On November 13, 2018 Helix BioPharma Corp. (TSX, FSE: "HBP"), an immuno-oncology company developing drug candidates for the prevention and treatment of cancer, reported a strategic update of its LDOS47 clinical program (Press release, Helix BioPharma, NOV 13, 2018, View Source [SID1234531459]).

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Helix’s L-DOS47 strategic development plan has two parts. The first part is to ensure L-DOS47 will be used in a well-established treatment setting, while being ready to be applied in novel therapies. For this reason, L-DOS47 clinical programs will focus primarily in a combination setting. In this plan L-DOS47 will be studied with well-established chemotherapeutics and in combination with novel immunotherapy. The Company is well advanced in carrying out the study of L-DOS47 with chemotherapy in lung cancer. The planning for combining with immunotherapies in this indication is also in progress.

In the second part of the strategic development plan, the Company will focus on expanding the utility of L-DOS47 to indications other than lung cancer. In choosing a new indication for L-DOS47, the company has considered available preclinical and clinical L-DOS47 data, consulted with key opinion leaders and considered the best strategic application of limited financial resources. To this end, the Company has recently announced the start of a new pancreatic cancer program.

As of today, the Company has completed a monotherapy study of L-DOS47 in lung cancer, with two combination studies in the same indication that are actively recruiting patients. The Company is also working diligently to prepare for regulatory filing of a new pancreatic cancer study with the United Sates Food and Drug Administration ("FDA").

The following is a status update of active studies currently taking place.

LDOS001

LDOS001 is a Phase I dose escalation study of L-DOS47 with pemetrexed and carboplatin for the first line treatment in recurrent or metastatic non-squamous non-small cell lung cancer. A total of seven (7) cohorts comprising of L-DOS47 doses at 0.59, 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 ug/kg were approved. To date, five (5) cohorts have been completed and a total of 12 patients were dosed. No dose limiting toxicity was observed. In cohort 1, one patient had a partial response (36% tumor regression). In cohort 2, three other patients had partial response (40%, 44% and 91% tumor regression) and one additional patient experienced stable disease for 13.3 months. In cohort 4, one patient had a partial response (69% tumor regression). The company expects to enroll six more patients to complete recruitment for study dosing cohorts if no dose limiting toxicity is observed.

LDOS003

LDOS003 is a phase II, open-Label, randomized study of immunoconjugate L-DOS47 in combination with vinorelbine and cisplatin versus vinorelbine and cisplatin alone in patients with lung adenocarcinoma. Regulatory and Ethics approvals to dose patients were first received from Ukraine in March and from Poland in April. While the company had planned to enroll patient shortly thereafter, the program was delayed due to financial constraints. The company has recently reprioritized its resources and expects to enroll patients in this study immediately.

LDOS006

The Company recently announced the launch of a U.S. Phase I/II study of L-DOS47 in combination with doxorubicin for the treatment of metastatic pancreatic cancer. The study will be led by Dr. Daniel Von Hoff and his team. The Company is currently completing the study protocol and related documents necessary for an investigational new drug ("IND") application to the FDA.

On November 13, 2018 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its Dolaflexin and other proprietary platforms, reported financial results and a business update for the third quarter ended September 30, 2018 (Press release, Mersana Therapeutics, NOV 13, 2018, View Source [SID1234531431]).

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"We continue to make significant strides towards building a leadership position in ADCs. In the third quarter, we progressed our Phase 1 dose escalation trial of XMT-1536 for solid tumors expressing NaPi2b and resumed enrollment on our new protocol for the Phase 1 dose escalation trial of XMT-1522 for HER2-expressing cancers," said Anna Protopapas, President and CEO of Mersana Therapeutics. "In addition to advancing our two clinical programs, we have developed innovative new platforms that are enabling us to greatly expand the reach of our therapeutics and the productivity of our discovery engine."

