On May 14, 2020 Boehringer Ingelheim reported the acquisition of Northern Biologics Inc., a wholly owned subsidiary of Northern LP (Press release, Boehringer Ingelheim, MAY 14, 2020, View Source [SID1234557981]). By acquiring this entity, which focuses on therapeutic antibodies targeting the tumor microenvironment, Boehringer Ingelheim is now positioned at the forefront of the stromal biology space – an emerging area in cancer immunology . The seller will retain the Northern Biologics name and will continue to drive certain preclinical efforts on one of the programs, while Boehringer Ingelheim will be responsible for clinical, regulatory and commercial development of the acquired programs.

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The total transaction includes an upfront payment, milestones and other consideration payments.

The first program, now in late preclinical development, is an antibody inhibitor of Periostin, a secreted matricellular protein overexpressed in the immunosuppressive stroma microenvironment of many solid tumor types. Targeting these stromal cells can help turn previously ‘cold’ tumors – non-reactive, immunologically inactive tumors – to ‘hot’ tumors – those that are susceptible or accessible to host immune system attack. The antibody program targeting Periostin has emerged as a promising therapy to overcome stromal mechanisms of immune exclusion and suppression.

The second program targets a key regulator of myeloid cells that is important for enhancing anti-tumor T-cell function. Targeting myeloid cells is a focus area of research and clinical development for Boehringer Ingelheim and the acquired program offers combination opportunities across Boehringer Ingelheim’s portfolio.

"This acquisition provides Boehringer Ingelheim with two complementary assets to our existing cancer immunology portfolio and supports our strategy to target ‘cold’ tumors with synergistic combination approaches," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim. "Driving innovation in tumor stroma and myeloid cell biology is yet another example of how we are ‘Taking Cancer On’ by exploring first-in-class approaches to provide the best treatment options for cancer patients."

"We are gratified by this transaction with Boehringer Ingelheim, which simultaneously accelerates these promising assets into the clinic," said Philip Vickers, Ph.D., President and CEO of Northern Biologics. "I am proud of the Northern R&D team, which discovered and advanced these compounds in the emerging field of tumor stroma and myeloid cell biology."

Founding investor Versant Ventures established Northern Biologics in Toronto’s MaRS Discovery District in collaboration with the University of Toronto and Princess Margaret Cancer Centre in 2014. The programs acquired by Boehringer Ingelheim were discovered and translated into clinical candidates by Northern’s Toronto-based research team. Northern Biologics retains rights to its lead asset, MSC-1, an anti-LIF 1 antibody that recently successfully completed Phase 1 clinical trials.

The Northern Biologics-Boehringer Ingelheim acquisition represents the second recent transaction for a Versant-built company operating out of the MaRS discovery district in Toronto. It follows the August 2019 acquisition of BlueRock Therapeutics, which also drew on technology locally developed by Canadian scientists.

This acquisition positions Boehringer Ingelheim as a leader in the field of stromal targeting biology and, along with a series of strategic acquisitions and collaborations over the past two years, further strengthens the company’s broad and diverse oncology pipeline. By combining its world-class, in-house research and development with that of highly innovative biotechnology companies, Boehringer Ingelheim is developing innovative cancer immunology therapies and accelerating the delivery of the next generation of cancer treatments.

On May 14, 2020 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the first quarter ended March 31, 2020, and provided a corporate update (Press release, VBL Therapeutics, MAY 14, 2020, View Source [SID1234558005]).

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"We reached an important milestone in our development of VB-111 in ovarian cancer with the recent positive outcome of the interim analysis of the ongoing Phase 3 OVAL study, which demonstrated the potential benefit of VB-111 over standard-of-care in a randomized-controlled study," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "A second planned interim analysis which will assess overall survival in the two treatment arms, is expected in the third quarter this year. We are pleased to be making progress also in our MOSPD2 antibody programs. We recently presented promising new data in NASH and colitis models in a Poster of Distinction at Digestive Disease Week, and also published a peer review manuscript on the potential of MOSPD2 antibodies to treat multiple sclerosis (MS). New data on our MOSPD2 bi-specific antibodies will be presented in a late breaking session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in June. Based on these positive developments, we successfully raised additional $18.1 million in gross proceeds, in spite of the COVID-19 pandemic complexities. Our current cash position is expected to fund our operations into the third quarter of 2022."

