On June 2, 2021 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that on May 26, 2021 the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization for NEXPOVIO (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy (Press release, Karyopharm, JUN 2, 2021, View Source [SID1234583380]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conditional marketing authorization is supported by data from the positive Phase 2b STORM study, which evaluated selinexor in adult patients with heavily pretreated, triple class refractory multiple myeloma and was published in the New England Journal of Medicine (Chari, et al.) in August 2019. Under the provisions of conditional approval by the MHRA, continued authorization for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial and is subject to additional monitoring. This marketing authorization follows a similar authorization granted by the European Commission and valid in all 27 European Union (EU) member countries which was announced on March 29, 2021.

About the Phase 2b STORM Pivotal Trial

The Phase 2b STORM trial (Selinexor Treatment of Refractory Myeloma) was an international, multi-center, single-arm, open-label study which enrolled 123 adult patients (Part 2 of the trial) with heavily pretreated, triple class refractory multiple myeloma. Adult patients in the trial had a median of seven previous therapeutic regimens, including a median of 10 unique anti-myeloma agents.

For the study’s primary endpoint, oral selinexor achieved an overall response rate of 26% (95% confidence interval [CI], 19, 35) and the trial therefore met its primary endpoint (n=123). Minimal response per IMWG criteria was observed in 16 (13%) patients and 48 patients (39%) had stable disease. All responses were adjudicated by an Independent Review Committee. Among the modified intent to treat population enrolled in STORM Part 2, eighty–three (83) patients had relapse and/or refractory multiple myeloma that was refractory to two proteasome inhibitors (bortezomib, carfilzomib), two immunomodulators (lenalidomide, pomalidomide) and an anti-CD38 monoclonal antibody (daratumumab), the efficacy analysis was based on these 83 patients. A secondary efficacy endpoint included overall survival (OS), defined as the duration from start of study treatment to death due to any cause. The median OS was 8.6 months in the total population (n=123) studied and 15.6 months in adult patients who had a minimal response or better.

Karyopharm’s request for conditional authorization in the UK was based upon the same patient population that served as the basis for accelerated FDA approval of XPOVIO (selinexor) in the U.S. The overall response rate in this patient population (n=83) was 25.3 % (95% confidence interval [CI], 16.4, 36).

The most common adverse reactions in the STORM trial (≥20%) were thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of adult patients. Serious adverse reactions occurred in 58% of adult patients. Treatment discontinuation rate due to adverse reactions was 27%.

About Multiple Myeloma in Europe

Multiple myeloma (MM) is an incurable cancer with significant morbidity and the second most common hematologic malignancy. In 2020, there were approximately 51,000 new cases and 32,000 deaths from MM in Europe1. While the treatment of MM has improved over the last 20 years, and overall survival has increased considerably, the disease remains incurable, and nearly all adult patients will eventually relapse and develop disease that is refractory to all authorized anti-MM therapies. Therefore, there continues to be a high unmet medical need for new therapies, particularly those with novel mechanisms of action.

About NEXPOVIO (selinexor)

NEXPOVIO, which is marketed as XPOVIO in the U.S., is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. NEXPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). NEXPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. NEXPOVIO has been granted conditional marketing authorization by the European Commission in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Therapeutic indication for NEXPOVIO in the UK, EU as well as the EEA Countries of Iceland, Liechtenstein and Norway

NEXPOVIO is indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

SELECT IMPORTANT SAFETY INFORMATION

NEXPOVIO is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.

Contraindications: Hypersensitivity to selinexor.

Special warnings and precautions for use:

Recommended concomitant treatments
Adult patients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for adult patients at risk of dehydration.
Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with NEXPOVIO.

Haematology
Adult patients should have their complete blood counts (CBC) assessed at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment.

Thrombocytopenia: Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in adult patients receiving selinexor, which can be severe (Grade 3/4). Adult patients should be monitored for signs and symptoms of bleeding and evaluated promptly.

Neutropenia: Severe neutropenia (Grade 3/4) has been reported with selinexor.
Adult patients with neutropenia should be monitored for signs of infection and evaluated promptly.

Gastrointestinal toxicity: Nausea, vomiting, diarrhoea, which sometimes can be severe and may require the use of anti-emetic and anti-diarrhoeal medicinal products.