Recent Highlights and Updates

Clinical Programs

· Continued evaluation of once every four week schedule in the Phase 1 dose escalation study of XMT-1536 for the treatment of NaPi2b-expressing. XMT-1536 is a first-in-class Dolaflexin ADC targeting NaPi2b, which is broadly expressed in epithelial ovarian cancer and non-squamous non-small cell lung cancer. XMT-1536 has previously been studied on a once every three week schedule and this quarter we initiated evaluation of a once every four week dosing regimen. This dosing regimen has thus far been well tolerated and, based on the results of this cohort, the company has advanced the study to the next higher dosing level. A phase 2 recommended dose on XMT-1536 is expected in the first half of 2019. Additional data may be shared before selection of a phase 2 dose as it matures and informs our expansion and phase 2 plans.

· Resumed enrollment of Phase 1 dose escalation study of XMT-1522 for the treatment of HER2-expressing cancers. As reported on September 17, 2018, the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the Phase 1 study of XMT-1522 and the trial has resumed enrollment. The company expects to select a phase 2 dose in mid2019.

· Presented preclinical data on XMT-1536, a NaPi2b-targeting ADC, at the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer (IASLC WCLC 2018). In a poster titled "MERS67 is a Novel anti-NaPi2b Antibody and Demonstrates Differential Expression Patterns in Lung Cancer Histologic Subtypes," Mersana demonstrated that proprietary immunohistochemistry reagent MERS67 has the ability to quantify NaPi2b expression in lung adenocarcinoma (ACA). These

data indicate potential uses of MERS67 in characterizing and selecting patients for the XMT1536 clinical trial.

Discovery & Platform Progress

· Substantially advanced research on new ADC platforms. The Company intends to present data on two new platforms at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium from November 13-16, 2018, in Dublin, Ireland.

· The first abstract, titled "Discovery of the novel, homogeneous payload platform Dolasynthen for Antibody-Drug Conjugates" characterizes Dolasynthen, a next-generation platform allowing for drug homogeneity and precise control of Drug-to- Antibody ratio.

· The second abstract, titled "Indole-Biaryl Pyrrolobenzodiazepines (I-BiPs): A potent and well-tolerated class of DNA mono-alkylating payload for antibody-drug conjugates (ADCs)" characterizes Alkymer, a DNA damaging platform demonstrating superiority in both efficacy and tolerability to existing DNA damaging platforms.

· Performed additional preclinical studies demonstrating the potential of XMT-1522 in NSCLC. The Company intends to present preclinical data on XMT-1522 at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium. The abstract, titled "Target Expression/Efficacy Relationship of XMT-1522, a HER2-targeting Antibody Drug Conjugate (ADC), in an Unselected Series of Non-small Cell Lung Cancer (NSCLC) Primary Human Carcinoma Xenografts" demonstrates deep and durable responses with XMT-1522 treatment across a broad range of patient derived NSCLC xenografts.

Upcoming Events

· The Company will give a corporate presentation at the Credit Suisse Healthcare Conference on November 14, 2018, in Scottsdale, AZ.

· The Company is participating in the 9th Annual World ADC meeting from November 12-15, 2018, in San Diego, CA. Tim Lowinger, the company’s Chief Scientific Officer, will be chairing the meeting.

· The Company will present three data abstracts at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium from November 13-16, 2018, in Dublin, Ireland.

Financial Results

· Cash, cash equivalents and marketable securities as of September 30, 2018, were $86.1 million, compared to $125.2 million as of December 31, 2017. The company expects that its cash, cash equivalents and marketable securities will enable it to fund its operating plan into 2020.

· Collaboration revenue for the third quarter 2018 was approximately $2.2 million, compared to $6.3 million for the same period in 2017, driven primarily by a reduction of clinical costs in the quarter required to support Takeda collaboration activities and a change in timelines required to achieve a phase 2 dose.

·Research and development expenses for the third quarter 2018 were approximately $15.2 million, compared to $11.4 million for the same period in 2017, driven primarily by an increase in clinical and in regulatory expenses due to the progress of our lead programs and manufacturing costs to support future clinical development.

· General and administrative expenses for the third quarter 2018 were approximately $4.4 million, compared to $2.9 million for the same period in 2017, driven primarily by increased employee-related expenses due to increase in personnel costs and increased professional fees.

