On April 15, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the U.S. launch of ONTRUZANT (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin (Press release, Merck & Co, APR 15, 2020, View Source [SID1234556347]). ONTRUZANT is available in both 150 mg single-dose vials and 420 mg multiple-dose vials.

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ONTRUZANT will be introduced in the U.S. at a list price (wholesaler acquisition cost) of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of Herceptin. Wholesaler acquisition costs do not include discounts to payers, providers, distributors and other purchasing organizations.

ONTRUZANT is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. Serious and sometimes fatal side effects have been reported with trastuzumab products. Subclinical and clinical cardiac failure have been reported. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing regimens. Discontinue ONTRUZANT treatment for cardiomyopathy. Administration of ONTRUZANT can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome. Exposure to ONTRUZANT during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Exacerbation of chemotherapy-induced neutropenia can also occur. Detection of HER2 protein overexpression is necessary for selection of patients appropriate for ONTRUZANT therapy.

ONTRUZANT is being launched in the U.S. by Merck as part of a development and commercialization agreement with Samsung Bioepis. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Merck will be responsible for all commercialization activities for products approved in its partnered territories, including the U.S.

ONTRUZANT was approved by the FDA in January 2019 based on the review of Samsung Bioepis’ comprehensive data package, which included extensive structural and functional analytical data, nonclinical and clinical pharmacokinetic data, and a comparative clinical study demonstrating that ONTRUZANT is highly similar to its reference product, Herceptin, in terms of the safety, purity and potency of the product.

On Feb. 5, 2020, Merck announced that it intends to spin-off products from its Women’s Health, trusted Legacy Brands and Biosimilars businesses, including ONTRUZANT, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT will become a product of the new company.

ONTRUZANT Indications and Usage

Adjuvant Breast Cancer

ONTRUZANT is indicated for adjuvant treatment of HER2-overexpressing node-positive or node negative (ER/PR-negative or with one high-risk feature) breast cancer:

As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
As part of a treatment regimen with docetaxel and carboplatin
As a single agent following multimodality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Breast Cancer

ONTRUZANT is indicated:

In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Metastatic Gastric Cancer

ONTRUZANT is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Selected Safety Information

Cardiomyopathy

Administration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving a trastuzumab product with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed congestive heart failure (CHF) died of cardiomyopathy.
Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT. Discontinue ONTRUZANT treatment in patients receiving adjuvant therapy and withhold ONTRUZANT in patients with metastatic disease for clinically significant decrease in left ventricular function.
Infusion Reactions; Pulmonary Toxicity

Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
Embryo-Fetal Toxicity

Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.
Warnings and Precautions

Cardiomyopathy

Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF).

There is a 4 to 6-fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving trastuzumab products as a single agent or in combination therapy compared with those not receiving trastuzumab products. The highest absolute incidence occurs when a trastuzumab product is administered with an anthracycline.

Withhold ONTRUZANT for ≥ 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values. The safety of continuation or resumption of ONTRUZANT in patients with trastuzumab product-induced left ventricular cardiac dysfunction has not been studied.

Patients who receive anthracycline after stopping ONTRUZANT may also be at increased risk of cardiac dysfunction.

Cardiac Monitoring: Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:

Baseline LVEF measurement immediately prior to initiation of ONTRUZANT
LVEF measurements every 3 months during and upon completion of ONTRUZANT
Repeat LVEF measurement at 4-week intervals if ONTRUZANT is withheld for significant left ventricular cardiac dysfunction.
LVEF measurements every 6 months for at least 2 years following completion of ONTRUZANT as a component of adjuvant therapy.
Infusion Reactions

Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia.

In post-marketing reports, serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable, including progressive worsening, initial improvement followed by clinical deterioration or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction.

Interrupt ONTRUZANT infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions.

There are no data regarding the most appropriate method of identification of patients who may safely be retreated with trastuzumab products after experiencing a severe infusion reaction. Prior to resumption of trastuzumab infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated trastuzumab infusions, others had recurrent severe infusion reactions despite pre-medications.

Embryo-fetal Toxicity

Trastuzumab products can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of females of reproductive potential prior to the initiation of ONTRUZANT. Advise pregnant women and females of reproductive potential that exposure to ONTRUZANT during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of ONTRUZANT.

Pulmonary Toxicity

Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.

Exacerbation of Chemotherapy-induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3 to 4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not.

