1stOncology™: Cancer Intelligence Service – Page 10852 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Samsung Biologics Establishes Partnership with China Biotech GeneQuantum Healthcare to Collaborate on ADC Development

On November 1, 2020 Samsung Biologics (207940.KS) reported that it has entered into a strategic partnership with GeneQuantum Healthcare, a China biotech company, to jointly develop an antibody drug conjugate (ADC) for the treatment of non-small-cell lung carcinoma (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors (Press release, Samsung BioLogics, NOV 1, 2020, View Source [SID1234569613]). The agreement signals Samsung Biologics’ accelerated entry into the China market.

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!

GeneQuantum Healthcare recently received the US FDA’s Investigational New Drug (IND) Good to Proceed Letter in May this year for its first anti-HER2 ADC asset, which was manufactured via GeneQuantum’s patented intelligent ligase-dependent conjugation (iLDC) technology platform.

Samsung Biologics’ approach to entering the Chinese market is strategic. The Chinese biopharmaceutical market was worth 38.5 billion USD in 2019 and is expected to a grow at a rate of 14.4% annually. This new collaboration with a Chinese company follows Samsung Biologics’ recent development partnership with an innovative biotech, APRINOIA Therapeutics, further marking the company’s strategic entry and presence in the market. GeneQuantum had previously signed its CDO contract with a CDMO partner for its first asset, however has notably chosen Samsung Biologics for its second antibody candidate. As a result of Samsung Biologics’ recognized capabilities to achieve best-in-class client satisfaction, the company is currently having extensive discussions with a vast number of potential Chinese clients in the market.

Samsung Biologics has showcased a record of achievements in recent years. The company has dramatically reduced the time required for development stage, taking 6 months to DS manufacturing, and 7 months to DP manufacturing. Samsung Biologics has also recently announced its proprietary cell line technology, S-CHOice, in August this year, which shows improved titers up to two-fold from the industry average and maintains over 90% of cell viability.

Owing to these proven features, the company’s CDO business unit has acquired nearly 60 contracts within a 2-year period, gaining recognition in the global market. Through these extended partnerships, especially with leading Chinese biotech companies, Samsung Biologics aims to further demonstrate its high-quality CDO capabilities and technology in the Chinese market to provide greater accessibility to breakthrough treatments for patients.

"GeneQuantum is excited to collaborate with Samsung Biologics, a global leading partner with proven development capabilities in the market," said Dr. Gang Qin, CEO of GeneQuantum. "One of the decision-making aspects for this partnership was Samsung Biologics’ dedication and commitment to providing high-quality services. With this mutually beneficial partnership, we aim to further expand on this development scope to bring innovative treatments for patients."

"We are extremely proud that our CDO capabilities are continuously being recognized in the Chinese market, especially amid the current global climate," said Dr. Tae Han Kim, CEO of Samsung Biologics. "By joining forces with a leading biotech company with a distinguished reputation in the market, we hope to further expand on the partnership to provide effective and affordable treatments for patients with unmet medical needs."

LabCorp and BML of Japan Expand Development and Commercialization Agreement for Precision Medicine in Japan

On November 1, 2020 LabCorp (NYSE: LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, and BML, a leading Japanese provider of clinical laboratory testing services, reported an expanded agreement to provide development and delivery of companion diagnostics in Japan (Press release, LabCorp, NOV 1, 2020, View Source [SID1234569597]). This collaboration broadens the potential network of laboratories used by pharmaceutical and biopharmaceutical companies to support companion diagnostic development and commercialization. The collaboration is intended to increase access to healthcare providers in Japan, and further accelerate the adoption of companion diagnostics that are used in drug development and clinical trials.

The collaboration will initially focus on the commercial availability of assays that have been developed and validated both analytically and clinically at LabCorp’s drug development business, Covance. The companies expect the first application of the new agreement will address unmet needs in oncology.
LabCorp is an established leader in the development, validation, and commercialization of companion diagnostics, which are key enablers of precision medicine. The company has been involved in the development of drugs and their associated companion diagnostics for more than 20 years, and has more U.S. Food & Drug Administration-approved companion diagnostics than any other company. BML, a leader in clinical diagnostic testing in Japan, has more than 53 laboratories and 116 customer service locations, and processes more than 1.5 billion diagnostic tests per year.

"Companion diagnostics are a key component of our precision medicine strategy, enabling healthcare providers to identify the patients who are most likely to benefit from targeted and novel therapies," said Steve Anderson, Ph.D., chief scientific officer of Covance and senior vice president at LabCorp. "This partnership with BML further expands our reach to Japan and benefits our biopharmaceutical clients who need global solutions for precision medicine, with the ultimate goal of improving health and improving lives for patients around the world."

