On August 18, 2022, Halozyme Therapeutics, Inc. (the "Company," "we," "us" or "our") completed its previously reported that sale of $720.0 million in aggregate principal amount of 1.00% Convertible Senior Notes due 2028 (the " Convertible Notes"), including $95.0 million in aggregate principal amount of 1.00% Convertible Senior Notes due 2028 purchased pursuant to the exercise by the initial purchasers of the Convertible Notes (the "Initial Purchasers") of the option (the "Notes Option") to purchase additional Securities in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, Halozyme, AUG 18, 2022, View Source [SID1234618483]). The Convertible Notes were issued under an indenture, dated as of August 18, 2022, (the "Indenture") between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee (the "Trustee"). The Company offered and sold the Convertible Notes in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act. The Initial Purchasers offered and sold the Convertible Notes to "qualified institutional buyers" pursuant to the exemption from registration provided by Rule 144A under the Securities Act. The offer and sale of the Convertible Notes and the shares of common stock issuable upon conversion of the Convertible Notes have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold absent registration or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements.

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The Company received net proceeds from the offering of approximately $701.4 million. The Company expects to use a portion of the net proceeds to repay all of the $250.0 million outstanding under its term loan facility due 2026. The Company used a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions consummated concurrently with or shortly after the offering (the "Note Repurchases"). In connection with the Note Repurchases, the Company paid approximately $77.6 million in cash, which includes accrued interest, and issued approximately 1.51 million shares of its common stock, to settle such exchanges. In addition, the Company used approximately $90.0 million of the net proceeds from the offering to repurchase shares of its common stock under its existing stock repurchase program (the "Share Repurchases") concurrently with the closing of the offering. The Company previously announced Share Repurchases for the remainder of the calendar year 2022 of up to $200.0 million, a $100.0 million increase from the previously announced amount, with such remaining additional repurchases to commence immediately following the closing of the offering.

The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company’s common stock from time to time under its existing stock repurchase program, working capital, capital expenditures, potential acquisitions and strategic transactions.

The Convertible Notes will pay interest semi-annually in arrears on February 15th and August 15th of each year at an annual rate of 1.00% and will be convertible into cash, and, if applicable, shares of the Company’s common stock, at the Company’s election, based on the applicable conversion rate at such time. The Convertible Notes are general unsecured obligations of the Company and will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the Convertible Notes, will rank equally in right of payment with all of the Company’s existing and future liabilities that are not so subordinated, will be effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness and will be structurally subordinated to all indebtedness and other liabilities (including trade payables) of the Company’s current or future subsidiaries.

Holders may convert their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on December 31, 2022, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, the "measurement period") in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on Company’s common stock, as described in the offering memorandum; (4) if we call such notes for redemption; and (5) at any time from, and including, February 15, 2028 until the close of business on the second scheduled trading day immediately before the maturity date.

The initial conversion rate for the Convertible Notes will be 17.8517 shares of common stock per $1,000 in principal amount of Convertible Notes, equivalent to a conversion price of approximately $56.02 per share of common stock. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid interest.

Subject to certain exceptions, holders may require the Company to repurchase, for cash, all or part of their Convertible Notes upon a "Fundamental Change" (as defined in the Indenture) at a price equal to 100% of the principal amount of the Convertible Notes being repurchased plus any accrued and unpaid interest, if any, up to, but excluding, the "Fundamental Change Repurchase Date" (as defined in the Indenture). In addition, upon a "Make-Whole Fundamental Change" (as defined in the Indenture) prior to the maturity date of the Convertible Notes, the Company will, in some cases, increase the conversion rate for a holder that elects to convert its Convertible Notes in connection with such Make-Whole Fundamental Change. The Company may not redeem the Convertible Notes prior to August 15, 2025 and on or before the 30th scheduled trading day immediately before the maturity date.