Drug Interactions

Patients who receive anthracycline after stopping trastuzumab products may be at increased risk of cardiac dysfunction because of trastuzumab’s long washout period based on population PK Analysis. If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab products. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.

Adverse Reactions

The most common adverse reactions in patients receiving trastuzumab products in the adjuvant and metastatic breast cancer setting are fever, chills, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of trastuzumab product treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity.

In the metastatic gastric cancer setting, the most common adverse reactions (≥ 10%) that were increased (≥ 5% difference) in the patients receiving trastuzumab as compared to patients receiving chemotherapy alone were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. The most common adverse reactions which resulted in discontinuation of trastuzumab treatment in the absence of disease progression were infection, diarrhea, and febrile neutropenia.

Use in Specific Populations

Lactation

There is no information regarding the presence of trastuzumab products in human milk, the effects on the breastfed infant, or the effects on milk production. Published data suggest human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ONTRUZANT treatment and any potential adverse effects on the breastfed child from ONTRUZANT or from the underlying maternal condition. This consideration should also take into account the trastuzumab product wash out period of 7 months.

Pediatric Use

The safety and effectiveness of trastuzumab products in pediatric patients have not been established.

Geriatric Use

Trastuzumab has been studied in patients who were 65 years of age or over in the adjuvant and metastatic breast cancer treatment settings. The risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease, or adjuvant therapy.

Please see Prescribing Information for ONTRUZANT (trastuzumab-dttb) including Boxed Warning about cardiomyopathy, infusion reactions (pulmonary toxicity), and embryo-fetal toxicity at View Source

On April 15, 2020 TScan Therapeutics, a biopharmaceutical company focused on the development of T cell receptor (TCR) therapies which reprogram a patient’s own T cells to recognize shared cancer targets, reported an agreement with Novartis to discover and develop novel TCR-engineered T cell therapies (Press release, TScan Therapeutics, APR 15, 2020, View Source [SID1234556330]). The collaboration includes an upfront technology access fee and research funding totaling $30 million, and potential milestone payments contingent on clinical, regulatory and sales success that could aggregate in the hundreds of millions of dollars. The collaboration will leverage TScan’s proprietary platform to discover novel cancer antigens that may be targeted by TCR-based therapies.

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"As one of the only companies able to efficiently discover novel cancer antigens that can be targeted with TCR-based therapies, we are delighted to be collaborating with Novartis to develop important TCR treatments," said David P. Southwell, President and Chief Executive Officer, TScan. "We see expansive potential for our platform and this collaboration gives us the opportunity to work with Novartis to develop novel TCR therapies, while at the same time preserving our ability to develop our own proprietary pipeline in both liquid and solid tumors."

Under the agreement, TScan will identify and characterize TCRs, and Novartis will have the option to license and develop TCRs for up to three novel targets. Novartis will also have rights of first negotiation for additional targets and TCRs that arise from the collaboration. In addition to the milestones, Novartis will pay TScan mid-single to low double-digit royalties on net sales for each product. TScan is free to develop TCRs against targets not licensed by Novartis.

"Novartis is a proven leader in the area of T cell therapy, and this collaboration helps us move rapidly and effectively toward our goal of delivering life-changing therapies to patients," added Gavin MacBeath, Chief Scientific Officer, TScan.

On April 15, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported the pricing of its offering of $200,000,000 aggregate principal amount of 1.500% convertible senior subordinated notes due 2026 (the "notes") in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Coherus Biosciences, APR 15, 2020, View Source [SID1234556329]).

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In connection with the pricing of the notes, Coherus entered into privately negotiated capped call transactions with one or more of the initial purchasers or their respective affiliates and/or other financial institutions (the "option counterparties"). If the initial purchasers exercise their option to purchase additional notes, Coherus expects to enter into additional capped call transactions with the option counterparties. The cap price of the capped call transactions will initially be $25.9263 per share, which represents a premium of approximately 75% over the last reported sale price of Coherus’ common stock of $14.815 per share on April 14, 2020, and is subject to certain adjustments under the terms of the capped call transactions.

With respect to the notes, their issuance and sale is scheduled to settle on April 17, 2020, subject to customary closing conditions. Coherus also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date notes are first issued, up to an additional $30,000,000 principal amount of notes.

The notes will be general unsecured obligations of Coherus, and will be subordinated to the Coherus’ designated senior indebtedness. The notes will accrue interest at a rate of 1.500% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, beginning on October 15, 2020. The notes will mature on April 15, 2026, unless earlier repurchased or converted.