"Our collaboration with LabCorp allows BML to provide our clients with robust companion diagnostics services for the patients who need them in Japan. It builds on our trusted relationship with Covance, which has provided clinical trials testing services to our pharmaceutical partners for over 10 years," said Dr. Kensuke Kondo, president of BML. "Our combined ability to bridge the time gaps between the development phase and drug approval through to national reimbursement, along with the benefit of having a centralized laboratory testing facility, gives our respective customers the advantage of early adoption of their drug. BML’s experience with local testing requirements, quality standards and logistical expectations will ensure instant access to high-quality testing."

BML has collaborated with LabCorp’s drug development business Covance for a decade across over a thousand projects. The collaboration created the Covance-BML Trial Laboratory to manage the growing demand for in-country laboratory testing services that support drug development and clinical trials for pharmaceutical companies. Terms of the new agreement have not been disclosed.

Stealth BioTherapeutics to Report Third Quarter 2020 Financial Results on Thursday, November 5, 2020

On October 30, 2020 Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, reported that it will report third quarter 2020 financial results on Thursday, November 5, 2020, before the market opens (Press release, Stealth Biologics, OCT 30, 2020, View Source [SID1234569615]).

Management will host a conference call at 8:30 am ET that day to discuss the financial results and provide a general business update. The call can be accessed by dialing (877)-407-0989 (domestic) or (201)-389-0921 (international) and referencing conference ID 13710878. A live audio webcast of the event can be accessed by visiting the Investors & News section of Stealth’s Investor website, https://investor.stealthbt.com/. A replay of the webcast will be archived on Stealth’s website for 30 days following the event.

Training the innate immune system to fight cancer

On October 30, 2020 Trained Therapeutix Discovery reported that Existing immuno-oncology therapies primarily leverage one branch of our immune system—adaptive immunity—by recruiting T cells to fight cancer (Press release, Trained Therapeutix Discovery, OCT 30, 2020, View Source [SID1234569612]). A research team led by scientists at the Icahn School of Medicine at Mount Sinai has now found a possible way to tap into the other branch, the innate immune system.

In a study published in Cell, the team described a "nanobiologic," which they designed with tiny materials engineered from a natural molecule and then paired with a therapeutic. The nanobiologic targets the bone marrow, a factory of immune cells. In mice, adding the drug to medicines that block PD-1 and CTLA-4 significantly shrank tumors that were refractory to those checkpoint inhibitors.

A startup called Trained Therapeutix Discovery, or TTxD, is testing the nanobiologic treatment to treat cancer and serious infections, with the goal of moving them into human studies in two to four years.

While the adaptive immune system can target specific antigens once it memorizes them on first encounter, the innate immune system, which acts as the body’s first line of defense, was long believed to lack such memory. But a recent discovery showed that the innate immune system can be "trained." This so-called trained immunity works by manipulating progenitor cells in the bone marrow, which can later develop into mature immune cells.

The Mount Sinai-led team set out to find out whether bone marrow-aimed materials bearing trained immunity-inducing components can elicit a durable anti-cancer innate immune response. The researchers screened a library of nanobiologics and came up with a lead candidate, dubbed MTP10-HDL, which they determined possessed the best combination of stability and immunity-promoting capacity at a relatively low dose.

In mouse models of melanoma, the drug inhibited tumor growth better than a placebo did. At the most effective dosing tested, the mean tumor volume among treated mice was about half of that in the control group.

RELATED: Q32 Bio banks $60M as it ramps up ‘immune rebalancing’ programs

The scientists then set out to determine whether MTP10-HDL can boost the effect of PD-1 and CTLA-4 inhibitors, which work by removing tumors’ suppressive signals to cancer-killing T cells in the adaptive immune system.

Neither PD-1/CTLA-4 monotherapy nor the combination of both had any anti-tumor effects on a melanoma type that’s known to be resistant to the checkpoint inhibitors. But pairing MTP10-HDL with either drug led to a significantly lower tumor growth rate, and combining all three together "strongly suppressed tumor growth rate," the team reported.

Further analysis revealed that MTP10-HDL reshaped the immune cell populations in the bone marrow and the spleen. The trained cells also changed the tumor microenvironment, priming the immune system in a way that allowed checkpoint inhibitors to work better.

