On July 21, 2021 AbbVie (NYSE: ABBV) reported the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to venetoclax (VENCLEXTA) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes (MDS) based on revised International Prognostic Scoring System (IPSS-R) (Press release, AbbVie, JUL 21, 2021, View Source [SID1234584996]). A BTD is intended to expedite the development and review of medications to treat a serious medical condition and is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies.1 This marks the sixth BTD granted to venetoclax.

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MDS are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells.2 Patients living with MDS may experience symptoms such as infection, anemia, spontaneous bleeding, and easy bruising. Roughly 10,000 patients in the US are diagnosed with MDS each year3 and around 30 percent of those patients will progress to acute myeloid leukemia (AML). Although MDS can occur at any age, it is most commonly found in patients aged 60 and older.4

"MDS is a devastating diagnosis – not only does it have the potential to greatly impact patients’ quality of life, but 30 percent of patients will also progress to AML," said Jalaja Potluri, executive medical director, oncology, AbbVie. "This Breakthrough Therapy Designation underscores the need for more treatment options for these patients and the utility of venetoclax to potentially treat different forms of blood cancer."

This designation is supported by data from the Phase 1b M15-531 study. In addition to the Phase Ib M15-531 study, venetoclax is being investigated in combination with azacitidine for the treatment of MDS in the Phase Ib M15-522 study in patients with relapsed or refractory disease, and the Phase 3 randomized VERONA study in patients with newly diagnosed higher-risk MDS.

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

About VENCLEXTA (venetoclax)
VENCLEXTA/VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Uses of VENCLEXTA (venetoclax) in US

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.

Important VENCLEXTA (venetoclax) US Safety Information

US VENCLEXTA Important Safety Information

What is the most important information I should know about VENCLEXTA?
VENCLEXTA can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?
Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?
VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

On July 21, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that Venclexta (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the revised International Prognostic Scoring System (IPSS-R) (Press release, Genentech, JUL 21, 2021, View Source [SID1234584989]). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anemia and debilitating fatigue that can profoundly affect a person’s quality of life. In some cases, MDS can also progress into acute myeloid leukemia (AML). Every year in the United States, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.

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"Higher-risk MDS is associated with poor prognosis, reduced quality of life, and limited treatment options," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We are pleased that the FDA has granted Venclexta its sixth Breakthrough Therapy Designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine."

This designation was granted based on interim results from the Phase Ib M15-531 study investigating Venclexta plus azacitidine in people with previously untreated, higher-risk MDS. BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies. This is the 38th BTD for Genentech’s portfolio of medicines, and the 11th designation for its hematology portfolio.

This most recent designation reinforces the potential of Venclexta-based combinations across several blood cancers, including MDS. In the United States, Venclexta has been granted six BTDs by the FDA: one for previously untreated chronic lymphocytic leukemia (CLL), two for relapsed or refractory CLL, two for previously untreated AML, and one for MDS. Venclexta is already approved in the United States in combination with azacitidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, and in the European Union in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy. Venclexta is also approved in the United States and European Union in combination with Rituxan (rituximab) for the treatment of adult patients with CLL who have received at least one prior therapy; in combination with Gazyva (obinutuzumab) for the treatment of adult patients with previously untreated CLL; and as a monotherapy for the treatment of CLL in the presence of 17p deletion or TP53 mutation in people who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

About Myelodysplastic Syndromes (MDS)

MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells. This can lead to weakness, frequent infections, anemia and debilitating fatigue. In some cases, MDS can also progress into acute myeloid leukemia (AML). Every year in the United States, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.

There are several classifications of MDS – very low-risk to very high-risk – determined by the composition of the bone marrow, blood cell counts, and chromosomal alterations. Higher-risk disease is defined as intermediate, high- or very high-risk based on the revised International Prognostic Scoring System (IPSS-R), which is a risk assessment scale that uses five prognostic indicators to predict the course of a patient’s disease. Approximately half (45%) of patients present with higher-risk MDS, which is associated with a poorer prognosis and short life expectancy.