At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their notes at their option into shares of Coherus’ common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. The initial conversion rate is 51.9224 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $19.26 per share of common stock. The initial conversion price represents a premium of approximately 30.0% over the last reported sale of $14.815 per share of Coherus’ common stock on the Nasdaq Global Market on April 14, 2020.

The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events. If a "make-whole fundamental change" (as defined in the indenture for the notes) occurs, Coherus will, in certain circumstances, increase the conversion rate for a specified time for holders who convert their notes in connection with that make-whole fundamental change.

The notes will not be redeemable at Coherus’ election before maturity.

If a "fundamental change" (as defined in the indenture for the notes) occurs, then, subject to a limited exception, noteholders may require Coherus to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

Coherus estimates that the net proceeds from the offering will be approximately $193.3 million (or approximately $222.4 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Coherus. Coherus intends to use $15.8 million of the net proceeds to fund the cost of entering into the capped call transactions described above. Coherus intends to use the remainder of the net proceeds from the offering for opportunistic pipeline acquisitions or licenses, working capital, and other general corporate purposes, which may include other debt repayment in the future. Coherus has not entered into any agreements or commitments with respect to any material acquisitions or licenses at this time. If the initial purchasers exercise their option to purchase additional notes, then Coherus intends to use a portion of the additional net proceeds to fund the cost of entering into additional capped call transactions as described above.

With respect to the capped call transactions, in connection with establishing their initial hedges, the option counterparties or their respective affiliates expect to enter into various derivative transactions with respect to Coherus’ common stock and/or purchase shares of Coherus’ common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Coherus’ common stock or the notes at that time.

In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Coherus’ common stock and/or purchasing or selling Coherus’ common stock or other securities of Coherus in secondary market transactions following the pricing of the notes and prior to the maturity of the notes. This activity could also cause or avoid an increase or decrease in the market price of Coherus’ common stock or the notes, which could affect the value of Coherus’ common stock that noteholders will receive upon conversion of the notes.

The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, the notes or the shares of common stock issuable upon conversion of the notes, nor will there be any sale of the notes or such shares, in any state or other jurisdiction in which such offer, sale or solicitation would be unlawful.

On April 14, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that interim Phase II TACTI-002 clinical data has been selected for a poster short talk presentation as part of the high-impact paper presentation program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, scheduled for 27 and 28 April (Press release, Immutep, APR 14, 2020, View Source [SID1234556346]).

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This presentation was originally accepted as a late-breaking poster for the AACR (Free AACR Whitepaper) Annual Meeting prior to the event being rescheduled as two virtual events due to the ongoing COVID-19 pandemic, including AACR (Free AACR Whitepaper) Virtual Annual Meetings I and II. The data in this presentation relates to Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 protein based on the LAG-3 immune control mechanism, as part of a combination treatment with pembrolizumab, an anti-PD-1 therapy.

Presentation Details:

Title: ‘Initial results from a phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble lag-3 protein) and pembrolizumab’
Date: Monday, April 27, 2020
Session: VPO.CT02.Phase II Clinical Trials: CT202
Presenter: Dr. Martin Forster, MBBS FRCP PhD, TACTI-002 clinical trial Principal Investigator, University College London Cancer Institute in the United Kingdom
The abstract title was published today on the AACR (Free AACR Whitepaper) website at View Source!/9045/presentation/10803.

The submitted abstract and the virtual poster presentation will also be accessible on Immutep’s website at www.immutep.com/investors-media/presentations.html on the day of the poster presentation.

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line HNSCC or NSCLC in first and second line.

On April 14, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that it will present updates on its ongoing Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, for the treatment of advanced solid tumors in an oral presentation at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I on April 27, 2020 at 11:45 AM EST (Press release, Compugen, APR 14, 2020, View Source [SID1234556327]).

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The presentation, titled, "COM701 demonstrates preliminary antitumor activity as monotherapy and in combination with nivolumab in patients with advanced solid tumors", will include updates from the dose escalation arms of COM701 monotherapy and in combination with nivolumab. The presentation will be delivered by Ryan Sullivan, M.D., Assistant Professor, Medicine, Harvard Medical School and Assistant Professor, Hematology/Oncology, Massachusetts General Hospital.

The presentation will be made available on Compugen’s website at www.cgen.com following the conclusion of the presentation.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, discovered by Compugen’s computational discovery platform in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signs of anti-tumor activity in a heavily pretreated patient population.