On January 29, 2020 Cerus Corporation (Nasdaq: CERS) reported the pricing of a registered underwritten public offering of its common stock for proceeds of approximately $55.0 million, before deducting estimated offering expenses payable by Cerus (Press release, Cerus, JAN 29, 2020, View Source [SID1234553644]). The offering is expected to close January 31, 2020, subject to customary closing conditions. All of the shares sold in the offering were sold by Cerus. In addition, Cerus has granted the underwriter a 30-day option to purchase up to an additional $8.25 million of shares of its common stock. On January 28, 2020, the last sale price of the shares as reported on The Nasdaq Global Market was $4.15 per share.

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BTIG, LLC is acting as sole book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-219727) relating to the shares of common stock described above was previously filed by Cerus with the Securities and Exchange Commission ("SEC") and declared effective on January 8, 2018. This offering is being made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting BTIG, LLC at 65 East 55th Street, New York, NY, 10022, by email at [email protected] or by telephone at (212) 593-7555.

This press release shall 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On January 29, 2020 Starpharma (ASX: SPL, OTCQX: SPHRY) reported its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2019 (Press release, Starpharma, JAN 29, 2020, View Source [SID1234553660]).

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Starpharma’s cash balance as at 31 December 2019 was $35.9 million, with net operating cash outflows for the quarter of $0.5 million, compared to $4.6 million last quarter. Receipts for the quarter included the $4.9 million R&D tax incentive refund received in December 2019. Product supply and royalty receipts for VivaGel BV totalled $0.9 million for the quarter.

The cash balance does not include the anticipated US$3 million milestone payment from AstraZeneca which is expected to be received during the March quarter.

Cash outflows for the quarter include the manufacture of VivaGel BV product to support the roll-out in multiple regions, including the UK, Eastern Europe and Asia. Cash outflows also included expenditure on Starpharma’s three DEP clinical programs, including several new sites across the DEP studies. Outflows also included expenditure on the dual strategy to achieve FDA approval through the formal review process, as well as preparation, including start-up activities, for a possible VivaGel BV treatment clinical trial.

Key recent events:

AstraZeneca commenced the phase 1 clinical trial of its first DEP product, AZD0466. The successful dosing of the first patient in this trial triggered a US$3 million milestone payment, which is expected to be received in the coming weeks.
DEP cabazitaxel trial progressed from phase 1 to phase 2 on positive results. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose. The trial transitioned seamlessly into phase 2, with two new sites initiated and recruitment underway.
Patients continue to be recruited into the phase 2 trial for DEP docetaxel, with efficacy signals observed in a variety of tumour types including non-small cell lung cancer, prostate cancer, and several hard to treat tumours. Six sites in the UK are currently recruiting patients, including two new sites – the Christie and the Beatson (Glasgow).
Patients continue to be recruited into the dose escalation phase of the phase 1/2 trial for DEP The three leading cancer sites actively recruiting for this trial are the Christie, the Royal Marsden and Newcastle Freeman Hospital.
VivaGel BV was launched in the UK under the brand Betafem BV Gel.
Starpharma supplied product to Mundipharma to support the roll-out of VivaGel BV in Europe, including countries in Central and Eastern Europe, where launches are expected in the coming months.
Further regulatory approvals were granted in Asia. Advanced marketing activities are underway, and product has been delivered by Starpharma in preparation for launch.
Aspen continued to advance their marketing and promotional activities for Fleurstat BVgel in Australia, and preparations have progressed for the New Zealand launch, including product supply by Starpharma and training of sales representatives.
Starpharma progressed its dual strategy regarding FDA approval of VivaGel BV with ongoing support from a team of expert FDA consultants (regulatory, statistical, clinical, legal; several ex-FDA). This includes seeking formal review of some of the FDA’s initial conclusions, as well as preparation for a possible BV treatment trial.
VivaGel condom was granted marketing approval in Europe. LifeStyles has commenced marketing preparations ahead of the launch of the VivaGel condom under the brand name Absolute DUAL PROTECTION.
New DEP candidate, DEP gemcitabine, was advanced for development upon demonstrating significantly enhanced anti-tumour activity compared with Gemzar (gemcitabine), both alone and in combination with Nab‑paclitaxel (Abraxane), in a human pancreatic cancer model.
Several new DEP patents were filed covering DEP in combination with marketed anticancer agents and novel DEP
Dr Jackie Fairley, Starpharma CEO, commented: "It was a key milestone for Starpharma to see AstraZeneca treat its first patient with our partnered DEP product, AZD0466. AstraZeneca describes AZD0466 as having the potential to be a ‘best-in-class’ agent in this field due to its ability to target both Bcl2 and Bcl/xL. We will follow the progress of the AZD0466 trial, which is currently being conducted in multiple sites in the US, with interest. In our internal portfolio, we progressed DEP cabazitaxel into phase 2 on positive phase 1 results and we delivered excellent data on our new candidate, DEP gemcitabine. With four DEP products now in the clinic, and a pipeline of high-potential candidates, the DEP platform is generating a deep portfolio of valuable products".