Many anti-cancer researches have shifted their focus to the innate immune system. For example, companies such as Artiva Biotherapeutics are working on natural kill cell therapies. While T-cell therapies need priming to attack specific antigens on tumor cells, NK cells, as part of the innate immune system, don’t need such preparation.

Researchers at Mount Sinai are working with their collaborators to develop nanobiologics for human testing. "Our study is a significant advancement for both trained immunity and cancer treatment, with real potential to move quickly into use in patients," said lead author Willem Mulder, Ph.D., a professor at the Icahn School of Medicine there, in a statement.

Helix BioPharma Corp. announces fiscal 2020 year-end results

On October 30, 2020 Helix BioPharma Corp. (TSX: "HBP"), ("Helix" or the "Company"), a clinical-stage biopharmaceutical company developing unique therapies in the field of immuno-oncology based on its proprietary technological platform DOS47, reported its financial results for the 2020 fiscal year ended July 31, 2020 (Press release, Helix BioPharma, OCT 30, 2020, View Source [SID1234569584]).

OVERVIEW

The Company reported a consolidated net loss and total comprehensive loss of $9,174,000 or $0.07 loss per common share for fiscal 2020 (2019-$7,526,000 or $0.07 loss per common share. This includes a net loss from discontinued operations in fiscal 2020 of $613,000 (2019-$719,000) related to the Company’s planned divestiture of Helix Immuno-Oncology S.A. ("HIO").

The Company began the year with a working capital deficiency of $3,534,000 until August 21, 2019 when the Company closed a series of private placements in fiscal 2020 for total gross proceeds of approximately $16,000,000. A portion of these private placement financings included the disposition of a 49.0% stake in HIO. On July 8, 2020 HIO completed a direct Series B private placement which resulted in a dilution of the Company’s holding in HIO down to 42.51% as at July 31, 2020 and subsequently on September 3, 2020, HIO closed a direct Series C private placement which further diluted the Company’s holding in HIO down to 29.89%.

On June 26, 2020, the Company announced that it had entered into agreements with HIO, pursuant to which the Company cancelled an aggregate amount of approximately $2,700,000 of intercompany debt owed to the Company by HIO. As a result, all transferred assets related to Biphasix and V-DOS47 have been automatically reassigned and transferred from HIO back to the Company without any formality. In addition, the Company also ceased financing HIO with immediate effect.

Also, on June 26, 2020, the Company announced the receipt of a non-binding offer for PLN6,700,000 from CAIAC Fund Management AG ("CAIAC") to purchase the Company’s remaining shares in HIO. The transaction was initially expected to close no later than August 31, 2020 but has since been deferred to the end of October 30, 2020, subject to the satisfaction of certain conditions. As of the filing date of this press release the Company has not yet closed the transaction with CAIAC though both parties continue to work through the process to finalize and close the transaction.

Effective October 21, 2020, the financial advisory services agreement dated July 2, 2018 between the Company and ACM Consulting Management AG and the investor relations and advisory services agreement dated July 2, 2018 between the Company and ACM Consulting Management Est. were terminated by mutual agreement of the parties.

As previously disclosed, the Company has also been in discussions, during the year, with various capital market firms, both in the U.S. and Canada, with the goal of raising additional sufficient capital to qualify for a NASDAQ listing and further advance the Company’s clinical development programs.

At present, the only clinical program enrolling patients is the Company’s U.S. Phase Ib/II LDOS006 study (L-DOS47 in combination with doxorubicin) in the treatment of patients with metastatic pancreatic cancer who have progresses 1 on at least two prior treatment regimens. COVID-19 had impacted patient enrollment and as a result, the Company is in the process of adding two additional clinical trial sites in other U.S. jurisdictions.

The Company’s clinical studies in non-small cell lung cancer patients, a U.S. Phase I LDOS001 study (L-DOS47 in combination with pemetrexed and carboplatin) and a European Phase II LDOS003 study (L-DOS47 in combination with vinorelbine and cisplatin), have completed patient enrolment.

For LDOS001, the Company is working through the process of completing the anti-drug antibody assays, which from a timing perspective, have been hampered by COVID-19. Once the analysis is complete, the clinical study database lock will be initiated with the goal of finalizing the clinical study report by April 2021.

As for LDOS003, the Company previous disclosed that the first stage of the study related to dose escalation would be concluded and that any progression to the second stage would only proceed if a third-party was willing to partner with the Company on the study. The Company is in a contractual dispute with the CRO that is managing the clinical study. Until such time the dispute is resolved, the Company expects a delay in completing final monitoring, close out activities and finalizing the clinical study report. The Company is currently in discussion with the CRO in order to resolve the matter.