About the M15-531 study

The M15-531 [NCT02942290] study is a Phase Ib, open-label, non-randomized, multicenter, dose-finding study evaluating Venclexta (venetoclax) in combination with azacitidine in treatment-naïve patients with higher-risk myelodysplastic syndromes (MDS) comprising a dose-escalation portion and a safety expansion portion. The primary objectives of the study are to assess the safety profile and pharmacokinetics and determine the recommended Phase II dose and dosing schedule of Venclexta in combination with azacitidine. The response criteria specified in the M15-531 study are based on the modified International Working Group 2006 response criteria for MDS.

About Venclexta

Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers.

Venclexta Indications

Venclexta is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or

‒ have other medical conditions that prevent the use of standard chemotherapy.

It is not known if Venclexta is safe and effective in children.

Important Safety Information

What is the most important information patients should know about Venclexta?

Venclexta can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient’s doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein.

The patient’s doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS.

Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased.

The patient’s doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient’s doctor may again check for the risk of TLS and change the patient’s dose.

What patients should not take Venclexta?

Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS.

Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects.
Patients must not start new medicines during treatment with Venclexta without first talking with their doctor.
Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they:

Have kidney or liver problems.
Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium.
Have a history of high uric acid levels in the blood or gout.
Are scheduled to receive a vaccine. Patients should not receive a "live vaccine" before, during, or after treatment with Venclexta, until the patient’s doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta.
Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient’s doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away.
Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient’s breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose.
What to avoid while taking Venclexta:

Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood.

What are the possible side effects of Venclexta?

Venclexta can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient’s doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient’s doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta.
Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta.

The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet.

The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.

These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at 1-800-FDA-1088 or View Source Report side effects to Genentech at 1-888-835-2555.

Please see the Venclexta full Prescribing Information, including the Medication Guide, for additional Important Safety Information.

On July 20, 2021 RemedyBio, an immunology focused discovery and development company, reported the final closing of an additional €8M ($9.4M) in equity financing from the EIC Fund, completing a €10.5M ($12.4M) funding award to the company by the EIC Accelerator (Press release, Remedy Biologics, JUL 20, 2021, View Source [SID1234644116]). This additional €8M financing complements the EIC grant funding of €2.5M ($3M) already awarded to RemedyBio in June 2020, to develop a Rapid Pandemic Response Platform based on its proprietary NanoreactorTM platform. This financing follows RemedyBio’s selection from almost 4,000 company proposals submitted to the EIC Accelerator in 2020.

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RemedyBio’s technology is designed to rapidly and simultaneously analyze millions of single immune cells from an individual sample. After succeeding in flagging powerful new antibodies against SARS-CoV-2 from the immune system of COVID-19 infected patients, the platform is now being tuned to respond to new variants and future diseases. The aim is to create a rapid passive therapy against new strains of COVID-19 and, primarily, to control future pandemics more rapidly, by making therapies for new viruses available in less than 90 days.

"This financing from the EIC Fund will enable us to advance our technology development and therapeutic discovery activities, and forge collaborations with leading pharma partners and key clinical and research groups," said Daniel Crowley, CEO of RemedyBio. "We are delighted to have the support of the EIC Fund. It fills an important financing gap, supporting European companies with innovative technologies to create deep scientific programs and commercial partnerships. In our case, this will drive transformative biological insights and new therapy discoveries."

This investment will fund the significant development of RemedyBio’s innovative, proprietary Nanoreactor platform as well as advancing its key therapeutic pipeline assets. The Nanoreactor platform has been developed by RemedyBio, originating from intellectual property exclusively licensed from Dublin City University (DCU), following a decade-long R&D programme led by Dr. Paul Leonard, the company’s chief scientist and co-founder. The platform has created a step-change in the speed, scale and quality of single cell analysis and discovery, paving the way for powerful new antibodies and cell therapies. Its high-throughput identification capabilities open fresh insights into immune system interactions – driving a new era in precision medicine against viral diseases, cancer and auto-immune disorders.

