On June 15, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the Medicines and Healthcare products Regulatory Agency (MHRA; the UK equivalent of the FDA) has given approval to initiate a Phase I clinical trial of INKmune, a novel therapy to prime the patient’s own NK cells to attack their cancer, in patients with high-risk Myelodysplastic Syndrome (MDS) (EUDRACT 2019-004820-40) (Press release, INmune Bio, JUN 15, 2020, View Source [SID1234561101]). This single center Phase I trial will be the first-in-man study using INKmune. Based on the current environment and timetable of its clinical site, INmune Bio is targeting the study initiation in the 2nd half of this year.

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"Patients with MDS are mostly elderly; in this population high-dose chemotherapy or bone marrow transplant are usually too toxic," said Dr. Marion Wood, consultant hematologist and the medical director for this INKmune program. "With this clinical trial, we hope to show that INKmune will provide an effective and better tolerated therapeutic option for those patients who are poorly served by current therapies." Patients with high-risk MDS will be enrolled to receive at least 3 doses of INKmune therapy via intravenous infusion, without the need for any type of conditioning therapy or pretreatment. The Phase I trial, called Laurel, will include at least 9 patients enrolled at a single center in the UK and has the capacity for an extension cohort.

"Recent research has shown that MDS patients who survive beyond two years are those with good NK cell activity (Tsirogianni et al 2019). INKmune has been shown to boost the function of NK cells from MDS patients in laboratory experiments. We will target those patients whose NK cells demonstrate a response to INKmune in the laboratory. This is part of our precision approach to immunotherapy," said Dr. Mark Lowdell, CSO of INmune Bio and discoverer of the science behind INKmune. "We are excited to be able to test it as a treatment in this group of patients facing an unmet therapeutic need."

"Professor Lowdell and his team in the UK have worked closely with the MHRA to get this trial through regulatory approval, despite the challenges of the COVID-19 pandemic," said RJ Tesi MD, CEO of INmune. "The INKmune program is the second oncology platform entering the clinic for INmune Bio."

On June 15, 2020 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has commenced an underwritten public offering of 4,000,000 shares of its common stock (Press release, Constellation Pharmaceuticals, JUN 15, 2020, View Source [SID1234561100]). All of the shares are being offered by Constellation. In addition, Constellation expects to grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock sold in the public offering.

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J.P. Morgan, Jefferies, Cowen and RBC Capital Markets are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey is acting as lead manager and Baird is acting as co-manager for the offering. The offering is subject to market and other 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.

The shares are being offered by Constellation pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on December 9, 2019.

This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

On June 15, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that its abstract has been accepted for oral virtual presentation at the 3rd Annual Next Gen Immuno-Oncology Congress, which takes place from 25-26 June 2020 (Press release, BerGenBio, JUN 15, 2020, View Source [SID1234561099]).

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The presentation to be given by Prof. Hani Gabra MD PhD, CMO BerGenBio, will provide an update of results from a phase II trial (BGBC008), evaluating bemcentinib in combination with MSD’s Keytruda (pembrolizumab) in previously treated non-small cell lung cancer (NSCLC) patients with confirmed progression, including positive top line clinical and translational data from stage 1 of Cohort B in patients having failed prior immune checkpoint therapy.

The presentation will be available on the Company website in the Presentations section on 25 June: www.bergenbio.com/investors/presentations/

Title: Targeting AXL to leverage checkpoint immunotherapy: ​Updated results of the BGBC008 phase II study of bemcentinib and pembrolizumab in recurrent NSCLC

Date and time: 25 June 2020, 10am EST

Session name: Targeted Antibodies and Cellular Therapy

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On June 15, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported presentation of final results of its Phase 1b study, and preliminary positive data from its Phase 2 study, in relapsed or refractory acute myeloid leukemia (AML) (Press release, Cardiff Oncology, JUN 15, 2020, View Source [SID1234561098]). The data was presented as a virtual poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) annual conference.

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The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window.
The EHA (Free EHA Whitepaper) poster presentation is available for download from the Scientific Presentations page on the Cardiff Oncology website at View Source

"While the trial is still ongoing, we are encouraged by the efficacy we are seeing thus far in patients with relapsed/refractory AML, particularly the durability of response observed in some patients," said Dr. Amer Zeidan, lead investigator and associate professor of Medicine at the Yale School of Medicine, and the medical director of Hematology Early Therapeutics Research at Yale Cancer Center. "As we continue with enrollment and assessment of efficacy in the Phase 2 portion of the trial, I look forward to seeing additional clinical benefit with the combination of onvansertib and decitabine in our patients in an indication that is in dire need of new safe and effective treatment options."