The Indenture contains certain events of default after which the Convertible Notes may be due and payable immediately. Such events of default include, without limitation, the following: (1) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any Convertible Note; (2) a default for 30 days in the payment when due of interest on any Convertible Note; (3) the Company’s failure to deliver, when required by the Indenture, a fundamental change notice or other notices pursuant to the Indenture; (4) a default in the Company’s obligation to convert a Convertible Note in accordance with the Indenture upon the exercise of the conversion right with respect thereto, if such default is not cured within two business days after its occurrence; (5) a default in the Company’s obligations described in the Indenture with respect to consolidation, merger and sale of assets of the Company; (6) a default in any of the Company’s obligations or agreements under the Indenture or the Convertible Notes (other than a default set forth in the preceding (1), (2), (3), (4) or (5)) where such default is not cured or waived within 60 days after notice to the Company by the Trustee, or to the Company and the Trustee by holders of at least 25% of the aggregate principal amount of Convertible Notes then outstanding, which notice must specify such default, demand that it be remedied and state that such notice is a "notice of default"; (7) a default by the Company or any of the Company’s subsidiaries with respect to any one or more mortgages, agreements or other instruments under which there is outstanding, or by which there is secured or evidenced, any indebtedness for money borrowed of at least $50.0 million (or its foreign currency equivalent) in the aggregate of the Company or any of the Company’s subsidiaries, whether such indebtedness exists as of the date the Company first issues the Convertible Notes or is thereafter created, where such default: (x) constitutes a failure to pay the principal of, or premium or interest on, any of such indebtedness when due and payable at its stated maturity, upon required repurchase, upon declaration of acceleration or otherwise, in each case after the expiration of any applicable grace period; or (y) results in such indebtedness becoming or being declared due and payable before its stated maturity, in each case where such default is not cured or waived within 30 days after notice to the Company by the Trustee or to the Company and the Trustee by holders of at least 25% of the aggregate principal amount of Convertible Notes then outstanding; and (8) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of the Company’s "significant subsidiaries", as defined in the Indenture.

The foregoing description of the Indenture and Convertible Notes is qualified in its entirety by reference to the text of the Indenture and the Form of Convertible Note, copies of which are attached as Exhibits 4.1 and 4.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

Capped Call Transactions

On August 15, 2022, in connection with the pricing of the Notes, the Company entered into capped call transactions (the "Base Capped Call Transactions") with each of Bank of America, N.A., Mizuho Markets Americas LLC, Bank of Montreal, Royal Bank of Canada and Wells Fargo Bank, National Association (collectively, the "Capped Call Counterparties"). On August 16, 2022, in connection with the Initial Purchasers’ exercise of the Notes Option, the Company entered into additional capped call transactions with the Capped Call Counterparties (together with the Base Capped Call Transactions, the "Capped Call Transactions"). The Capped Call Transactions are expected generally to reduce potential dilution to holders of our common stock on any conversion of the Convertible Notes or at our election (subject to certain conditions) offset any cash payments we are required to make in excess of the principal amount of such converted Convertible Notes, as the case may be, with such reduction or offset subject to a cap. The cap price of the Capped Call Transactions is initially $75.4075 per share of common stock, representing a premium of 75% above the last reported sale price of $43.09 per share of common stock on August 15, 2022, and is subject to certain adjustments under the terms of the Capped Call Transactions.

The Capped Call Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock or purchasing or selling our common stock in secondary market transactions following the pricing of the Convertible Notes and prior to the maturity of the Convertible Notes (and are likely to do so during the relevant valuation period under the capped call transactions or following any early conversion of the Convertible Notes or repurchase of the Convertible Notes by us on any fundamental change repurchase date, any redemption date or otherwise, in each case if the Company exercises our option to terminate the relevant portion of the Capped Call Transactions). This activity could also cause or avoid an increase or decrease in the market price of our common stock or the Convertible Notes, which could affect the holders’ ability to convert the Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the Convertible Notes, it could affect the amount and value of the consideration that the holder will receive on conversion of such Convertible Notes.

The Capped Call Transactions are separate transactions entered into by the Company with the Capped Call Counterparties, are not part of the terms of the Convertible Notes, and will not affect any holder’s rights under the Convertible Notes. Holders of the Convertible Notes will not have any rights with respect to the Capped Call Transactions.