· Net loss for the third quarter 2018 was $17.1 million, or $0.75 per share, compared to a net loss of $7.7 million, or $0.35 per share, for the same period in 2017. Weighted average common shares outstanding for the quarter ended September 30, 2018 were 23,152,019 and 22,242,129 for the quarter ended September 30, 2017.

Conference Call

Mersana Therapeutics will host a conference call and webcast at 8:00 am ET on November 13 to report financial results for the third quarter 2018 and provide certain business updates. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 8060459. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com

About Dolaflexin

The Dolaflexin platform is designed to increase the efficacy, safety, and tolerability of ADCs by overcomin key limitations of existing technologies. Dolaflexin consists of Fleximer, a biodegradable, highly biocompatible, water soluble polymer, to which are attached multiple molecules of Mersana’s proprietary auristatin drug payload using a linker specifically optimized for use with Mersana’s polymer. The high water-solubility of the Fleximer polymer compensates for the low solubility of the payload, surrounding the payload and protecting it from aggregation and maintaining stability in circulation. Multiple molecules of this Dolaflexin polymer-drug conjugate can then be attached to an antibody of choice, which significantly increases the payload capacity of the resulting ADC. This approach differs from most other ADC technologies that conjugate the payload directly to the antibody. Using its Dolaflexin platform, Mersana has been able to generate ADCs with a very high Drug-to-Antibody Ratio (DAR), between 10 to 15, while maintaining desirable pharmacokinetics and drug-like properties. This represents a three to four-fold increase in DAR relative to traditional ADC approaches. The Dolaflexin platform also incorporates the DolaLock technology, an engineered controlled bystander effect. Auristatin F hydroxypropyl amide (AF-HPA), the initial auristatin drug release product, is freely cell permeable and has bystander-killing capabilities. Intra-tumor metabolism then facilitates the conversion of AF-HPA to auristatin F (AF), which is non-cell permeable, highly potent, and "locked" into the tumor. This enhancement improves both the efficacy and tolerability of Mersana’s ADC candidates.

About XMT-1522

XMT-1522 is a Dolaflexin ADC targeting HER2-expressing tumors. XMT-1522 contains a proprietary HER2 antibody which is conjugated with Mersana’s Dolaflexin platform — a Fleximer polymer linked with a proprietary auristatin payload. XMT-1522 provides a drug load of approximately 12 molecules per antibody, specifically designed to improve potency while simultaneously increasing tolerability. XMT-1522 has the potential to extend HER2-targeted therapy beyond the current "HER2-positive" populations into patients with lower levels of HER2 expression. XMT-1522 is in Phase 1 clinical trials in patients with advanced tumors expressing HER2, including breast cancer, non-small-cell-lung cancer (NSCLC) and gastric cancer patients. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

About XMT-1536

XMT-1536 is a Dolaflexin ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and is comprised of an average of 10-15 DolaLock payload molecules conjugated to XMT-1535, a proprietary humanized anti-NaPi2b antibody. NaPi2b is an antigen highly expressed in the majority of non-squamous NSCLC and epithelial ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer, non-small cell lung cancer (NSCLC) and other cancers. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov.

On November 13, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the third quarter 2018 (Press release, Cyclacel, NOV 13, 2018, View Source [SID1234531427]). The Company’s net loss applicable to common shareholders for the three months ended September 30, 2018 was $2.1 million. As of September 30, 2018, cash and cash equivalents totaled $19.0 million.

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"We continue to execute on our strategy to rapidly develop CYC065 and CYC140 in hematological malignancies and CYC065 in advanced solid tumors," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The Phase 1 study evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and the CYC140 first-in-human study are open for enrollment. Two further protocols evaluating combinations of CYC065 and sapacitabine are in development. Our alliance with MD Anderson allows us to parallel track the development of our drugs in a cash-sparing manner while utilizing MD Anderson’s expertise to recruit patients across four studies. We estimate that our cash resources will be sufficient to fund operations until the second quarter of 2020. We are also pleased to report that the IST evaluating sapacitabine and olaparib in BRCA positive patients with breast cancer has started to enroll."