Presentation Highlights
Safety and Tolerability:
•In Phase 1b, the maximum tolerated dose (MTD) was established at 60 mg/m2 with no dose-limiting toxicities through this dose level
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•Treatment-related toxicities continue to be primarily on-target hematological; with rash and mucositis being reported at higher onvansertib doses
Efficacy
Completed Phase 1b:
•Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m2), indicating a large therapeutic window
•Of the 21 patients evaluable for efficacy in the completed Phase 1b dose escalation study, 7 (33%) achieved an objective response; 5 (31%) of 16 patients who achieved a complete response (CR/CRi) were treated at the four highest onvansertib dose levels (27 – 90 mg/m2)
•3 patients remain on treatment; time since clinical response is 6, 12 and 15 months, respectively
Ongoing Phase 2:
•Of the 7 patients completing 1 cycle of treatment as of the data cutoff, 28% achieved an objective response:
◦1 patient achieved a CRi at cycle 1 and a CR at cycle 2; time since response is 3 months and the patient continues on treatment
◦1 patient achieved a partial response at cycle 1 and remains on treatment
Biomarker Analysis:
•Decreases in mutant ctDNA after 1 cycle of treatment were highly predictive of clinical response
•Target engagement in circulating blasts was associated with greater decrease in bone marrow blasts

About the Phase 2 Clinical Trial of Onvansertib in AML
The Phase 2 AML trial (NCT03303339) of onvansertib in combination with decitabine will enroll 32 patients who are either treatment naïve and not candidates for induction therapy or who have relapsed disease after treatment with one prior regimen. Patients will receive onvansertib, administered orally, on days 1 through 5 of each 21-28-day cycle in combination with decitabine. The primary efficacy endpoint of objective response (CR + CRi) will be assessed in patients who complete at least 1 cycle of treatment.
About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology
-2-
believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), KRAS-mutated colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.
Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).
Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array/Pfizer, Ignyta/Roche and Genentech.

On June 15, 2020 Genoscience Pharma, a clinical-stage biotechnology company dedicated to discovering and developing anticancer treatment drugs, reported that its poster demonstrating promising results from a combination study with a PD-1 inhibitor in a transgenic mouse model of hepatocarcinoma (HCC) was selected for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held June 22-24, 2020 in a virtual format only due to COVID-19 worldwide crisis (Press release, GenoScience, JUN 15, 2020, View Source [SID1234561097]).

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This in vivo study was performed the ASV-B transgenic immunocompetent mouse model of HCC. Animals were treated by the vehicle, GNS561 or PD-1 inhibitor as monotherapy or GNS561 in combination with PD-1 inhibitor. Results showed an outstanding anticancer response, with a 59% and 77% decrease of the macronodules count using GNS561 alone and in the combination group compared to controls respectively.

"We are delighted to be presenting this positive in vivo study at the AACR (Free AACR Whitepaper) Meeting 2020. These results may open a new horizon in the area of immuno-oncology by enlarging indication of the use of immune checkpoint inhibitors in tumor types that are marginally sensitive to immunotherapy or for patients developing resistance to checkpoint inhibitors. We believe our results provide a strong rationale for combining our drug to a PD-1 inhibitor antibody in clinical trials with HCC patients." said Pr Eric Raymond, Chief Medical Officer at Genoscience Pharma.

"We are looking forward to assess this combination in HCC patients, for which immunotherapy hasn’t answered the current medical need.", commented Pr Philippe Halfon, President and Founder of Genoscience Pharma.

The details for the Company’s poster presentation are as follows:

Presenting Author: Dr Madani RACHID, PharmD, MSc.

Poster title: GNS561, A NEW ORAL CLINICAL-STAGE SMALL MOLECULE COMBINED WITH ANTI-PD1 SHOWED REMARKABLE ANTI-TUMOR EFFECTS IN A TRANSGENIC IMMUNOCOMPETENT HEPATOCELLULAR CARCINOMA MOUSE MODEL (ASV-B), Poster 899.

Presentation date and time: June 22, 2020 (from 9 am to 6 pm)