The form of the Capped Call Transaction confirmation (the "Capped Call Confirmation") is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference. The foregoing description of the Capped Call Confirmation does not purport to be complete and is qualified in its entirety by reference to such exhibit.

On August 18, 2022 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported financial results for the second quarter and first half of 2022 and provided a business update (Press release, CureVac, AUG 18, 2022, View Source [SID1234618482]).

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"CureVac has pioneered a technology that is changing today’s medicine. As a central mRNA player, we are executing on our 2022 goals in our three core competencies: broad technology platform, solid product development pipeline, and large GMP manufacturing capacities. By extending our clinical development into modified mRNA, we are further broadening the potential of our mRNA technology platform for several product development programs. In addition, our integrated manufacturing capabilities are instrumental in enabling ongoing supply of clinical material and in delivering on our pandemic preparedness contract with the German government," said Franz-Werner Haas, Chief Executive Officer of CureVac. "At the same time, we continue to accelerate our core oncology strategy through the acquisition of Frame Cancer Therapeutics. This synergistic acquisition brings a complementary bioinformatics platform in-house that translates genetic tumor information into tailored therapies. We are committed to driving innovation in our three therapeutic areas to fight disease by enabling the body to make its own drugs."

"In the second quarter of 2022, the wind-down costs related to our first-generation vaccine candidate, CVnCoV, still impacted our financial position but continue to decrease as we conclude our remaining commitments," said Pierre Kemula, Chief Financial Officer of CureVac. "At the same time, we are driving forward our corporate transformation from a biotech to a fully integrated biopharma company and advancing our three core competencies with now over 1,000 employees. Moving into the second half of 2022, we are further broadening our mRNA technology platform and advancing our programs in prophylactic vaccines as well as executing on our core strategy in oncology."

Selected Business Updates

Prophylactic Vaccines

Executing on Broad Second-Generation mRNA Vaccine Program, Jointly Developed with GSK

CureVac aims to be at the forefront of delivering second-generation mRNA-based vaccines against a range of relevant infectious diseases and is executing on a broad mRNA vaccine program in colla­boration with GSK. The optimized second-generation mRNA backbone targets improved intracellular mRNA translation for increased and extended protein expression, resulting in earlier and stronger immune responses compared to CureVac’s first-generation COVID-19 candidate, CVnCoV.

Second-generation mRNA-based vaccines are expected to allow for flexible protection against one or more emerging COVID-19 variants and to enable new mRNA vaccines against other infectious diseases, such as influenza, as well as potential combination vaccines against different viruses.

Expanding Clinical Development into Modified mRNA Technology

Modified, Omicron-Targeting COVID-19 Vaccine Candidate

CureVac is delivering on its previously announced 2022 clinical development program in prophylactic vaccines by initiating a Phase 1 study with the modified COVID-19 mRNA vaccine candidate CV0501. The candidate is being administered as a booster dose to previous COVID-19 vaccination. Developed in collaboration with GSK, CV0501 is based on CureVac’s second-generation mRNA backbone and uses a modified mRNA technology. It is designed to specifically protect against the Omicron variant.

As clinical studies of the second-generation backbone expand into modified mRNA, targeting the Omicron variant will further explore the potential of the improved backbone design as a booster vaccine for any relevant COVID-19 variant.

The Phase 1 CV0501 dose-escalation study will be conducted at clinical sites in the U.S., the UK, Australia and the Philippines and is expected to enroll up to 180 healthy, COVID-19 vaccinated adults to evaluate the safety and reactogenicity of a single booster dose of CV0501 in the dose range of 12µg to 50µg. Additional dose levels below 12µg and above 50µg may be evaluated if supported by safety and immunogenicity data at these dose levels. The study follows the start of a Phase 1 study in March 2022 that evaluates the unmodified second-generation COVID-19 vaccine candidate CV2CoV in the U.S. Data from both studies are expected to be reported as a combined data set.