First Quarter and Key Corporate Highlights:

VB-111:

●The independent Data Safety Monitoring Committee (DSMC) reviewed un-blinded data from the ongoing OVAL study in ovarian cancer and determined that the study has met the interim pre-specified criterion, of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification.
●The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.
●The CA-125 response rate observed in the Phase 3 interim analysis is at least as good as the response rate seen in Phase 2, which enrolled similar population of patients with platinum-resistant ovarian cancer. The results will be presented at ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.
●The OVAL interim analysis results were discussed by Dr. Bradley J. Monk of Arizona Oncology on a KOL call hosted by the Company on March 26.
●NanoCarrier Co., Ltd., the Japanese licensee for VB-111, announced its intention to extend the ongoing global Phase 3 OVAL clinical trial in ovarian cancer to patients in Japan.
●The Israel Innovation Authority (IIA) awarded a non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS) (approximately $0.9 million) to fund development of VB-111.
●The planned studies of VB-111 in metastatic colorectal cancer and GBM are expected to start patient recruitment as soon as the COVID-19 situation allows.
MOSPD2:

●Published a new peer review manuscript demonstrating the potential of MOSPD2 antibodies for multiple sclerosis (MS).
○VBL’s data offer a differentiated approach to potential treatment of relapsing as well as progressive MS disease
●New preclinical data on MOSPD2 antibodies for treatment of NASH and colitis were presented at Digestive Disease Week (DDW).
○Data demonstrate the potential of VBL’s proprietary MOSPD2 mAbs for chronic inflammatory indications, via a novel and distinct mechanism targeting monocyte migration
○The study was rated in the top 10% of all abstracts in this category and was selected as Poster of Distinction
VB-201:

●A milestone event was reached under VBL’s collaborative agreement with a world-leading European animal health company, evaluating use of VB-201 for veterinary applications.
Quarter Ended March 31, 2020 Financial Results:

●Cash Position: At March 31, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $31.6 million and working capital of $24.6 million. VBL expects that its cash and cash equivalents and short-term bank deposits with the addition approximately $16.7 million from the net proceeds of the Registered Direct Offerings of which we have announced on May 7, 2020 and on May 11, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.
●Revenues: Revenues for the three-month period ended March 31, 2020 were $366 thousand, compared to $219 thousand in the same period of 2019.
●R&D Expenses: Research and development expenses, net, after government grants, in the three-month period ended March 31, 2020, were $4.8 million, compared to $3.3 million in the same period in 2019.
●G&A Expenses: General, administrative and marketing expenses for the three-month period ended March 31, 2020, were $1.2 million, compared to the $1.3 million in the same period in 2019.
●Comprehensive Loss: VBL reported a net loss for three-month period ended March 31, 2020 of $5.4 million, or ($0.15) per diluted share, compared to a net loss of $4.2 million, or ($0.12) per diluted share, in the same period of 2019.
For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.

Conference Call:

Thursday May 14th @ 8:30amET

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Israel: 1 809 406 247
Conference ID: 13703295
Webcast: View Source

On May 14, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the initiation of patient dosing in a Phase 1 dose escalation study evaluating XMT-1592, its Dolasynthen ADC targeting NaPi2b (Press release, Mersana Therapeutics, MAY 14, 2020, View Source [SID1234558034]). XMT-1592 is the Company’s first clinical candidate created using its new customizable and homogenous Dolasynthen ADC platform.

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"XMT-1592 has shown a differentiated preclinical profile, particularly in NSCLC where we saw a four-fold increase in efficacy over XMT-1536, consistent with increased exposure to the DolaLock payload in the tumor, and we look forward to working to validate the clinical differentiation of this candidate," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "XMT-1592 also has the potential to further extend our leadership position in NaPi2b-expressing malignancies, and we are very pleased to have reached this important 2020 goal of advancing this promising ADC candidate into the clinic."