Key Company Highlights

·Announced a three-year strategic alliance agreement with The University of Texas MD Anderson Cancer Center enabling clinical evaluation of three Cyclacel medicines in patients with hematological malignancies. MD Anderson will conduct four clinical studies, with a total projected enrollment ofpatients, investigating CYC065, CYC140 and sapacitabine either as single agents or in combination with approved drugs.

·Opened for enrollment the Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at AACR (Free AACR Whitepaper) 2018 showed enhanced activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination also demonstrated activity in two CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.

·First patient dosed in the Phase 1b/2 investigator-sponsored trial (IST) of sapacitabine with olaparib, an approved PARP inhibitor, in BRCA positive patients with breast cancer. Preclinical data support the hypothesis that dual targeting of the DNA damage response pathway by combining olaparib with sapacitabine may enhance the efficacy of standard of care treatment for BRCA positive patients with breast cancer.

·Activated the CYC140 first-in-human study in advanced leukemias. CYC140 is a novel, small molecule, selective polo-like-kinase 1 (PLK1) inhibitor. CYC140 is differentiated from other PLK1 inhibitors, demonstrating potent and selective target inhibition and high activity in xenograft models of human cancers when dosed orally at non-toxic doses.

þ 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466

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www.cyclacel.com – [email protected]

·Progressed patient enrollment in part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced solid tumors including those with Mcl-1, MYC or cyclin E amplified cancers relevant to CYC065’s mechanism of action. Part 2 is evaluating increased dosing frequency of two days per week for two weeks of a three-week cycle.

·Completed meetings with three European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The regulators provided consistent guidance on next steps and Cyclacel is evaluating a potential request for a meeting with the Scientific Advice Working Party of the European Medicines Agency.

·Appointed Robert J. Spiegel, M.D. to the Board of Directors. Dr. Spiegel brings over 30 years of R&D and operational experience in the biopharmaceutical industry as well as advisory experience to venture capital and private equity funds.

·Entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC as sales agent, pursuant to which the agent may sell shares of common stock having an aggregate offering price of up to $5.0 million by any method that is deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act of 1933 as amended.

Financial Highlights

As of September 30, 2018, cash and cash equivalents totaled $19.0 million compared to $23.9 million as of December 31, 2017. The decrease of $4.9 million in the nine-months was primarily due to net cash used in operating activities, including $1.2 million of R&D tax credit received from the United Kingdom government.

Research and development expenses were $1.2 million for the three months ended September 30, 2018 compared to $1.0 million for the same period in 2017.

General and administrative expenses were $1.3 million for the three months ended September 30, 2018 compared to $1.2 million for the same period in 2017.

Other income, net for the three months ended September 30, 2018 was $0.1 million compared to $36,000 for the same period of the previous year.

The United Kingdom R&D and tax credits were $0.3 million for the three months ended September 30, 2018 compared to $0.2 million for the same period in 2017.

Net loss for the three months ended September 30, 2018 was $2.1 million compared to $1.9 million for the same period in 2017. With the cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $19.0 million as of September 30, 2018, will be sufficient to finance operations until the second quarter of 2020.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 3775807

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On November 13, 2018 Sutro Biopharma, Inc. (NASDAQ: STRO), reported that the U.S. Food and Drug Administration (FDA) has concluded their 30-day review of the Investigational New Drug (IND) application for STRO-002 to be evaluated in a Phase1 clinical study as a potential treatment for ovarian and endometrial cancer (Press release, Sutro Biopharma, NOV 13, 2018, View Source [SID1234531416]). The antibody-drug conjugate STRO-002 targets folate receptor-α, a cell-surface protein expressed in 80% of ovarian and endometrial cancers.

"The ability to begin our Phase I clinical study marks an important milestone that expands Sutro’s clinical development pipeline and further validates our technology for the design of unique and potent antibody-drug conjugates," said Bill Newell, Sutro’s Chief Executive Officer. "The Phase 1 clinical trial of STRO-002 is expected to begin in early 2019 with the goal to investigate the safety, tolerability and preliminary anti-tumor activity of STRO-002 in patients with gynecologic malignancies."

Patients with ovarian cancer will be enrolled during the dose escalation-phase of the study, and two separate cohorts for ovarian and endometrial cancer will be evaluated during dose expansion.