COVID-19 studies are being conducted alongside CureVac and GSK’s jointly developed influenza vaccine program, in which clinical evaluation of the unmodified seasonal influenza candidate CVSQIV and the modified candidate FLU SV mRNA have similarly been initiated.

Modified Influenza Vaccine Candidate

CureVac has dosed the first participant in a Phase 1 study of the modified influenza vaccine candidate FLU SV mRNA, developed in collaboration with GSK, completing initiation of all studies in the previously announced 2022 clinical development program in prophylactic vaccines. FLU SV mRNA is a monovalent vaccine candidate based on CureVac’s second-generation mRNA backbone.

By leveraging the semi-parallel conduct of clinical studies in modified vaccine candidates across influenza and COVID-19, the Phase 1 study is designed to rapidly evaluate the safety and reactogenicity of the modified second-generation backbone with increased accuracy and efficiency.

The Phase 1 FLU SV mRNA dose-escalation study will be conducted in Canada, Spain and Belgium, and is expected to enroll up to 198 healthy adult participants to evaluate the safety, reactogenicity and immunogenicity of FLU SV mRNA in up to five dose levels ranging from 2µg to 54µg. Later-stage clinical development is expected to evaluate a multivalent form of the candidate, which would range in dose up to 200µg – the upper limit of the dose range in the complementary study of the modified COVID-19 candidate CV0501.

The study follows the start of a Phase 1 study in February 2022 to evaluate an unmodified, multivalent influenza vaccine candidate, CVSQIV, at clinical sites in Panama. Data from both studies are expected to be reported as a combined data set.

Protection of Intellectual Property Rights

Over the last 22 years, CureVac has developed proprietary foundational technology related to mRNA design, delivery and manufacturing that has materially contributed to the development of safe and efficacious COVID-19 vaccines.

On July 5, 2022, CureVac moved to assert its intellectual property rights by filing a lawsuit in the German Regional Court in Düsseldorf against BioNTech SE and two of its subsidiaries. CureVac is seeking fair compensation for infringement of a portfolio of CureVac’s intellectual property rights,
EP 1 857 122 B1, EP 3 708 668 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974 U1, utilized in the manufacture and sale of Comirnaty, BioNTech and Pfizer’s mRNA COVID-19 vaccine.

The company does not seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and its partner Pfizer.

Oncology

Acquisition of Frame Cancer Therapeutics Accelerates Oncology Strategy

Based on its recent progress in prophylactic vaccines, most notably the second-generation mRNA backbone, CureVac is broadening its foundation in oncology and preparing to build up a meaningful portfolio of cancer vaccine candidates based on promising new tumor antigens predicted to elicit strong immune responses.

Within this strategy, CureVac is following two approaches. The first approach assesses tumor antigens shared by different cancer patients for the development of off-the-shelf cancer vaccines. The second approach is tailored to a patient’s individual tumor profile.

To advance both approaches, in June 2022 CureVac acquired Frame Cancer Therapeutics, a private company focused on using advanced genomics and bioinformatics to identify both shared and unique neoantigens across different cancer types. The acquisition complements existing in-house expertise to identify and validate promising neoantigens for mRNA cancer vaccine candidates.

The former Frame Cancer Therapeutics site was inaugurated as CureVac Netherlands B.V. and is located at one of the largest science hubs in Europe. The new oncology hub will further develop the proprietary FramePro platform, which has the potential to identify a broad panel of neoantigens that go beyond conventional neoantigens. FramePro strongly increases the likelihood of developing cancer vaccines, both personalized and off-the-shelf, that are highly effective in activating the human immune system against cancer.

The total consideration for the Frame Cancer Therapeutics acquisition is €34 million, to be paid mostly in CureVac shares. Following a 50% upfront payment, the residual amount will be split across two project milestone-driven steps.

The acquisition of Frame Cancer Therapeutics follows a strategic oncology partnership with Belgium-based company myNEO in May 2022. The highly synergistic technologies are expected to accelerate CureVac’s oncology strategy by accessing novel classes of tumor antigens and identifying those with the highest confidence of success for potential clinical testing. The RNA Printer, CureVac’s automated end-to-end solution for smaller-scale, rapid manufacturing of GMP-grade mRNA vaccines and thera­peutics, will play an integral part in enabling the development of these novel cancer vaccine candidates.