"We also achieved key milestones for VivaGel BV, with the launch into the UK market. We continue to work closely with our partners to support the roll-out in Europe and Asia, as well as the New Zealand launch. In the last few months, several submissions have also been prepared and submitted for countries in other regions. During the next quarter we are focussed on accelerating our clinical trials, wherever possible, and working towards further regulatory approvals and launches for VivaGel BV," concluded Dr Fairley.

On January 29, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the publication of previously released interim clinical data in the February 2020 issue of peer-reviewed journal, Glioma (Press release, DelMar Pharmaceuticals, JAN 29, 2020, View Source [SID1234553645]). The article highlights results from the first 22 patients of the Company’s ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (GBM). The article can be accessed online via View Source;year=2019;volume=2;issue=4;spage=167;epage=173;aulast=Guo.

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In the article, which was co-authored by lead investigator Professor Zhong-ping Chen of Sun Yat-sen University Cancer Center (SYSUCC) in Guangzhou, China, where the study is currently being conducted, of the 22 patients who had completed at least one cycle of treatment as of that date, median progression-free survival (PFS) with VAL-083 as reported was 9.9 months (confidence interval, or CI, 7.3-12.0 months). For the 18 patients initially receiving the intended treatment dose (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median PFS as reported was 10.4 months (CI 6.0-12.0 months). While this is not a head-to-head trial, historically, temozolomide (TMZ) has been demonstrated to have 6.9 months PFS in unmethylated GBM patients.

"This publication represents an important additional validation of VAL-083 as a first-line treatment. Given that an external panel of experts reviewed both the protocol and the interim data and were willing to publish based on the results and inclusive of the fact that the data came from a study originating in China. This publication is from a world-renowned journal and we believe it demonstrates the potential to achieve one of the first new treatments for GBM in many years. We look forward to providing continued updates on the development of VAL-083 as they become available," commented Saiid Zarrabian, DelMar’s Chief Executive Officer.

The Phase 2 trial is a single-arm, open-label study testing VAL-083 in combination with standard radiotherapy in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The clinical trial in newly-diagnosed GBM patients is designed to determine if first-line treatment with VAL-083 plus radiotherapy can provide improvements over the historical efficacy of standard of care TMZ plus radiotherapy. In the publication, authors outlined the two parts of the study. The first is a dose escalation and induction format to enroll up to ten patients to receive VAL-083 at 20, 30 or 40 mg/m2/day for three days every 21 days concurrently with standard radiation and VAL-083 for up to eight additional cycles. The second part of the study is an expansion phase to enroll up to 20 additional patients. The publication highlighted the first 23 patients enrolled, 14 of whom had been treated in the expansion phase.

Myelosuppression was the most common adverse event in the patients assessed, and pharmacokinetic assessments indicated that the levels of VAL-083 were as high in the cerebrospinal fluid as in plasma two hours after infusion.

About VAL-083

VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies.

On January 29, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has granted marketing authorisation for the expanded use of Erleada▼ (apalutamide) to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (Press release, Janssen Pharmaceuticals, JAN 29, 2020, View Source [SID1234553661]).