Weight loss and anorexia: Adult patients should have their body weight, nutritional status and volume checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

Confusional state and dizziness: Patients should be instructed to avoid situations where dizziness or confusional state may be a problem and to not take other medicinal products that may cause dizziness or confusional state without adequate medical advice. Patients should be advised not to drive or operate heavy machinery until symptoms resolve.

Hyponatraemia: Adult patients should have their sodium levels checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

Tumour lysis syndrome (TLS): TLS has been reported in adult patients receiving therapy with selinexor. Adult patients at a high risk for TLS should be monitored closely. Treat promptly in accordance with institutional guidelines.

Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females: Women of childbearing potential and male adult patients of reproductive potential should be advised to use effective contraceptive measures or abstain from sexual activity to prevent pregnancy during treatment with selinexor and for at least 1 week following the last dose of selinexor.

Breast-feeding: It is unknown whether selinexor or its metabolites are excreted in human milk. A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with selinexor and for 1 week after the last dose.

Elderly population
Patients 75 years and older had a higher incidence of discontinuation due to an adverse reaction, higher incidence of serious adverse reactions, and higher incidence of fatal adverse reactions.

Undesirable effects
Summary of the safety profile
The most frequent adverse reactions (≥30%) of selinexor in combination with dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased appetite, decreased weight, diarrhoea, vomiting, hyponatraemia, neutropenia and leukopenia.
The most commonly reported serious adverse reactions (≥3%) were pneumonia, sepsis, thrombocytopenia, acute kidney injury, and anaemia.

Description of selected adverse reactions
Infections: Infection was the most common non-haematological toxicity. Upper respiratory tract infection and pneumonia were the most commonly reported infections with 25% of reported infections being serious and fatal infections occurring in 3% of treated adult patients.

Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

On June 2, 2021 Immune Therapeutics Inc. (OTC-PINK: IMUND) (the "Company") reported that the Company has received and signed a non-binding term sheet to enter into an agreement that would provide working capital and wipe out a significant portion of its long-standing Debt (Press release, Immune Therapeutics, JUN 2, 2021, View Source [SID1234583378]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company received the term sheet from existing Immune Shareholders to provide the funds necessary to complete the restructuring of Immune. According to the agreement, the investors will lend a minimum of $700,000 and a maximum of $1,500,000 to the Company in exchange for non-convertible promissory notes bearing interest at 5%.

In connection with the transactions above, to the extent a noteholder holds any warrants to purchase shares of common stock of Borrower ("Warrants"), Lender shall have the right to apply all or any portion of the Debt under this Note toward exercising such Warrants, upon the terms and subject to the conditions provided in the Warrants. Upon converting the warrants, the lenders have a one-year lock-up agreement with leak-out provisions.

In addition, the Company is negotiating with former employees, current management, directors, and other accounts payable and hopes to settle shortly. Closing the transactions contemplated by the Letter of Intent is subject to several conditions being satisfied, including completing due diligence.,

Earlier this year, the Company successfully restructured its toxic convertible promissory Note in default since May of 2018 issued by Iliad Research & Trading, L.P., for $425,000.00 on October 20, 2017. The Note carried 22% percent interest default interest and was convertible into common shares of Immune stock at a 60% discount to market.

The Note was purchased by Global Reverb Corp and a shareholder in November of 2020. The parties agreed to restructure the balance of $697,000 (reflecting the total principal, interest, and penalties) associated with the instrument. Under the terms of the restructuring, the lenders canceled the existing Iliad Note. Two new notes were issued; one to Global Reverb and one to the shareholder. The notes are for one year with a one-year extension bearing 5% interest. There is no conversion feature on the restructured balance.

The agreement provides for filing a 14A Proxy within 30 days of closing the agreement and funding. The 14A will provide for a new slate of 5 Directors and Officers. To appoint Turner & Stone LLP as auditors of the Company to hold office until the conclusion of the next general meeting at which accounts are laid before the Company. To conduct any other business properly brought before the Annual Meeting. The lenders will appoint two advisors to the Board until the shareholders during the transaction.

"The restructuring of the notes and funding is a significant achievement for the Company, and we are thankful that our existing lenders agreed that a restructuring would benefit the Company and its growth initiatives. The restructuring improved our balance sheet and was one of the critical next steps in our strategic plan as we are continually working and uplifting. We believe that the amendment of these notes and additional funding is a key accomplishment and that our current market cap does not accurately reflect the value of the Company and the emerging opportunity in biotech," stated Kevin Phelps, Company CEO.