Corporate Development

CureVac strengthens its focus on oncology with the appointment of Myriam Mendila, M.D., an experienced industry leader and medical doctor, as Chief development Officer. Dr. Mendila has a global track record of more than 20 years in product development, medical affairs, pharmacovigilance and healthcare compliance as well as global product strategy, including commercial strategy, at Roche, Genentech and Novartis. Her international experience, combined with her expertise in building a broad product portfolio, especially in oncology across different cancer types, will be vital to the successful expansion of CureVac’s oncology pipeline and organization.

Dr. Mendila’s appointment will take effect on February 1, 2023. Until then, Dr. Ulrike Gnad-Vogt, Senior Vice President Area Head Oncology at CureVac, will act as interim Chief Development Officer.

Financial Update for the Second Quarter and First Half of 2022

Cash Position

Cash and cash equivalents were €573.6 million as of June 30, 2022, down from €811.5 million as of December 31, 2021. In the first six months of 2022, cash used in operations was mainly allocated to payments in connection with purchases of materials for use in R&D and settling CMO contracts as part of the wind-down activities for CureVac’s first-generation CVnCoV vaccine program; in the same period of 2021, cash used in operations was mainly allocated to prepayments to CROs and CMOs in relation to the CVnCoV program. As CureVac settled the majority of its financial obligations related to the CVnCoV program as of June 30, 2022, the company expects a significant decrease in cash outflows, relating to this program, in future periods.

Revenues

Revenues amounted to €20.1 million and €44.5 million for the three and six months ended June 30, 2022, representing a decrease of €2.3 million and increase of €12.1 million, or a decrease of 10% and an increase of 37%, from €22.4 million and €32.4 million for the same periods in 2021.

The increase for the six-month period ending June 30, 2022, was primarily driven by revenues from the two collaborations with GSK. In the first quarter of 2022, CureVac received a €10 million milestone payment related to the start of the seasonal influenza clinical trial. €5.3 million of this milestone was recognized pro rata as revenue in the first six months of 2022. Under both GSK collaboration agreements, total revenues of €43.0 million were recognized for the first six months of 2022, compared to €29.3 million in the same period of the prior year.

Operating Result

Operating loss amounted to €60.3 million and €75.6 million for the three and six months ended June 30, 2022, representing a decrease of €87.5 million and €188.0 million from €147.8 million and €263.6 million for the same periods in 2021.

The operating result was affected by several key drivers:

Cost of sales increased primarily in relation to write-off of raw material due to a decline in production planning following the transfer of reserved production capacity to GSK. The increase was partially offset by a decrease in third-party costs as certain expenses for set-up activities for production process for CVnCoV did not recur in 2022.
The decrease in research and development expenses was primarily driven by significantly lower research and development costs with the upcoming termination of the CVnCoV Phase 2b/3 clinical study. The first six months of 2021 were mainly impacted by our Phase 2b/3 clinical trial for CVnCoV. As of December 2021, CureVac accrued all remaining CVnCoV clinical trial costs. With the declining number of continuing study participants and due to cost re-negotiation of existing contracts in the first six months of 2022, CureVac’s estimate of remaining clinical trial costs decreased, resulting in a reversal of €21.3 million of the provision recorded as of December 2021. Additionally, research and development costs were positively impacted by a net gain for a change in the estimate in the contract termination provision, resulting primarily in GSK taking over committed capacity at a CMO in the first quarter of 2022.
Other income was positively impacted by compensation from GSK amounting to €32.5 million for reimbursement of pre-payments and production set-up activities at a CMO.
Financial Result (Finance Income and Expenses)

Net financial result for the three- and six-month periods ended June 30, 2022, was positive with €2.7 million and €2.8 million, respectively, representing an increase of €7.1 million and €3.6 million from a loss of €4.4 million and €0.8 million for the same periods in 2021. The financial result for the six months ended June 30, 2022, was also driven by foreign exchange gains, like for the six months ended June 30, 2021. This gain was partially compensated by lower impact of negative interest on cash, held in liquid funds to be available for use for development and manufacturing activities.

