On January 14, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported an update on its outlook for 2020, including financial guidance (Press release, Halozyme, JAN 14, 2020, View Source [SID1234553164]).

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"We have made tremendous progress repositioning the company to focus solely on driving the growth and profitability of our ENHANZE business," said Dr. Helen Torley, president and chief executive officer. "Looking ahead, we anticipate a number of value-creating financial and ENHANZE-related milestones will be achieved during 2020."

Anticipated 2020 ENHANZE Key Events

U.S. Food and Drug Administration (FDA) decision on the approval of the Biologics License Application submitted by ENHANZE collaboration partner Janssen Biotech, Inc. (Janssen) in July 2019 for Daratumumab SC.
European Medicines Agency (EMA) decision on the approval of the extension application submitted by Janssen-Cilag International NV (Janssen) in July 2019 for Daratumumab SC.
Completion in Q1 2020 of regulatory submissions to the FDA and EMA by Roche seeking approval for the fixed-dose combination of Perjeta and Herceptin utilizing ENHANZE in combination with intravenous chemotherapy.
At least 3 new Phase 3 and 1 Phase 2 clinical trial initiations by ENHANZE collaboration partners.
Initiation of at least five new Phase 1 clinical trials with partner products utilizing the ENHANZE drug delivery technology.
Update on Capital Return Program

On November 4, 2019 the Company announced its Board of Directors approved a plan to repurchase up to $350 million in stock over the next three years. Subsequently, on November 12, 2019 the Company announced the Board further approved the repurchase of an additional $200 million worth of shares in conjunction with an offering of convertible senior notes, due 2024, resulting in a total three-year share repurchase authorization of up to $550 million.

As of December 31, 2019, the Company had repurchased 8.5 million shares of Halozyme stock under this program. In addition, 2.1 million shares had been delivered to the Company as part of a $50 million Accelerated Share Repurchase (ASR), which is expected to be completed in the first quarter of 2020. Following completion of the ASR, the Company will have repurchased a total of $200 million worth of shares. As of December 31 2019, the Company had 136.7 million shares outstanding.

The Company plans to repurchase an additional number of shares, up to $150 million worth, during 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

2020 Financial Guidance

For 2020, Halozyme expects revenues of $230 million to $245 million, representing growth of 18% to 26% over the 2019 expected revenue of approximately $195 million.

The Company expects sustainable profitability beginning in the second quarter of 2020. Also, the Company continues to project annualized operating expenses, excluding cost of goods sold, of between $65 million and $75 million will be achieved by the fourth quarter of 2020.

On January 14, 2020 Biomica, an emerging biopharmaceutical company developing innovative microbiome-based therapeutics, and a subsidiary of Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), reported that it has entered a service agreement with Biose Industrie, a France based CDMO, for the scale-up production of its drug candidates, microbial consortia BMC121 & BMC127 for its Immuno-Oncology program (Press release, Biomica, JAN 14, 2020, View Source;bmc127-for-its-immuno-oncology-program-300985551.html [SID1234553161]). This agreement will accelerate the Company’s Immuno-Oncology program which is currently planned to enter the clinic in 2021 for proof of concept studies.

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Biose Industrie is a drug-GMP certified manufacturer of bacteria-based APIs and clinical and commercial products. Biomica engaged with Biose for the scale-up development and GMP production of a clinical batch of its drug candidates.

As previously announced, BMC121 & BMC127 were recently evaluated in pre-clinical studies in a mouse cancer model under Biomica’s immuno-oncology program, aiming to improve the efficacy of immune checkpoint inhibitors therapy. The results of these trials validated the Company’s computational predictions by demonstrating preliminary positive effects when administered in combination with checkpoint inhibitor therapy (anti-PD1), compared to using checkpoint inhibitor therapy alone. This effect was manifested in improved anti-tumor immune response through multiple bacterial-induced mechanisms of action.

Dr. Elran Haber, Biomica CEO, stated: "We are very pleased to work with Biose Industrie, an expert in GMP manufacturing of bacteria-based therapeutics. In parallel with on-going additional preclinical activities, this is an important step in the advancement of our Immuno-Oncology program, as we prepare for initiation of first in man, proof of concept clinical trials that are currently anticipated to begin next year."

Dr. Adrien Nivoliez, Biose industrie CEO, stated: "Biose Industrie is proud to collaborate with Biomica in the development of this novel LBP within the exciting field of Immuno-Oncology. This is another example of Biose Industrie’s ability to support and partner for both Drug Product and Drug Substance within the world of Microbiome Therapeutics, assisting Biotech’s and pharmaceutical companies in their drive to treat patients."

About BMC121 & BMC127

Developed as Live Bacterial Products (LBPs), BMC121 & BMC127 are rationally-designed LBP consortia comprised of unique bacterial strains that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity though multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

On January 14, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), or Idera or the Company, reported an update on its tilsotolimod clinical development program and providing a corporate outlook for 2020 (Press release, Idera Pharmaceuticals, JAN 14, 2020, View Source [SID1234553159]).

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"We made tremendous progress last year with the tilsotolimod clinical development program, and we are positioned well going into this pivotal year," stated Vincent Milano, Idera’s Chief Executive Officer. "Our ILLUMINATE-301 registrational trial of tilsotolimod in anti-PD-1 refractory metastatic melanoma is enrolling at a rate that dramatically exceeded our expectations. We expect to complete enrollment this quarter, setting up the possibility of data before the end of this year. We believe the rapid enrollment in this randomized trial is a testament to the critical unmet need for this patient group as well as to the growing appreciation from global investigators for both intratumoral administration and the mechanism of action of tilsotolimod."

Continued Milano, "We also will add to the overall body of clinical evidence for tilsotolimod with additional data readouts expected in the second quarter. Final analysis of ILLUMINATE-204 will include median overall survival (OS) for the first time, and ILLUMINATE-206 will provide safety and preliminary efficacy in microsatellite-stable colorectal cancer (MSS-CRC) as a triple combination of ipilimumab, nivolumab and tilsotolimod in this immunorefractory indication."

"Lastly, we recently entered into a financing agreement that provides financial resources for these critical catalysts and beyond. Overall, we are looking forward to 2020 and delivering on the goals we set for patients and our investors when we initiated the development of tilsotolimod."

ILLUMINATE (tilsotolimod) Clinical Development Program

ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory metastatic melanoma:

•Approximately 100 sites active in 11 countries;
•Planned enrollment target of 454 patients;
•As of January 13, 2020, 427 patients enrolled, representing 94% enrollment; and
•Targeting completion of enrollment during Q1 2020; and data in Q4 2020/Q1 2021.

ILLUMINATE 206 – Phase 2, open-label, multi-cohort, multi-center study to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab for the treatment of solid tumors:

•Trial initiated on September 30, 2019, leading with the MSS-CRC cohort;
•Initial safety run-in cohort of 10 patients with MSS-CRC fully enrolled; and
•Preliminary objective response rate (ORR) and safety data from this cohort expected in Q2 2020.

ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with anti-PD-1 refractory metastatic melanoma:

•Completed enrollment with 52 patients (49 evaluable) at tilsotolimod 8 mg with ipilimumab in February 2019; and
•Final results from the ILLUMINATE 204 trial are expected to be released in Q2 2020;
oData to be presented include ORR, median OS, duration of response (DOR) and safety.

Upcoming Corporate Presentation

Idera Chief Executive Officer Vincent Milano will provide a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 7:30 AM PT/ 10:30 AM ET. The conference is being held at the Westin St. Francis Hotel in San Francisco, CA. A copy of the Company’s J.P. Morgan corporate presentation will be posted on the Investors’ page of the Company’s corporate website on Wednesday January 15, 2020 prior to the opening of the U.S. markets.

Live audio webcast of Idera’s presentations will be accessible in the Investors section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational TLR 9 agonist that received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, provide benefit for some patients, but these therapies are limited in patients whose immune responses are missing or weak. Intratumoral injections with tilsotolimod are designed to selectively enable the tumor-specific T-cells to recognize and attack cancers that remain elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

On January 14, 2020 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that the European Commission (EC) has granted Orphan Drug Designation to its lead oncology candidate, Motixafortide (BL-8040), for the treatment of pancreatic cancer, based on a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) (Press release, BioLineRx, JAN 14, 2020, View Source [SID1234553158]). Last year, Motixafortide received Orphan Drug Designation for the treatment of Pancreatic Cancer from the US Food and Drug Administration (FDA).

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"The Orphan Drug status we received for Motixafortide, from both the US and European regulatory bodies, is of significant strategic importance for the development of our lead product for the treatment of pancreatic cancer, an extremely difficult to treat indication with a poor response to the currently available treatments," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We recently reported very encouraging initial data from the triple combination arm of our ongoing Phase 2a COMBAT/KEYNOTE-202 study in second line metastatic pancreatic cancer patients, which served as the basis for this ODD, and we believe that this designation will maximize the potential to make this new treatment available for patients in the fastest way possible."

Motixafortide is currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada).

The EMA grants orphan medicinal product designation to investigational drugs intended to treat, prevent or diagnose a life-threatening or chronically debilitating disease affecting fewer than five in 10,000 people in the EU and for which no satisfactory treatment is available or, if such treatment exists, the medicine must be of significant benefit to those affected by the condition. Orphan medicinal product designation provides regulatory and financial incentives for companies to develop and market therapies, including ten years of market exclusivity, protocol assistance, fee reductions and EU-funded research.

About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).

About Pancreatic Cancer
Pancreatic cancer has a low rate of early diagnosis and a poor prognosis. Its incidence rate in the US is estimated at 3.2% of new cancer cases. Each year, about 185,000 individuals globally are diagnosed with this condition, and an estimated 55,000 individuals were diagnosed with pancreatic cancer in the US during 2018. Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed until it reaches an advanced stage. Surgical resection does not offer adequate treatment since only 20% of patients have resectable tumors at the time of diagnosis. The overall five-year survival rate among all pancreatic cancer patients is 7-8%, which constitutes the highest mortality rate among solid tumor malignancies. The overall median survival is less than one year from diagnosis, highlighting the need for the development of new therapeutic options.

Despite advances in chemotherapeutics and immunotherapy, increases in median and overall survival rates in pancreatic cancer have been modest. Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel in combination with gemcitabine (Abraxane) for first-line treatment in 2013 and Onivyde in combination with fluorouracil and leucovorin for second-line treatment in 2015. The limited clinical benefits demonstrated by these existing standard treatment options reinforce the need for additional approaches.

On January 14, 2020 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Dr. Steven Hildemann as Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs and Pharmacovigilance effective March 1, 2020 (Press release, Ipsen, JAN 14, 2020, View Source [SID1234553156]). Based in Paris, France, Dr. Hildemann will report directly to Aymeric Le Chatelier, CEO, Ipsen and serve on the Executive Leadership Team .

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Aymeric Le Chatelier, CEO, Ipsen, commented, "As we advance as a leading global biopharmaceutical company focused on innovation and Specialty Care, it is my great pleasure to appoint Dr. Hildemann to lead Ipsen’s Global Medical Affairs, Patient Affairs and Pharmacovigilance organizations through patient-centric leadership, sound medical governance and business conduct. With over 20 years of service in the pharmaceutical industry and 10 years as a physician-scientist in academic medicine, he brings a wealth of experience in medical affairs, clinical operations and patient safety from major global biopharmaceutical companies. Dr. Hildemann will play a crucial role in delivering on our global medical and patient safety strategy, engaging in structured, ethical and high-quality dialogue with patients, external and internal stakeholders throughout the entire life-cycle of Ipsen’s portfolio."

Dr. Hildemann will act as a strategic partner to Ipsen’s scientific, clinical and business teams. He will provide a global medical strategy based on real value to patients and caregivers. In close partnership with R&D, Dr. Hildemann will lead the generation of post-launch clinical trial data by defining, prioritizing, optimizing or guiding studies in line with this strategy. As a member of the Executive Leadership team, he will actively contribute to the overall management and strategic leadership of the company.

Prior to joining Ipsen, Dr.Hildemann held leadership roles in science-based bioethics and built an innovative digital health startup in cancer care after serving for five years as Chief Medical Officer, Senior Vice President, Head of Global Medical Affairs and Global Patient Safety at Merck. He also held several strategic leadership positions with biopharmaceutical companies such as Pharmacia-Pfizer and Schering-Plough-MSD. Dr Hildemann is board certified in internal medicine and cardiology with broad clinical training across internal medicine including medical oncology, gastroenterology, rheumatology and pulmonary oncology at university hospitals in Munich, Germany. Throughout his career, he has engaged in part-time clinical practice, late-stage pharmaceutical research and medical teaching. Dr. Hildemann received his MD-PhD at the Albert Ludwig University of Freiburg, Germany, where he continues to serve as an adjunct Professor of Medicine.