"At Enterprise Ireland, we welcome this substantial EIC Fund investment in an Irish high potential start-up," said Garrett Murray, national director for Horizon Europe at Enterprise Ireland. "RemedyBio is a great example of an Irish company that has succeeded in winning competitive funding through the EIC and, in Ireland, through the Disruptive Technology Innovation Fund (DTIF) for oncology cell therapy applications, to help fund its development

and advance its scaling strategy. Enterprise Ireland is here to support and advise ambitious and innovative Irish start-ups considering application for competitive EIC financing as part of their funding journey."
Heidi Kakko, member of the Investment Committee of the European Innovation Council Fund said, "This financing round will enable Remedy Biologics to develop a Rapid COVID- 19 Passive Therapy Response Platform. We are glad the EIC Fund is supporting this breakthrough company, which is playing a pioneering role in creating new solutions in immune therapeutics. This shows how the EU contribution is crucial in tackling the Covid19 response."
About the EIC Fund
Established in June 2020, the European Innovation Council Fund (EIC Fund) is a breakthrough initiative of the European Commission to make direct equity and quasi- equity investments (between €500.000 and €15 million) in European high impact and deep tech start-ups and scale ups. The EIC Fund provides patient capital and invests in companies from any sector, across all EU countries and countries associated to Horizon 2020.
The EIC Fund aims to fill a critical financing gap and its main purpose is to have a high impact by accompanying companies with disruptive technologies in their growth. Its objective is to crowd in market players, further sharing risks by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to empower and support female founders as well as contributing to reduce the innovation divide among EU countries. www.eic.ec.europa.eu/investment-opportunities
About Enterprise Ireland
Enterprise Ireland (EI) services are geared towards helping Irish companies win international sales. These services include funding support, export assistance, development of competitiveness in international markets, R&D and assistance with R&D collaboration. EI also provides access to its global network of contacts. www.enterprise-ireland.com

On July 20, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported the start of clinical development for its second program, a next generation autotaxin inhibitor designated IOA-289 (Press release, iOnctura, JUL 20, 2021, View Source [SID1234640246]). IOA-289 will be the first autotaxin inhibitor to be investigated in oncology.

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The Italian Medicines Agency (AIFA) has authorized a phase 1a dose-escalation study for IOA-289 in healthy volunteers. The healthy volunteer study prepares the way for a phase 1b trial of IOA-289, which iOnctura plans to conduct in patients with pancreatic cancer. iOnctura’s Phase Ib trial in pancreatic cancer is expected to begin in 2022.

"We are very excited to progress our highly differentiated autotaxin inhibitor, IOA-289, as our second clinical program," said Catherine Pickering, CEO of iOnctura. "This is another significant milestone for iOnctura demonstrating our strong development pipeline and capabilities of our team. We are looking forward to translating the promise demonstrated in our preclinical studies into humans."

In many types of cancer, including pancreatic cancer, high expression of autotaxin and the product it generates (lysophosphatidic acid – LPA) correlate with poor outcomes. IOA-289 has a unique chemistry and has demonstrated promising effects in several preclinical solid tumor models including pancreatic cancer. It has also exhibited greater potency and less toxicity than first-generation autotaxin inhibitors that have until now only been trialed in fibrotic disease indications.

The Phase 1a healthy volunteer study will involve a total of forty volunteers (2 receiving placebo, and 6 actively dosed in each of 5 dose escalation cohorts) and will explore a 10-fold dose-range of IOA-289. Topline data from the study are expected to be available in Q4 2021.

The short preparatory study in healthy volunteers will garner key information on the safety, pharmacokinetics and pharmacodynamics of IOA-289 enabling iOnctura to accelerate into a Phase 1b trial in pancreatic cancer.

On July 20, 2021 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the closing of its initial public offering of 21,562,500 shares of common stock, which includes the exercise in full by the underwriters of their option to purchase 2,812,500 additional shares, at an initial public offering price of $16.00 per share (Press release, Erasca, JUL 20, 2021, View Source [SID1234639385]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Erasca, were $345.0 million. Erasca’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol "ERAS."

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J.P. Morgan, Morgan Stanley, BofA Securities, Evercore ISI, and Guggenheim Securities acted as joint book-running managers for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission (SEC) and became effective on July 15, 2021. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.