Pre-Tax Loss

Pre-tax loss was €57.6 million and €72.8 million, respectively, for the three and six months ended June 30, 2022, compared to €152.2 million and €264.4 million in the same respective periods of 2021.

On August 18, 2022 Jemincare, a leading pharmaceutical company from China, reported that it and its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., have entered into an exclusive worldwide license agreement with Roche (SIX: RO, ROG;OTCQX: RHHBY) and Genentech, a member of the Roche Group, for the development and commercialization of its androgen receptor degrader, JMKX002992 (Press release, Shanghai Jemincare Pharmaceutical, AUG 18, 2022, View Source [SID1234618480]).

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Under the terms of the agreement, Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs. In return, Genentech will pay Jemincare a USD 60 million upfront payment. Jemincare is also entitled to receive up to USD 590 million in additional payments upon achievement of certain development, regulatory and sales-based milestone targets. Jemincare is also entitled to receive tiered royalties on net sales.

JMKX002992 is a novel oral degrader of the androgen receptor, a confirmed disease driver in prostate cancer. JMKX002992 has the potential to treat patients with prostate cancer who have developed resistance to current therapies.

"We are delighted to enter into collaboration with Roche, one of the world’s leading pharmaceutical companies providing transformative innovative solutions across major disease areas, and Genentech, a worldwide leading innovator in oncology. We trust this partnership could significantly enhance and accelerate the development and potential commercialization of JMKX002992 to benefit patients. This is our third innovative therapy partnered globally. We are proud of this achievement within only four years since the establishment of our R&D center. Jemincare will continue to realize our commitment to benefit patients with innovative solutions." said Mr. Hong Liang, President of Jemincare Pharmaceutical Group.

"Prostate cancer remains a leading cause of death in men worldwide," said James Sabry, Global Head of Roche Pharma Partnering. "Certain forms of prostate cancer can be particularly difficult to treat. Jemincare’s novel oral androgen receptor degrader will complement our efforts to develop new treatment options for patients with advanced prostate cancer."

On August 18, 2022 Targovax reported its first half and second quarter 2022 results (Presentation, Targovax, AUG 18, 2022, View Source [SID1234618481]).

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On August 18, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that it will present updated data from the expansion phase of its ongoing Phase 1 trial of BCA101, a bifunctional antibody designed to target the TGFβ trap to EGFR+ tumors, in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (Press release, Bicara Therapeutics, AUG 18, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-clinical-data-from-lead-precision-tumor-modulator-program-bca101-at-esmo-congress-2022 [SID1234618479]). The meeting is being held at the Paris Expo Porte de Versailles in Paris, France and virtually from September 9-13, 2022.

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Details of the oral presentation are as follows:

Session Category: Mini Oral session: Investigational immunotherapy
Presentation Title: A phase 1 trial of the bifunctional EGFR/TGFβ fusion protein BCA101 alone and in combination with pembrolizumab in patients with advanced solid tumors
Presenter: Glenn J. Hanna, MD
Date/Time: Saturday, September 10, 2022 at 2:55 p.m. GMT (8:55 a.m. EST)

About BCA101

BCA101 is a first-in-class EGFR / TGF-β-trap bifunctional antibody designed to enhance both innate and adaptive immune responses directly at the site of the tumor by binding to the well-validated EGFR antigen and disabling TGF-β, a signaling molecule that plays a key role in suppressing the immune response in the tumor microenvironment. Promising preclinical data suggest that BCA101 is superior to the anti-EGFR antibody cetuximab in preventing tumor recurrence, as well as in restoring immune activation. An ongoing Phase 1/1b clinical trial of BCA101, initiated in July 2020, has enrolled cohorts of patients in a dose-escalation study with BCA101 as a single agent, as well as in combination with pembrolizumab, a PD-1 inhibitor and a recommended dose for expansion has been declared. For more information, please visit study number NCT04429542 at www.clinicaltrials.gov.