On behalf of the Board of directors of Immune- many of whom are investing alongside you – thank you for your investment and continued shareholder support. We look forward to sharing our progress with you in the coming weeks.

This news release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements about the reverse stock split, authorized shares reduction and the related timing of implementation and effects thereof. Forward-looking statements are statements other than statements of historical fact. These forward-looking statements are generally identified by the words "believe," "expect," "anticipate," "estimate," "intend," "plan," "may," "should," "could," "will," "would," and "will be," and variations of such words and similar expressions, although not all forward-looking statements contain these identifying words. Although we believe the expectations and forecasts reflected in the forward-looking statements are reasonable, we can give no assurance they will prove to have been correct. They can be affected by inaccurate or changed assumptions or by known or unknown risks and uncertainties.

On June 2, 2021 GeneCentric Therapeutics, a company making precision medicine more precise, reported upcoming data presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, being held virtually June 4th through 8th (Press release, GeneCentric Therapeutics, JUN 2, 2021, View Source [SID1234583377]). The presentations will focus on the ongoing collaborations with Basilea Pharmaceutica International Ltd and their Lisavanbulin Phase 2 clinical program in glioblastoma. Lisavanbulin is a prodrug of the lipophilic small molecule BAL27862, a novel tumor checkpoint controller that promotes tumor cell death by modulating the spindle assembly checkpoint. A key aspect of the current collaboration is the development of biomarkers, including differentially expressed genes, that may predict response to lisavanbulin and could serve as a potential predictive response signature in glioblastoma and other tumor types.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the poster presentations are as follows:

Title: Expression of end-binding protein 1 (EB1), a potential response-predictive biomarker for lisavanbulin, in glioblastoma and various other solid tumor types.
Session: Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology
Date: 4 June 2021
Abstract Number: 3118
Title: The potential utility of end-binding protein 1 (EB1) as response-predictive biomarker for lisavanbulin: A phase 2 study of lisavanbulin (BAL101553) in adult patients with recurrent glioblastoma.
Session: Central Nervous System Tumors
Date: 4 June 2021
Abstract Number: TPS2068
GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform and the associated pipeline of response signatures is being leveraged alongside traditional immunohistochemistry (IHC) to better characterize patients most likely to respond to lisavanbulin.

"We are excited to highlight ongoing clinical collaborations and our novel RNA-based technologies at the ASCO (Free ASCO Whitepaper) annual meeting," said Michael Milburn, PhD, GeneCentric President and CEO. " While most conferences have been virtual this past year, GeneCentric has experienced expansive growth in collaborations as well as enhanced interest in our deep expertise in RNA-based genomic solutions which parse out the complexities of tumor biology."

On June 2, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) ("MorphoSys"), and Constellation Pharmaceuticals, Inc., (NASDAQ: CNST) ("Constellation") reported that they have entered into a definitive agreement whereby MorphoSys will acquire Constellation for $34.00 per share in cash, which represents a total equity value of $1.7 billion (Press release, Constellation Pharmaceuticals, JUN 2, 2021, View Source [SID1234583376]). The transaction has been unanimously approved by the management board (Vorstand) and the supervisory board (Aufsichtsrat) of MorphoSys, as well as the Board of Directors of Constellation and is expected to close in the third quarter of 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Constellation is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics that address serious unmet medical needs in patients with various forms of cancer. Constellation’s two lead product candidates, pelabresib (CPI-0610), a BET inhibitor, and

CPI-0209, a second-generation EZH2 inhibitor, are in mid- to late-stage clinical trials and have broad therapeutic potential to offer meaningful benefits to patients with various hematological and solid tumors. Pelabresib has the potential to be a first- and best-in-class BET inhibitor and is currently in Phase 3 clinical trials for myelofibrosis, a bone marrow cancer that disrupts the body’s normal production of blood cells. CPI-0209 is currently in Phase 2 with best-in-class potential for treating hematological and solid tumors. Constellation’s pipeline also includes numerous preclinical compounds.