Research and development

Research and development expenses for fiscal 2020 totalled $5,868,000 (2019-$4,948,000). L-DOS47 research and development expenses for fiscal 2020 totalled $4,715,000 (2019-$3,530,000).

L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., the LDOS003 Phase II clinical study in Poland and the Ukraine and the Company’s new LDOS006 Phase Ib/II pancreatic clinical study in the U.S.

For fiscal 2020 when compared to fiscal 2019 the increase in spending mainly reflects drug substance manufacturing spend of $590,000, costs associated with the new LDOS006 pancreatic trial in the U.S. of $1,144,000 and costs associated with finalizing and reporting on LDOS001 of $168,000. Offsetting the increased spend was a reduction in spending of $354,000 related to the Company’s LDOS003 and a further reduction of $278,000 related to the Moffitt Cancer Centre research collaboration.

CAR-T research and development expenses for fiscal 2020 totalled $64,000 (2019-$333,000). The Company’s collaboration with ProMab Biotechnologies Inc. has been impacted by the Coronavirus pandemic and as such certain planned activities have been deferred.

Trademark and patent related expenses for fiscal 2020 totalled $516,000 (2019-$435,000). The Company continues to ensure it adequately protects its intellectual property.

Stock based compensation expense for fiscal 2020 totalled $117,000 (2019-$197,000). The amount represents the expense associated with the vesting of stock options that were granted, over their vesting period.

Operating, general and administration

Operating, general and administration expenses for fiscal 2020 totalled $2,748,000 (2019-$1,827,000). The increase is mainly the result of higher expenses associated with various third-party advisor services such as investor and media relations, legal, business development activities and investment banking services. During the year, the Company has been in discussions with various capital market firms, both in the U.S. and Canada, with the goal of raising additional capital to qualify the Company for a listing on a U.S. stock exchange such as NASDAQ. Stock based compensation expense for fiscal 2020 totalled $353,000 (2019-$164,000). The amount represents the expense associated with the vesting of stock options that were granted, over their vesting period.

LIQUIDITY AND CAPITAL RESOURCES

The Company reported a consolidated net loss and total comprehensive loss of $9,174,000 for the fiscal year ended July 31, 2020 (July 31, 2019-$7,526,000). As at July 31, 2020 the Company had working capital of $2,735,000, shareholders’ equity of $2,981,000, a deficit of $180,516,000. As at July 31, 2019 the Company had a working capital deficiency of $3,534,000, shareholders’ deficiency of $3,281,000 and a deficit of $171,531,000. The Company experienced a working capital deficiency throughout fiscal 2018 and 2019 until August 21, 2019 when the Company closed the first of a series of private placements for total gross proceeds of approximately $16,000,000. A portion of the private placement financings included the total disposition of a 49.0% stake in HIO. On July 8, 2020 HIO completed a direct Series B private placement which resulted in a dilution of the Company’s holding in HIO down to 42.51% as at July 31, 2020 and subsequently on September 3, 2020, HIO closed a direct Series C private placement which further diluted the Company’s holding in HIO down to 29.89%.

On June 26, 2020, the Company announced the receipt of a non-binding offer from CAIAC, as designated trustee of an alternative investment fund to be established, to purchase the Company’s remaining shares in HIO. The transaction was initially expected to close no later than August 31, 2020 but has since been deferred to the end of October 30, 2020, subject to the satisfaction of certain conditions, including, but not limited to, the negotiation of binding documentation, the receipt of a minimum of PLN7,300,000 by CAIAC pursuant to a financing, and the receipt of all required regulatory approvals. As of the filing of this press release, the Company had not yet closed the transaction with CAIAC though both parties continue to work through the process to finalize and close the transaction. There can be no assurance that the closing of the divestment will occur on the terms set out herein or at all.

In addition, the Company has been in discussions, during the year, with various capital market firms, both in the U.S. and Canada, with the goal of raising additional sufficient capital ($15,000,000 to $20,000,000) in order to qualify for a NASDAQ listing and further advance the Company’s clinical development programs. T

he Company’s group cash reserves of $4,235,000 as at July 31, 2020 are insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see planned research and development initiatives through to completion. Though the funds raised have assisted the Company in dealing with its working capital deficiency, additional funds are required to advance the Company’s clinical and preclinical programs and deal with working capital requirements To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs.

The Company’s consolidated financial statements, management’s discussion and analysis and annual information form will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website at www.helixbiopharma.com.