"Ovarian and endometrial cancer patients need targeted treatment options with better tolerability and efficacy," commented Dr. Wendel Naumann, MD Gynecologic Oncologist Professor, Dept. Ob/Gyn Levine Cancer Institute, Carolinas Medical Center.

In preclinical studies, STRO-002 effectively delivered its cytotoxin to targeted cancer cells without significant accumulation of a toxic metabolite in the blood. Testing of clinically relevant doses in non-human primates showed no evidence of ocular toxicity, a vexing problem associated with conventional ADCs containing standard tubulin-inhibiting agents.

"This is an important development for ADC-based cancer therapeutics and could provide new means to achieving greater anti-tumor activity in the clinic before the onset of dose-limiting side effects," added Dr. Arturo Molina, Sutro’s Chief Medical Officer.

Unlike first-generation ADCs, STRO-002 is a homogeneous, site-specific antibody-drug conjugate that incorporates a novel, proprietary linker-warhead, thereby enabling effective and precise payload delivery to targeted cancer cells. Preclinical studies demonstrated STRO-002’s potent in vitro cytotoxicity in ovarian and endometrial cancer cell lines, and tumor growth inhibition in multiple in vivo ovarian and endometrial cancer models. Safety studies conducted in non-human primates have shown tolerability at clinically relevant doses with no observed ocular toxicity.

About STRO-002

STRO-002 was developed with Sutro’s proprietary cell-free protein synthesis and site-specific conjugation platform, XpressCF+TM, which enables precise design, rapid empirical optimization, and manufacture of site-specific ADCs. Sutro’s technology results in highly optimized ADCs comprising a single molecular species, in contrast to first-generation commercial ADCs that comprise a mixture of imprecisely conjugated antibodies. STRO-002 has been engineered to use Sutro’s novel, proprietary SC239 linker-warhead, designed for increased stability and potency, which results ineffective targeting of cancer cells and precise delivery of the payload.

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On November 13, 2018 Kleo Pharmaceuticals Inc., an immuno-oncology company pioneering a new class of bi-specific, small molecule compounds designed to emulate or enhance biologics against cancer, reported the closing of an oversubscribed $21 million Series B financing to advance its first clinical candidates through IND-enabling studies and into the clinic in 2020 (Press release, Kleo Pharmaceuticals, NOV 13, 2018, View Source [SID1234531411]). The financing was led by the company’s development partner, PeptiDream, Inc., (TOKYO:4587), with participation from current strategic investor Biohaven Pharmaceuticals Inc. (NYSE:BHVN).

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Kleo’s lead candidates are based on the Company’s modular Antibody Recruiting Molecules (ARMs) technology, which enables Kleo’s compounds to bind at one end to specific targets on cancer cells and to the body’s endogenous antibodies. This unique approach redirects the activity of any ARM-bound antibody against the cancer cells without inhibiting the antibody’s native function. In parallel, Kleo is continuing to advance its two additional immuno-oncology therapy platforms, including its Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs).

Douglas Manion, CEO of Kleo Pharmaceuticals, said, "Successful completion of this financing represents an important step in the translation of our groundbreaking approach into therapies that may improve patients’ lives. Having improved the modularity of our platforms and expanded the applicability of our ARMs to recruit antibodies to target cancer cells, we are now well funded to advance our first next-generation candidates into human clinical studies. We are excited to welcome our development partner PeptiDream to our community of investors, and we’re humbled by the continued support of our founding investor Biohaven."

Patrick Reid, CEO of PeptiDream, stated, "We have worked with Kleo since July 2017 and we are impressed by the scientific progress they have made in validating their technology platforms. We are enthusiastic about the robust pipeline they are building from all three of their unique immunotherapy platforms and we are very happy to be a part of it, both as a strategic partner and now as an investor. We believe Kleo’s clinical candidates represent a paradigm shift in immuno-oncology development that elegantly delivers the therapeutic power of highly complex bi-specific antibodies, but in a more simple, less costly, and potentially more beneficial manner. When combined with PeptiDream’s robust discovery platform, we expect Kleo to generate many novel drug franchises that can bring incredible value for patients suffering from cancer."