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"Prostate cancer is the most prevalent form of cancer in men throughout Europe, and the expanded approval of apalutamide marks a significant advancement for those living with mHSPC," said Prof. Dr. med. Axel S. Merseburger, Chairman of the Department of Urology, Campus Lübeck, University Hospital Schleswig-Holstein, Kiel, Germany. "In prostate cancer treatment, our primary goal is always to delay progression of disease and prolong survival, to ensure the best possible outcomes for patients. Today’s news is therefore an encouraging development for patients within Europe, for whom the importance of an additional treatment option that can both delay progression and extend survival cannot be underestimated."

The EC approval is based on data from the Phase 3 TITAN study, which assessed the addition of apalutamide to ADT in a broad range of patients with mHSPC, regardless of disease volume, prior treatment with docetaxel or staging at initial diagnosis. The dual primary endpoints of the study were overall survival (OS) and radiographic progression-free survival (rPFS).2 Apalutamide plus ADT significantly improved OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95% CI, 0.51-0.89; p=0.0053).2 In both study arms, median OS was not reached.2 Apalutamide plus ADT also significantly improved rPFS compared to placebo plus ADT with a 52 percent reduction in risk of radiographic progression or death compared to placebo plus ADT (HR=0.48; 95% CI, 0.39-0.60; p<0.0001).2 The median rPFS was 22.1 months for placebo plus ADT and not reached for apalutamide plus ADT.2 The two-year OS rates, after a median follow up of 22.7 months, were 82 percent for apalutamide plus ADT compared to 74 percent for placebo plus ADT.2 These results were published in The New England Journal of Medicine.2,3

The safety profile observed in the TITAN study for apalutamide plus ADT was consistent with that described in previous studies. In the study, 42 percent of patients on apalutamide plus ADT experienced Grade 3/4 adverse events (AEs), compared to 41 percent of patients on placebo plus ADT.2 The most common Grade ≥3 AEs for apalutamide plus ADT versus placebo plus ADT were hypertension (8.4 percent vs. 9.1 percent) and skin rash (6.3 percent vs. 0.6 percent). Treatment discontinuation due to AEs was 8 percent in the apalutamide arm compared to 5 percent in the placebo arm.2

"We are delighted with the EC’s approval of the extended use of apalutamide, which makes an important treatment option potentially available to over 100,000 patients living with mHSPC across Europe," said Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "It is vital to fight cancer at this stage of the disease with an efficacious new line of treatment, to delay progression to the late and fatal mCRPC stage and, crucially, prolong survival. Janssen remains committed to transforming treatment outcomes for patients and improving lives throughout the prostate cancer journey."

"We continue to be encouraged by the clinical trial data for apalutamide, which demonstrates that the addition of apalutamide to ADT improves outcomes for a broad range of patients with mHSPC, compared to ADT alone," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology at Janssen Research & Development, LLC. "This approval is welcome news for patients with mHSPC and highlights our focus of addressing areas of high unmet need across the prostate cancer disease continuum."

In Europe, apalutamide is also approved for use in adults with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.4

About the TITAN Study2,3
TITAN is a Phase 3 randomised, placebo-controlled, double-blind study in men with mHSPC regardless of extent of disease or prior docetaxel treatment history. The study included 1,052 patients in intention-to-treat (ITT) population in 23 countries across 260 sites in North America, Latin America, South America, Europe and Asia Pacific. Patients with mHSPC were randomised 1:1 and received either apalutamide (240 mg) plus continuous androgen deprivation therapy (ADT) (n=525), or placebo plus ADT (n=527). The recruitment period for the study spanned from December 2015 to July 2017. The study included a broad population of patients with mHSPC, including patients with both low- and high-volume disease, those who were newly diagnosed, or those who had received prior definitive local therapy or prior treatment with up to six cycles of docetaxel or up to six months of ADT for mHSPC. Participants were treated until disease progression or the occurrence of unacceptable treatment-related toxicity. An independent data-monitoring committee was commissioned by the sponsor to monitor safety and efficacy before unblinding and make study conduct recommendations. Dual primary endpoints of the study were OS and rPFS. Secondary endpoints included time to cytotoxic chemotherapy, time to pain progression, time to chronic opioid use and time to skeletal-related event. Exploratory endpoints included time to PSA progression, time to second progression-free survival and time to symptomatic progression. For additional study information, visit ClinicalTrials.gov.