"This transformational acquisition represents a major step forward for MorphoSys as we bolster our position in hematology-oncology," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "Both pelabresib and CPI-0209 have broad potential and we look forward to unlocking their full benefits for cancer patients. Our existing clinical and commercial expertise is ideally suited to accelerate Constellation’s programs, enabling us to maximize Constellation’s potential and bring these novel therapies to market. With Constellation’s high-potential product candidates, complementary R&D capabilities, and outstanding team, we can further advance our mission in the fight against cancer."

"We are proud that MorphoSys has recognized the strength of our team, our expertise in epigenetics, and our high-potential oncology development pipeline and discovery programs," said Jigar Raythatha, President and Chief Executive Officer of Constellation. "Becoming part of MorphoSys creates an industry leader with commercial capabilities, a deep R&D pipeline and complementary small molecule and biologics discovery and translational capabilities, as well as the financial strength to compete to win. Our shareholders will receive attractive, immediate and certain cash value for their shares, the employees of the combined entity will have a broader platform and greater opportunities, and patients will potentially benefit from innovative new therapies that address serious unmet needs."

Strategic Funding Partnership with Royalty Pharma

MorphoSys also announced that it has entered into a long-term strategic funding partnership with Royalty Pharma plc (Nasdaq: RPRX) ("Royalty Pharma") (together with the Constellation transaction, the "Transactions"). The terms of the agreement between MorphoSys and Royalty Pharma provide for the following, under certain conditions and upon closing of the transaction with Constellation:

$1.425 Billion Upfront Payment: Royalty Pharma will make a $1.425 billion upfront payment to MorphoSys, supporting its growth strategy. The proceeds will be used to support the financing of the Constellation transaction and development of the combined pipeline.
$350 Million Development Funding Bonds: Royalty Pharma will provide MorphoSys with access to up to $350 million in Development Funding Bonds with the flexibility to draw over a one-year period.
Milestone Payments: Royalty Pharma will make additional payments of up to $150 million to MorphoSys upon reaching clinical, regulatory and commercial milestones for otilimab, gantenerumab and pelabresib.
Royalties: Royalty Pharma will have the rights to receive 100% of MorphoSys’ royalties on net sales of Tremfya, 80% of future royalties and 100% of future milestone payments on otilimab, 60% of future royalties on gantenerumab, and 3% on future net sales of Constellation’s clinical stage assets (pelabresib and CPI-0209).
Equity Investment: After completion of the transaction and subject to the required approvals of the management board (Vorstand) and the supervisory board (Aufsichtsrat) of MorphoSys, Royalty Pharma is expected to invest $100 million in a cash capital increase of MorphoSys under an authorization to exclude subscription rights of existing shareholders. The new MorphoSys shares will be listed on the Frankfurt Stock Exchange.
Jean-Paul Kress continued, "We are thrilled to announce this partnership with Royalty Pharma, which is providing more than $2 billion to fuel our proprietary drug development and commercialization. We are confident they will be a strong financial partner for years to come, enabling us to fund our growth and – with the addition of Constellation’s innovative pipeline – bring our attractive new candidates to patients."

"In acquiring Constellation, MorphoSys has a significant opportunity to drive clinical and commercial success," said Pablo Legorreta, Chief Executive Officer of Royalty Pharma. "We are excited to join forces to further advance the combined company’s pipeline and positively impact patients."

Benefits of the Transaction

Accelerates Growth Strategy with Exciting Mid- to Late-Stage Product Candidates. The transaction accelerates MorphoSys’ strategy to grow through proprietary drug development and commercialization. Constellation’s lead product candidates, pelabresib and CPI-0209, have broad potential, with expected approvals across a range of oncology indications in the coming years. Constellation’s lead compounds fit well with MorphoSys’ proven clinical development, regulatory and commercial capabilities, and MorphoSys is well positioned to rapidly advance and unlock the potential of the Constellation portfolio.
Bolsters Position in Hematology-Oncology and Expands into Solid Tumors. Constellation adds an attractive, complementary pipeline of highly innovative late- to early-stage cancer therapy candidates, augmenting MorphoSys’ existing pipeline in hematologic malignancies and expanding into potential therapies for solid tumors.
Strengthens Cutting-Edge Research and Technology Organization. The transaction leverages MorphoSys’ expertise in biologics and Constellation’s expertise in epigenetics and small molecule discovery platforms to develop a broad range of oncology therapies. Constellation adds exciting, pioneering science and attractive preclinical compounds targeting epigenetic regulators. Together, MorphoSys’ and Constellation’s highly talented research and development teams will strengthen earlier stage and emerging science to bring exciting new cancer therapies to patients.
Anchored by Strategic Funding Partnership. Royalty Pharma’s strategic funding partnership will fuel the expansion of the combined company’s capabilities to help accelerate the development, approval and commercial reach of breakthrough cancer treatments. This long-term commitment will help deliver significant value to all stakeholders.
Transaction Details