This Phase 1, open-label, dose-escalation study is designed to determine the maximum tolerated dose (MTD) of XMT-1592 in patients with non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. Upon completion of the dose-escalation portion of the study, the Company will determine the path forward to further assess the safety and activity of XMT-1592 in the expansion portion of the study.

About XMT-1592

XMT-1592 is an ADC targeting NaPi2b-expressing tumors. XMT-1592 was created with the Dolasynthen platform, retaining the Company’s proprietary NaPi2b antibody and auristatin DolaLock payload with controlled bystander effect plus the added benefits of site-specific conjugation, precise drug-to-antibody ratio, and even greater hydrophilicity for further enhanced drug-like properties and tumor exposure. In preclinical studies, Dolasynthen has shown four times greater efficacy in a patient-derived lung tumor model in comparison to Dolaflexin, a platform that has already shown success when targeted to NaPi2b.

On May 14, 2020 Orion Corporation reported new ARAMIS Phase III data to be presented at ASCO (Free ASCO Whitepaper) 2020: Nubeqa (darolutamide) significantly improved overall survival with a favorable safety profile in men with non-metastatic prostate cancer (Press release, Orion , MAY 14, 2020, View Source [SID1234558050]).

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Darolutamide significantly reduced risk of death by 31 percent (HR=0.69, 95% CI 0.53-0.88; p=0.003) in men with non-metastatic castration-resistant prostate cancer (nmCRPC)
Darolutamide significantly delayed the time to pain progression, time to first initiation of cytotoxic chemotherapy, and time to first symptomatic skeletal event (SSE)
Darolutamide continues to demonstrate a favorable safety profile, with no new safety signals observed, even with a longer treatment duration, allowing men with nmCRPC to maintain their active lifestyle
ARAMIS data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program on Friday, May 29, and will be available on the ASCO (Free ASCO Whitepaper) website (View Source)
Abstract 5514
Darolutamide (Nubeqa) is shown to significantly improve overall survival (OS) and significantly delay the onset of cancer-associated symptoms, while minimizing the toxicity associated with treating men with non-metastatic castration-resistant prostate cancer (nmCRPC). These data from the pre-specified final OS analysis of the Phase III ARAMIS trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, which takes place from May 29-31, 2020.

Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months for darolutamide plus androgen deprivation therapy (ADT) compared to 18.4 months for placebo plus ADT (p<0.001); however, OS data were not yet mature at the time of the MFS analysis.

"Men with nmCRPC typically do not have cancer symptoms. In selecting a treatment for these patients, my goal as a clinician is to improve their overall survival while limiting side effects and drug interactions," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France. "These data add to the growing evidence for darolutamide as an effective treatment option with a favorable safety profile that extends patients’ lives and delays cancer symptoms and morbidities, without disrupting their daily activities."

Final OS Analysis Presented at ASCO (Free ASCO Whitepaper) Virtual Scientific Program
Men receiving darolutamide plus ADT demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003).

Darolutamide has a distinct chemical structure and inhibits the growth of prostate cancer cells while limiting the burden of side effects on patients’ everyday lives. With extended follow-up, darolutamide’s safety profile remains favorable, allowing men with nmCRPC to continue their daily lives without disruption. Consistent with the previously reported primary analysis results, darolutamide plus ADT showed a favorable tolerability confirmed by a longer-term safety analysis compared to ADT alone, without clinically relevant increases in rates of hypertension, falls or central nervous system (CNS) effects. In the follow-up analysis of secondary endpoints, all secondary endpoints were statistically significant. Darolutamide plus ADT significantly delayed time to pain progression, time to first initiation of cytotoxic chemotherapy and time to first symptomatic skeletal event (SSE) versus placebo plus ADT.

Under the brand name Nubeqa, darolutamide is developed jointly by Orion and Bayer, and indicated for the treatment of men with nmCRPC, who are at high risk of developing metastatic disease. The approvals of Nubeqa in the European Union (EU), U.S., Australia, Brazil, Canada, and Japan are based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus ADT compared to placebo plus ADT.

About the ARAMIS trial
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

About Nubeqa (darolutamide)
Darolutamide was approved in March 2020 in the European Union (EU) under the brand name Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Nubeqa has also received regulatory approval in the U.S., Australia, Brazil, Canada as well as Japan, and filings in other regions are underway or planned by Bayer.

Nubeqa is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age.

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.

Prostate cancer that is confined to the prostate region which is treated with ADT but keeps progressing without showing metastases, even when the amount of testosterone is reduced to very low levels in the body, is known as non-metastatic castration-resistant prostate cancer (nmCRPC). In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death. About one-third of men with nmCRPC go on to develop metastases within two years.

On May 14, 2020 NanOlogy, LLC, a clinical-stage oncology company, reported that updated data from two of its ongoing clinical trials were presented as abstracts last week through the DDW ePosters and ePresentations site (Press release, NanOlogy, MAY 14, 2020, View Source [SID1234558067]). The clinical trials are evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac (submicron particle paclitaxel) suspension for treatment of locally advanced pancreatic cancer (LAPC) and mucinous cystic neoplasms (MCNs/IPMNs) of the pancreas.

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The lead author of the abstract on intratumoral NanoPac for LAPC is Neil Sharma, MD (Parkview Cancer Institute – Fort Wayne, IN). The lead author of the abstract on intracystic NanoPac for MCNs/IPMNs is Mohamed O. Othman, MD (Baylor College of Medicine – Houston, TX).

Pancreatic Cancer

The Phase 2a dose-rising and expansion trial is evaluating over 6 months the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI in patients with LAPC, concurrent with or following SOC therapy for the disease. After completing the dose-rising cohort (n=11), a dose expansion cohort has now fully enrolled (n=22) in which patients receive 2 monthly intratumoral (IT) injections of NanoPac. FDA has also recently allowed expansion of up to 30 additional patients who will receive up to 4 monthly IT injections.

Dr. Sharma’s abstract submitted to DDW in December 2019 reports data from the first 7 evaluable subjects from the dose expansion cohort. No drug-related local or systemic SAEs were reported including no reports of acute pancreatitis in any subject, 4 subjects had a partial response, 2 had stable disease, and 1 had progressive disease. Encouraging data has continued to accrue from the fully enrolled dose expansion (2- injection) cohort, which are expected to be presented later in 2020.

Pancreatic Cyst

The Phase 2a dose rising and expansion trial is evaluating over 6 months the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with MCNs/IPMNs. The study has now completed enrollment (n=19) with patients in the dose expansion phase (n=8) receiving two intracystic injections of NanoPac 12 weeks apart.

Dr. Othman’s abstract also submitted in December reports data from the first 9 subjects who had completed the trial. No confirmed drug-related local or systemic SAEs were reported including no reports of acute pancreatitis. Plasma paclitaxel levels have not exceeded 1 ng/mL indicating that NanoPac particles are retained in the cyst over time. Evaluation of cyst volume showed decreases ranging from 8% to 89% in 8 subjects, 6 of whom showed a volume decrease > 50%. Cyst volume increased in 1 subject.

Based on encouraging results from both trials, NanOlogy is designing follow-on clinical protocols for evaluation by FDA.

In 2020, about 57,600 new cases of pancreatic cancer will be diagnosed in the U.S. and 47,050 people will die from the disease. Pancreatic cancer is currently the third most frequent cause of cancer related death in western countries and is predicted to become the second leading cause of death from cancer within the next 10 years. It is one of the few cancers for which no meaningful improvement in survival has been achieved over recent time with only an 8% survival rate at 5 years.

MCNs/IPMNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. While estimates vary widely, as many as 30,000 new cases of high risk MCNs/IMPNs are diagnosed annually in the U.S. These patients may ultimately be required to undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with high morbidity. No approved drug therapy exists in the U.S to treat the condition.

In addition to pancreatic neoplasms, NanOlogy clinical programs are advancing in genitourinary, peritoneal, lung, and dermal cancers.

The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (10,507,195) both valid until 2036 in the US and pending globally.