About apalutamide
Apalutamide is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and metastatic hormone-sensitive prostate cancer (mHSPC).4 In the U.S. apalutamide is indicated for the treatment of nmCRPC and mHSPC.5

About Metastatic Hormone-Sensitive Prostate Cancer
Metastatic hormone-sensitive prostate cancer (mHSPC), also referred to as metastatic castration sensitive prostate cancer (mCSPC), refers to prostate cancer that still responds to androgen deprivation therapy (ADT) and has spread to other parts of the body.6 Patients with mHSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options.7,8,9

On January 29, 2020 Eli Lilly and Company (NYSE: LLY) reported that the U.S. Food and Drug Administration (FDA) has granted priority review for the New Drug Application (NDA) for selpercatinib (LOXO-292), for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer (Press release, Eli Lilly, JAN 29, 2020, View Source [SID1234553646]). The NDA is based on data from the LIBRETTO-001 Phase 1/2 trial in RET-altered lung and thyroid cancers. The FDA has filed the NDA and set a Prescription Drug User Fee Act (PDUFA) date in the third quarter of this year.

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"We are pleased the FDA granted priority review status for the NDA for selpercatinib. This represents an important step toward providing a new precision therapy for people living with certain RET-driven cancers," said Anne White, president of Lilly Oncology. "Combined with the recent opening of our two Phase 3 selpercatinib clinical trials, we are thrilled with the positive momentum of this program and hope to deliver a practice-changing treatment to patients with RET-driven cancers as soon as possible."

In previous regulatory actions, based on early data from the Phase 1/2 LIBRETTO-001 trial, the FDA granted selpercatinib Breakthrough Therapy Designation for treatment in people with:

Metastatic RET-fusion-positive NSCLC who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy;
RET-mutant MTC who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment option; and
Advanced RET-fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
In 2019, selpercatinib received orphan drug designation for the treatment of RET fusion-positive NSCLC and for the treatment of RET fusion-positive and RET-mutant thyroid cancers including poorly differentiated thyroid cancer, undifferentiated or anaplastic thyroid cancer, MTC and locally advanced or metastatic follicular or papillary thyroid cancer.

In December of 2019, Lilly opened two selpercatinib Phase 3 trials: LIBRETTO-431 for patients with treatment-naïve RET fusion-positive NSCLC, and LIBRETTO-531 for patients with treatment-naïve RET-mutant MTC. Each trial will enroll 400 patients.

About RET-Driven Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2 percent of NSCLC, 10-20 percent of papillary and other thyroid cancers and a subset of other cancers. Activating RET point mutations account for approximately 60 percent of MTC. RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

About LIBRETTO-001
The LIBRETTO-001 Phase 1/2 trial was the largest clinical trial of patients with RET-driven cancers treated with a RET inhibitor. The trial included a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). The Phase 2 portion of the trial had a primary endpoint of objective response rate (ORR) and secondary endpoints of duration of response (DoR), progression free survival (PFS) and safety. Results from the NSCLC population were presented at the 2019 IASLC World Congress on Lung Cancer (WCLC), while results from the thyroid populations were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress.

About LIBRETTO-431
LIBRETTO-431 is a randomized Phase 3 clinical trial of patients with treatment-naïve RET fusion-positive NSCLC. The trial will enroll 400 patients with advanced or metastatic RET fusion-positive NSCLC who have received no prior systemic therapy for metastatic disease. Enrolled trial participants will be randomized 1:1 to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC. RET fusions may be identified using local testing. This trial’s efficacy endpoints are PFS, overall survival (OS), ORR, DoR, and intracranial ORR. For patients randomized to the control arm, crossover is allowed at progression.

About LIBRETTO-531
LIBRETTO-531 is a randomized Phase 3 clinical trial of patients with treatment-naïve RET-mutant MTC. The trial will enroll 400 patients with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease. Enrolled trial participants will be randomized 2:1 to receive either selpercatinib or physician’s choice of cabozantinib or vandetanib as initial treatment of their advanced or metastatic RET-mutant MTC. RET mutations may be identified using local testing. This trial’s efficacy endpoints are PFS, treatment failure-free survival (TFFS), OS, ORR, and DoR. For patients randomized to the control arm, crossover is allowed at progression.

About Selpercatinib (LOXO-292)
Selpercatinib (LOXO-292) is a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. Selpercatinib was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms.