On March 16, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the year ended December 31, 2019 and provided a preview of its planned activities for 2020 (Press release, Sutro Biopharma, MAR 16, 2020, View Source [SID1234555576]).

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"We were looking forward to sharing updated safety and efficacy data from our Phase 1 trial for STRO-002 during the AACR (Free AACR Whitepaper) Annual Meeting 2020 as a follow up to the encouraging interim safety data we presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in late October 2019," said Bill Newell, Sutro’s Chief Executive Officer. "With the cancellation of the AACR (Free AACR Whitepaper) meeting, we are considering alternative opportunities to present these data in the second quarter. STRO-002 and STRO-001 are our two proprietary antibody drug conjugate (ADC) product candidates progressing in Phase 1 clinical trials. Additionally, each of our three current collaborations has yielded novel oncology product candidates in three distinct therapeutic protein formats that are either in clinical development or in the late stages of preclinical development. All of these candidates are based on our proprietary and integrated cell-free protein synthesis platform XpressCF and site-specific conjugation platform XpressCF+, which allows us to rapidly and precisely create optimally designed, next-generation protein therapeutics candidates."

Recent Business Highlights and Developments

STRO-002 Clinical Program

STRO-002 is a potential best-in-class ADC directed against folate receptor-alpha (FolRα), which is highly expressed in ovarian cancer.
Phase 1 dose-escalation, with dose expansion, clinical trial that is enrolling women with advanced ovarian and endometrial cancers, had initial safety and efficacy data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 29, 2019.
Based on the reported data to date in heavily pre-treated patients who have not been pre-selected based on FolRα expression levels, STRO-002 has been generally well-tolerated. No ocular toxicity signals have been observed, with no patients receiving prophylactic corticosteroid eye drops.
Dose escalation in the Phase 1 trial is continuing and the maximum tolerated dose has not yet been reached.
Additional Phase 1 dose-escalation phase safety and efficacy data was accepted as a late-breaking abstract to be presented at the AACR (Free AACR Whitepaper) Annual Meeting, which was cancelled recently. We plan to release updated data in the second quarter of 2020.
Phase 1 dose expansion trial is expected to begin enrolling patients in the second half of 2020.
STRO-001 Clinical Program

STRO-001 is a potential first-in-class and best-in-class ADC directed against CD74, which is highly expressed in many B cell malignancies.
Phase 1 dose-escalation, with dose expansion, clinical trial that is enrolling patients with multiple myeloma and non-Hodgkin lymphoma, had initial safety data presented at the EHA (Free EHA Whitepaper) Congress in June 2019. A safety data update that included several additional patients was released in an abstract in association with the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference on November 6, 2019.
Based on the reported data to date in heavily pre-treated patients, STRO-001 has been generally well-tolerated and no ocular toxicity signals have been observed, with no patients receiving prophylactic corticosteroid eye drops.
Dose escalation in the Phase 1 trial is continuing and the maximum tolerated dose has not yet been reached.
Additional Phase 1 dose-escalation phase safety and efficacy data is expected in the second half of 2020.
Phase 1 dose expansion trial is expected to begin enrolling patients in the first half of 2021.
Cytokine-Derivative Programs (Collaboration with Merck & Co.)

Sutro is collaborating with Merck on two research programs to discover new therapeutics for cancer and autoimmune diseases. Merck has the right to nominate a third program under this collaboration.
In March 2020, Merck extended by one year the research term of the collaboration’s first program, which includes a payment to Sutro. The collaboration is advancing Sutro’s novel cytokine-derivative product candidate towards IND-enabling studies.
BCMA ADC Clinical Program (Collaboration with Bristol Myers Squibb; formerly Celgene)

BMS received FDA clearance on its IND application for CC-99712, a novel ADC therapeutic targeting B-cell maturation antigen (BCMA), for the treatment of multiple myeloma in the second quarter of 2019.
BMS is currently enrolling patients in a Phase 1 trial focused on patients with relapsed and refractory multiple myeloma.
BMS will be responsible for the worldwide clinical development and commercialization of CC-99712. Sutro is entitled to development and regulatory milestone payments and tiered royalties ranging from mid to high single digit percentages from BMS.
Bispecific ADC Clinical Development Candidate (Collaboration with EMD Serono)

In the third quarter of 2019, EMD Serono designated an undisclosed bispecific ADC as a clinical development candidate with approval to advance to IND-enabling studies, which triggered a financial milestone received by Sutro.
Sutro will manufacture the bispecific ADC for the early clinical supply of the candidate and is eligible for further milestones and royalties. EMD Serono will be responsible for the drug product, clinical development and commercialization of this clinical development candidate.
24-Valent Pneumococcal Conjugate Vaccine (SutroVax Relationship)

Under a license from Sutro, SutroVax has right to use the XpressCF and XpressCF+ platforms to discover and develop vaccine candidates for the treatment or prophylaxis of infectious diseases.
SutroVax is progressing their broader spectrum pneumococcal conjugate vaccine (SVX-24) through the late stages of preclinical development and is targeting an IND filing for 2021.
SutroVax is responsible for performing all research and development activities while Sutro provides technical support and supplies XtractCF and other materials to SutroVax under a supply agreement.
Sutro is eligible to receive four percent (4%) royalties on worldwide net sales of any licensed vaccine candidates for human health use. Also, Sutro retains the right to discover and develop vaccines for treatment or prophylaxis of any disease not caused by an infectious pathogen, including cancer.
Sutro Unveiled Innovative Cancer Therapy Approach Using Precise Tumor Targeted Immunostimulant ADCs at World ADC London

On March 4 at the World ADC London meeting, Sutro announced it has expanded its ADC technology platform to include tumor targeting immunostimulant ADCs, or IADCs.
Sutro’s XpressCF+ Platform has enabled a groundbreaking technology to engineer homogeneous, dually conjugated ADCs with both immunostimulant and cytotoxic warheads on a single ADC molecule.
Sutro’s novel IADCs are designed to deliver two different drugs directly to the tumor, and not only kill tumor cells but also locally prime an immune response to the patient’s particular tumor cells. Sutro believes that its IADC approach creates a new therapeutic opportunity by combining the best features of an ADC with the biology of a personalized vaccine.
Full 2019 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2019, Sutro had cash, cash equivalents and marketable securities of $133.5 million, as compared to $204.5 million as of December 31, 2018, which represents net cash usage of $16.9 million and $71.0 million during the fourth quarter and year ended December 31, 2019, respectively.

On February 28, 2020, Sutro entered into a loan and security agreement, under which Sutro borrowed $25.0 million, with approximately $9.6 million of such amount used to repay the outstanding principal, interest and final payment fees under a prior loan with the same lenders.

Revenue

Revenue was $42.7 million for the year ended December 31, 2019, compared to $38.4 million for 2018, principally related to the Merck, BMS, and EMD Serono collaborations. On January 1, 2019, Sutro adopted Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606). For more information on the impact of the adoption of the new revenue standard, see "Notes to Financial Statements" contained in Part II, Item 8 of Sutro’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2020. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the year ended December 31, 2019, were $98.2 million, compared to $75.6 million in 2018, including non-cash stock-based compensation of $10.3 million and $2.9 million, and depreciation and amortization expense of $4.8 million and $4.5 million, in 2019 and 2018, respectively. Total operating expenses for 2019 were comprised of research and development expenses of $65.6 million and general and administrative expenses of $32.6 million, with both expense types expected to increase in 2020 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On March 16, 2020 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has already enrolled seven patients for the compassionate use program for Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, MAR 16, 2020, View Source [SID1234555573]). Results of treatment in this patient group indicate that Namodenoson was found to have a good safety profile and was well tolerated, with no severe adverse events reported. Can-Fite’s compassionate use program is managed by Dr. Salomon Stemmer, a key opinion leader in the field of liver cancer, and Professor at the Institute of Oncology, Rabin Medical Center, Israel.

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The Company also reports that an additional two patients from the former Phase II study are still undergoing Namodenoson treatment, each with an overall survival of more than 2.5 years.

Recently, the Company successfully concluded an End-of-Phase II meeting with the FDA which agreed with Can-Fite’s proposed pivotal Phase III trial design of Namodenoson for the treatment of patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis to support a New Drug Application (NDA) submission and approval. In addition, the Company also submitted a Phase III protocol and Registration Plan to the European Medicines Agency (EMA) for Namodenoson and expects to receive a response from the EMA in the next few weeks. Can-Fite plans to work concurrently with the two agencies, the FDA and EMA, with the expectation to register the drug in parallel upon successful conclusion of the Phase III study.

"We are grateful to Dr. Stemmer for leading this compassionate use program, making Namodenoson available to patients who have exhausted all other treatment options. Based on the encouraging results of our recent Phase II trial, in which Namodenoson demonstrated clinical benefits in patients with underlying CPB7 cirrhosis, Can-Fite is committed to providing Namodenoson to fulfill the unmet medical need in this population," stated Can-Fite CEO Dr. Pnina Fishman.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On March 16, 2020 Boehringer Ingelheim reported the launch of a patient outcomes database which will provide clinicians with important information when considering optimal treatment for non-small cell lung cancer (NSCLC) patients harboring specific uncommon epidermal growth factor receptor (EGFR) mutations (Press release, Boehringer Ingelheim, MAR 16, 2020, View Source [SID1234555568]). The real-world database includes all available data from such patients treated with afatinib.

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The data from 693 NSCLC patients published in the Journal of Thoracic Oncology (JTO) support the use of afatinib against the most prevalent uncommon EGFR mutations. In patients who had not previously received any form of EGFR tyrosine kinase inhibitor (TKI), treatment with afatinib demonstrated activity against major uncommon mutations (median time-to-treatment-failure (TTF): 10.8 months; 95% CI: 8.1–16.6; overall response rate (ORR): 60.0%), compound mutations (14.7 months; 95% CI: 6.8–18.5; 77.1%), other uncommon mutations (4.5 months; 95% CI: 2.9–9.7; 65.2%). Median duration of response (DoR) was 17.1, 16.6, and 9.0 months, respectively. Outcome in patients with exon 20 insertions was heterogeneous with a TTF of 4.2 months (95% CI: 2.8 – 5.3) with 3% having complete remissions and 5% being on treatment for more than 3 years.i

The pooled analysis was based on global clinical outcome data from 693 patients with NSCLC driven by uncommon EGFR mutations, who received afatinib as part of clinical trials, compassionate use or expanded access programs, phase IIIb trials, non-interventional trials and case series/studies in more than 40 countries. The mutations included: (29% major uncommon EGFR mutations [G719X, L861Q and S768I], 25% T790M, 21% exon 20 insertion, 13% other uncommon EGFR mutation, 12% compound mutation) which had been available via the new searchable database www.uncommonEGFRmutations.com.

This new data supports previous findings from a post-hoc analysis of the LUX-Lung trials, which demonstrated significant clinical activity of afatinib against the most prevalent uncommon mutations.ii Of the EGFR TKI prospective randomized trials to date, only IPASS (gefitinib),iii NEJ002 (gefitinib),iv and LUX-Lung 2, 3 and 6 (afatinib),v, vi included patients with uncommon EGFR mutations, meaning clinical data for other EGFR TKIs against uncommon mutations is lacking. While other TKIs have shown efficacy in a first-line setting in patients with NSCLC and common mutations (Del19, L858R), their clinical activity against uncommon mutations remains largely unknown.

Lead author Dr James Chih-Hsin Yang from the Department of Oncology at the National Taiwan University Hospital said, "The relative scarcity of prospective clinical data concerning the up to 23% of NSCLC EGFR M+ cases that fall into the ‘uncommon mutation’ category can compromise effective treatment decisions. The results from this pooled analysis, alongside the post-hoc LUX-Lung results, should support afatinib as the first-choice treatment for NSCLC patients with uncommon EGFR mutations. Additionally, the uncommon mutation database, which is going to be continuously updated as new data becomes available, will be an invaluable clinical decision-making tool for the treatment of this patient sub-population moving forward."

"The value and the richness of these new combined data establishes afatinib as the meaningful treatment option for patients with uncommon EGFR mutation in addition to its recognized role as first-line therapy for common EGFR mutations," said Dr Victoria Zazulina, Global Head of Oncology, Medicine, at Boehringer Ingelheim. "We hope that this new searchable database will inform clinical decisions and therapeutic choices for patients with various types of uncommon EGFR mutations."

The uncommon mutation data summarized within the paper are available in a searchable online database at www.uncommonEGFRmutations.com. The database can be accessed globally by clinicians and non-clinicians alike and will be regularly updated as new data becomes available.

Boehringer Ingelheim in Oncology
Cancer takes away loved ones, time and untapped potential. At Boehringer Ingelheim we are providing new hope for patients by taking cancer on. We are collaborating with the oncology community to deliver scientific breakthroughs to transform the lives of patients. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

Boehringer Ingelheim
Improving the health of humans and animals is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros, corresponded to 18.1 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

On March 15, 2020, Progenics Pharmaceuticals, Inc. (the "Company"), as borrower, and Lantheus Medical Imaging, Inc. ("Lantheus Medical Imaging"), a subsidiary of Lantheus Holdings, Inc., as lender, reported that it has entered into a bridge loan agreement, pursuant to which Lantheus Medical Imaging agreed to provide for a secured short-term loan to the Company on or after May 1, 2020 in an aggregate principal amount of up to $10 million (the "Bridge Loan Agreement") (Filing, 8-K, Progenics Pharmaceuticals, MAR 15, 2020, View Source [SID1234555579]). The bridge loan matures on the earlier to occur of (a) September 30, 2020 and (b) the date on which the Company enters into a debt financing or similar arrangements or any amendment to, or replacement of, its existing debt, provided by one or more third parties following the termination date of the Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the "Merger Agreement"), as filed by the Company with the Securities and Exchange Commission on a Current Report on Form 8-K on February 20, 2020, in either case, having aggregate net cash proceeds that exceed the amount then required to repay all obligations under the Bridge Loan Agreement in full in cash.

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The Company will use the proceeds of the bridge loan for working capital and other general corporate purposes. The proceeds will not be used in connection with any related party transaction, the purchase or repurchase of any capital stock of the Company, acquisition of assets or other merger activity unrelated to the Merger Agreement, or in any manner that would reasonably be expected to prevent the merger from constituting a tax-free reorganization described in Section 368(a) and related provisions of the Internal Revenue Code of 1986.

The bridge loan bears interest at rate per annum of 9.5%. No amortization, interest or other payments are required to be paid under the Bridge Loan Agreement until the maturity date, provided that if the Company or any of its subsidiaries receives net cash proceeds from any debt financing or other similar arrangement entered into outside the ordinary course of business, the Company is required to prepay the bridge loan in an amount equal to such net cash proceeds within two business days thereof. The Company may make voluntary prepayments at any time and from time to time (provided that any partial voluntary prepayment will not be in an amount less than $500,000) together with accrued interest thereon, without premium or penalty.

The bridge loan is secured through the pledge to Lantheus Medical Imaging of all of the issued and outstanding shares of capital stock of Molecular Insight Pharmaceuticals, Inc., a subsidiary of the Company ("MIPI"), and any debt of MIPI owed to the Company.

The obligation of Lantheus Medical Imaging to fund the bridge loan on or after May 1, 2020 is subject to customary conditions, including, among other things, the following:

the execution and delivery of the Bridge Loan Agreement, stock pledge agreement to be entered into by and between the Company and Lantheus Medical Imaging and other specified documents and certificates delivered in connection therewith;

no change in recommendation (as defined in the Merger Agreement) of the Company’s Board of Directors; and

no material adverse effect (as defined in the Merger Agreement) or material breach by the Company under the Merger Agreement, in respect of which Lantheus Holdings, Inc. has terminated the Merger Agreement.

Without the prior consent of Lantheus Medical Imaging, the Company will not permit MIPI to (i) declare, set aside, make or pay any dividend or other distribution (whether in cash, stock or property) in respect of any of its securities, other than dividends or distributions by wholly-owned subsidiaries of MIPI to MIPI or a wholly-owned subsidiary of MIPI, (ii) split, subdivide, consolidate, combine or reclassify any of its securities or issue or allot, or propose or authorize the issuance or allotment of, any other securities or equity rights in respect of, in lieu of, or in substitution for, any of its securities, (iii) repurchase, redeem or otherwise acquire any securities or equity rights of MIPI or any subsidiary of MIPI, (iv) issue, allot, sell, grant, pledge or otherwise encumber any securities or equity rights, (v) merge or consolidate with any person, or acquire the securities in, or any material amount of assets of, any other person or (vi) incur or suffer to exist (or permit any subsidiary of MIPI to incur or suffer to exist) any Indebtedness (as defined in the Bridge Loan Agreement) owing to any affiliate of the Company (other than to the Company, MIPI or any of MIPI’s other subsidiaries). Additionally, the Company is required to cause MIPI to comply with the interim period operating covenants and the covenant to provide notice of certain material events, in each case, set forth in the Merger Agreement, with the same effect as if such covenants were fully incorporated therein, mutatis mutandis.

The Company is required to use commercially reasonable efforts to enter into a debt financing with net cash proceeds in excess of the amount then required to repay all obligations in full in cash promptly following the termination of the Merger Agreement.

On March 13, 2020 Major venture capitalist firm Flagship Pioneering has brought together two of its sister biotech companies to create a new, singly focused effort (Press release, Torque Therapeutics, MAR 13, 2020, View Source,autoimmune%20disorders%20and%20infectious%20diseases [SID1234573748]).

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Torque Therapeutics and Cogen Immune Medicine now become Repertoire Immune Medicines, a combined biotech looking to tap into the curative powers of our immune system to prevent, treat and cure cancer, autoimmune disorders and infectious diseases.

Torque CEO John Cox, an ex-Biogen exec who also shepherded its spinoff Bioverativ through its $11.6 billion acquisition by Sanofi, becomes the new company’s chief.

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Torque has been working on what it calls "deep-primed adoptive cell transfer" treatments it believes can surmount the hurdles that limit the use of cell therapy in cancer. These include getting past the microenvironment around a tumor that quashes the immune system and shuts down T-cell function.

The company "deep-primes" T cells to target multiple tumor antigens and puts cytokine and immunomodulators on their surfaces to call forth an immune response in the tumor microenvironment, the company says. Its first program, TRQ-1501, primes T cells to carry IL-15, a cytokine that promotes the proliferation of natural killer cells.

This will continue under the new biotech but will combine the work of Cogen, which also tapped the power of a patient’s immune system to fight disease. Now, it’s working on technologies for its so-called DECODE discovery and DEPLOY product platforms that "allow in-depth characterization of the immune synapse and the ability to rationally design, and clinically develop, multi-clonal immune medicines."

Repertoire has three discovery technologies that are at the heart of its immune synapse deciphering platform:

MCR, cell-based reporter assays to experimentally quantify MHC-specific peptide display and de-orphan TCR clonotypes across virtually unlimited peptide-MHC libraries;
‍CIPHER, MHC multimer-based assays to detect and measure TCR clonotypes, peptide-MHC reactivity and phenotypes on a single-cell level;
CAPTAN, internally developed deep-learning computational tools to classify platform hits and leverage large data sets to predict TCR reactivity beyond what is currently possible.
It said in a statement it is currently working on clinical trials "using autologous T cells primed against cancer antigens and tethered to IL-15." Specifically, Repertoire is testing its first dose escalation safety trial with TRQ15-01, using its PRIME platform to prepare the patient’s T cells and its TETHER platform to link an IL-15 nanogel immune modulator to the T cells.

"Repertoire is pioneering a new class of therapies based on high throughput, high content interrogation of the intrinsic ability of T cells to prevent, or cure diseases," said Noubar Afeyan, Ph.D., CEO of Flagship Pioneering and co-founder and chairman of Repertoire Immune Medicines.

He added: "Our products will be designed to leverage the highly evolved, potent and clinically-validated mechanism of the natural immune synapse to provide immune security to patients. With these ambitious goals in mind, we are pleased to have a proven leader, John Cox, as CEO to realize our shared vision to dramatically improve outcomes for those in need or at risk."