Under the terms of the merger agreement, an indirect wholly-owned subsidiary of MorphoSys will promptly commence a tender offer to acquire all of the outstanding shares of Constellation’s common stock at a price of $34.00 per share in cash. Following successful completion of the tender offer, MorphoSys will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.

MorphoSys plans to pay an all-cash consideration for the transaction. The tender offer is not subject to a financing condition.

The purchase price of $34.00 per share in cash represents a premium of approximately 70% to Constellation’s volume-weighted average price for the last five trading days.

Consummation of the tender offer is subject to various conditions including a minimum tender of at least a majority of outstanding Constellation shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the receipt of any approvals or clearances required to be obtained under the applicable antitrust laws, and other customary conditions. The transaction is expected to close in the third quarter of 2021.

Following close, MorphoSys will remain headquartered in Munich, Germany, and will maintain a significant commercial and R&D presence in Boston, Massachusetts.

Advisors

Goldman Sachs Bank Europe SE acted as financial advisor to MorphoSys and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor. Centerview Partners LLC acted as financial advisor to Constellation and Wachtell, Lipton, Rosen & Katz as its legal advisor. Goodwin Procter LLP acted as legal advisor to Royalty Pharma.

Conference Call

MorphoSys will host a conference call and webcast to discuss the transaction on June 2, 2021 at 2:00 p.m. CEST, or 8:00 a.m. EDT. The webcast and accompanying slides can be accessed in the Media and Investors section, under Conferences, of MorphoSys’ website at View Source or at View Source After the call, a slide-synchronized audio replay of the conference will be available at the same location.

On June 2, 2021 Genmab A/S (Nasdaq: GMAB) and Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) reported that the companies have entered into an oncology research and development collaboration (Press release, Bolt Biotherapeutics, JUN 2, 2021, View Source [SID1234583375]). Together, the companies will evaluate Genmab antibodies and bispecific antibody engineering technologies in combination with Bolt’s proprietary Boltbody immune-stimulating antibody conjugate (ISAC) technology platform, with the goal of discovering and developing next-generation, immune-stimulatory, antibody-based conjugate therapeutics for the treatment of cancer. This research collaboration will evaluate multiple bispecific ISAC concepts to identify up to three clinical candidates for development. Genmab will fund the research, along with the preclinical and clinical development of these candidates through clinical proof of concept.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This exciting collaboration will provide a unique opportunity to combine Genmab’s innovative bispecific antibody technologies with Bolt’s powerful, advanced ISAC technology to develop targeted antibody products with the potential to transform cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Genmab’s partnership approach is part of our DNA and we are pleased to be collaborating with Bolt to develop and deliver potential next-generation cancer therapeutics to patients in need of novel treatment options."

Randall Schatzman, Ph.D., Chief Executive Officer of Bolt, explained, "Our joint vision is to leverage Genmab’s and Bolt’s innovative technologies to develop a completely new type of ISAC with the aim to transform the way cancer is treated. Creating bispecific ISACs turbo-charged with potent immune stimulants is a novel concept that has tremendous potential for patients. We are delighted to be collaborating with the Genmab team and to have their deep expertise in discovering and developing bispecific antibodies brought to bear on this approach as we continue our mission to develop treatments that address key unmet needs for patients with cancer."

Financial Terms
Under the terms of the agreement, Genmab will pay Bolt an upfront payment of USD 10 million. Genmab will also make a USD 15 million equity investment in Bolt. Bolt is eligible to receive total potential milestone payments of up to USD 285 million per therapeutic candidate exclusively developed and commercialized by Genmab, along with tiered royalties. Genmab will fully fund pre-clinical and early clinical development of all candidates. If a candidate is co-developed, development costs will be split 50:50 between the two companies, and the companies will be solely responsible for commercialization costs in their respective territories and shall pay each other royalties on product sales.