 2020 and provided a corporate update (Press release, VBI Vaccines, JUL 31, 2020, View Source [SID1234562653]).

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Jeff Baxter, President and CEO, commented: "The second quarter of 2020 was again a time of unprecedented disruption, with the COVID-19 pandemic continuing to have severe global public health, societal, and economic consequence. We have implemented and maintained measures required to ensure the safety and wellbeing of all our employees, while also continuing to achieve milestones that we hope will enable VBI to contribute meaningfully to public health solutions. As a result of the commitment, dedication, and passion of the entire VBI team, the remainder of 2020 is expected to be a milestone-rich period across our pipeline. To support the ongoing advancement of VBI’s pipeline candidates, we strengthened our balance sheet over the last few months. With $86 million in cash, cash equivalents, and short term investments, we continue to be well-positioned to capitalize on the growth and value-driving opportunities ahead."

Recent Highlights and Upcoming Program Milestones

Financing

April 2020: $57.5 million gross proceeds raised in an underwritten public offering
May 2020: Up to $50 million debt financing facility secured with K2 HealthVentures (K2HV), a healthcare-focused specialty finance company
May 2020: Repaid $15.3 million of debt to Perceptive Credit Holdings L.P.
Sci-B-Vac: Tri-Antigenic Prophylactic HBV Vaccine

May and July 2020: Productive pre-BLA and pre-submission meetings held with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively
Q4 2020: Submission of applications for regulatory approvals in the U.S., Europe, and Canada expected to begin
VBI-1901: Glioblastoma (GBM) Cancer Vaccine Immunotherapeutic Candidate

June 2020: Data presented at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighting:
Observation of a confirmed partial response in a patient treated with VBI-1901 + GM-CSF, with recurrent GBM tumor reduction of greater than 50%
Evidenced by five out of the six tumor responses seen to-date, identification of a normal baseline CD4+/CD8+ T cell ratio as a promising, potentially predictive biomarker strategy associated with tumor responses
Q4 2020: Initial immunologic and tumor response data expected from the Phase 2a VBI-1901 + AS01B study arm
Results observed to-date support further clinical development – exploring potential registrational study, expected to initiate in 2021
VBI-2901: Trivalent Prophylactic Pan-Coronavirus Candidate

As part of the collaboration with the National Research Council of Canada (NRC), announced in March 2020, a series of three pre-clinical animal models began in Q2 to evaluate:
Trivalent vaccine constructs targeting SARS-CoV-2, SARS-CoV, and MERS-CoV vs. monovalent vaccine constructs targeting SARS-CoV-2
Multiple different adjuvants
Pre-fusion vs. post-fusion spike proteins
Q3 2020: Pre-clinical data expected to enable selection of the optimal clinical vaccine candidate(s)
Q4 2020: Clinical study materials expected to be available
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

H2 2020: Initial human proof-of-concept data expected from ongoing Phase 1b/2a study
Formation of Commercial Advisory Board

May 2020: To support the Company’s commercial strategy, VBI formed a Commercial Advisory Board consisting of leading experts in public health policy, epidemiology, and vaccine development, with members Damian Braga (Chair), Eddy A. Bresnitz, M.D., M.S.C.E., Michael D. Decker, M.D., M.P.H., and John D. Grabenstein, Ph.D., R.Ph.

Second Quarter 2020 Financial Highlights

Cash Position: VBI ended the second quarter of 2020 with $86.1 million in cash, cash equivalents, and short term investments compared to $44.2 million as of December 31, 2019. Short term investments consist of guaranteed income certificates held with Schedule 1 Canadian banks for maturity terms greater than 3 months, but less than one year from the date of acquisition.
Net Cash Used in Operating Activities: Net cash used in operations for the six months ended June 30, 2020 was $15.5 million compared to the $26.3 million for the same period in 2019. The decrease is the result of the completion of the Sci-B-Vac Phase 3 clinical studies, the first of which (PROTECT) was completed in June 2019, the second of which (CONSTANT) was completed in January 2020.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $0.3 million for the six months ended June 30, 2020 compared to $2.9 million for the same period in 2019. The decrease was due to the completion of the modernization and capacity increase of VBI’s manufacturing facility in Rehovot, Israel, which re-commenced operations in May 2019.
Revenue: Revenue in the second quarter of 2020 was $0.2 million compared to $0.6 million for the same period in 2019. The decrease was due to a decrease in product revenue of Sci-B-Vac on a named-patient basis during the three months ended June 30, 2020 compared to the three months ended June 30, 2019. The decrease was also related to a decrease in R&D services revenue for VBI-2601 following the initiation of the clinical study in November 2019 as part of the ongoing collaboration with the Brii Biosciences.
Cost of Revenues: Cost of revenues was $2.1 million for the second quarter of 2020 compared to $2.4 million for the same period in 2019. This slight decrease is due to lower costs related to R&D services revenue.
Research and Development (R&D): R&D expenses were $2.4 million for the second quarter of 2020, compared to $7.4 million for the same period in 2019. The decrease in R&D expenses is the result of the completion of the Sci-B-Vac Phase 3 studies and is offset by an increase in expenses due to the ongoing Phase 1/2a study of VBI-1901.
General and Administrative (G&A): G&A expenses were $3.9 million for the second quarter of 2020, compared to $3.2 million for the same period in 2019. The increase is a result of the increase in pre-commercialization activities for Sci-B-Vac.
Net Loss: Net loss and net loss per share for the second quarter of 2020 were $9.5 million and $0.04, respectively, compared to a net loss of $13.2 million and a net loss per share of $0.13 for the second quarter of 2019.